Typhoid Vaccine

Class: Vaccines
ATC Class: J07AP01
VA Class: IM100
Brands: Typhim Vi, Vivotif

Introduction

Live, attenuated vaccine (Vivotif)101 102 103 b and inactivated vaccine (Typhim Vi).101 102 123 b Typhoid vaccine live oral (Vivotif) contains the Ty21a strain of Salmonella typhi.101 102 103 Parenteral typhoid Vi polysaccharide vaccine (Typhim Vi) contains purified cell surface polysaccharide antigens extracted from S. typhi of the Ty2 strain.101 102 123 Typhoid vaccines are used to stimulate active immunity to typhoid fever.101 102 103 123 Different typhoid vaccines (e.g., whole-cell vaccines) may be available in other countries.101 102 114 126 134 135

Uses for Typhoid Vaccine

Prevention of Typhoid Fever

Prevention of typhoid fever in individuals at risk of intimate exposure to a known typhoid carrier (e.g., continued household contact), in those traveling to areas where typhoid fever is endemic because of poor food or water sanitation, and in laboratory workers with frequent contact with Salmonella typhi bacilli.102 103 123 b

Typhoid fever is an acute, life-threatening febrile illness caused by S. typhi bacteria transmitted via food and/or water contaminated with feces, urine, vomitus, or respiratory secretions from typhoid fever carriers.a Typhoid fever is uncommon in the US, but is endemic in many less well-developed areas of the world that have poor sanitation and primitive water systems.101 137 WHO estimates that about 22 million cases of typhoid fever occur with about 200,000 related deaths annually.101 c Approximately 2–4% of individuals with acute typhoid develop a chronic carrier state.103 123 CDC receives reports of about 400 cases of typhoid fever each year in the US, mostly among recent travelers to other countries.101 102 b

USPHS Advisory Committee on Immunization Practices (ACIP) and AAP do not currently recommend routine immunization against typhoid fever for individuals residing in the US.102 103 123 Although immunization against typhoid fever was recommended in the past for individuals in the US attending summer camps or residing in areas where natural disasters (e.g., flooding) had occurred or for control of common-source outbreaks of typhoid fever, this no longer is considered necessary because of the low probability of exposure in the US.102 103 123 Routine immunization against typhoid fever is warranted for sewage workers only in areas with endemic typhoid.102

ACIP and AAP recommend vaccination using oral live typhoid vaccine (Vivotif) or parenteral inactivated typhoid vaccine (Typhim Vi) for adults, adolescents, and children at high risk of exposure to S. typhi bacilli.101 102 b Efficacy of these vaccines appears to be comparable when administered as recommended;102 105 107 109 111 114 115 116 117 118 119 120 121 123 124 125 126 however, the vaccines have different contraindications (see Contraindications under Cautions) and different minimum age limits for use in children (see Pediatric Use under Cautions).102 103 123

Other factors to consider when selecting a typhoid vaccine include immunization schedule, response time, patient compliance, storage facilities, and immune status of the vaccinee.102 123 126 Because Vivotif is self-administered over a 1-week period and compliance errors (i.e., dosing errors, improper storage) have been reported, Typhim Vi may be preferred in patients in whom compliance is likely to be a problem.131

Individuals with acute typhoid infection and those who are chronic typhoid carriers should not receive typhoid vaccine.103 123

Vivotif and Typhim Vi will not prevent typhoid fever caused by Salmonella species other than S. typhi (e.g., S. paratyphi type A or B) and will not prevent infections caused by other bacteria known to cause enteric disease.103 123

Preexposure Vaccination Against Typhoid Fever in High-risk Groups

Preexposure vaccination in individuals who are or will be at high risk of exposure to S. typhi.101 102 b

Household contacts of known typhoid carriers should be vaccinated with typhoid vaccine because of increased risk of exposure to typhoid fever.102 103 123 b

Travelers to areas where there is a recognized risk of exposure to typhoid fever (e.g., many countries in Africa, Asia, Central and South America) should be vaccinated against typhoid fever.101 103 123 137 b Although vaccination is not currently required for international travel,101 137 it is recommended for travelers who may have prolonged exposure to contaminated food and drink in areas with persistent typhoid epidemics or in smaller villages or rural areas outside the usual tourist itinerary.101 123 137 b In addition to vaccination, travelers should use caution in selecting food and water in these areas since the vaccines are not 100% effective and vaccine-induced immunity can be overwhelmed by a large inoculum of S. typhi.101 103 123 b (See Limitations of Vaccine Effectiveness under Cautions.)

HIV-infected individuals should not receive Vivotif since the vaccine contains live, attenuated bacteria.102 103 122 If typhoid vaccine is indicated, HIV-infected individuals may receive Typhim Vi.102 122 USPHS/IDSA Prevention of Opportunistic Infections Working Group recommends use of Typhim Vi in HIV-infected individuals at risk of exposure to typhoid fever.136 (See Individuals with Altered Immunocompetence under Cautions.)

Typhoid Vaccine Dosage and Administration

Administration

Vivotif is administered orally;103 Typhim Vi is administered by IM injection.123

Oral Administration

Vivotif: Administer orally.101 102 103 b d Do not administer parenterally.103

Take on an empty stomach (approximately 1 hour before or 2 hours after a meal).101 102 103 114 b d

Do not chew or open the enteric-coated capsules.103 114 d Swallow whole with cool or lukewarm (≤37°C [body temperature]) liquid (water).101 102 103 b d

Do not drink alcohol within 2 hours after the dose.d (See Specific Drugs under Interactions.)

