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Human Papillomavirus Vaccine

Class: Vaccines
ATC Class: J07BF01
VA Class: IM100
Brands: Cervarix, Gardasil, Gardasil 9

Introduction

Inactivated (recombinant) virus vaccine.1 2 37 105 134 Commercially available in US as a bivalent, a quadrivalent, and a nonavalent (9-valent) vaccine containing virus-like particles (VLPs) of the major capsid (L1) proteins of certain human papillomavirus (HPV) types.1 2 37 Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant (2vHPV; Cervarix) contains VLPs of HPV types 16 and 18;37 human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant (4vHPV; Gardasil) contains VLPs of HPV types 6, 11, 16, and 18;1 and human papillomavirus 9-valent vaccine, recombinant (9vHPV; Gardasil 9) contains VLPs of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.2 Used to stimulate active immunity to HPV serotypes represented in the vaccine.1 2 37 105 166 201 202

Uses for Human Papillomavirus Vaccine

Prevention of Disease Caused by HPV

2vHPV (Cervarix): Prevention of cervical cancer, cervical intraepithelial neoplasia (CIN) grades 1, 2, or worse, and cervical adenocarcinoma in situ (AIS) caused by HPV types 16 and 18 in females 9 through 25 years of age.37

4vHPV (Gardasil): Prevention of cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18 in females 9 through 26 years of age.1 Also used for prevention of precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18, including cervical intraepithelial neoplasia (CIN) grades 1 and 2/3, cervical adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN) grades 2 and 3, vaginal intraepithelial neoplasia (VaIN) grades 2 and 3, and anal intraepithelial neoplasia (AIN) grades 1, 2, and 3, in females 9 through 26 years of age.1

4vHPV (Gardasil): Prevention of anal cancer caused by HPV types 16 and 18 and prevention of precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18, including AIN grades 1, 2, and 3, in males 9 through 26 years of age.1

4vHPV (Gardasil): Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11 in females and males 9 through 26 years of age.1

9vHPV (Gardasil 9): Prevention of cervical, vulvar, vaginal, and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 in females 9 through 26 years of age.2 Also used for prevention of precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, including CIN grades 1 and 2/3, cervical AIS, VIN grades 2 and 3, VaIN grades 2 and 3, and AIN grades 1, 2, and 3, in females 9 through 26 years of age.2

9vHPV (Gardasil 9): Prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 and prevention of precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, including AIN grades 1, 2, and 3, in males 9 through 15 years of age.2

9vHPV (Gardasil 9): Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11 in females 9 through 26 years of age and males 9 through 15 years of age.2 Also recommended in certain males 16 through 26 years of age who are unvaccinated or incompletely vaccinated.202

Anogenital HPV is the most common sexually transmitted infection in US;105 166 201 approximately 79 million individuals already infected and 14 million more become infected each year (about 50% of cases are occurring in adolescents and young adults 15 through 24 years of age).105 166 201 344 Most HPV infections are asymptomatic and resolve spontaneously within 1–2 years, but some low-risk (nononcogenic) HPV types cause anogenital warts (condyloma acuminata) and some high-risk (oncogenic) HPV types are associated with persistent anogenital infections, dysplastic lesions, and development of cervical and other anogenital cancers (e.g., penile, vulvar, vaginal, anal).105 166 201 344 Low-risk HPV types 6 and 11 cause about 90% of all cases of genital warts and high-risk HPV types 16 and 18 cause about 70% of all cases of cervical and anogenital cancer in females and about 70% of all cases of anal cancer in males.105 166 201 344

All 3 HPV vaccines provide protection against disease caused by high-risk (oncogenic) HPV types 16 and 18;1 2 37 201 202 203 9vHPV (Gardasil 9) also provides protection against disease caused by 5 additional high-risk (oncogenic) types (HPV types 31, 33, 45, 52, 58).2 202 203

Both 4vHPV (Gardasil) and 9vHPV (Gardasil 9) provide protection against disease caused by the low-risk HPV types 6 and 11;1 2 201 202 2vHPV (Cervarix) does not provide protection against disease caused by these low-risk HPV types.201 202

USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and others recommend routine vaccination against HPV in all females 9 through 26 years of age using a 3-dose series of HPV vaccine.28 155 156 199 200 201 202 344 These experts state that 9vHPV (Gardasil 9), 4vHPV (Gardasil), or 2vHPV (Cervarix) can be used for routine vaccination in these females.200 202

