Impact of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine in a sexually active population of North American women.
OBJECTIVE
The purpose of this study was to inform policy regarding human papillomavirus (HPV) vaccination in North America. We measured the clinical impact of HPV-6/-11/-16/-18 vaccination in North American women.


METHODS
The study enrolled 21,954 women, the majority aged 16-25, across 5 studies of a quadrivalent HPV vaccine or its HPV-16 vaccine prototype. The North American subjects (n = 5996) were pooled from these trials, and the prevalence of HPV-6/-11/-16/-18 exposure was measured. The impact of vaccination on the burden of anogenital HPV lesions in an intention-to-treat population (regardless of enrollment HPV status) was calculated.


RESULTS
At enrollment, the median age was 20 years; 13% of the women had had a Papanicolaou test abnormality, and 76% of the women had negative tests results for all 4 vaccine HPV types. With approximately 3 years of follow-up evaluations in the intention-to-treat population (regardless of enrollment HPV status), vaccination reduced the rate of HPV-16- and -18-related precancers and HPV-6/-11/-16/-18-related genital lesions by 66.4% (95% CI, 42.7%-81.1%) and 57.7% (95% CI, 27.3%-76.3%), respectively.


CONCLUSIONS
The administration of HPV vaccine to sexually active North American women reduced the burden of HPV-6/-11/-16/-18-related disease. Catch-up vaccination programs in this population are warranted.
Barr
Eliav
E
Department of Vaccines and Biologics Clinical Research, Merck Research Laboratories, North Wales, PA 19454-1099, USA. Eliav_barr@merck.com
Gause
Christine K
CK
Bautista
Oliver M
OM
Railkar
Radha A
RA
Lupinacci
Lisa C
LC
Insinga
Ralph P
RP
Sings
Heather L
HL
Haupt
Richard M
RM
D000293:Adolescent; D000328:Adult; D052685:Alphapapillomavirus; D002170:Canada; D005260:Female; D005831:Genital Diseases, Female / Q000517:prevention & control* / Q000821:virology*; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D030361:Papillomavirus Infections / Q000517:prevention & control*; D053918:Papillomavirus Vaccines; D011647:Puerto Rico; D012725:Sexual Behavior; D014481:United States; D014860:Warts / Q000517:prevention & control* / Q000821:virology*
D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines