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Clinical Trial
. 2020 Oct 1;112(10):1030-1037.
doi: 10.1093/jnci/djaa010.

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

Sabrina H Tsang  1 , Joshua N Sampson  1 , John Schussler  2 , Carolina Porras  3 , Sarah Wagner  1   4 , Joseph Boland  1   4 , Bernal Cortes  3 , Douglas R Lowy  1 , John T Schiller  1 , Mark Schiffman  1 , Troy J Kemp  5 , Ana Cecilia Rodriguez  6 , Wim Quint  7 , Mitchell H Gail  1 , Ligia A Pinto  5 , Paula Gonzalez  3 , Allan Hildesheim  1 , Aimée R Kreimer  1 , Rolando Herrero  3   8 ; Costa Rica HPV Vaccine Trial (CVT) Group
Affiliations
Clinical Trial

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

Sabrina H Tsang et al. J Natl Cancer Inst. .

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.

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Figures

Figure 1.
Figure 1.
Vaccine efficacy (VE) against incident HPV infection over time. VE against incident infection with (A) HPV31, (B) HPV33, (C) HPV45, (D) HPV31/33/45, (E) HPV16/18, (F) other oncogenic HPVs, and (G) other nononcogenic HPVs over time, in the 3-dose group. Ptrend for VE over 11 years (excluding year 1) is presented to demonstrate stability of protection. All tests were two-sided.
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