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Typhoid Vaccine

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

Introduction

Commercially available in US as an oral live, attenuated vaccine (typhoid vaccine live oral Ty21a; Vivotif)102 103 115 and as a parenteral inactivated Vi polysaccharide vaccine (typhoid Vi polysaccharide vaccine; Typhim Vi).102 115 123 Other typhoid vaccines (e.g., inactivated whole-cell vaccines, inactivated protein-conjugated Vi polysaccharide vaccines) may be available in other countries.102 141

Uses for Typhoid Vaccine

Prevention of Typhoid Fever

Prevention of typhoid fever in US travelers planning to visit areas with a recognized risk of exposure to Salmonella enterica serovar Typhi.102 103 115 123

Prevention of typhoid fever in individuals with intimate exposure (e.g., household contact) to a known typhoid carrier.102 103 123

Prevention of typhoid fever in laboratory personnel with frequent contact with Salmonella Typhi bacilli.102 103 123

Typhoid fever is a potentially severe and occasionally life-threatening, febrile, enteric illness caused by Salmonella Typhi.102 103 105 115 138 139 141 Usually acquired by ingestion of food and/or water contaminated with feces from individuals who have typhoid fever or are chronic typhoid carriers.102 103 105 115 138 139 141 Overall case-fatality rate in patients who receive early and appropriate antibacterial treatment is typically <1%;102 if left untreated, case-fatality rate may be ≥10–20%.102 141 Approximately 2–4% of individuals with acute typhoid fever develop a chronic carrier state.103 123

Typhoid fever is uncommon in the US, but endemic in many less well-developed areas of the world that have poor sanitation and primitive water systems.102 115 138 139 About 22 million cases of typhoid fever and about 200,000 typhoid-related deaths occur annually worldwide.115 In the US, about 300–400 confirmed cases of typhoid fever are reported annually,102 115 almost all in recent travelers to other countries (most commonly southern Asia).102 115 139

USPHS Advisory Committee on Immunization Practices (ACIP) and CDC state that routine vaccination against typhoid fever not recommended for individuals residing in the US,102 115 but preexposure vaccination is recommended for those at high risk of exposure to Salmonella Typhi.102 115

When vaccination against typhoid fever indicated, either typhoid vaccine live oral Ty21a or typhoid Vi polysaccharide vaccine can be used unless contraindicated.102 105 115 Consider that 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 immunocompetence of the vaccinee (see Warnings/Precautions under Cautions).102 123 126 Because typhoid vaccine live oral Ty21a is self-administered over a 1-week period and compliance errors (i.e., dosing errors, improper storage) may occur, typhoid Vi polysaccharide vaccine may be preferred if compliance is likely to be a problem.131

Efficacy of typhoid vaccine live oral Ty21a and typhoid Vi polysaccharide vaccine appear to be comparable when administered as recommended;102 105 107 109 111 114 115 116 117 118 119 120 121 123 124 125 126 neither vaccine is expected to provide protection against typhoid fever in all vaccine recipients.102 103 105 115 123

Typhoid vaccines will not provide protection against S. enterica serovar Paratyphi or any Salmonella other than Salmonella Typhi and will not provide protection against other bacteria known to cause enteric disease.103 123

Typhoid vaccines are not used for treatment of typhoid fever and should not be used in individuals with acute Salmonella Typhi infection or in chronic typhoid carriers.103 123

There is no evidence to support use of typhoid vaccine to control common source outbreaks or disease following natural disasters or in individuals attending rural summer camps.103 123

Preexposure Vaccination Against Typhoid Fever in High-risk Groups

Travelers to areas with a recognized risk of exposure to Salmonella Typhi should be vaccinated against typhoid fever.103 105 115 123 The disease is endemic in many less well-developed areas of the world that have poor sanitation and primitive water systems.115 138 141

CDC recommends typhoid vaccination for travelers to many Asian, African, and Latin American countries, but no longer recommends typhoid vaccination for travelers to certain Eastern European and certain Asian countries.102 115 138 141 In recent years, most US cases of typhoid fever reported in individuals who had traveled to southern Asia (especially the Indian subcontinent including India, Bangladesh, or Pakistan) or Africa.115 139

Although risk is greatest for travelers who have prolonged exposure to possibly contaminated food and beverages in areas with persistent typhoid epidemics or in smaller cities and villages or rural areas outside usual tourist itinerary, even short-term travel (<1 week) to high-incidence areas is associated with risk for typhoid fever.102 115

In addition to vaccination, individuals traveling to areas with risk of typhoid fever 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 Salmonella Typhi.103 105 115 123 (See Limitations of Vaccine Effectiveness under Cautions.)

