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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06681636




Registration number
NCT06681636
Ethics application status
Date submitted
5/11/2024
Date registered
8/11/2024
Date last updated
8/11/2024

Titles & IDs
Public title
Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure
Scientific title
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
Secondary ID [1] 0 0
HPV9-VINIF2427
Universal Trial Number (UTN)
Trial acronym
HPV9vxFSW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HPV Infection 0 0
Cervical Cancer 0 0
Anogenital Cancer 0 0
Anogenital Warts 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Human papillomavirus 9-valent vaccine, Recombinant

Experimental: Group 1 FSW - 100 FSWs aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months

Active comparator: Group 2 non-FSW - 100 non-FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months

Active comparator: Group 3 FSW - 100 FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-2-6 months


Treatment: Other: Human papillomavirus 9-valent vaccine, Recombinant
HPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison between antibody responses after the 3rd dose ofregular vaccine schedules among FSW and after the 2nd dose of the extended schedule
Timepoint [1] 0 0
7 months from the first doses
Secondary outcome [1] 0 0
Comparison of antibody responses after each doses among FSW according to HPV infection status pre-vaccination
Timepoint [1] 0 0
19 months after the 1st doses
Secondary outcome [2] 0 0
Comparison of antibody response after 3 doses of extended schedule between FSW and non-FSW
Timepoint [2] 0 0
19 month after the first doses
Secondary outcome [3] 0 0
Celular response after each vaccine dose
Timepoint [3] 0 0
19 months after the 1st dose
Secondary outcome [4] 0 0
HPV persistent during 19 month or more among vaccines
Timepoint [4] 0 0
at least 19 months after the first dose

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
26 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria

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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
14/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Murdoch Children Research Institute - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Vietnam
State/province [1] 0 0
Hai Phong

Funding & Sponsors
Primary sponsor type
Other
Name
National Institute of Hygiene and Epidemiology, Vietnam
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Murdoch Childrens Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Hai phong Center for Disease Control
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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
Trial website
https://clinicaltrials.gov/study/NCT06681636
Trial related presentations / publications
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.
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.
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.
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.
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.
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.2022.13.4.894. eCollection 2022 Oct-Dec.
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.
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.
Dobson SR, McNeil S, Dionne M, Dawar M, Ogilvie G, Krajden M, Sauvageau C, Scheifele DW, Kollmann TR, Halperin SA, Langley JM, Bettinger JA, Singer J, Money D, Miller D, Naus M, Marra F, Young E. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women: a randomized clinical trial. JAMA. 2013 May 1;309(17):1793-802. doi: 10.1001/jama.2013.1625.
Public notes

Contacts
Principal investigator
Name 0 0
Hong T Duong, MD, PhD
Address 0 0
National Institute of Hygiene and Epidemiology, Vietnam
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trang V Nguyen, PhD
Address 0 0
Country 0 0
Phone 0 0
84902028181
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06681636