ACIP, AAP, and others recommend routine vaccination against HPV in all males 9 through 21 years of age using a 3-dose series of 9vHPV (Gardasil 9) or 4vHPV (Gardasil).105 155 156 199 200 201 202 344 These experts also recommend vaccination with a 3-dose series of 9vHPV (Gardasil 9) or 4vHPV (Gardasil) in previously unvaccinated males 22 through 26 years of age who have sex with men or are immunocompromised, including those with HIV infection.155 200 202 344

ACIP states that 9vHPV (Gardasil 9) can be used to continue or complete the vaccination series in individuals who previously received 1 or more doses of 2vHPV (Cervarix) or 4vHPV (Gardasil).203

ACIP has made no recommendations to date regarding whether 9vHPV (Gardasil 9) should be used in individuals who already completed a 3-dose series of 2vHPV (Cervarix) or 4vHPV (Gardasil).203 Consider that, although 9vHPV (Gardasil 9) targets 5 additional high-risk HPV types, benefits of protection against these HPV types is limited mostly to females for prevention of cervical cancers and precancers.202 203 Data not available to date regarding efficacy or immunogenicity of 1, 2, or 3 doses of 9vHPV (Gardasil 9) in individuals who previously received 2vHPV (Cervarix) or 4vHPV (Gardasil);203 no evidence to date of any serious safety concerns in those who received 9vHPV (Gardasil 9) at least 12 months after completing a 3-dose series of 4vHPV (Gardasil).203

Ideally, administer HPV vaccine before potential exposure to HPV occurs through sexual activity; however, age-appropriate individuals who are sexually active and may have already been exposed to HPV should still be vaccinated to provide protection against infection with vaccine HPV types not already acquired.1 19 155 166 201

Prevaccination HPV testing or screening (e.g., Papanicolaou [Pap] testing or screening for high-risk HPV DNA, type-specific HPV DNA tests, HPV antibody test) not needed and not recommended.28 166 201 344 HPV vaccine can be used regardless of history of anogenital warts, abnormal Pap or HPV tests, or anogenital precancer.166 344

Does not prevent infection or disease caused by HPV types not represented in the vaccine.1 2 12 37 105 201 204

Does not provide protection against disease from vaccine and nonvaccine HPV types to which an individual has previously been exposed through sexual activity.1 2 37 201

Not used for treatment of active genital warts and not used for treatment of precancerous or dysplastic lesions (e.g., AIN, CIN, VIN, VaIN) or cervical, vulvar, vaginal, or anal cancer.1 2 105

Human Papillomavirus Vaccine Dosage and Administration

Administration

IM Administration

Administer by IM injection.1 2 37

Do not administer IV, sub-Q, or intradermally.1 2 37

Administer IM in deltoid region of upper arm1 2 37 or anterolateral aspect of upper thigh.1 2

To ensure delivery of vaccine into muscle, make IM injections at a 90° angle to the skin using a needle length appropriate for the individual’s age and body mass, thickness of adipose tissue and muscle at injection site, and injection technique.134

Shake well immediately prior to administration to provide a uniform, white, cloudy suspension.1 2 37 Discard if vaccine contains particulates, appears discolored, or cannot be resuspended with thorough agitation.1 2 37

Do not dilute; do not mix with any other vaccine or solution.1 2 37

Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination;1 2 37 134 may be accompanied by transient neurologic signs (e.g., visual disturbance, paresthesia, tonic-clonic limb movements).1 2 37 134 Occurs most frequently in adolescents and young adults.134 Have procedures in place to avoid falling injury and restore cerebral perfusion following syncope.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 (See Syncope under Cautions.)

May be given simultaneously with other age-appropriate vaccines.105 134 166 199 200 (See Interactions.) When multiple vaccines are administered during a single health-care visit, each parenteral vaccine should be given with a different syringe and at different anatomic sites.134 Injection sites should be separated by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.134

Dosage

Data not available regarding interchangeability of 2vHPV (Cervarix), 4vHPV (Gardasil), and 9vHPV (Gardasil 9).2 105 201 203 If the HPV vaccine previously administered is unknown or unavailable or if transitioning to 9vHPV (Gardasil 9), ACIP and AAP state that any HPV vaccine can be used to continue or complete the vaccination series in females to provide protection against HPV types 16 and 18 and either 9vHPV (Gardasil 9) or 4vHPV (Gardasil) can be used to continue or complete the vaccination series in males.105 201 202

If interruptions occur resulting in an interval between doses longer than recommended, there is no need to start the vaccination series over.105 166 201

Do not use an accelerated schedule (i.e., using intervals between doses shorter than recommended).105 166 If a dose is given using a shorter than recommended interval, some experts recommend repeating the dose.105

Pediatric Patients

Prevention of Disease Caused by HPV
Females 9 through 18 Years of Age (2vHPV; Cervarix)
IM

