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Durability of Cross-Protection by Different Schedules of the Bivalent HPV Vaccine: The CVT Trial.

ABSTRACT: BACKGROUND:The Costa Rica HPV Vaccine Trial has documented cross-protection of the bivalent HPV vaccine against HPV31/33/45 up to 7 years after vaccination, even with one dose of the vaccine. However, the durability of such protection remains unknown. Here, we evaluate the efficacy of different schedules of the vaccine against HPV31/33/45 out to 11?years postvaccination, expanding to other nontargeted HPV types. METHODS:We compared the rates of HPV infection in vaccinated women with the rates in a comparable cohort of unvaccinated women. We estimated the average vaccine efficacy (VEavg) against incident infections and tested for a change in VE over time. RESULTS:Among 3-dose women, we observed statistically significant cross-protection against HPV31/33/45 (VEavg = 64.4%, 95% confidence interval [CI] = 57.7% to 70.0%). Additionally, we observed borderline, statistically significant cross-protection against HPV35 (VEavg = 23.2%, 95% CI = 0.3% to 40.8%) and HPV58 (VEavg = 21.2%, 95% CI = 4.2% to 35.3%). There was no decrease in VE over time (two-sided Ptrend?>?.05 for HPV31, -33, -35, -45, and -58). As a benchmark, VEavg against HPV16/18 was 82.0% (95% CI = 77.3% to 85.7%). Among 1-dose women, we observed comparable efficacy against HPV31/33/45 (VEavg = 54.4%, 95% CI = 21.0% to 73.7%). Acquisition of nonprotected HPV types was similar between vaccinated and unvaccinated women, indicating that the difference in HPV infection rates was not attributable to differential genital HPV exposure. CONCLUSIONS:Substantial cross-protection afforded by the bivalent vaccine against HPV31/33/45, and to a lesser extent, HPV35 and HPV58, was sustained and remained stable after 11?years postvaccination, reinforcing the notion that the bivalent vaccine is an effective option for protection against HPV-associated cancers.

SUBMITTER: Tsang SH

PROVIDER: S-EPMC7566371 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Durability of Cross-Protection by Different Schedules of the Bivalent HPV Vaccine: The CVT Trial.

Tsang Sabrina H SH Sampson Joshua N JN Schussler John J Porras Carolina C Wagner Sarah S Boland Joseph J Cortes Bernal B Lowy Douglas R DR Schiller John T JT Schiffman Mark M Kemp Troy J TJ Rodriguez Ana Cecilia AC Quint Wim W Gail Mitchell H MH Pinto Ligia A LA Gonzalez Paula P Hildesheim Allan A Kreimer Aimée R AR Herrero Rolando R

Journal of the National Cancer Institute 20201001 10

<h4>Background</h4>The Costa Rica HPV Vaccine Trial has documented cross-protection of the bivalent HPV vaccine against HPV31/33/45 up to 7 years after vaccination, even with one dose of the vaccine. However, the durability of such protection remains unknown. Here, we evaluate the efficacy of different schedules of the vaccine against HPV31/33/45 out to 11 years postvaccination, expanding to other nontargeted HPV types.<h4>Methods</h4>We compared the rates of HPV infection in vaccinated women wi ...[more]

PMID: 32091596

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Project description:Background:Previously, we demonstrated similar human papillomavirus (HPV)16/18 vaccine efficacy estimates and stable HPV16/18 antibody levels four years postvaccination in a nonrandomized analysis of women who received a varying number of doses of the bivalent HPV16/18 vaccine. Here we extend data to seven years following initial vaccination. Methods:We evaluated HPV16/18-vaccinated women who received one (n?=?134), two (n 0/1 = 193, n 0/6 = 79), or three doses (n?=?2043) to a median of 6.9?years postvaccination. Cervical HPV DNA was measured with the SPF10- DEIA-LiPA PCR system; HPV16/18-specific antibody levels were measured using enzyme-linked immunosorbent assays (n?=?486). Infection and immunological measures were compared across vaccine dose groups. Prevalent HPV infection at year 7 was also compared with an unvaccinated control group (UCG). All statistical tests were two-sided. Results:Among women in the three-dose, two-dose 0/6 , two-dose 0/1 , and one-dose groups, cumulative incident HPV16/18 infection rates (No. of events/No. of individuals) were 4.3% (88/2036, 95% confidence interval [CI] = 3.5% to 5.3%), 3.8% (3/78, 95% CI?=?1.0% to 10.1%), 3.6% (7/192, 95% CI?=?1.6% to 7.1%), and 1.5% (2/133, 95% CI?=?0.3% to 4.9%; P = 1.00, .85, .17 comparing the two-dose 0/6 , two-dose 0/1 , and one-dose groups to the three-dose group, respectively). The prevalence of other carcinogenic and noncarcinogenic HPV types, excluding HPV16/18/31/33/45, were high and not statistically different among all dose groups, indicating that the low incidence of HPV16/18 in the one- and two-dose groups was not due to lack of exposure. At seven years, 100% of participants in all dose groups remained HPV16 and HPV18 seropositive. A non-statistically significant decrease in the geometric mean of the HPV16 antibody levels between years 4 and 7 was observed among women in the three-dose group: -10.8% (95% CI = -25.3% to 6.6%); two-dose (0/6?months) group: -17.3% (95% CI = -39.3% to 12.8%), two-dose (0/1?month) group: -6.9% (95% CI = -22.1% to 11.2%), and one-dose group: -5.5% (95% CI = -29.7% to 27.0%); results were similar for HPV18. Conclusions:At an average of seven years of follow-up, we observed similar low rates of HPV16/18 infections and slight, if any, decreases in HPV16/18 antibody levels by dose group.

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Durability of Cross-Protection by Different Schedules of the Bivalent HPV Vaccine: The CVT Trial.

Publications

Durability of Cross-Protection by Different Schedules of the Bivalent HPV Vaccine: The CVT Trial.

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