It is essential that remaining capsules be stored in a refrigerator until the vaccination series is completed.103 (See Storage under Stability.)

IM Administration

Typhim Vi: Administer by IM injection.101 102 123 b Do not administer IV.123

IM injections preferably should be made into the deltoid area in adults and into the deltoid or the vastus lateralis in children.123 To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual's age and body mass.100

Administer undiluted.123 Do not mix with any other vaccine or solution.100 123 b

Avoid use of the gluteal area or any area where there may be a nerve trunk.123 Generally, do not administer vaccines into buttock muscle in children because of potential for injection-associated injury to the sciatic nerve.100

Avoid injection of vaccines into or near blood vessels.123

Dosage

Dose and dosing schedule vary according to the individual's age and specific vaccine administered (Vivotif, Typhim Vi).103 123 b Follow dosage recommendations for the specific preparation used.102

Pediatric Patients

Preexposure Vaccination Against Typhoid Fever in High-risk Groups
Children and Adolescents 6–18 Years of Age (Vivotif)
Oral

Primary immunization consists of 4 doses.101 102 103 b Each dose consists of one enteric-coated capsule.102 103

Give first dose on a selected date; give second, third, and fourth doses every other day after the first dose over a 1-week period.101 102 103 b

Primary immunization with the recommended vaccination series before an expected exposure to typhoid fever ensures the highest level of protection.102 103 Those who complete the 4-dose series at least 1 week prior to possible typhoid exposure probably will be protected.102 103 b c d

Data not available concerning use of Vivotif as a booster in individuals who received primary immunization with a different typhoid vaccine.102 103 ACIP states that the 4-dose Vivotif vaccination series is a reasonable alternative for booster immunization in individuals previously vaccinated with a parenteral inactivated typhoid vaccine.102

Duration of immunity and need for subsequent doses not fully determined.102 103 b For travelers or individuals at continued or repeated risk of exposure to typhoid fever, additional (booster) doses (i.e., 4-dose vaccination series) are recommended every 5 years.102 103 b (See Duration of Immunity under Cautions.)

Children and Adolescents 2 –18 Years of Age (Typhim Vi)
IM

Primary immunization consists of a single 25-mcg dose.102 123 b Each dose consists of 0.5 mL from the commercially available prefilled single-dose syringe or multidose vial.102 123 b

Those who receive the recommended dose given at least 2 weeks prior to possible exposure to typhoid fever probably will be protected.102 123 b c

Data not available concerning use of Typhim Vi for booster immunization in individuals who received primary immunization with a different typhoid vaccine.102 123 b ACIP states that a single dose of Typhim Vi is a reasonable alternative as a booster for individuals previously vaccinated with another parenteral inactivated typhoid vaccine.102

Duration of immunity and need for subsequent doses not fully determined.102 123 114 b For travelers or individuals at continued or repeated risk of exposure to typhoid fever, an additional (booster) dose of 0.5 mL is recommended every 2 years.102 123 114 b (See Duration of Immunity under Cautions.)

Adults

Preexposure Vaccination Against Typhoid Fever in High-risk Groups
Adults ≥19 Years of Age (Vivotif)
Oral

Primary immunization consists of 4 doses.102 103 b Each dose consists of one enteric-coated capsule.102 103

Give first dose on a selected date; give second, third, and fourth doses every other day after the first dose over a 1-week period.102 103 b

Primary immunization with the recommended vaccination series before an expected exposure to typhoid fever ensures the highest level of protection.102 103 Those who complete the 4-dose series at least 1 week prior to possible typhoid exposure probably will be protected.102 103 b

Data not available concerning use of Vivotif as a booster in individuals who received primary immunization with a different typhoid vaccine.102 103 b ACIP states that the 4-dose Vivotif vaccination series is a reasonable alternative as a booster for individuals previously vaccinated with a parenteral inactivated typhoid vaccine.102

Duration of immunity and need for subsequent doses not fully determined.102 103 114 b For travelers or individuals at continued or repeated risk of exposure to typhoid fever, additional (booster) doses (i.e., 4-dose vaccination series) are recommended every 5 years.103 114 b (See Duration of Immunity under Cautions.)

Adults ≥19 Years of Age (Typhim Vi)
IM

Primary immunization consists of a single 25-mcg dose.102 123 b Each dose consists of 0.5 mL from the commercially available prefilled single-dose syringe or multidose vial.102 123 b

Those who receive the recommended single dose at least 2 weeks prior to possible exposure to typhoid fever probably will be protected.102 123 b

Data not available concerning use of Typhim Vi for booster immunization in individuals who received primary immunization with a different typhoid vaccine.102 123 b ACIP states that a single dose of Typhim Vi is a reasonable alternative as a booster for individuals previously vaccinated with another parenteral inactivated typhoid vaccine.102

Duration of immunity and need for subsequent doses not fully determined.102 123 b For travelers or individuals at continued or repeated risk of exposure to typhoid fever, an additional (booster) dose of 0.5 mL is recommended every 2 years.123 b (See Duration of Immunity under Cautions.)

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No specific dosage recommendations.

