Two candidate vaccines to prevent infection with human papillomavirus (HPV) Types 11 and 16 were studied in similar double-blind, placebo-controlled, dose-escalation trials. L1 virus-like particle (VLP) vaccines were made from recombinant L1 capsid protein of HPV11 or HPV16. Participants received 10, 20, 50, or 100 μg of HPV11 L1 VLPs, 10, 40, or 80 μg of HPV16 L1 VLPs, or placebo at Months 0, 2, and 6. Serum geometric mean antibody levels at Month 7 were 258, 644, 647, and 1112 milli-Merck units (mMU)/ml for the 10, 20, 50, and 100 μg doses of the HPV11 L1 VLP vaccine, respectively, and 479, 808, and 732 mMU/ml for the 10, 40, and 80 μg doses of the HPV16 L1 VLP vaccine, respectively. Antibody to HPV11 and 16 was still present at Month 36 in 96.8 and 93.5% of vaccinees, respectively. Both vaccines were well tolerated and were associated with only mild to moderate injection-site reactions.
- Cervical intraepithelial neoplasia
- Condyloma acuminata
- Controlled trials
- Viral vaccines
ASJC Scopus subject areas
- Infectious Diseases
- Public Health, Environmental and Occupational Health