Efficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA Trials.
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Kreimer Aimée R, Struyf Frank, Del Rosario-Raymundo Maria Rowena, Hildesheim Allan, Skinner S Rachel, Wacholder Sholom, Garland Suzanne M, Herrero Rolando, David Marie-Pierre, Wheeler Cosette M, Costa Rica Vaccine Trial Study Group Authors, González Paula, Jiménez Silvia, Lowy Douglas R, Pinto Ligia A, Porras Caroline, Rodriguez Ana Cecilia, Safaeian Mahboobeh, Schiffman Mark, Schiller John T, Schussler John, Sherman Mark E, PATRICIA Study Group Authors, Bosch F Xavier, Castellsague Xavier, Chatterjee Archana, Chow Song-Nan, Descamps Dominique, Diaz-Mitoma Francisco, Dubin Gary, Germar Maria Julieta, Harper Diane M, Lewis David J M, Limson Genara, Naud Paulo, Peters Klaus, Poppe Willy A J, Ramjattan Brian, Romanowski Barbara, Salmeron Jorge, Schwarz Tino F, Teixeira Julio C, Tjalma Wiebren A A, HPV PATRICIA Principal Investigators/Co-Principal Investigator Collaborators, GSK Vaccines Clinical Study Support Group
Аннотация
METHODS: Summary data from the Costa Rica Vaccine Trial (CVT; NCT00128661) and ~the PATRICIA trial (NCT001226810), two phase 3, double-blind, randomised controlled clinical trials of the HPV-16/18 AS04-adjuvanted vaccine in young women, were combined in a post-hoc analysis (GlaxoSmithKline [GSK] e-track number 202142) to investigate the efficacy of fewer than three doses of the HPV-16/18 vaccine after 4 years of follow-up. Women were randomly assigned to receive three doses of the HPV-16/18 vaccine or to a control vaccine; yet, some received fewer doses. After exclusion of women with less than 12 months of follow-up or those who were HPV-16/18 DNA-positive at enrolment (for the HPV-16/18 endpoint), we calculated vaccine efficacy against one-time detection of incident HPV infections after three, two, and one dose(s). The primary study endpoint was one-time detection of first incident HPV-16/18 infections accumulated during the follow-up phase.
FINDINGS: We assessed vaccine efficacy against incident HPV-16/18 infection in the modified total vaccinated cohort (22 327 received three doses, 1185 two doses, 543 one dose). Vaccine efficacy against incident HPV-16/18 infections for three doses was 77·0% (95% CI 74·7-79·1), two doses was 76·0% (62·0-85·3), and one dose was 85·7% (70·7-93·7). Vaccine efficacy against incident HPV-31/33/45 infections for three doses was 59·7% (56·0-63·0), two doses was 37·7% (12·4-55·9), and one dose was 36·6% (-5·4 to 62·2). Vaccine efficacy against incident HPV-16/18 infection for two-dose women who received their second dose at 1 month was 75·3% (54·2-87·5) and 82·6% (42·3-96·1) for those who received the second dose at 6 months (CVT data only). Vaccine efficacy against HPV-31/33/45 for two-dose women who received their second dose at 6 months (68·1%, 27·0-87·0; CVT data only), but not those receiving it at one month (10·1%, -42·0 to 43·3), was similar to the three-dose group.
INTERPRETATION: 4 years after vaccination of women aged 15-25 years, one and two doses of the HPV-16/18 vaccine seem to protect against cervical HPV-16/18 infections, similar to the protection provided by the three-dose schedule. Two doses separated by 6 months additionally provided some cross-protection. These data argue for a direct assessment of one-dose efficacy of the HPV-16/18 vaccine.
FUNDING: US National Cancer Institute, National Institutes of Health Office of Research on Women's Health, and Ministry of Health of Costa Rica (CVT); GlaxoSmithKline Biologicals SA (PATRICIA).