Cautions for Typhoid Vaccine

Contraindications

  • Oral live typhoid vaccine (Vivotif): Hypersensitivity to any ingredient in the formulation.101 103 Also contraindicated in individuals with altered immunocompetence and in those with acute febrile illness.101 102 103

  • Parenteral inactivated typhoid vaccine (Typhim Vi): Hypersensitivity to any ingredient in the formulation.101 123 Also contraindicated in individuals with previous hypersensitivity reactions to any typhoid vaccine.101 102 123 b

Warnings/Precautions

Warnings

Individuals with Altered Immunocompetence

Because severe complications have been reported following vaccination with live, attenuated virus or bacterial vaccines in individuals with altered immunocompetence (e.g., patients with leukemia, lymphoma, generalized malignancy, asymptomatic or symptomatic HIV infection, those receiving immunosuppressive therapy)101 and because safety of oral live typhoid vaccine (Vivotif) has not been established in immunocompromised individuals, this vaccine should not be used in such individuals.101 102 103 122 However, ACIP states that Vivotif can be used, if indicated, in patients who have altered immunocompetence because of asplenia, renal failure, diabetes, alcoholism, or alcoholic cirrhosis.122

If typhoid vaccination is considered necessary in individuals with altered immunocompetence, parenteral inactivated typhoid vaccine (Typhim Vi) theoretically would be a safer alternative than the oral vaccine.102 122 However, the vaccine may be less immunogenic in immunocompromised individuals than in immunocompetent individuals.122 123 ACIP currently states that recommendations concerning use of parenteral inactivated typhoid vaccine in individuals with altered immunocompetence generally are the same as those for individuals who are not immunocompromised.122

Individuals with GI Disorders

Oral live typhoid vaccine (Vivotif) should not be used in individuals with acute GI illness since the vaccine requires replication in the gut for effectiveness.103 b d Postpone initiating the vaccination series in patients with persistent diarrhea or vomiting.103 d

Sensitivity Reactions

Hypersensitivity Reactions

Allergic reactions (e.g., anaphylactic shock, pruritus, rash, urticaria, difficulty breathing, hypotension, serum sickness) have been reported rarely with typhoid vaccine.103 123

A history of previous sensitivity reactions to typhoid vaccine should be obtained prior to administration.102 123

Epinephrine and other appropriate agents should be readily available in case anaphylaxis or other serious allergic reaction occurs.123

General Precautions

Transmission of Vaccine Bacteria

Oral typhoid vaccine (Vivotif) contains live, attenuated bacteria.103 Secondary transmission of vaccine bacteria has not been documented following administration of Vivotif; however, these organisms may be shed transiently in the stools of vaccinees.102 103

Concomitant Illness

A decision to administer or delay vaccination in an individual with a current or recent febrile illness depends on the severity of symptoms and etiology of the illness.100

Manufacturer of Vivotif states that the vaccine should not be administered to individuals during an acute febrile illness. 103 Manufacturer of Typhim Vi states that the vaccine may be given to individuals with acute infection or febrile illness if withholding the vaccine poses greater risk to the patient.123

ACIP states that minor acute illness, such as mild diarrhea or mild upper respiratory tract infection (with or without fever) generally does not preclude vaccination, but vaccination should be deferred in individuals with moderate or severe acute illness (with or without fever) until they have recovered from the acute phase of the illness.100

Individuals with Bleeding Disorders

Parenteral inactivated typhoid vaccine (Typhim Vi): Because bleeding may occur following IM administration in individuals with thrombocytopenia or a bleeding disorder (e.g., hemophilia) or in those receiving anticoagulant therapy, use caution in such individuals.100 123

ACIP states that vaccines may be given IM to individuals who have bleeding disorders or are receiving anticoagulant therapy if a clinician familiar with the patient's bleeding risk determines that the preparation can be administered with reasonable safety.100 In these cases, use a fine needle (23 gauge) to administer the vaccine and apply firm pressure to the injection site (without rubbing) for ≥2 minutes.100 If patient is receiving antihemophilia therapy, administer the IM vaccine shortly after a scheduled dose of such therapy.100

Advise individual and/or their family about the risk of hematoma from IM injections.100

Limitations of Vaccine Effectiveness

May not protect all vaccine recipients against typhoid fever infection.103 123 b Vaccine-induced immunity can be overwhelmed by large inocula of S. typhi.102 Even travelers who have been immunized against typhoid fever should take precautions to avoid contact with or ingestion of potentially contaminated food or water.103

Oral live typhoid vaccine (Vivotif): Optimum immune response may not be achieved unless the complete 4-dose vaccination series is used.101 102 103 b Individuals who complete the 4-dose series at least 1 week prior to possible typhoid exposure probably will be protected.101 102 103 b

Parenteral inactivated typhoid vaccine (Typhim Vi): Individuals who receive a single dose given at least 2 weeks prior to possible typhoid exposure probably will be protected.101 102 123

May not prevent infection in individuals who do not achieve protective antibody titers; the minimum titer needed to confer immunity has not been established.103 123

Vivotif and Typhim Vi provide protection only against S. typhi.103 123 These vaccines do not provide protection against other Salmonella species (e.g., S. paratyphi A or B).123

Duration of Immunity

Duration of protection and need for subsequent doses after initial and additional (booster) doses of typhoid vaccine not fully determined.102 103 114 123 Natural infection with S. typhi generally confers lifelong immunity; however, the nature of this immunity is complex and includes both humoral and cell-mediated components.a

Oral live typhoid vaccine (Vivotif): Although additional long-term follow-up studies are needed, limited evidence suggests that protective levels of antibodies following the recommended 4-dose vaccination series may persist for at least 5 years.102 103 Additional (booster) doses (i.e., 4-dose oral vaccination series) of Vivotif recommended every 5 years if continued or renewed exposure to typhoid fever is expected.102 103