Primary immunization consists of a series of 3 doses.37 199 Each dose consists of entire contents (0.5 mL) of commercially available single-dose prefilled syringe.37

Manufacturer states give second and third dose 1 and 6 months, respectively, after first dose.37

Routine vaccination: ACIP, AAP, and others recommend giving first dose at 11 through 12 years of age (may be given to females as young as 9 years of age), second dose 1–2 months after first dose, and third dose 6 months after first dose (at least 4 months after second dose).105 199 201 202

Catch-up vaccination in females 13 through 18 years of age who have not previously received the complete 3-dose series: Use same intervals between doses as those recommended for routine vaccination.105 199 200

Females 9 through 18 Years of Age (4vHPV; Gardasil)
IM

Primary immunization consists of a series of 3 doses.1 199 Each dose consists of entire contents (0.5 mL) of commercially available single-dose prefilled syringe.1

Manufacturer states give second and third doses 2 and 6 months, respectively, after first dose.1

Routine vaccination: ACIP, AAP, and others recommend giving first dose at 11 through 12 years of age (may be given to females as young as 9 years of age), second dose 1–2 months after first dose, and third dose 6 months after first dose (at least 4 months after second dose).105 199 201 202

Catch-up vaccination in females 13 through 18 years of age who have not previously received the complete 3-dose series: Use same intervals between doses as those recommended for routine vaccination.105 199 200

Males 9 through 18 Years of Age (4vHPV; Gardasil)
IM

Primary immunization consists of a series of 3 doses.1 199 Each dose consists of entire contents (0.5 mL) of commercially available single-dose vial or prefilled syringe.1

Manufacturer states give second and third doses at 2 and 6 months, respectively, after first dose.1

Routine vaccination: ACIP, AAP, and others recommend giving first dose at 11 through 12 years of age (may be given to males as young as 9 years of age), second dose 1–2 months after first dose, and third dose 6 months after first dose (at least 4 months after second dose).105 199 201 202

Catch-up vaccination in males 13 through 18 years of age who have not previously received the complete 3-dose series: Use same intervals between doses as those recommended for routine vaccination.105 199 200

Females 9 through 18 Years of Age (9vHPV; Gardasil 9)
IM

Primary immunization consists of a series of 3 doses.2 202 Each dose consists of entire contents (0.5 mL) of commercially available single-dose vial or prefilled syringe.2

Manufacturer states give second and third doses 2 and 6 months, respectively, after first dose.2

Routine vaccination: ACIP, AAP, and others recommend giving first dose at 11 through 12 years of age (may be given to females as young as 9 years of age), second dose 1–2 months after first dose, and third dose 6 months after first dose (at least 4 months after second dose).105 199 201 202

Catch-up vaccination in females 13 through 18 years of age who have not previously received the complete 3-dose series: Use same intervals between doses as those recommended for routine vaccination.105 199 200

Continuation or completion of vaccination series in females 13 through 18 years of age who previously received 1 or more doses of 2vHPV (Cervarix) or 4vHPV (Gardasil): Use same intervals between doses as those recommended for routine vaccination.203

Males 9 through 15 and 16 through 18 Years of Age (9vHPV; Gardasil 9)
IM

Primary immunization consists of a series of 3 doses.2 202 Each dose consists of entire contents (0.5 mL) of commercially available single-dose vial or prefilled syringe.2

Manufacturer states give second and third doses 2 and 6 months, respectively, after first dose.2

Routine vaccination: ACIP, AAP, and others recommend giving first dose at 11 through 12 years of age (may be given to males as young as 9 years of age), second dose 1–2 months after first dose, and third dose 6 months after first dose (at least 4 months after second dose).105 199 201 202

Catch-up vaccination in males 13 through 18 years of age who have not previously received the complete 3-dose series: Use same intervals between doses as those recommended for routine vaccination.105 199 200

Continuation or completion of vaccination series in males 13 through 18 years of age who previously received 1 or more doses of 4vHPV (Gardasil): Use same intervals between doses as those recommended for routine vaccination.203

Adults

Prevention of Disease Caused by HPV
Females 19 through 25 Years of Age (2vHPV; Cervarix)
IM

Primary immunization consists of a series of 3 doses.37 200 Each dose consists of entire contents (0.5 mL) of commercially available single-dose vial or prefilled syringe.37

Manufacturer states give second and third doses at 1 and 6 months, respectively, after first dose.37

Routine or catch-up vaccination: Give second dose 1–2 months after first dose and third dose 6 months after first dose (at least 4 months after second dose).200 201 202

Females 19 Through 26 Years of Age (4vHPV; Gardasil)
IM

Primary immunization consists of a series of 3 doses.1 200 Each dose consists of entire contents (0.5 mL) of commercially available single-dose vial or prefilled syringe.1

