Cervical HPV natural history among young Western Cape, South African women: The randomized control EVRI Trial
Introduction
Human papillomavirus (HPV) is the most common sexually transmitted infection (STI), one that can infect multiple anatomic sites in both men and women. Persistent HPV infection is the necessary cause of cervical cancer and causes 90% of anal, 50% of penile, 43% of vulvar, 70% of vaginal, and 33–72% oropharyngeal cancers worldwide.1, 2 Women and men residing in southern African countries have among the highest burden of HPV infection and related cancers worldwide.3, 4, 5, 6
There are two licensed HPV vaccines that are highly efficacious in preventing 70% of cervical disease among women through protection against HPV16 and HPV18 infections. Recently a 9-valent HPV vaccine was licensed in the United States that increases prevention of cervical disease to 90% through the protection from HPV types 16, 18, 31, 33, 45, 52, and 58.7 The uptake of the vaccine is of major public health importance, especially in countries that have no or poor cervical cancer screening programs.
Within the context of a Phase II Trial to assess the feasibility of conducting a placebo-controlled randomized HPV vaccine trial to prevent HIV infection, we assessed cervical HPV status at enrollment and 7-months post-enrollment among women at high-risk for HIV.
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Population
Women residing in the Western Cape, South Africa were enrolled from November 2012 to July 2013 in a preparedness study, the Efficacy of HPV Vaccine to Reduce HIV Infection (EVRI) Trial (NCT01489527). A full description of study procedures and conduct of the trial has been published elsewhere.8 Briefly, women aged 16–24 that were HIV-negative and non-pregnant were enrolled in a Phase II randomized controlled trial of Gardasil (4-valent HPV (4vHPV) vaccine) vs. placebo (saline).
Trial-eligible
Results
The vaccine treatment groups were similar with respect to their enrollment demographic characteristics (Table 1). However, women randomized to receive the HPV vaccine were more likely to have ever been pregnant, have more male lifetime sexual partners, and have abnormal cervical cytology compared to women randomized to receive the placebo. Although women reported a wide range of number of lifetime sexual partners, the median number of partners reported was only two among those receiving placebo
Discussion
We have described the incidence, prevalence and persistence of cervical HPV among young South African women participating in randomized placebo-controlled HPV vaccine trial. The study arms were comparable in their enrollment demographic characteristics and prevalence of vaccine HPV types (6/11/16/18). Prevalence and incidence of cervical HPV was very high in this study population of women residing in a community of high HIV prevalence. The data presented here clearly demonstrate rapid cervical
Conflicts of interest
A.R.G. is on the Speaker's Bureau of Merck. 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. For the remaining authors, no conflicts of interest were declared.
Funding source
Merck (IISP39582) was the main sponsor of this trial and provided the study product. This work was also supported by the National Cancer Institute at the National Institutes of Health (Cancer Prevention Fellowship R25T CA147832 to S.L.S.).
Acknowledgments
The authors acknowledge the contributions of Charlotte Lawn, Wendy Adendorff, Zukiswa Gloria Ncume, Kayoko Kennedy, Dale Barrios, Jeannie Vaughn, David Jackson, Shahieda Isaacs, Nafiisah Chotun, Donna J. Ingles, and all study participants, without whom this study would not have been possible.
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