Parenteral inactivated typhoid vaccine (Typhim Vi): Limited data indicate that antibody titers remain elevated for at least 12 months after a single dose in children 5–15 years of age residing in typhoid-endemic areas and for at least 36 months in healthy US adults.123 128 129 Additional (booster) dose of Typhim Vi recommended every 2 years if continued or renewed exposure to typhoid fever is expected.123

Improper Storage and Handling

Improper storage or handling of vaccines may result in loss of vaccine potency and reduced immune response in vaccinees.100

Oral live typhoid vaccine (Vivotif): Unstable when exposed to ambient temperatures.103 126 131 Remaining capsules must be stored in a refrigerator until the vaccination series is completed.103 Do not administer Vivotif that has been mishandled or has not been stored at the recommended temperature (2–8°C).103 126 131 (See Storage under Stability.)

Parenteral inactivated typhoid vaccine (Typhim Vi): Not adversely affected by elevated temperatures (e.g., those that occur in tropical areas).124 126 Therefore, the parenteral vaccine may be preferred in situations in which continuous refrigeration cannot be ensured.124 126

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.100

Specific Populations

Pregnancy

Oral live typhoid vaccine (Vivotif) and parenteral inactivated typhoid vaccine (Typhim Vi): Category C.103 123

Safety data not available on use of typhoid vaccines in pregnant women.101 102 b Typhoid vaccine should be given to pregnant women only if clearly needed.103 123

AAP states that Vivotif is contraindicated in pregnant women.b

Because Typhim Vi is an inactivated vaccine, the theoretical risk to the fetus is expected to be low.100 AAP states that use of Typhim Vi may be considered on an individual basis.b When giving a vaccine during pregnancy, delaying vaccination until the second or third trimester, if possible, is a reasonable precaution to minimize the possibility of teratogenicity.123 b

Lactation

Not known whether antigens contained in typhoid vaccine are distributed into milk following oral or IM administration.103 123 Use with caution in nursing women.103 123

Because inactivated vaccines (e.g., Typhim Vi) do not multiply within the body, they should not pose any unusual problems for lactating women or their infants.100 101

The manufacturers state that there currently are no data to warrant use of typhoid vaccines in nursing women in an attempt to provide passive transfer of antibodies to protect an infant from typhoid fever.103 123

Pediatric Use

Oral live typhoid vaccine (Vivotif): Safety and efficacy not established in children <6 years of age.102 103 Although efficacy not established, limited evidence indicates adverse effects were uncommon when the vaccine was used in children 1–5 years of age.102 Has not been studied in children <1 year of age.102

Parenteral inactivated typhoid vaccine (Typhim Vi): Safety and efficacy not established in children <2 years of age.102 123 Has not been studied in children <1 year of age.101 102

Common Adverse Effects

Oral live typhoid vaccine (Vivotif): Abdominal pain, nausea, headache, fever, diarrhea, vomiting, skin rash.101 102 103 114 b d

Parenteral inactivated typhoid vaccine (Typhim Vi): Injection site reactions (pain, tenderness, erythema, induration),102 123 125 130 135 b malaise/generalized aches,123 129 130 headache,102 123 125 130 135 b myalgia/muscle aches,123 130 nausea,123 125 130 diarrhea,123 130 feverishness,123 130 decreased activity/lethargy,123 130 vomiting.123

Interactions for Typhoid Vaccine

Live Vaccines

Oral live typhoid vaccine (Vivotif): May be administered simultaneously with or at any interval before or after a parenteral live vaccine (e.g., measles, mumps, and rubella virus vaccine live [MMR], varicella virus vaccine live, yellow fever vaccine).100 Data not available regarding the immunogenicity of Vivotif administered concurrently or within 30 days of other live virus vaccines.100 However, ACIP and AAFP state that if use of Vivotif is warranted, it should not be delayed because of administration of other live virus vaccines (injectable or intranasal).100 102

Parenteral inactivated typhoid vaccine (Typhim Vi): Specific interaction studies involving Typhim Vi and other vaccines have not been conducted to date.123 However, since Typhim Vi is an inactivated vaccine, it generally can be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after live vaccines.100

Inactivated Vaccines and Toxoids

Oral live typhoid vaccine (Vivotif): Can be administered simultaneously with or at any interval before or after inactivated vaccines.100

Parenteral inactivated typhoid vaccine (Typhim Vi): Specific drug interaction studies involving Typhim Vi and other vaccines commonly administered prior to international travel (e.g., hepatitis A, meningococcal, poliovirus, tetanus) have not been conducted to date.123 However, since Typhim Vi is an inactivated vaccine, it generally can be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after other inactivated vaccines.100

Specific Drugs

Drug

Interaction

Comments

Alcohol

Vivotif: Alcohol may affect dissolution of the vaccine capsules and may inactivate the vaccined

Vivotif: Avoid alcohol for 2 hours after each vaccine dosed

Anti-infective agents (e.g., sulfonamides)

Vivotif: Potential for anti-infectives with activity against S. typhi to inhibit immune response to the vaccine103

Typhim Vi: Manufacturer states that specific drug interaction studies involving the vaccine and other drugs (e.g., anti-infectives) not conducted to date123

Vivotif: Manufacturer states do not use in individuals receiving anti-infectives;103 d ACIP, CDC, and AAFP state an interval of ≥24 hours should elapse between administration of an anti-infective dose and the vaccine;100 101 102 AAP states that anti-infectives should be avoided for ≥24 hours before the first dose and for 7 days after the fourth vaccine doseb

