Abstract
BackgroundHPV infection is the primary cause of cervical cancer, a leading cause of cancer among women in Kenya and many sub-Saharan African countries. High coverage of HPV vaccination is a World Health Organization priority to eliminate cervical cancer globally, but vaccine supply and logistics limit widespread implementation of the current two or three dose HPV vaccine schedule.MethodsWe are conducting an individual randomized controlled trial to evaluate whether a single dose of the bivalent (HPV 16/18) or nonavalent (HPV 16/18/31/33/45/52/58/6/11) HPV vaccine prevents persistent HPV infection, a surrogate marker for precancerous lesions and cervical cancer. The primary objective is to compare the efficacy of immediate, single-dose bivalent or nonavalent vaccination with delayed HPV vaccination. Kenyan women age 15–20 years old are randomized to immediate bivalent HPV and delayed meningococcal vaccine (group 1), immediate nonavalent HPV vaccine and delayed meningococcal vaccine (group 2), or immediate meningococcal vaccine and delayed HPV vaccine (group 3) with 36 months of follow-up. The primary outcome is persistent vaccine-type HPV infection by month 18 and by month 36 for the final durability outcome. The secondary objectives include to (1) evaluate non-inferiority of antibody titers among girls and adolescents (age 9 to 14 years) from another Tanzanian study, the DoRIS Study (NCT02834637), compared to KEN SHE Study participants; (2) assess the memory B cell immune response at months 36 and 37; and (3) estimate cost-effectiveness using the trial results and health economic models.DiscussionThis study will evaluate single-dose HPV vaccine efficacy in Africa and has the potential to guide public health policy and increase HPV vaccine coverage. The secondary aims will assess generalizability of the trial results by evaluating immunobridging from younger ages, durability of the immune response, and the long-term health benefits and cost of single-dose HPV vaccine delivery.Trial registrationClinicalTrials.gov NCT03675256. Registered on September 18, 2018
Highlights
Background and rationale {6a} Cervical cancer, caused primarily by the human papillomavirus (HPV), is a leading cause of incident cancer cases among women in Africa [1]
In countries that have achieved high HPV vaccine coverage at population level and that use the multi-age cohort vaccination approach of immunizing 9–26 year olds, HPV-associated moderate or severe precancerous lesions have decreased by almost 100% compared to countries with single-cohort vaccination or low routine vaccination demonstrating the substantial impact of widespread HPV vaccination on precancerous lesions [6]
Through our previous Human immunodeficiency virus (HIV) prevention trials (Partners in Prevention HSV/HIV Transmission Study, Partners pre-exposure prophylaxis (PrEP) Study, ASPIRE Study [23,24,25]), we have found that community and stakeholder consultations are important at every stage of the Discussion This randomized, double-blind, controlled trial will provide data on single-dose HPV vaccine efficacy among adolescent girls and young women age 15–20 years
Summary
Background and rationale {6a} Cervical cancer, caused primarily by the human papillomavirus (HPV), is a leading cause of incident cancer cases among women in Africa [1]. In sub-Saharan Africa where more than 80% of cervical cancer cases occur, HPV vaccine coverage remains low and cervical cancer screening and treatment is limited [4]. HPV infection is the primary cause of cervical cancer, a leading cause of cancer among women in Kenya and many sub-Saharan African countries. High coverage of HPV vaccination is a World Health Organization priority to eliminate cervical cancer globally, but vaccine supply and logistics limit widespread implementation of the current two or three dose HPV vaccine schedule
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