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| Name | Class |
|---|---|
| Murdoch Childrens Research Institute | OTHER |
| CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES | UNKNOWN |
| Hai Phong Center for Disease Control | OTHER_GOV |
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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
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 FSW | Experimental | 100 FSWs aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months |
|
| 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 |
|
| Group 3 FSW | Active Comparator | 100 FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-2-6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of antibody responses after each doses among FSW according to HPV infection status pre-vaccination | Antibody GMT at 2m, 7m, 18m and 19m between FSW who are HPV DNA+/seropositive with FSW who are HPV DNA-/seronegative at baseline. | 19 months after the 1st doses |
| Comparison of antibody response after 3 doses of extended schedule between FSW and non-FSW |
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Inclusion Criteria:
Exclusion criteria
Participants meeting any of the following criteria will be excluded from the trial:
Female sex workers or female non-sex workers aged 18-26 years
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trang V Nguyen, PhD | Contact | 84902028181 | nvt@nihe.org.vn | |
| Tuan A Le, MD, PhD | Contact | 84983738688 | lat@nihe.org.vn |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Murdoch Children Research Institute | Parkville | Victoria | 3052 | Australia | ||
| Center for Supporting Community Development Initiatives SCDI-Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32045545 | Background | 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. | |
| 30710841 | 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. |
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Individual participant data will not be shared. Results will be reported as grouped data
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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.
|
Antibody GMT at 18m and 19m between FSW and non-FSW. |
| 19 month after the first doses |
| Celular response after each vaccine dose | Proportion of HPV16 and 18-specific B/T cells at baseline, 2m, 7m, 18m and 19m. | 19 months after the 1st dose |
| HPV persistent during 19 month or more among vaccines | 4. Incidence (detection of the specific-type HPV DNA at least once during the follow-up period) and persistent HPV infection (defined as detection of the same HPV type in at least 2 samples not interrupted by negative sample during the follow-up period). | at least 19 months after the first dose |
| Tuan A Le, MD, PhD | National Institute of Hygiene and Epidemiology, Vietnam | Principal Investigator |
| Haiphong |
| 180000 |
| Vietnam |
|
| Hai Phong Center for Disease Control | Haiphong | 180000 | Vietnam |
|
| 16735288 | 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. |
| 34972721 | Result | 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. |
| 34517047 | 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. |
| 36817494 | 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. |
| 18433504 | 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. |
| 22306855 | 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. |
| 23632723 | 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. |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D002583 | Uterine Cervical Neoplasms |
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000634046 | Human Papillomavirus Recombinant Vaccine nonavalent |
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