Antimalarial agents (e.g., chloroquine, mefloquine, proguanil)

Vivotif: Potential for antimalarials with antibacterial activity against Salmonella to inhibit the immune response to the vaccine103

Vivotif: Although mefloquine inhibits growth of S. typhi in vitro, including the Ty21a strain contained in the vaccine,102 132 133 no clinical evidence to date that mefloquine or chloroquine interferes with the immune response to the vaccine103 b

Vivotif: Concurrent use of proguanil (200 mg daily; not commercially available in the US as a single-entity preparation) with the vaccine resulted in decreased immune response103

Typhim Vi: Manufacturer states specific drug interaction studies involving the vaccine and other drugs (e.g., antimalarial agents) not conducted to date123

Vivotif: Manufacturer states the vaccine may be administered in patients receiving mefloquine103

To minimize the potential for an inhibitory effect, ACIP states the vaccine should be administered ≥24 hours before or after a mefloquine dose;100 102 132 133 AAP states mefloquine may be administered simultaneously with the vaccineb

Vivotif: Although an interval of ≥7 days was previously recommended between vaccination and initiation of chloroquine antimalarial prophylaxis, more recent evidence indicates special precautions not necessary102 103 132 133 b

Vivotif: Manufacturer and AAP state that proguanil therapy should be delayed until ≥10 days after the fourth vaccine dose103 b

Hepatitis A (HepA) vaccine

Vivotif: Data not available regarding simultaneous administration with HepA vaccine103

Typhim Vi: Concomitant administration of HepA vaccine and parenteral inactivated typhoid vaccine does not appear to affect the immune response or adverse reactions to the vaccinese

Immune globulin (IGIM, IGIV) or specific immune globulin (HBIG, RIG, TIG, VZIG)

Vivotif: No evidence that immune globulin preparations interfere with the immune response to the vaccine100 101 102

Typhim Vi: Specific drug interaction studies not available123

Vivotif: May be administered simultaneously with or at any time before or after antibody-containing preparations without a substantial decrease in the immune response to the vaccine100 101

Typhim Vi: May be administered simultaneously (using different syringes and different injection sites) or at any time before or after immune globulins100

Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)

Typhim Vi: Immune response may be reduced in patients receiving immunosuppressive agents122 123

Vivotif: Contraindicated in patients receiving immunosuppressive therapy102 103 122

If typhoid vaccination is considered necessary in individuals receiving immunosuppressive agents, Typhim Vi is recommended102 122

Measles, mumps, and rubella vaccine (MMR)

Vivotif: Data not available regarding the immunogenicity of oral live typhoid vaccine administered concurrently or within 30 days of MMR 100 102

Vivotif: May be administered simultaneously with or at any interval before or after MMR100 102

Typhim Vi: May be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after MMR100

Meningococcal vaccine

Vivotif: Data not available regarding simultaneous administration with meningococcal vaccine103

Typhim Vi: Has been administered concomitantly with MCV4 (Menactra) without reduced antibody response or increased adverse effectsg

Typhim Vi: May be administered simultaneously with MCV4 (Menactra) or at any interval before or after meningococcal vaccine (using different syringes and different injection sites)g

Poliovirus vaccine live oral (OPV; no longer commercially available in the US)

Vivotif: Although there is a theoretical risk that oral typhoid vaccine may interfere with the immune response to OPV,109 no evidence that OPV suppresses the immune response to typhoid vaccine103

Vivotif: Some experts suggest that ≥2 weeks should elapse between the last dose of Vivotifand OPV 109

Tetanus toxoid

Data not available regarding simultaneous administration of tetanus vaccine and Vivotif or Typhim Vi103 123

Varicella vaccine

Vivotif: Specific data not available regarding immunogenicity of oral live typhoid vaccine administered concurrently or within 30 days of varicella vaccine100 102

Typhim Vi: Since this typhoid vaccine is an inactivated vaccine, interactions with live vaccines such as varicella vaccine are unlikely100

Vivotif: May be administered simultaneously with or at any interval before or after varicella vaccine100

Typhim Vi: May be administered simultaneously (using different syringes and different injection sites) or at any interval before or after varicella vaccine100

Yellow fever vaccine

Vivotif: Although specific data not available regarding simultaneous administration, a bivalent vaccine (not commercially available in the US) containing a live oral typhoid vaccine and a cholera vaccine has been administered concomitantly with yellow fever vaccine without a decrease in immune response to the typhoid vaccine or an increase in adverse effectsf

Typhim Vi: Yellow fever vaccine has been administered concomitantly at a different site with parenteral inactivated typhoid vaccine with or without concomitant HepA vaccine (Vaqta) without any apparent decrease in the immune response or increase in adverse effects101 103 e

Vivotif: May be administered simultaneously with or at any interval before or after yellow fever vaccine100 102

Typhim Vi: May be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after yellow fever vaccine100 e

Stability

Storage

Oral

Capsules

Vivotif: 2–8°C.102 103 Potency is adversely affected by exposure to warmer temperatures.102 103

Store remaining capsules in a refrigerator until 4-dose vaccination series is completed.102 103 b d

Vivotif does not contain thimerosal or any other preservatives.103

Parenteral

Injection, for IM Use

Typhim Vi: 2–8°C.123 Do not freeze.123

Typhim Vi does not contain thimerosal, but contains phenol 0.25% as a preservative.123