Vaccination against typhoid fever and other precautions (safe food and water precautions, frequent handwashing) are especially important for travelers to high-risk areas because fluoroquinolone-resistant and multidrug-resistant Salmonella Typhi have become common or are reported with increasing frequency in many regions of the world (e.g., Indian subcontinent, Africa).102 115 139 141

The most recent information regarding geographic areas with a recognized risk of typhoid fever and additional information on vaccination and other precautions for prevention of typhoid fever are available from CDC at and .115 138

Close contacts of chronic typhoid carriers with intimate exposure (e.g., household contact) to a documented Salmonella Typhi chronic carrier (defined as excretion of Salmonella Typhi in urine or stool for >1 year) should be vaccinated against typhoid fever.102

Laboratory personnel routinely exposed to cultures of Salmonella Typhi or specimens containing the bacilli or who work in laboratory environments where these cultures or specimens are routinely handled should be vaccinated against typhoid fever.102

Typhoid Vaccine Dosage and Administration

Administration

Typhoid vaccine live oral Ty21a: Administer orally.103

Typhoid Vi polysaccharide vaccine: Administer by IM injection.123

Oral Administration

Typhoid Vaccine Live Oral Ty21a

Administer orally as enteric-coated capsules.103

Take with cool or lukewarm (≤37°C [body temperature]) liquid (water) approximately 1 hour before a meal.103

Swallow whole immediately after placement in mouth;103 do not chew.103

Do not administer to individuals with acute GI illness103 105 or persistent diarrhea or vomiting.103 (See Acute Illness under Cautions.)

Capsules must be refrigerated (2–8°C) until just prior to administration.103 It is essential that remaining capsules be placed back in the refrigerator after each dose until the 4-dose vaccination series is completed.103 (See Storage under Stability.)

IM Administration

Typhoid Vi Polysaccharide Vaccine

Administer IM undiluted.123 Do not mix with any other vaccine.123

Should appear clear and colorless;123 discard if turbid or contains particulates.123

IM injections preferably should be made into the deltoid area in adults and into the deltoid or anterolateral thigh in children.123

Do not inject into gluteal area or any area where there may be a nerve trunk.123

To ensure delivery into muscle, make IM injections at a 90° angle to the skin using a needle length appropriate for individual's age and body mass.134

Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination;123 134 such reactions occur most frequently in adolescents and young adults.134 Syncope and secondary injuries may be averted if vaccinees sit or lie down during and for 15 minutes after vaccination.134 If syncope occurs, observe patient until symptoms resolve.134

If multiple vaccines are administered during a single health-care visit, give each parenteral vaccine using different syringe and different injection site.134 Separate injection sites by ≥1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.134

Dosage

Dosing schedules (i.e., number of doses, timing prior to potential exposure) differ between typhoid vaccine live oral Ty21a and typhoid Vi polysaccharide vaccine.103 123 Follow dosage recommendations for the specific preparation used.102 103 123

Pediatric Patients

Preexposure Vaccination Against Typhoid Fever in High-risk Groups
Children and Adolescents ≥6 Years of Age (Typhoid Vaccine Live Oral Ty21a; Vivotif)
Oral

Primary immunization consists of 4 doses.102 103 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 first dose over a 1-week period (e.g., Sunday, Tuesday, Thursday, and Saturday or day 0, 2, 4, and 6).102 103

Complete the 4-dose regimen ≥1 week prior to potential exposure to Salmonella Typhi.102 103

Duration of response and optimum booster schedule not established.102 103 Revaccination with same 4-dose regimen recommended every 5 years in those with continuing or repeated exposure to Salmonella Typhi.102 103 115 (See Duration of Immunity under Cautions.)

