Dose-ranging studies of the safety and immunogenicity of human papillomavirus Type 11 and Type 16 virus-like particle candidate vaccines in young healthy women

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...

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Bibliographic Details
Published in:Vaccine 2004-07, Vol.22 (21), p.2943-2952
Main Authors: Fife, Kenneth H, Wheeler, Cosette M, Koutsky, Laura A, Barr, Eliav, Brown, Darron R, Schiff, Melissa A, Kiviat, Nancy B, Jansen, Kathrin U, Barber, Harriet, Smith, Judith F, Tadesse, Amha, Giacoletti, Katherine, Smith, Paula R, Suhr, Gretchen, Johnson, Daniel A
Format: Article
Language:English
Subjects:
Adolescent
Adult
Antibodies, Viral - analysis
Antibodies, Viral - biosynthesis
Applied microbiology
Biological and medical sciences
Capsid Proteins - immunology
Cervical cancer
Cervical intraepithelial neoplasia
Condyloma acuminata
Confidence intervals
Controlled trials
Dose-Response Relationship, Immunologic
Double-Blind Method
Endpoint Determination
Female
Fundamental and applied biological sciences. Psychology
Human papilloma virus 11
Human papillomavirus
Human papillomavirus 11
Human papillomavirus 16
Humans
Immunization Schedule
Infections
Medical sciences
Microbiology
Miscellaneous
Papillomaviridae - immunology
Papillomavirus Vaccines
Studies
Tumors
Vaccines
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Viral vaccines
Viral Vaccines - administration & dosage
Viral Vaccines - adverse effects
Viral Vaccines - immunology
Virology
Womens health
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Summary: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.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2003.11.058