Manufacturer states give second and third doses at 2 and 6 months, respectively, after first dose.1

Routine or catch-up vaccination: Give second dose 1–2 months after first dose and third dose 6 months after first dose (at least 4 months after second dose).200 201 202

Males 19 through 26 Years of Age (4vHPV; Gardasil)
IM

Primary immunization consists of a series of 3 doses.1 200 Each dose consists of entire contents (0.5 mL) of commercially available single-dose vial or prefilled syringe.1

Manufacturer states give second and third doses 2 and 6 months, respectively, after initial dose.1

Routine or catch-up vaccination: Give second dose 1–2 months after first dose and third dose 6 months after first dose (at least 4 months after second dose).200 201 202

Females 19 through 26 Years of Age (9vHPV; Gardasil 9)
IM

Primary immunization consists of a series of 3 doses.2 202 Each dose consists of entire contents (0.5 mL) of commercially available single-dose vial or prefilled syringe.2

Manufacturer states give second and third doses 2 and 6 months, respectively, after first dose.2

Routine or catch-up vaccination: Give second dose 1–2 months after first dose and third dose 6 months after first dose (at least 4 months after second dose).201 202

Continuation or completion of vaccination series in females 19 through 26 years of age who previously received 1 or more doses of 2vHPV (Cervarix) or 4vHPV (Gardasil): Use same intervals between doses as those recommended for routine vaccination.203

Males 19 through 26 Years of Age (9vHPV; Gardasil 9)
IM

Primary immunization consists of a series of 3 doses.2 202 Each dose consists of entire contents (0.5 mL) of commercially available single-dose vial or prefilled syringe.2

Routine or catch-up vaccination: Give second dose 1–2 months after first dose and third dose 6 months after first dose (at least 4 months after second dose).201 202

Continuation or completion of vaccination series in males 19 through 26 years of age who previously received 1 or more doses of 4vHPV (Gardasil): Use same intervals between doses as those recommended for routine vaccination.203

Special Populations

Hepatic Impairment

No specific dosage recommendations.1 2 37

Renal Impairment

No specific dosage recommendations.1 2 37

Geriatric Patients

Safety and efficacy not established in females or males ≥65 years of age.1 2 37

Cautions for Human Papillomavirus Vaccine

Contraindications

  • 2vHPV (Cervarix): History of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine.37

  • 4vHPV (Gardasil): Hypersensitivity to any vaccine component (including severe allergic reactions to yeast).1 19 Hypersensitivity to a previous dose.1

  • 9vHPV (Gardasil 9): Hypersensitivity to any vaccine component (including severe allergic reactions to yeast).2 Hypersensitivity to a previous dose of 9vHPV (Gardasil 9) or 4vHPV (Gardasil).2

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions (e.g., anaphylactic/anaphylactoid reactions, bronchospasm, urticaria, angioedema, generalized rash, erythema multiforme) reported.1 2 29 35 36 37

Most reported cases of anaphylaxis occurred following the first dose in the HPV vaccination series.36 In an Australian vaccination program in adolescents and women 12–26 years of age, the rate of anaphylaxis following HPV vaccination was 2.6 cases per 100,000 doses.36

The cause of hypersensitivity reactions following administration of HPV vaccine is unclear.35 36 When sensitivity tests were performed in individuals who had suspected anaphylaxis following a dose of HPV vaccine, skin prick or intradermal tests using the vaccine, yeast, or polysorbate 80 generally were negative.29 35 However, at least one patient had a positive intradermal test that was consistent with IgE-mediated hypersensitivity.35

Appropriate medical treatment and supervision must be available in case an anaphylactic reaction occurs following the administration of the vaccine.1 37

Yeast Allergy

4vHPV (Gardasil) and 9vHPV (Gardasil 9) are manufactured using Saccharomyces cerevisiae (yeast);1 2 each dose contains <7 mcg of yeast protein.1 2

Data from the Vaccine Adverse Event Reporting System (VAERS) indicate that recombinant yeast-derived vaccines pose a minimal risk for anaphylactic reactions in individuals with a history of allergic reactions to yeast.23

Latex Sensitivity

2vHPV (Cervarix): Some packaging components of prefilled single-dose syringes (i.e., tip caps) contain dry natural latex.37 Some individuals may be hypersensitive to natural latex proteins.37

ACIP states that vaccines supplied in vials or syringes containing dry natural rubber or natural rubber latex may be administered to individuals with latex allergies other than anaphylactic allergies (e.g., history of contact allergy to latex gloves), but should not be used in those with a history of severe (anaphylactic) allergy to latex unless the benefits of vaccination outweigh the risk of a potential allergic reaction.134 Contact-type allergy is the most common type of latex sensitivity.134

Syncope

Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity reported following vaccination with 2vHPV (Cervarix), 4vHPV (Gardasil), or 9vHPV (Gardasil 9).1 2 37 Tonic-clonic movements are transient and typically respond to restoration of cerebral perfusion by maintaining vaccinee in a supine or Trendelenburg position.1 2 37

Syncope also reported with other vaccines; occurs most frequently in adolescents and young adults.134

Observe vaccinee for 15 minutes following vaccination;1 2 37 have procedures in place to avoid falling injury and restore cerebral perfusion if syncope occurs.1 2 37 134 (See Administration under Dosage and Administration.)

