Single-dose HPV vaccination efficacy among adolescent girls and young women in Kenya (the KEN SHE Study): study protocol for a randomized controlled trial

被引：26

作者：

Barnabas, Ruanne, V ^{[1
,2
,3
,4
]}

Brown, Elizabeth R. ^{[4
,5
,6
]}

Onono, Maricianah ^{[7
]}

Bukusi, Elizabeth A. ^{[1
,7
]}

Njoroge, Betty ^{[7
]}

Winer, Rachel L. ^{[3
]}

Donnell, Deborah ^{[1
,4
,6
]}

Galloway, Denise ^{[8
]}

Cherne, Stephen ^{[8
]}

Heller, Kate ^{[1
]}

Leingang, Hannah ^{[1
]}

Morrison, Susan ^{[1
]}

Rechkina, Elena ^{[1
]}

McClelland, R. Scott ^{[1
,2
,3
]}

Baeten, Jared M. ^{[1
,2
,3
]}

Celum, Connie ^{[1
,2
,3
]}

Mugo, Nelly ^{[1
,7
]}

机构：

[1] Univ Washington, Dept Global Hlth, Seattle, WA 98195 USA

[2] Univ Washington, Div Allergy & Infect Dis, Seattle, WA 98195 USA

[3] Univ Washington, Dept Epidemiol, Seattle, WA 98195 USA

[4] Fred Hutchinson Canc Res Ctr, Vaccine & Infect Dis Div, 1124 Columbia St, Seattle, WA 98104 USA

[5] Univ Washington, Dept Biostat, Seattle, WA 98195 USA

[6] Fred Hutchinson Canc Res Ctr, Human Biol Div, 1124 Columbia St, Seattle, WA 98104 USA

[7] Kenya Govt Med Res Ctr, Nairobi, Kenya

[8] Univ Washington, Dept Lab Med & Pathol, Seattle, WA 98195 USA

来源：

TRIALS | 2021年 / 22卷 / 01期

基金：

比尔及梅琳达.盖茨基金会;

关键词：

Human papillomavirus; Randomized controlled trial; Single-dose vaccination; Reduced dose schedule; Multi-age cohort; CLINICAL VALIDATION; HIV PREVENTION; MEN;

D O I：

10.1186/s13063-021-05608-8

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Background: 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. Methods: We 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. Discussion: This 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.

引用

页数：19

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