Actions

  • Typhoid vaccine live oral (Vivotif) is a lyophilized preparation of live S. typhi of the attenuated Ty21a strain.102 103 111 114 The vaccine bacteria are cultured on a suitable nutrient medium, stabilized, and lyophilized.103

  • Typhoid Vi polysaccharide vaccine Typhim (Vi) is a sterile solution of 0.9% sodium chloride containing purified cell surface Vi (“virulence”) polysaccharide extracted from S. typhi of the Ty2 strain.102 123 The vaccine bacteria are cultured on a suitable nutrient medium; the capsular polysaccharide is then precipitated using cetrimonium bromide and purified.123

  • Oral live typhoid vaccine (Vivotif) and parenteral inactivated typhoid vaccine ( Typhim Vi) are commercially available as monovalent vaccines prepared using slightly different strains of S. typhi.102 103 123 b Efficacy of these vaccines appears to be comparable when administered as recommended.102 105 107 109 111 114 115 116 117 118 119 120 121 123 124 125 126

  • Vivotif and Typhim Vi are highly immunogenic; 50–80% of vaccinees achieve an adequate immune response against typhoid.101 b Efficacy of Vivotif appears to be greater in older children and adults than in young children.111 121

  • Vivotifstimulates active immunity to typhoid fever by inducing production of both serum and intestinal antibodies and cell-mediated immune responses.102 103 126 Following primary immunization with Vivotif, serum titers of antibodies to the O antigen of S. typhi appear to correlate with protection against typhoid fever.126 Administration of Vivotif may elicit a local immune response in the intestinal tract.103 Ability of S. typhi to elicit a protective immune response depends on possession by the bacilli of a complete lipopolysaccharide.103 The S. typhi (Ty21a) strain in Vivotif is limited in its ability to produce a complete lipopolysaccharide;103 111 112 however, sufficient complete lipopolysaccharide apparently is produced to elicit an adequate immune response.103 111 112 114 115 119

  • Typhim Vi stimulates active immunity to S. typhi by inducing production of antibodies to the Vi antigen.123 124 125 126 127 128 129 130 The Vi antigen is considered to be a virulence factor of S. typhi, apparently protecting the organism from the actions of complement;102 111 125 126 129 antibodies to the Vi antigen confer protection against typhoid fever.102 111 123 124 125 126 129

  • A reduced immune response to typhoid vaccine and lower antibody titers may occur in immunocompromised individuals (e.g., HIV-infected individuals, those with leukemia, lymphoma, or generalized malignancy, those receiving immunosuppressive therapy).123

  • The principal mode of transmission of typhoid infection is enteric (i.e., through fecal contamination and oral ingestion) most commonly through direct contact with an infected person or with an item contaminated by a typhoid carrier.b Onset of illness is usually gradual with signs and symptoms such as high fever, headache, malaise, anorexia, lethargy, abdominal pain and tenderness, splenomegaly, hepatomegaly, and rose spots.101 b Invasive infection and mortality from typhoid infection are typically higher in infants, elderly individuals, and those with immunosuppressive conditions, hemoglobinopathies, malignancies, and HIV infection.b

  • Natural infection with S. typhi generally results in lifelong immunity; however, the nature of this immunity is complex and includes both humoral and cell-mediated components.a

  • The minimum titer of anti-typhoid antibodies conferring protection against typhoid has not been established.123 Experience using typhoid vaccines in individuals from areas without endemic disease (e.g., US residents) who travel to endemic regions is limited; however, seroconversion rates following primary immunization with Vivotif or Typhim Vi in these individuals appear to be comparable to or higher than those attained in residents of endemic areas.102 103 123 Evidence from antibody-titer studies suggests that both the oral and parenteral typhoid vaccines provide protection in vaccinees residing in nonendemic areas.102 103 123 129

Advice to Patients

  • Prior to administration of the vaccine dose, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient's legal representative (VISs are available at ).c

  • Advise patient and/or patient's parent or guardian of the risks and benefits of vaccination with typhoid vaccine.103 123 c

  • Advise patient and/or patient's parent or guardian that routine typhoid vaccination is not recommended in the US, but typhoid vaccine is used to prevent typhoid in individuals at high risk of exposure to typhoid (e.g., travelers, household contacts of a typhoid carrier, certain laboratory workers).103 123 c

  • Advise patient and/or patient's parent or guardian that oral or parenteral typhoid vaccine may not provide protection in all vaccinees.102 103 123 c In addition to vaccination, importance of taking precautions against exposure to typhoid fever by avoiding contact with or ingestion of potentially contaminated food or water.101 102 c

  • When oral typhoid vaccine (Vivotif) is used, importance of completing the 4-dose vaccination series as directed (i.e., a dose on day 1, 3, 5, and 7).103 b c Advise vaccinees to swallow capsules whole with cool or lukewarm liquid on an empty stomach (approximately 1 hour before or 2 hours after a meal), avoid drinking alcohol for 2 hours after each dose, and store remaining capsules in the refrigerator until the entire regimen is completed.102 103 114 b c d Importance of completing the vaccination series at least 1 week prior to possible exposure to typhoid fever and importance of receiving additional (booster) doses (i.e., 4-dose vaccination series) every 5 years if at continued or repeated risk of exposure.102 103 114 b

  • When parenteral typhoid vaccine (Typhim Vi) is used, importance of receiving the initial dose at least 2 weeks prior to possible exposure to typhoid fever and importance of receiving additional (booster) doses every 2 years if at continued or repeated risk of exposure.102 114 123 b

  • Importance of notifying clinicians if patient is immunocompromised since oral typhoid vaccine (Vivotif) should not be used in individuals with a weakened immune system (e.g., leukemia, lymphoma, HIV/AIDS) or in those receiving treatment that may weaken the immune system (e.g., high-dose corticosteroids)101 102 103 122 c since such patients may have a reduced immune response to vaccination.122 123 c (See Individuals with Altered Immunocompetence under Cautions.)