Data not available regarding use as a booster in individuals previously vaccinated with typhoid Vi polysaccharide vaccine or any other typhoid vaccine.103

Children and Adolescents ≥2 Years of Age (Typhoid Vi Polysaccharide Vaccine; Typhim Vi)
IM

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

Administer the vaccine dose ≥2 weeks prior to potential exposure to Salmonella Typhi.102 123

Duration of response and optimum booster schedule not established.102 123 Revaccination with a single 0.5-mL dose recommended every 2 years in those with continuing or repeated exposure to Salmonella Typhi.102 115 123 (See Duration of Immunity under Cautions.)

Data not available regarding use as a booster in individuals previously vaccinated with typhoid vaccine live oral Ty21a or any other typhoid vaccine.123

Adults

Preexposure Vaccination Against Typhoid Fever in High-risk Groups
Adults ≥18 Years of Age (Typhoid Vaccine Live Oral Ty21a; Vivotif)
Oral

Primary immunization consists of 4 doses.102 103 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 first dose over a 1-week period (e.g., Sunday, Tuesday, Thursday, and Saturday or day 0, 2, 4, and 6).102 103

Complete the 4-dose regimen ≥1 week prior to potential exposure to Salmonella Typhi.102 103

Duration of response and optimum booster schedule not established.102 103 Revaccination with same 4-dose regimen recommended every 5 years in those with continuing or repeated exposure to Salmonella Typhi.102 103 115 (See Duration of Immunity under Cautions.)

Data not available regarding use as a booster in individuals previously vaccinated with typhoid Vi polysaccharide vaccine or any other typhoid vaccine.103

Adults ≥18 Years of Age (Typhoid Vi Polysaccharide Vaccine; Typhim Vi)
IM

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

Administer the vaccine dose ≥2 weeks prior to potential exposure to Salmonella Typhi.102 123

Duration of response and optimum booster schedule not established.102 123 Revaccination with a single 0.5-mL dose recommended every 2 years in those with continuing or repeated exposure to Salmonella Typhi.102 115 123 (See Duration of Immunity under Cautions.)

Data not available regarding use as a booster in individuals previously vaccinated with typhoid vaccine live oral Ty21a or any other typhoid vaccine.123

Special Populations

Hepatic Impairment

No specific dosage recommendations.103 123

Renal Impairment

No specific dosage recommendations.103 123

Geriatric Patients

No specific dosage recommendations.103 123

Cautions for Typhoid Vaccine

Contraindications

  • Typhoid vaccine live oral Ty21a: Hypersensitivity to any component of the vaccine or enteric-coated capsule.103

  • Typhoid Vi polysaccharide vaccine: Hypersensitivity to any ingredient in the formulation.123

Warnings/Precautions

Warnings

Individuals with Altered Immunocompetence

Typhoid vaccine live oral Ty21a: Contains live, attenuated bacteria and should not be used in individuals with congenital or acquired immunodeficiencies, including HIV-infected individuals and those receiving immunosuppressive therapy.103 155 225 Manufacturer states safety not established in individuals deficient in ability to mount a humoral or cell-mediated immune response;103 do not use in such individuals, regardless of any possible benefits.103 May be used in healthy immunocompetent individuals who reside in a household with immunocompromised patients.225

Typhoid Vi polysaccharide vaccine: May be used in individuals with altered immunocompetence, including HIV-infected patients; those who are severely immunocompromised because of congenital immunodeficiency, leukemia, lymphoma, aplastic anemia, generalized malignancy, or therapy with alkylating agents, antimetabolites, radiation, or corticosteroids; patients with solid organ transplants or chronic immunosuppressive therapy; or patients with asplenia, renal failure, diabetes mellitus, alcoholism, or alcoholic cirrhosis.102 134 155

ACIP states that recommendations concerning use of typhoid Vi polysaccharide vaccine in individuals with altered immunocompetence are the same as those for individuals who are not immunocompromised.134 However, immunization may be less effective in individuals with altered immunocompetence since antibody responses to vaccine antigens may be reduced in such individuals.123 134