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as a result of disease (e.g., congenital immunodeficiency, HIV infection, hematologic or generalized malignancy) or immunosuppressive therapy.105 155 156 200 Consider possibility that the immune response to the vaccine and efficacy may be reduced in these individuals.1 2 37 105 155 156 166 200 201

Although data not available regarding safety, efficacy, and immunogenicity in individuals with HIV infection, ACIP, AAP, CDC, and others state that recommendations regarding use of HPV vaccine in HIV-infected individuals are the same as those for individuals who are not infected with HIV.155 156 199 200 HIV-infected individuals 9 through 26 years of age should receive the usually recommended 3-dose HPV vaccination series,155 156 199 200 preferably with 4vHPV (Gardasil) or 9vHPV (Gardasil 9).202

Concomitant Illness

A decision to administer or delay vaccination in an individual with a current or recent acute illness depends on the severity of symptoms and etiology of the illness.134

ACIP states that HPV vaccines may be administered to age-appropriate individuals with minor acute illnesses such as diarrhea or mild upper respiratory tract infection (with or without fever), but recommends deferring vaccination in those with moderate or severe acute illness (with or without fever).134

Individuals with Bleeding Disorders

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 vaccine can be administered with reasonable safety.134 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.134 If patient is receiving therapy for hemophilia, administer the IM vaccine shortly after a scheduled dose of such therapy.134

Advise individual and/or their family about the risk of hematoma from IM injections.134

Limitations of Vaccine Effectiveness

May not protect all vaccine recipients against HPV infection.1 2 37

Vaccination with HPV vaccine does not substitute for routine cervical cancer screening.1 2 19 37 Female recipients should continue to undergo cervical cancer screening (e.g., Pap tests) according to current recommendations for such testing.1 2 37 105 166 201 202 344

Male and female recipients of HPV vaccine should continue anal cancer screening if recommended by health-care professional.1 2

HPV vaccine does not provide protection against disease due to HPV types not contained in the vaccine and does not provide protection from vaccine and non-vaccine HPV types an individual previously has been exposed to through sexual activity.1 2 37

May be used in patients who already have become infected with HPV (including HPV types represented in the vaccine).1 Although the vaccine will not provide any beneficial effects in regard to preexisting HPV infections, it will provide protection against the vaccine HPV types that the vaccinee has not already acquired.1 19

Not used for treatment of active genital warts.1 2

Not used for treatment of precancerous or dysplastic lesions (e.g., AIN, CIN, VIN, VaIN) and not used for treatment of cervical, vulvar, vaginal, or anal cancer.1 2

Duration of Immunity

Duration of immunity following the 3-dose vaccination series of 2vHPV (Cervarix), 4vHPV (Gardasil), or 9vHPV (Gardasil 9) not determined.1 2 37

Data to date suggest that 2vHPV induces anti-HPV antibody levels against HPV types 16 and 18 that are maintained for at least 6 years.37 51

Data to date suggest that 4vHPV induces anti-HPV antibody levels against HPV types 6, 11, 16, and 18 that are maintained for at least 5 years.20 22 166

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 (See Storage under Stability.)

Do not administer HPV vaccine that has been mishandled or has not been stored at the recommended temperature.134

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

2vHPV (Cervarix), 4vHPV (Gardasil), and 9vHPV (Gardasil 9): Category B.1 2 37

Manufacturers state use during pregnancy only when clearly needed.1 2 37

ACIP, AAP, ACOG, and others state HPV vaccine is not recommended for use in pregnant women.28 105 155 166 200 201 202

Although pregnancy testing not needed before initiation of the 3-dose HPV vaccine series,105 166 201 202 question sexually active individuals about the possibility of pregnancy.105 Delay initiation of the vaccine series until pregnancy is completed.166 If a woman is found to be pregnant after series initiated, defer any remaining doses until after completion of the pregnancy.28 105 166 200 201 202