  • Importance of informing clinicians of a history of allergic reactions to typhoid vaccine or any ingredient in the formulation.c

  • Importance of informing clinicians if any adverse reactions (including allergic reactions) occur with typhoid vaccine.c Clinicians or individuals can report any adverse reactions that occur following vaccination to the Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or .c

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.c Importance of notifying clinicians if receiving therapy with anti-infective or antimalarial agents.103 c d (See Specific Drugs under Interactions.)

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.c d

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Typhoid Vaccine Live Oral

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, enteric-coated

2–6.8 × 109 CFU of viable Salmonella typhi Ty21a

Vivotif (with sucrose 26–130 mg, lactose 100–180 mg, and magnesium 2.6–4.4 mg; preservative-free; available as a 7-day mnemonic pack of 4 capsules)

Berna

Typhoid Vi Polysaccharide Vaccine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IM use

25 mcg Vi capsular polysaccharide per 0.5 mL

Typhim Vi (with phenol 0.25%)

Sanofi Pasteur

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Typhim VI 25MCG/0.5ML Solution (SANOFI PASTEUR): 1/$65.99 or 2/$179.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions June 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

100. Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006; 55(RR-15):1-47.

101. Centers for Disease Control and Prevention. Health information for international travel, 2008. Atlanta, GA: US Department of Health and Human Services; 2008. Updates available from CDC website. Accessed 2008 Apr 4.

102. Centers for Disease Control Immunization Practices Advisory Committee (ACIP). Typhoid immunization: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR Recomm Rep. 1994; 43(RR-14):1-7.

103. Berna Products Corp. Vivotif (typhoid vaccine live oral Ty21a) prescribing information. Coral Gables, FL; 2006 Aug.

104. Schwartz E, Shlim DR, Eaton M et al. The effect of oral and parenteral typhoid vaccination on the rate of infection with Salmonella typhi and Salmonella paratyphi A among foreigners in Nepal. Arch Intern Med. 1990; 150:349-51. [IDIS 263329] [PubMed 2105702]

105. Levine MM, Ferreccio C, Black RE. Large-scale field trial of Ty21a live oral typhoid vaccine in enteric-coated capsule formulation. Lancet. 1987; 1:1049-52. [IDIS 229932] [PubMed 2883393]

106. Bencic Z. Typhoid vaccines. Lancet. 1987; 2:682-3. [PubMed 2887958]

107. Levine MM, Ferreccio C. Typhoid vaccines. Lancet. 1988; 1:173. [PubMed 2892999]

108. Kelleher PC, Kelley LR, Rickman LS. Anaphylactoid reaction after typhoid vaccination. Am J Med. 1990; 89:822-3. [IDIS 275914] [PubMed 2252054]

109. Wolfe MS. Precautions with oral live typhoid (Ty21a) vaccine. Lancet. 1990; 336:631-2. [IDIS 271230] [PubMed 1975401]

110. Wyeth Laboratories Inc. Typhoid vaccine USP prescribing information. Marietta, PA; 1990 Mar 16.

111. Levine MM, Taylor DN, Ferreccio C. Typhoid vaccine comes of age. Pediatr Infect Dis J. 1989; 8:374-81. [PubMed 2664693]

112. Germanier R, Fuer E. Isolation and characterization of Gal E mutant Ty 21a of Salmonella typhi: a candidate strain for a live, oral typhoid vaccine. J Infect Dis. 1975; 131:553-8. [PubMed 1092768]

113. Gilman RH, Hormick RB, Woodward WE et al. Evaluation of UDP-glucose-4-epineraseless mutant of Salmonella typhi as a live oral vaccine. J Infect Dis. 1977; 136:717-23. [IDIS 92785] [PubMed 925379]

114. Woodruff BA, Pavia AT, Blake PA. A new look at typhoid vaccination: information for the practicing physician. JAMA. 1991; 265:756-9. [IDIS 277641] [PubMed 1990193]

115. Levine MM, Ferreccio C, Black RE et al. Progress in vaccines against typhoid fever. Rev Infect Dis. 1989; 11(Suppl 3):S552-66. [IDIS 252276] [PubMed 2669099]

116. Cryz SJ Jr, Furer E, Levine MM. [Effectiveness of oral, attenuated live Salmonella typhi Ty21a vaccine in controlled field trials. Schweiz Med Wochenschr. 1988; 118:467-70. [PubMed 3375787]

117. Black RE, Levine MM, Ferreccio C et al. Efficacy of one or two doses of Ty21a Salmonella typhi vaccine in enteric-coated capsules in a controlled field trial. Vaccine. 1990; 8:81-4. [PubMed 2180234]

118. Bodhidatta L, Taylor DN, Thisyakorn U et al. Control of typhoid fever in Bangkok, Thailand, by annual immunization of school children with parenteral typhoid vaccine. Rev Infect Dis. 1987; 9:841-5. [IDIS 232260] [PubMed 3438648]

