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

NCT06681636 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: HPV9-VINIF2427
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 3

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

Conditions

HPV Infection; Cervical Cancer; Anogenital Cancer; Anogenital Warts

Keywords

human papillomavirus; HPV vaccine; Vietnam; Female sex workers; immunogenicity; protection; extended schedule; HPV infection; cervical cancer

Outcome Measures

Primary Outcomes (1)

• Comparison between antibody responses after the 3rd dose ofregular vaccine schedules among FSW and after the 2nd dose of the extended schedule

  geometric mean titer (GMT) ratios and 95% confidence intervals (CI) of HPV- specific antibody responses to HPV16 and HPV18 at 7m between FSWs aged 18-26 years who received either the standard (0, 2m, 6m) or extended 3-dose (at 0, 6m and 18m) 3-dose 9vHPV schedule and age-matched non-FSWs who received the extended 3-dose 9vHPV schedule (at 0, 6m and 18m).

  7 months from the first doses

Secondary Outcomes (4)

• Comparison of antibody responses after each doses among FSW according to HPV infection status pre-vaccination

  19 months after the 1st doses

• Comparison of antibody response after 3 doses of extended schedule between FSW and non-FSW

  19 month after the first doses

• Celular response after each vaccine dose

  19 months after the 1st dose

• HPV persistent during 19 month or more among vaccines

  at least 19 months after the first dose

Study Arms (3)

Group 1 FSW

EXPERIMENTAL

100 FSWs aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months

Biological: Human papillomavirus 9-valent vaccine, Recombinant

Group 2 non-FSW

ACTIVE COMPARATOR

100 non-FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months

Biological: Human papillomavirus 9-valent vaccine, Recombinant

Group 3 FSW

ACTIVE COMPARATOR

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

Biological: Human papillomavirus 9-valent vaccine, Recombinant

Interventions

Human papillomavirus 9-valent vaccine, Recombinant BIOLOGICAL

HPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58

Also known as: Gardasil 9

Group 1 FSW; Group 2 non-FSW; Group 3 FSW

Eligibility Criteria

• Age: 18 Years - 26 Years
• Gender Eligibility Details: Female sex workers or female non-sex workers aged 18-26 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Hygiene and Epidemiology, Vietnam: lead
• Murdoch Childrens Research Institute: collaborator
• CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES: collaborator
• Hai Phong Center for Disease Control: collaborator

Study Sites (3)

Murdoch Children Research Institute

Parkville, Victoria, 3052, Australia

Location

Center for Supporting Community Development Initiatives SCDI-Vietnam

Haiphong, 180000, Vietnam

Location

Hai Phong Center for Disease Control

Haiphong, 180000, Vietnam

Location

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 36817494 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 23632723 RESULT

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms; Condylomata Acuminata

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Warts; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hong T Duong, MD, PhD

  National Institute of Hygiene and Epidemiology, Vietnam

  STUDY DIRECTOR

• Trang V Nguyen, PhD

  National Institute of Hygiene and Epidemiology, Vietnam

  PRINCIPAL INVESTIGATOR

• Tuan A Le, MD, PhD

  National Institute of Hygiene and Epidemiology, Vietnam

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trang V Nguyen, PhD

CONTACT

84902028181; nvt@nihe.org.vn

Tuan A Le, MD, PhD

CONTACT

84983738688; lat@nihe.org.vn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants (FSW groups) will be randomly assigned to either of the vaccine schedules and will be given IDs. The link between participant IDs and vaccine groups are only known by Investigator. Barcodes will be used for samples and no personal identification nor participant ID is allowed in the samples.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Manager, Center for Biomedical Researches

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 8, 2024
• Study Start: December 14, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); VN (2)