Report any exposure to the vaccine that occurs during pregnancy to the manufacturer at 888-825-5279 (2vHPV; Cervarix),37 202 the manufacturer at 877-888-4231 (4vHPV; Gardasil),1 202 or the pregnancy registry at 800-986-8999 (9vHPV ; Gardasil 9).2 202 Alternatively, report to VAERS at 800-822-7967 or .1 2 37 202

Lactation

Not known whether HPV vaccine is distributed into milk.1 2 37

Manufacturers state use with caution in nursing women.1 2 37

ACIP, AAP, ACOG, and others state the vaccine may be used in nursing women.28 105 166 201

Pediatric Use

2vHPV (Cervarix): Safety and efficacy not established in females <9 years of age or in males of any age.37

4vHPV (Gardasil): Safety and efficacy not established in females or males <9 years of age.1

9vHPV (Gardasil 9): Safety and efficacy not established in females or males <9 years of age.2

Adults 18 through 64 Years of Age

2vHPV (Cervarix): Safety and efficacy not established in females ≥26 years of age or in males of any age.37

4vHPV (Gardasil): Safety and efficacy not established in females or males ≥27 years of age.1

9vHPV (Gardasil 9): Safety and efficacy not established in females or males ≥27 years of age.2

Geriatric Use

Safety and efficacy not established in females or males ≥65 years of age.1 2 37

Common Adverse Effects

2vHPV (Cervarix) in females 9 through 25 years of age: Injection site reactions (pain, redness, swelling), fatigue, headache, myalgia, GI symptoms, arthralgia.37 42

4vHPV (Gardasil) in females 9 through 26 years of age: Injection site reactions (pain, swelling, erythema, pruritus, bruising),1 headache,1 fever,1 nausea,1 dizziness,1 diarrhea,1 vomiting.1

4vHPV (Gardasil) in males 9 through 26 years of age: Injection site reactions (pain, erythema, swelling, hematoma), headache, fever, pharyngolaryngeal pain, diarrhea, nasopharyngitis, nausea.1

9vHPV (Gardasil 9) in females 9 through 26 years of age: Injection site reactions (pain, swelling, erythema, pruritus, hematoma), headache, fever, nausea, dizziness, fatigue, oropharyngeal pain.2

9vHPV (Gardasil 9) in males 9 through 26 years of age: Injection site reactions (pain, erythema, swelling, hematoma), headache, fever, nausea.2

Interactions for Human Papillomavirus Vaccine

Other Vaccines

Although specific studies may not be available evaluating concurrent administration with each antigen, simultaneous administration of HPV vaccine with other age-appropriate vaccines, including live virus vaccines, toxoids, or inactivated or recombinant vaccines, during the same health-care visit is not expected to affect immunologic responses or adverse reactions to any of the preparations.105 134 Immunization against HPV can be integrated with immunization against diphtheria, tetanus, pertussis, hepatitis B, influenza, meningococcal disease, pneumococcal disease, poliovirus, measles, mumps, rubella, and varicella.105 134 Each parenteral vaccine should be administered using a different syringe and different injection site.134

Specific Drugs

Drug

Interaction

Comments

Estrogens/progestins

No evidence to date that hormonal contraceptives alter immunologic response to HPV vaccine1 2 37

Hepatitis B (HepB) vaccine

Concomitant administration of 3-dose vaccination series of 4vHPV (Gardasil) and HepB vaccine (Recombivax HB) (at different injection sites) during the same health-care visits in women 16–24 years of age did not decrease antibody response to either vaccine and did not increase incidence of clinically important adverse effects compared with administration during separate visits1 25

May be administered concomitantly (using different syringes and different injection sites)1

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

Potential for decreased antibody response to vaccines1 2 37

Meningococcal vaccine

MCV4 (Menactra): Concomitant administration with 4vHPV (Gardasil) and Tdap (Adacel) at 3 different injection sites in adolescents 11 through 17 years of age did not interfere with antibody responses to any of the vaccine antigens;1 increased incidence of swelling at 4vHPV (Gardasil) injection site compared with administration of 4vHPV (Gardasil) alone1

MCV4 (Menactra): Concomitant administration with 9vHPV (Gardasil 9) and Tdap (Adacel) at 3 different injection sites in adolescents 11 through 15 years of age did not interfere with antibody responses to any of the vaccine antigens;2 increased incidence of swelling at 9vHPV (Gardasil 9) injection site compared with administration of 9vHPV (Gardasil 9) alone2

May be administered concomitantly (using different syringes and different injection sites)1 2 233

Tetanus toxoid and reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap)

Tdap (Adacel): Concomitant administration with MCV4 (Menactra) and either 4vHPV (Gardasil) or 9vHPV (Gardasil 9) at 3 different injection sites in adolescents did not interfere with antibody responses to any of the antigens;1 2 increased incidence of swelling at HPV vaccine injection site compared with administration of HPV vaccine alone1 2