Sensitivity Reactions

Hypersensitivity Reactions

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

Prior to administration, take all known precautions to prevent adverse reactions, including a review of patient’s history with respect to health status and possible sensitivity to the vaccine, similar vaccines, or vaccine components.103 123

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

Typhoid vaccine live oral Ty21a: Contains live, attenuated bacteria and the vaccine strain may be shed transiently in the stool of vaccinees.102 103 Secondary transmission of the vaccine bacteria not documented.102 103

Acute Illness

Decision whether to administer or delay vaccination in an individual with a current or recent febrile illness depends largely on the severity of symptoms and etiology of the illness.134

Typhoid vaccine live oral Ty21a: Manufacturer states do not administer to individuals with acute febrile illness or acute GI illness (e.g., diarrhea or vomiting).103 The oral vaccine requires replication in the gut;105 may not be effective if given during GI illness or at time of ongoing diarrhea.105 141

Typhoid Vi polysaccharide vaccine: Manufacturer states may be deferred in individuals with acute infection or febrile illness, unless withholding the vaccine poses greater risk.123

ACIP states that minor acute illness, such as mild upper respiratory tract infection (with or without fever) generally does not preclude vaccination, but defer vaccination in individuals with moderate or severe acute illness (with or without fever) until they have recovered from the acute phase of the illness.134

Limitations of Vaccine Effectiveness

Typhoid vaccines may not protect all vaccine recipients against typhoid fever.102 103 115 123 Vaccine-induced immunity can be overwhelmed by large inoculum of Salmonella Typhi.102

Regardless of vaccination status, take precautions against exposure to Salmonella Typhi (e.g., safe food and water precautions, frequent handwashing).102

Typhoid vaccine live oral Ty21a: It is essential that all 4 doses be administered as recommended.103 Complete the 4-dose regimen ≥1 week before potential exposure to Salmonella Typhi.102 103 (See Dosage under Dosage and Administration.)

Typhoid Vi polysaccharide vaccine: Administer dose ≥2 weeks before potential exposure to Salmonella Typhi.102 123 (See Dosage under Dosage and Administration.)

Will not provide protection against Salmonella Paratyphi or any Salmonella other than Salmonella Typhi and will not provide protection against other bacteria that cause enteric disease.103 123

Not used for treatment of typhoid fever.103 123 Do not use in individuals with acute Salmonella Typhi infection103 123 or in chronic typhoid carriers.123

No evidence to support use of typhoid vaccine to control common source outbreaks or disease following natural disasters or in individuals attending rural summer camps.103 123

Duration of Immunity

Duration of protection after primary immunization with typhoid vaccines and need for revaccination or subsequent doses not fully determined.102 103 123

Typhoid vaccine live oral Ty21a: Some evidence suggests that protection against typhoid fever persists for at least 5 years (possibly 7 years) after completion of 4-dose vaccination series.102 103 Revaccination recommended every 5 years in those with continuing or repeated exposure to Salmonella Typhi.102 103 115

Typhoid Vi polysaccharide vaccine: 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 Revaccination recommended every 2 years in individuals with continuing or repeated exposure to Salmonella Typhi.123

Improper Storage and Handling

Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune response in vaccinees.134

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.134

Typhoid vaccine live oral Ty21a: Unstable when exposed to ambient temperatures and must be shipped and stored at 2–8°C.103 126 131 Do not administer if it has been mishandled or has not been stored at recommended temperatures.103 126 131 (See Storage under Stability.)

