HPV SEROSTATUS PRE- AND POST-VACCINATION IN A RANDOMIZED PHASE II PREPAREDNESS TRIAL AMONG YOUNG WESTERN CAPE, SOUTH AFRICAN WOMEN: THE EVRI TRIAL

Staci L Sudenga, B Nelson Torres, Matthys H Botha, Michele Zeier, Martha E Abrahamsen, Richard H Glashoff, Susan Engelbrecht, Maarten F Schim Van der Loeff, Louvina E Van der Laan, Siegfried Kipping, Douglas Taylor, Anna R Giuliano, Staci L Sudenga, B Nelson Torres, Matthys H Botha, Michele Zeier, Martha E Abrahamsen, Richard H Glashoff, Susan Engelbrecht, Maarten F Schim Van der Loeff, Louvina E Van der Laan, Siegfried Kipping, Douglas Taylor, Anna R Giuliano

Abstract

Background: HPV antibodies are a marker of past exposure to the virus. Our objective was to assess HPV serostatus pre- and post-vaccination among HIV-negative women.

Methods: Women aged 16-24 years old were randomized in a placebo controlled trial utilizing the 4-valent HPV (4vHPV) vaccine (NCT01489527, clinicaltrials.gov). Participants (n=389) received the 4vHPV vaccine or placebo following a three dose schedule. Sera were collected at Day 1 and Month 7 for assessment of HPV 6, 11, 16, and 18 neutralizing antibody levels using a multiplex competitive Luminex immunoassay (Merck) based on detecting the L1 capsid antigen for each HPV type.

Results: Seroprevalence was 73% for HPV6, 47% for HPV11, 33% for HPV16, and 44% for HPV18. Seroprevalence for any HPV type did not significantly differ by age or lifetime number of partners. The majority of participants (64%) had two or more 4vHPV antibodies present at enrollment and 12% had antibodies to all four. Among women in the vaccine arm, those that were seropositive for HPV16 at enrollment had higher titers at month 7 compared to women that were seronegative for HPV16 at enrollment; this trend holds for the other HPV types as well. Seroconversion among baseline seronegative participants in the placebo group ranged from 5% for HPV16 to 23% for HPV6.

Conclusion: HPV seroprevalence was high in this population, emphasizing the need to vaccinate prior to sexual debut.

Keywords: EVRI; HPV vaccine; cLIA; seroprevalence.

Conflict of interest statement

Conflicts of Interest A.R.G. is on the Speaker’s Bureau of Merck. M.H.B. is a speaker for Merck, GSK, Roche Diagnostics, and Pfizer. S.L.S. received a grant (IISP53280) from Merck Investigator Initiated Studies Program. M.F.S.v.d.L. received research funding from Sanofi-Pasteur MSD; he is a co-investigator in a Sanofi-Pasteur-MSD HPV vaccine trial; he sat on a vaccine advisory board of GSK; his institution received in-kind contribution for an HPV study from Stichting Pathologie Onderzoek en Ontwikkeling (SPOO); his institution receives research funding from Janssen Infectious Diseases and Vaccines. For the remaining authors, no conflicts of interest were declared.

Figures

Fig. 1
Fig. 1
The proportion of women that were seropositive for HPV at enrollment (n=389) by age category and 95% confidence intervals.
Fig. 2
Fig. 2
4vHPV seroprevalence. a. Combinations of HPV antibodies among women seropositive for at least one 4vHPV type (n=342); b. Among women that were seropositive for one or more of the 4vHPV types (n=342), the proportion of women for each HPV type that were “only” seropositive for that HPV type, or seropositive for that HPV type and seropositive for “another,” or not seropositive for that HPV type “other”.
Fig. 3
Fig. 3
Serostatus among the “Intention-to-treat” and “Per-protocol” Populations. a. Intention-to-treat: Proportion of participants that were seropositive to HPV at enrollment and month 7 regardless of genital HPV infection and serostatus at enrollment and 95% confidence intervals; b. Per-protocol: Among women that were HPV DNA negative and HPV seronegative at enrollment, the proportion of participants that were seropositive to HPV at month 7 and 95% confidence intervals.

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