119. Rone JK. Severe systemic reactions to typhoid vaccination: two cases and a review of the literature. Military Medicine. 1990; 155:272-4. [IDIS 267409] [PubMed 2122306]

120. Ferreccio C, Levine MM, Rodriguez H et al. Comparative efficacy of two, three, or four doses of TY21a live oral typhoid vaccine in enteric-coated capsules: a field trial in an endemic area. J Infect Dis. 1989; 159:766-9. [IDIS 253818] [PubMed 2647863]

121. Levine MM, Ferreccio C, Cryz S et al. Comparison of enteric-coated capsules and liquid formulation of Ty21a typhoid vaccine in randomized controlled field trial. Lancet. 1990; 336:891-4. [IDIS 273090] [PubMed 1976928]

122. Centers for Disease Control and Prevention. Recommendations of the Advisory Committee on Immunization Practices (ACIP): use of vaccines and immune globulins in persons with altered immunocompetence. MMWR Recomm Rep. 1993; 42(RR-4):1-18.

123. Sanofi-Pasteur. Typhim Vi (typhoid Vi polysaccharide vaccine) prescribing information. Swiftwater, PA; 2005 Dec.

124. Acharya IL, Lowe CU, Thapa R et al. Prevention of typhoid fever in Nepal with the Vi capsular polysaccharide of Salmonella typhi. N Engl J Med. 1987; 317:1101-4. [IDIS 234465] [PubMed 3657877]

125. Klugman KP, Koornhof HJ, Schneerson R et al. Protective activity of Vi capsular polysaccharide vaccine against typhoid fever. Lancet. 1987; 2:1165-9. [IDIS 235917] [PubMed 2890805]

126. Ivanoff B, Levine MM, Lambert PH. Vaccination against typhoid fever: present status. Bull World Health Organ. 1994; 72:957-71. [PubMed 7867143]

127. Ambrosch F, Fritzell B, Gregor J et al. Combined vaccination against yellow fever and typhoid fever: a comparative trial. Vaccine. 1994; 12:625-8. [PubMed 8085380]

128. Tacket CO, Levine MM, Robbins JB. Persistence of antibody titres three years after vaccination with Vi polysaccharide vaccine against typhoid fever. Vaccine. 1988; 6:307-8. [PubMed 3188615]

129. Keitel WA, Bond NL, Zahradnik JM et al. Clinical and serological responses following primary and booster immunization with Salmonella typhi Vi capsular polysaccharide vaccines. Vaccine. 1994; 12:195-9. [PubMed 8165850]

130. Arnold WSG, Harcus AW, St Clair Roberts J et al. Experience with Vi typhoid capsular polysaccharide vaccine in the U.K. J Infect. 1992; 25:63-6. [PubMed 1522324]

131. Kaplan DT, Hill DR. Compliance with live, oral Ty21a typhoid vaccine. JAMA. 1992; 267:1074. [IDIS 291845] [PubMed 1735924]

132. Horowitz H, Carbonaro CA. Inhibition of the Salmonella typhi oral vaccine strain, Ty21a, by mefloquine and chloroquine. J Infect Dis. 1992; 166:1462-4. [IDIS 306329] [PubMed 1431270]

133. Brachman PS, Metchock B, Kozarsky PE. Effects of antimalarial chemoprophylactic agents on the viability of the Ty21a typhoid vaccine strain. Clin Infect Dis. 1992; 15:1057-8. [IDIS 306008] [PubMed 1457647]

134. World Health Organization. International travel and health: vaccination requirements and health advice. Geneva: World Health Organization; 1995:62,84.

135. Cumberland NS, St Clair Roberts J, Arnold WSG et al. Typhoid Vi: a less reactogenic vaccine. J Int Med Res. 1992; 20:247-53. [PubMed 1397669]

136. US Public Health Service (USPHS) and Infectious Diseases Society of America (IDSA) Prevention of Opportunistic Infections Working Group. 2001 USPHS/IDSA guidelines for the prevention of opportunistic infections in persons infected with human immunodeficiency virus. From web site.

137. Anon. Advice for travelers. Med Lett Treat Guid. 2004; 2:33-40.

a. AHFS drug information 2008. McEvoy GK, ed. Typhoid vaccine. Bethesda, MD: American Society of Health-System Pharmacists.

b. American Academy of Pediatrics Committee on Infectious Diseases. Red Book: 2006 Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006:18-22, 34, 69-71, 98-103, 579-84.

c. Centers for Disease Control and Prevention. Typhoid vaccine information statement. 2004 May. From CDC website. Accessed 2008 Apr 4.

d. Berna Products Corp. Vaccine in a capsule: user's guide for travelers. 2007 Jan. From website. Accessed 2008 Apr 9.

e. Jong EC, Kaplan KM, Eves KA et al. An open randomized study of inactivated hepatitis A vaccine administered concomitantly with typhoid fever and yellow fever vaccines. J Travel Med. 2002; 9:66-70. [PubMed 12044272]

f. Kollaritsch H, Que JU, Kunz C et al. Safety and immunogenicity of live oral cholera and typhoid vaccines administered alone or in combination with antimalarial drugs, oral polio vaccine, or yellow fever vaccine. J Infect Dis. 1997; 175:871-5. [IDIS 384135] [PubMed 9086143]

g. Sanofi Pasteur. Menactra (meningococcal [groups A, C, Y and W-135] polysaccharide diphtheria toxoid conjugate vaccine) prescribing information. Swiftwater, PA; 2007 Oct.

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