Typhoid Vi polysaccharide vaccine: Not adversely affected by elevated temperatures (e.g., those that occur in tropical areas).124 126 (See Storage under Stability.) May be preferred in situations in which continuous refrigeration cannot be ensured.124 126

If there are concerns about mishandling, contact the manufacturer or state or local immunization or health departments for guidance on whether the vaccine is usable.134

Specific Populations

Pregnancy

Data not available regarding use of typhoid vaccines in pregnant women.102 115

Typhoid vaccine live oral Ty21a: Use during pregnancy only if clearly needed.103 ACIP states that live vaccines generally are contraindicated during pregnancy.102

Typhoid Vi polysaccharide vaccine: Use during pregnancy only when clearly needed.102 123 Manufacturer suggests that delaying vaccination until second or third trimester is a reasonable precaution to minimize possibility of teratogenicity.123

Lactation

Data not available regarding use of typhoid vaccines in nursing women.103 123

Typhoid vaccine live oral Ty21a: Not known whether distributed into milk.103 134 ACIP states that, although live vaccines do multiply in the woman’s body, most have not been shown to distribute into breast milk.134

Typhoid Vi polysaccharide vaccine: Not known whether distributed into milk.123 Manufacturer states use with caution.123 Although specific data not available, ACIP states breast-feeding generally not a contraindication for inactivated vaccines since inactivated organisms in the vaccines do not multiply within the body and such vaccines appear to pose no special problems for the woman or her nursing infant.115 134

Pediatric Use

Typhoid vaccine live oral Ty21a: Safety and efficacy not established in children <6 years of age;103 not indicated in this age group.103

Typhoid Vi polysaccharide vaccine: Safety and efficacy not established in children <2 years of age.123 As with other polysaccharide vaccines, antibody response may be inadequate in children <2 years of age.123 Manufacturer states a decision whether to use the vaccine in children <2 years of age depends on risk incurred by the child on the basis of the epidemiological context.123

Common Adverse Effects

Typhoid vaccine live oral Ty21a: Abdominal pain, nausea, headache, fever, diarrhea, vomiting, rash.102 103 115

Typhoid Vi polysaccharide vaccine: Injection site reactions (pain, tenderness, erythema, induration),102 123 125 130 135 malaise/generalized aches,123 129 130 headache,102 123 125 130 135 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

Other Vaccines

Typhoid vaccine live oral Ty21a: May be administered concurrently with or at any interval before or after inactivated vaccines, recombinant vaccines, polysaccharide vaccines, toxoids, or parenteral live vaccines.134 If use of the live, attenuated typhoid vaccine is warranted, do not delay because of administration of other live virus vaccines (injectable or intranasal).102 134

Typhoid Vi polysaccharide vaccine: Specific interaction studies not available.123 Because it is an inactivated vaccine, it generally can be administered concurrently with (using different syringes and different injection sites) or at any interval before or after inactivated vaccines, recombinant vaccines, polysaccharide vaccines, toxoids, or live vaccines.134

Specific Drugs

Drug

Interaction

Comments

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

Typhoid vaccine live oral Ty21a: Potential for anti-infectives with activity against Salmonella Typhi to inhibit multiplication of vaccine strain and decrease immune response to the vaccine102 103 115

Typhoid Vi polysaccharide vaccine: No specific studies123

Typhoid vaccine live oral Ty21a: Manufacturer states do not use in individuals receiving sulfonamides or other anti-infectives;103 ACIP states do not give vaccine until ≥3 days (72 hours) after last anti-infective dose and, if feasible, do not initiate or resume anti-infective until ≥3 days after last vaccine dose102

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

Typhoid vaccine live oral Ty21a: Potential for some antimalarials with antibacterial activity against Salmonella to interfere with immune response to the vaccine103 132 133

Typhoid vaccine live oral Ty21a: Decreased immune response to the vaccine when used concurrently with proguanil (200 mg daily; not available in US as single-entity preparation)103

Typhoid vaccine live oral Ty21a: No clinically important effect on immune response to the vaccine when given concurrently with chloroquine or mefloquine103

Typhoid Vi polysaccharide vaccine: No specific studies123

Typhoid vaccine live oral Ty21a: Manufacturer states do not give proguanil until ≥10 days after final vaccine dose;103 ACIP states the vaccine may be given concurrently with fixed combination of atovaquone and proguanil (atovaquone/proguanil) used for prophylaxis of malaria102

Typhoid vaccine live oral Ty21a: May be used in patients receiving chloroquine or mefloquine102 103

