Update on human papillomavirus vaccination: Where are we now?

Table 1 Phase III efficacy in women

	Future I	Future II	Patricia	CVT	Broad spectrum HPV vaccine study
Vaccine	Gardasil®	Gardasil®	Cervarix®	Cervarix®	Gardasil9®
Funding	Merck and Co., Inc.	Merck and Co., Inc.	GlaxoSmithKline	National Cancer Inst.	Merck and Co., Inc.
Number enrolled	6463	12167	18729	7466	14215
Number of countries	16	13	14	1	14
Duration of trial	4 yr	4 yr	4 yr	4 yr	4 yr
Age (yr)	16-24	15-26	15-25	18-25
Lifetime sexual partners	< 4	< 4	< 6	No restriction	< 4
Exclusions	Pregnancy, history of abnormal Pap smear or genital warts	Pregnancy, history of abnormal Pap smear	Pregnancy, breastfeeding, history of colposcopy, autoimmune disease/immunodeficiency, HPV 16/18-associated CIN2+ at enrollment	Pregnancy, breastfeeding, history of immunosuppression, hysterectomy, hepatitis A vaccination	Prior abnormal Pap smear, > 4 lifetime sexual partners, no prior abnormal finding on cervical biopsy
Primary endpoint	Incidence of vaccine-type HPV associated CIN1-3, AIS or cancer, combined incidence of vaccine-type HPV associated anogenital warts, VIN/VaIN1-3 or cancer	HPV 16 or 18 associated CIN2/3	Incidence of HPV 16 or 18 CIN2 or greater	HPV 16 or 18 persistent infection (12 mos.) or HPV 16 or 18 associated CIN2+	High-grade cervical, vulvar, and vaginal disease
Mean follow-up time	3 yr	3 yr	14.8 mo
Immunogenicity	99.5% seroconversion after 3 doses	99% seroconversion to vaccine-associated HPV types	99.5% seroconversion rates in women aged 15-25 yr		Non-inferior to quadrivalent vaccine

CVT: Costa Rica HPV Vaccine Trials; HPV: Human papillomavirus; VIN/VaIN: Vulvar/vaginal intraepithelial neoplasia.