Drug updated on 11/4/2024
| Dosage Form | Injection (intramuscular; 0.5 mL) |
| Drug Class | Vaccines |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in girls and women 9- through 26 years of age for the prevention of infection caused by the Human Papillomavirus (HPV) types 6, 11, 16, and 18 and the following diseases associated with the HPV types included in the vaccine: Ccervical, vulvar, and vaginal and anal cancer caused by HPV types 16 and 18, and genital warts (condyloma acuminata) caused by HPV types 6 and 11
- Indicated for the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18: Cervical adenocarcinoma in situ (AIS), cervical intraepithelial neoplasia (CIN) grade 2 and grade 3, vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3, vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3, and cervical intraepithelial neoplasia (CIN) grade 1
- Indicated in boys and men 9 through 26 years of age for the prevention of infection caused by HPV types 6, 11, 16, and 18 and the following diseases associated with the HPV types included in the vaccine: aAnal cancer caused by HPV types16 and 18, genital warts (condyloma acuminata) caused by HPV types 6 and 11, and anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, and 18.
Latest News
Summary
- This summary is based on the review of 16 systematic review(s)/meta-analysis(es). [1-16]
- The quadrivalent (4v-HPV) and bivalent (2v-HPV) vaccines show comparable effectiveness in preventing HPV (Human papillomavirus) infections involving carcinogenic strains (16/18/31/33/45/52/58) among female HPV infection-naive populations, while the 9-valent HPV (9v-HPV) vaccine demonstrates superior effectiveness against HPV 31/33/45/52/58 infections.
- For persistent HPV infections, the 9v-HPV vaccine was most effective for HPV 16 at 97%, and the 2v-HPV (Cecolin) vaccine was most effective for HPV 18 at 98%. The 4v-HPV vaccine showed effectiveness of 99% and 97% against CIN2+ associated with HPV 16 and 18, respectively, while 9v-HPV was ≥ 95% effective against persistent infections involving HPV 31, 33, 45, 52, and 58.
- HPV vaccination programs contributed to significant reductions in genital infections and HPV-related disease outcomes, with notable effectiveness among women with prior or ongoing HPV-related anogenital disease and individuals with recurrent respiratory papillomatosis (RRP).
- Studies report comparable antibody responses between two-dose and three-dose HPV vaccine schedules, with high immunogenicity in people living with HIV (PLHIV), who exhibit robust seroconversion rates that remain high over time despite slight antibody titer declines.
- No significant risk of premature ovarian insufficiency (POI) was observed with the quadrivalent HPV vaccine (4v-HPV) compared to controls or other HPV vaccines (2v-HPV and 9v-HPV).
- Inadvertent HPV vaccination during pregnancy did not significantly increase the risk of adverse pregnancy outcomes, including spontaneous abortion, stillbirth, small for gestational age, preterm birth, or birth defects.
- Most studies found no significant difference in serious adverse events between vaccinated groups and controls, with the nonavalent vaccine showing slightly more local adverse events (e.g., pain, redness) compared to the quadrivalent vaccine.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) Prescribing Information. | 2015 | Merck & Co., Inc., Rahway, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Human papillomavirus vaccination: good clinical practice recommendations from the Federation of Obstetric and Gynecological Societies of India. | 2020 | The Journal of Obstetrics and Gynaecology Research |
| Human papillomavirus vaccination 2020 guideline update: American Cancer Society guideline adaptation. | 2020 | Cancer Journal for Clinicians |
| Multidisciplinary, evidence-based consensus guidelines for human papillomavirus (HPV) vaccination in high-risk populations, Spain, 2016. | 2019 | Eurosurveillance |