Cholera vaccine

Possibility that buffer component of cholera vaccine live oral may interfere with typhoid vaccine live oral Ty21a enteric-coated tablets;142 specific data not available142

When both vaccines indicated, some experts recommend giving first dose of typhoid vaccine live oral Ty21a ≥8 hours after cholera vaccine live oral142

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

No specific data regarding concurrent use with typhoid vaccines103 123

Typhoid vaccines may be given concurrently with or at any time before or after antibody-containing preparations102 134

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

Typhoid vaccine live oral Ty21a: Data not available;103 immune response may be reduced in those receiving immunosuppressive agents134

Typhoid vaccine live oral Ty21a: Do not use in patients receiving immunosuppressive therapy;103 134 225 experts state give the vaccine ≥4 weeks prior to initiation of immunosuppressive therapy;225 ACIP states do not give live, attenuated vaccines until ≥3 months after immunosuppressive therapy discontinued134

Measles, mumps, and rubella vaccine (MMR)

No specific data regarding concurrent administration with typhoid vaccines102 123 134

Typhoid vaccine live oral Ty21a: May be given concurrently with or at any interval before or after MMR134

Typhoid Vi polysaccharide vaccine: May be given concurrently with (using different syringes and different injection sites) or at any interval before or after MMR134

Meningococcal vaccine

Typhoid vaccine live oral Ty21a: Data not available regarding concurrent administration with meningococcal vaccine103

Typhoid Vi polysaccharide vaccine: Has been administered concurrently with MenACWY-D (Menactra) at different site without reduced antibody response123 or increased adverse effects140

Typhoid Vi polysaccharide vaccine: May be given concurrently with (using different syringes and different injection sites) or at any interval before or after MenACWY-D134

Varicella vaccine

No specific data regarding concurrent administration with typhoid vaccines102 123 134

Typhoid vaccine live oral Ty21a: May be given concurrently with or at any interval before or after varicella vaccine134

Typhoid Vi polysaccharide vaccines: May be given concurrently with (using different syringes and different injection sites) or at any interval before or after varicella vaccine134

Yellow fever vaccine

Typhoid vaccine live oral Ty21a: Concurrent administration with yellow fever vaccine does not interfere with immune response to either vaccine103 136

Typhoid Vi polysaccharide vaccine: Has been given concurrently with yellow fever vaccine with or without concomitant HepA vaccine (Vaqta) without any apparent decrease in immune response or increase in adverse effects109

Typhoid vaccine live oral Ty21a: May be given concurrently with or at any interval before or after yellow fever vaccine134 136

Typhoid Vi polysaccharide vaccine: May be given concurrently with (using different syringes and different injection sites) or at any interval before or after yellow fever vaccine134

Stability

Storage

Oral

Capsules

Typhoid vaccine live oral Ty21a: 2–8°C in a dry place protected from light.103

Must be shipped and stored only at 2–8°C.103 Potency adversely affected by exposure to temperatures exceeding 2–8°C.103

Any remaining capsules must be placed back in a refrigerator after each dose until 4-dose vaccination series completed.103

Does not contain thimerosal or any other preservatives.103

Parenteral

Injection, for IM Use

Typhoid Vi polysaccharide vaccine: 2–8°C.123 Do not freeze.123

Does not contain thimerosal, but contains phenol 0.25% as a preservative.123

Actions

  • Typhoid vaccine live oral Ty21a: Contains live Salmonella Typhi of the attenuated Ty21a strain and is commercially available for oral administration as enteric-coated capsules.102 103

  • Typhoid Vi polysaccharide vaccine: Sterile solution of purified cell surface Vi (“virulence”) polysaccharide extracted from Salmonella Typhi of the Ty2 strain in isotonic phosphate-buffered 0.9% sodium chloride for IM injection.102 123

  • Principal mode of transmission of typhoid infection is enteric (i.e., through fecal contamination and oral ingestion); most commonly acquired through food and/or water contaminated with feces from an infected person or a chronic typhoid carrier.102 103 105 115 138 139 141 Onset of illness usually gradual with signs and symptoms such as high fever, headache, malaise, anorexia, lethargy, abdominal pain and tenderness, splenomegaly, hepatomegaly, and rose spots.105 115 Invasive infection and mortality from typhoid infection typically higher in infants, elderly individuals, and those with immunosuppressive conditions, hemoglobinopathies, malignancies, and HIV infection.105

