Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is a non-infectious recombinant 9-valent vaccine against HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil 9 is specifically indicated for the following:
Gardasil 9 is supplied as a suspension for intramuscular injection. Each dose of Gardasil 9 is 0.5-mL. Administer Gardasil 9 as follows:
Age Regimen: 9 through 14 years Schedule: 2-dose 0, 6 to 12 months*; 3-dose 0, 2, 6 months
*If the second dose is administered earlier than 5 months after the first dose, administer a third dose at least 4 months after the second dose.
Age Regimen: 15 through 45 years Schedule: 3-dose 0, 2, 6 months
The FDA approval for Gardasil 9 was based on four clinical trials, which included two Phase II trials and two Phase III trials also known as FUTURE (Females United To Unilaterally Reduce Endo/Ectocervical Disease) I and II clinical trials. All four clinical studies were placebo-controlled, double-blind, randomized trials, which enrolled a total of 20,541 women between the age of 16 and 26. No new cases of HPV-16 or 18 related cervical intraepithelial neoplasia (CIN) 2/3 or adenocarcinoma in situ (AIS) were reported in patients treated with the full treatment regimen of Gardasil 9 compared to 53 cases reported in the placebo group. Four new cases of HPV-6, 11, 16, or 18 related CIN or AIS were reported in Gardasil 9-administered patients, versus 83 for placebo, and one case of HPV-6, 11, 16, or 18 related genital warts was reported in the Gardasil 9-group, compared to 91 for placebo.
Gardasil 9 was also assessed in an active comparator-controlled, double-blind, randomized clinical trial in girls and women between the age of 16 and 26. The study enrolled 14,204 women who were vaccinated without pre-screening for the presence of HPV infection. It compared clinical efficacy of Gardasil 9 and Gardasil for five additional HPV types. In clinical trials, Gardasil 9 demonstrated 96.7% efficacy against the combined incidence of cervical, vaginal and vulvar cancers caused by HPV types 31, 33, 45, 52 and 58. It showed 98.6% efficacy against CIN 1, 96.3% efficacy against CIN 2 / 3 or AIS, 93.8% efficacy against vulvar or vaginal disease, 96.2% efficacy against persistent HPV infection six months or longer. It also showed 96.1% efficacy against persistent HPV infection 12 months or longer, 92.6% efficacy against abnormal pap tests, 96.9% efficacy against biopsy, and 87.5% efficacy against definitive therapy, related to HPV types 31, 33, 45, 52 and 58.
Adverse effects associated with the use of Gardasil 9 may include, but are not limited to, the following:
In girls and women 9 through 26 years of age:
In boys and men 9 through 26 years of age:
Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is a non-infectious recombinant 9-valent vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. HPV only infects human beings. Animal studies with analogous animal papillomaviruses suggest that the efficacy of L1 VLP vaccines may involve the development of humoral immune responses. Efficacy of Gardasil 9 against anogenital diseases related to the vaccine HPV types in human beings is thought to be mediated by humoral immune responses induced by the vaccine, although the exact mechanism of protection is unknown.
For additional information regarding Gardasil 9 and HPV related cancers, please visit the Gardasil 9 website.