May be administered concomitantly (using different syringes and different injection sites)1 2 105 134 199

Stability

Storage

Parenteral

Suspension, for IM Use (2vHPV; Cervarix)

2–8°C.37 Protect from freezing;37 discard if exposed to freezing temperatures.37

A fine, white deposit with a clear, colorless supernatant may be observed during storage; not considered a sign of deterioration.37

Does not contain thimerosal or any other preservative.37

Suspension, for IM Use (4vHPV; Gardasil)

2–8°C.1 Should be administered as soon as possible after removal from refrigeration, but can be kept at temperatures ≤25°C for up to 72 hours.1 Protect from light and freezing.1

Does not contain thimerosal or any other preservatives or antibiotics.1

Suspension, for IM Use (9vHPV; Gardasil 9)

2–8°C.2 Should be administered as soon as possible after removal from refrigeration, but can be kept between 8–25°C for up to 72 hours.2 Protect from light and freezing.2

Does not contain thimerosal or any other preservatives or antibiotics.2

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  • 2vHPV (Cervarix) is a suspension of VLPs of the major capsid proteins of 2 HPV types (types 16 and 18) classified as high-risk (oncogenic) types.37 201 The type-specific VLPs are replicated separately using recombinant DNA technology in Trichoplusia ni insect cells; purified using chromatographic and filtration methods; and adsorbed onto an aluminum-containing adjuvant system (AS04).37

  • 4vHPV (Gardasil) is a suspension of the VLPs of the major capsid proteins of 4 HPV types, including 2 high-risk (oncogenic) types (HPV types 16 and 18) and 2 low-risk (nononcogenic) types (HPV types 6 and 11).1 201 The type-specific VLPs are prepared separately using recombinant DNA technology in Saccharomyces cerevisiae; purified by a series of chemical and physical methods; and adsorbed onto preformed aluminum-containing adjuvant (amorphous aluminum hydroxyphosphate sulfate).1

  • 9vHPV (Gardasil 9) is a suspension of the VLPs of the major capsid proteins of 9 HPV types (types 6, 11, 16, 18, 31, 33, 45, 52, 58).2 This includes HPV VLPs representing the 4 HPV types contained in 4vHPV (Gardasil) and 5 additional high-risk (oncogenic) HPV types.2 202 The type-specific VLPs are prepared separately using recombinant DNA technology in S. cerevisiae; purified by a series of chemical and physical methods; and adsorbed onto preformed aluminum-containing adjuvant (amorphous aluminum hydroxyphosphate sulfate).2

  • HPV vaccine VLPs are structurally indiscernible from native HPV virions and stimulate active immunity to the HPV types represented in the vaccine.4 5 12 14 The VLPs do not contain DNA and are noninfectious.4 5 12 14

  • Vaccination with a 3-dose series of 2vHPV (Cervarix) can prevent disease caused by HPV types 16 and 18, including cervical cancer and precancerous genital lesions.37 Data from studies evaluating the bivalent vaccine in females 15 through 25 years of age indicate that >98% of vaccine recipients developed antibodies to HPV types 16 and 18; mean antibody titers peaked 1 month following the third vaccine dose and then declined to a level that was maintained for up to 76 months after study initiation.37 38 39 In another study, 99.5% of females 15 through 25 years of age who were seronegative at baseline were seropositive for antibodies to HPV types 16 and 18 at 1 month after the third vaccine dose.37 48

  • Vaccination with a 3-dose series of 4vHPV (Gardasil) can prevent diseases caused by HPV types 6, 11, 16, and 18, including genital warts caused by HPV types 6 and 11; cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18.1 Data from studies evaluating the quadrivalent vaccine indicate that 99.4–99.9% of female vaccine recipients and 97.4–99.9% of male vaccine recipients 9 through 26 years of age develop antibodies to HPV types 6, 11, 16, and 18 by 1 month following the third dose of vaccine.1 In clinical trials, mean antibody titers of anti-HPV 6, 11, 16, and 18 peaked in vaccinees at 1 month after the third vaccine dose.1

  • Vaccination with a 3-dose series of 9vHPV (Gardasil 9) can prevent diseases caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, including genital warts caused by HPV types 6 and 11; cervical, vulvar, vaginal, and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; and precancerous anal and genital lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.2 202 204 Data from studies evaluating the 9-valent vaccine indicate that at least 99.5% of female and male vaccine recipients 9 through 26 years of age develop antibodies to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 by 1 month after the third dose of vaccine.2 202 In clinical trials, mean antibody titers of anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 peaked in vaccinees at 1 month after the third vaccine dose.2