  • Efficacy of typhoid vaccine live oral Ty21a and typhoid Vi polysaccharide vaccine for prevention of typhoid fever appear to be comparable when the vaccines are administered as recommended;101 102 107 111 114 115 116 117 118 119 120 121 123 124 125 126 neither vaccine is expected to provide protection against typhoid fever in all vaccine recipients.102 103 105 115 123

  • Data obtained principally from studies involving populations where typhoid is endemic indicate that both vaccine types provide protection against typhoid fever in approximately 50–80% of vaccinees.105 115 Experience 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 typhoid vaccine live oral Ty21a or typhoid Vi polysaccharide vaccine in such individuals appear to be comparable to or higher than those attained in residents of endemic areas.102 103 123

  • Typhoid vaccine live oral Ty21a: Stimulates active immunity to typhoid fever by inducing production of both intestinal and serum antibodies and cell-mediated immune responses.102 103 126 Following primary immunization, serum titers of antibodies to the O antigen of Salmonella Typhi appear to correlate with protection against typhoid fever.126 Following oral administration, the vaccine strain replicates in the gut105 and may elicit a local immune response in the intestinal tract.103 Ability of Salmonella Typhi to elicit a protective immune response depends on possession by the bacilli of a complete lipopolysaccharide.103 The vaccine strain (Ty21a) in the oral vaccine is limited in its ability to produce a complete lipopolysaccharide;103 110 111 however, sufficient complete lipopolysaccharide apparently is produced to elicit an adequate immune response.103 110 111 115 119

  • Typhoid Vi polysaccharide vaccine: Stimulates active immunity to Salmonella 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 Salmonella 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

  • Reduced immune responses 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).123 134

  • Minimum titer of anti-typhoid antibodies conferring protection against typhoid following vaccination with typhoid vaccine not established.123

Advice to Patients

  • Prior to administration of typhoid vaccine, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient's legal representative (VISs are available at ).103 112 123

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

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

  • 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 In addition to vaccination, importance of taking other precautions against exposure to typhoid fever (e.g., safe food and water precautions, frequent handwashing).102 103 115 123

  • When using typhoid vaccine live oral Ty21a, importance of completing 4-dose vaccination series as directed (i.e., dose every other day for 4 doses).103 Advise vaccinees to swallow capsules whole with cool or lukewarm liquid on an empty stomach 1 hour before a meal and store remaining capsules in the refrigerator until entire 4-dose regimen is completed.102 103 Importance of completing the vaccination series ≥1 week prior to possible exposure to typhoid fever and importance of revaccination with the 4-dose series every 5 years if at continued or repeated risk of exposure.102 103 115

  • When using typhoid Vi polysaccharide vaccine, importance of receiving the dose ≥2 weeks prior to possible exposure to typhoid fever and importance of revaccination every 2 years if at continued or repeated risk of exposure.102 123 115

  • Importance of notifying clinicians if patient is immunocompromised since oral typhoid vaccine 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).102 103 115 (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.103 112 123

  • Importance of informing clinicians if any adverse reactions (including allergic reactions) occur with typhoid vaccine.103 112 123 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 .103 112 123 Also can be reported to the manufacturer at 800-533-5899 (PaxVax)103 or 800-822-2463 (Sanofi Pasteur).123

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.103 123 Importance of notifying clinicians if receiving therapy with anti-infective or antimalarial agents.103 (See Specific Drugs under Interactions.)

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.103 123

  • Importance of informing patients of other important precautionary information.103 123 (See Cautions.)

Preparations

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

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Typhoid Vaccine Live Oral Ty21a

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, enteric-coated

2–10 × 109 CFU of viable Salmonella Typhi Ty21a

Vivotif

PaxVax

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

Sanofi Pasteur

AHFS DI Essentials. © Copyright 2017, Selected Revisions July 24, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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

References

101. 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. [PubMed 2883393]

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