HPV InfectionPhase 2HPV9vxFSWNCT06681636
Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure
A Phase 2 study testing Human papillomavirus 9-valent vaccine, Recombinant in people with HPV Infection and Cervical Cancer, run by National Institute of Hygiene and Epidemiology, Vietnam at 3 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, Cervical Cancer, Anogenital Cancer
- What is being tested?
- Human papillomavirus 9-valent vaccine, Recombinant
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 14 Dec 2024to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Currently receiving immunosuppressive medication or anti-cancer chemotherapy.
- Known HIV infection.
- Known Congenital immune deficiency syndrome.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Vietnam2 sites
Center for Supporting Community Development Initiatives SCDI-Vietnam
Haiphong, 180000
Thanh TT Nham, MSc, 84912069823, thamnham@scdi.org.vn
Nhung TH Tran, BSc, 84326637935, nhungtran2@scdi.org.vn
Hai Phong Center for Disease Control
Haiphong, 180000
Kien T Dong, MD, MSc, 84987046688, dtk.skmt@gmail.com
Hai H Phan, MD, MPH, 84903265275, hai.cdc.haiphong@gmail.com
Australia1 site
Murdoch Children Research Institute
Parkville, Victoria, 3052
About this study
Official 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
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
Read the detailed description
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:
- 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.
- To compare antibody GMT at 18m and 19m between FSW and non-FSW.
- To determine cellular immune responses to HPV16 and 18 at baseline, 2m, 7m, 18m and 19m.
- 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:
- 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.
- HPV antibody GMT are similar at 18m and 19m between FSW and non-FSW who received the extended schedule.
- 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.
- No new vaccine-type HPV infection in FSW and non-FSW in all groups at 6m, 12m, 18m.
- Conditions
- HPV Infection, Cervical Cancer, Anogenital Cancer, Anogenital Warts
- Being tested
- Human papillomavirus 9-valent vaccine, Recombinant
- Keywords
- human papillomavirus, HPV vaccine, Vietnam, Female sex workers, immunogenicity, protection, extended schedule, HPV infection, cervical cancer
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms, Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human papillomavirus 9-valent vaccine, RecombinantBiological
Also called Gardasil 9
HPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58
| Study group | Role | What they receive |
|---|---|---|
| Group 1 FSW | Experimental | 100 FSWs aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months Receives: 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 Receives: 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 Receives: Biological: Human papillomavirus 9-valent vaccine, Recombinant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Antibody GMT at 2m, 7m, 18m and 19m between FSW who are HPV DNA+/seropositive with FSW who are HPV DNA-/seronegative at baseline.
Measured: 19 months after the 1st doses
Comparison of antibody response after 3 doses of extended schedule between FSW and non-FSW
Antibody GMT at 18m and 19m between FSW and non-FSW.
Measured: 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.
Measured: 19 months after the 1st dose
HPV persistent during 19 month or more among vaccines
- 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).
Measured: at least 19 months after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start14 Dec 2024 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Hygiene and Epidemiology, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- Murdoch Childrens Research Institute, CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES, Hai Phong Center for Disease Control
- Responsible party
- Principal investigator, Nguyen Van Trang, National Institute of Hygiene and Epidemiology, Vietnam
- Investigators
- Hong T Duong, MD, PhD, Study director, National Institute of Hygiene and Epidemiology, VietnamTrang V Nguyen, PhD, Principal investigator, National Institute of Hygiene and Epidemiology, VietnamTuan A Le, MD, PhD, Principal investigator, National Institute of Hygiene and Epidemiology, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681636
- Sponsor's protocol ID
- HPV9-VINIF2427
- Acronym
- HPV9vxFSW
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Results will be reported as grouped data
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.
PubMed 32045545Thi 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.
PubMed 30710841Vandepitte 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.
PubMed 16735288VAN 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.
PubMed 34972721Tuan 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.
PubMed 34517047Pham 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.
PubMed 36817494Hernandez 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.
PubMed 18433504Brown 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.
PubMed 22306855Dobson 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.
PubMed 23632723
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06681636
- Acronym / sponsor ID
- HPV9vxFSW / HPV9-VINIF2427
- Conditions
- HPV Infection, Cervical Cancer, Anogenital Cancer, Anogenital Warts
- Keywords
- human papillomavirus, HPV vaccine, Vietnam, Female sex workers, immunogenicity, protection, extended schedule, HPV infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Institute of Hygiene and Epidemiology, VietnamUniversity, hospital or other
- Collaborators
- Murdoch Childrens Research Institute, CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES, Hai Phong Center for Disease Control
- Study start
- 14 Dec 2024 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- 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.
- To compare antibody GMT at 18m and 19m between FSW and non-FSW.
- To determine cellular immune responses to HPV16 and 18 at baseline, 2m, 7m, 18m and 19m.
- 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:
- 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.
- HPV antibody GMT are similar at 18m and 19m between FSW and non-FSW who received the extended schedule.
- 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.
- No new vaccine-type HPV infection in FSW and non-FSW in all groups at 6m, 12m, 18m.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 FSW | Experimental | Biological: Human papillomavirus 9-valent vaccine, Recombinant100 FSWs aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months |
| Group 2 non-FSW | Active comparator | Biological: Human papillomavirus 9-valent vaccine, Recombinant100 non-FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months |
| Group 3 FSW | Active comparator | Biological: Human papillomavirus 9-valent vaccine, Recombinant100 FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-2-6 months |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human papillomavirus 9-valent vaccine, RecombinantAlso: Gardasil 9HPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58 | Biological | Group 1 FSW, Group 2 non-FSW, Group 3 FSW |
Primary outcome
Comparison between antibody responses after the 3rd dose ofregular vaccine schedules among FSW and after the 2nd dose of the extended schedule
Time frame: 7 months from the first doses
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).
4 secondary outcomes
Comparison of antibody responses after each doses among FSW according to HPV infection status pre-vaccination
Time frame: 19 months after the 1st doses
Comparison of antibody response after 3 doses of extended schedule between FSW and non-FSW
Time frame: 19 month after the first doses
Celular response after each vaccine dose
Time frame: 19 months after the 1st dose
HPV persistent during 19 month or more among vaccines
Time frame: at least 19 months after the first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Background: PubMed 32045545Nguyen 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.
- Background: PubMed 30710841Thi 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.
- Background: PubMed 16735288Vandepitte 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.
- Results publication: PubMed 34972721VAN 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.
- Results publication: PubMed 34517047Tuan 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.
- Results publication: PubMed 36817494Pham 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.
- Results publication: PubMed 18433504Hernandez 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.
- Results publication: PubMed 22306855Brown 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.
- Results publication: PubMed 23632723Dobson 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Results will be reported as grouped data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hong T Duong, MD, PhD study director
National Institute of Hygiene and Epidemiology, Vietnam
Trang V Nguyen, PhD principal investigator
National Institute of Hygiene and Epidemiology, Vietnam
Tuan A Le, MD, PhD principal investigator
National Institute of Hygiene and Epidemiology, Vietnam
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human papillomavirus 9-valent vaccine, Recombinant in people with HPV Infection and Cervical Cancer, run by National Institute of Hygiene and Epidemiology, Vietnam at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Vietnam, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trang V Nguyen, PhD (84902028181, nvt@nihe.org.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between antibody responses after the 3rd dose ofregular vaccine schedules among FSW and after the 2nd dose of the extended schedule (time frame: 7 months from the first doses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06681636, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.