  • Low-risk HPV types 6 and 11 cause about 90% of all cases of genital warts and high-risk HPV types 16 and 18 cause about 70% of all cases of cervical cancer, AIS, CIN 3, VIN 2/3, and VaIN 2/3 and 50% of all cases of CIN 2.105 166 201 202 344

  • High-risk HPV types 31, 33, 45, 52, and 58 cause about 14% of HPV-associated cancers in females (approximately 2800 cases annually) and 4% of HPV-associated cancers in males (approximately 550 cases annually).202 203

  • Minimum antibody titers that provide protection against infection with HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 not established to date.1 2 37 38 43

Advice to Patients

  • Prior to administration of each vaccine dose, provide copy of manufacturer’s patient information to the patient and/or patient’s parent or guardian.1 2 37 Also provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient’s legal representative (VISs are available at ).1 2 37 57 58 59

  • Advise patient and/or patient’s parent or guardian of the risks and benefits of HPV vaccination.1 2 37

  • Advise patient and/or patient’s parent or guardian that HPV vaccine does not provide protection against disease from vaccine and nonvaccine HPV types that an individual has previously been exposed to through sexual activity.1 2 37

  • Advise patient and/or patient’s parent or guardian that vaccination with HPV vaccine is not a substitute for routine cervical cancer screening.1 2 37 Vaccine recipients should continue to receive routine cervical cancer screening (e.g., Pap tests) according to current guidelines for such testing.1 2 37 105 201 202 344

  • Advise vaccine recipients not to discontinue anal cancer screening if it has been recommended by a health-care provider.1 2

  • Advise vaccine recipients to continue to practice behaviors that limit the risk of HPV exposure (e.g., sexual abstinence, monogamy, limited number of sexual partners, use of condoms).19 201 344

  • Importance of completing the 3-dose vaccination series of HPV vaccine, unless contraindicated.1 2 37

  • Advise patient and/or patient’s parent or guardian that fainting, sometimes resulting in falling with injury, has been reported following vaccination with HPV vaccine and the patient should be observed for 15 minutes after administration.1 2 19 37

  • Importance of contacting clinicians if a hypersensitivity reaction (difficulty breathing, wheezing, hives, rash, swollen glands [neck, armpit, or groin], joint pain, weakness, chest pain) occurs following a vaccine dose.1 2 Clinicians or individuals can report any adverse reactions that occur following vaccination to VAERS at 800-822-7967 or .1 2 37

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1 37

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 2 37 Advise vaccine recipients that HPV vaccine is not recommended for use in pregnant women1 2 19 28 37 or women who plan on becoming pregnant during the 3-dose vaccination series.2 37 If any exposure to HPV vaccine occurs during pregnancy, vaccinees and their clinicians are encouraged to contact the manufacturer at 888-825-5249 (2vHPV; Cervarix),37 202 the manufacturer at 877-888-4231 (4vHPV; Gardasil),1 202 the pregnancy registry at 800-986-8999 (9vHPV; Gardasil 9),2 202 or VAERS at 800-822-7967 or .1 2 37 202

  • Importance of informing patients of other important precautionary information.1 2 37 (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.

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injectable suspension, for IM use

20 mcg of HPV type 16 L1 and 20 mcg of HPV type 18 L1 protein per 0.5 mL

Cervarix

GlaxoSmithKline

Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injectable suspension, for IM use

20 mcg of HPV type 6 L1, 40 mcg of HPV type 11 L1, 40 mcg of HPV type 16 L1, and 20 mcg of HPV type 18 L1 protein per 0.5 mL

Gardasil

Merck

Human Papillomavirus 9-valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine, Recombinant

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injectable suspension, for IM use

30 mcg of HPV type 6 L1, 40 mcg of HPV type 11 L1, 60 mcg of HPV type 16 L1, 40 mcg of HPV type 18 L1, 20 mcg of HPV type 31 L1, 20 mcg of HPV type 33 L1, 20 mcg of HPV type 45 L1, 20 mcg of HPV type 52 L1, and 20 mcg of HPV type 58 L1 protein per 0.5 mL

Gardasil 9

Merck

AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions December 9, 2015. 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

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40. Paavonen J, Naud P, Salmerón J et al. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009; 374:301-14. [PubMed 19586656]

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54. Palefsky JM, Giuliano AR, Goldstone S et al. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Engl J Med. 2011; 365:1576-85. [PubMed 22029979]

55. Munoz N, Manalastas R, Pitisuttithum P et al. Safety, immonogenicity, and efficacy of quadrivalent human papilomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial. ,Lancet. 2009; 373:1949-57. [PubMed 19493565]

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