Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure

Официальное название

A Non-inferiority Study Comparing the Immunogenicity of a Standard or an Extended Three-dose Nonavalent Human Papillomavirus Vaccine Schedule Between High-risk Women Aged 18-26 Years and Age-matched Women in the General Population

Обзор

A Study to evaluate if the 3 dose extended schedule (0-6-18 months) for the HPV vaccine Gardasil-9 provide similar immune responses and short term protection against HPV infection compared to the regular 3 dose schedule (0-2-6 months) in high risk women in Vietnam

Подробное описание

Primary objective:

To determine whether antibody geometric mean titer (GMT) to vaccine type HPV16 and HPV18 at 7 months (m) are non-inferior between female sex workers (FSW) aged 18-26 years who received the standard (0, 2m, 6m) and those received the extended 3-dose (at 0, 6m and 18m) 9vHPV schedule and age-matched non-FSW who received an extended 3-dose (at 0, 6m and 18m) 9vHPV schedule. This extended 3-dose schedule is in line with the recommended schedule by the vaccine manufacturer in Vietnam.

Secondary objectives:

1. To compare antibody GMT at 2m, 7m, 18m and 19m between FSW who are HPV DNA+/seropositive with FSW who are HPV DNA-/seronegative at baseline. 2. To compare antibody GMT at 18m and 19m between FSW and non-FSW. 3. To determine cellular immune responses to HPV16 and 18 at baseline, 2m, 7m, 18m and 19m. 4. To measure incidence and 6m/12m/18m persistent HPV infection.

Primary hypothesis:

HPV antibody GMT to HPV16 and 18 in FSW is non-inferior to those of young women of the same age group (non-FSW) at 7m.

Secondary hypothesis:

1. HPV antibody GMT are similar at 2m, 7m, 18m and 19m between FSW who are HPV DNA+/seropositive and HPV DNA-/seronegative at month 0. 2. HPV antibody GMT are similar at 18m and 19m between FSW and non-FSW who received the extended schedule. 3. Cellular immune responses to HPV16 and 18 are similar between FSW and non-FSW at 2m, 7m, 18m and 19m who received the extended schedule. 4. No new vaccine-type HPV infection in FSW and non-FSW in all groups at 6m, 12m, 18m.

Вмешательства

• Биопрепарат Human papillomavirus 9-valent vaccine, Recombinant
  HPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58

Первичные конечные точки

• Comparison between antibody responses after the 3rd dose ofregular vaccine schedules among FSW and after the 2nd dose of the extended schedule [Срок оценки: 7 months from the first doses]

Вторичные конечные точки (4)

• Comparison of antibody responses after each doses among FSW according to HPV infection status pre-vaccination [Срок оценки: 19 months after the 1st doses]
• Comparison of antibody response after 3 doses of extended schedule between FSW and non-FSW [Срок оценки: 19 month after the first doses]
• Celular response after each vaccine dose [Срок оценки: 19 months after the 1st dose]
• HPV persistent during 19 month or more among vaccines [Срок оценки: at least 19 months after the first dose]

Критерии участия

Критерии включения

• Is between the reporting ages of 18-26 years at the time of recruitment.
• Engage in commercial sex in the last 6m (for FSW group) or have engaged in sexual activity (non-FSWs)
• Willing and able to give written informed consent.
• Willing to complete the follow-up requirements of the study.

Критерии исключения

Participants meeting any of the following criteria will be excluded from the trial:

• Pregnant or possibly pregnant
• Has received any HPV vaccine previously
• Has an axillary temperate greater than 38°C
• Known allergies to any vaccine component
• incapacity to provide consent
• Currently receiving immunosuppressive medication or anti-cancer chemotherapy.
• Known HIV infection.
• Known Congenital immune deficiency syndrome.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Вьетнам · 2 центра

• Center for Supporting Community Development Initiatives SCDI-Vietnam — Haiphong
• Hai Phong Center for Disease Control — Haiphong

Австралия · 1 центр

• Murdoch Children Research Institute — Parkville

Публикации

• Nguyen TP, Luu HN, Nguyen MVT, Tran MT, Tuong TTV, Tran CTD, Boffetta P. Attributable Causes of Cancer in Vietnam. JCO Glob Oncol. 2020 Feb;6:195-204. doi: 10.1200/JGO.19.00239. PMID 32045545
• Thi Nguyen DN, Simms K, Vu Nguyen HQ, Van Tran T, Nguyen NH, LaMontagne DS, Castle P, Canfell K. The burden of cervical cancer in Vietnam: Synthesis of the evidence. Cancer Epidemiol. 2019 Apr;59:83-103. doi: 10.1016/j.canep.2018.11.008. Epub 2019 Jan 30. PMID 30710841
• Vandepitte J, Lyerla R, Dallabetta G, Crabbe F, Alary M, Buve A. Estimates of the number of female sex workers in different regions of the world. Sex Transm Infect. 2006 Jun;82 Suppl 3(Suppl 3):iii18-25. doi: 10.1136/sti.2006.020081. PMID 16735288
• VAN Trang N, Prem K, Toh ZQ, Viet Ha BT, Ngoc Lan PT, Tran HP, Pham QD, VAN Khuu N, Jit M, Luu DT, Khanh Ly LT, Cao V, LE-Ha TD, Bright K, Garland SM, Anh DD, Mulholland K. Prevalence and Determinants of Vaginal Infection With Human Papillomavirus Among Female University Students in Vietnam. In Vivo. 2022 Jan-Feb;36(1):241-250. doi: 10.21873/invivo.12697. PMID 34972721
• Tuan LA, Prem K, Pham QD, Toh ZQ, Tran HP, Nguyen PD, Mai CTN, Ly LTK, Cao V, Le-Ha TD, Tuan NA, Jit M, Bright K, Brisson M, Nguyen TV, Garland S, Anh DD, Trang NV, Mulholland K. Anal human papillomavirus prevalence and risk factors among men who have sex with men in Vietnam. Int J Infect Dis. 2021 Nov;112:136-143. doi: 10.1016/j.ijid.2021.09.016. Epub 2021 Sep 10. PMID 34517047
• Pham QD, Prem K, Le TA, Van Trang N, Jit M, Nguyen TA, Cao V, Le-Ha TD, Chu MTN, Le LTK, Toh ZQ, Brisson M, Garland S, Murray G, Bright K, Dang DA, Tran HP, Mulholland EK. Prevalence and risk factors for human papillomavirus infection among female sex workers in Hanoi and Ho Chi Minh City, Viet Nam: a cross-sectional study. Western Pac Surveill Response J. 2022 Nov 7;13(4):1-11. doi: 10.5365/wpsar PMID 36817494
• Hernandez BY, Vu Nguyen T. Cervical human papillomavirus infection among female sex workers in southern Vietnam. Infect Agent Cancer. 2008 Apr 23;3:7. doi: 10.1186/1750-9378-3-7. PMID 18433504
• Brown B, Blas M, Cabral A, Carcamo C, Gravitt P, Halsey N. Randomized trial of HPV4 vaccine assessing the response to HPV4 vaccine in two schedules among Peruvian female sex workers. Vaccine. 2012 Mar 16;30(13):2309-14. doi: 10.1016/j.vaccine.2012.01.058. Epub 2012 Feb 1. PMID 22306855

Идентификаторы

NCT: NCT06681636 · HPV9-VINIF2427

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