A Phase 2 interventional study of Human papillomavirus 9-valent vaccine, Recombinant in HPV Infection, Cervical Cancer and Anogenital Cancer, sponsored by National Institute of Hygiene and Epidemiology, Vietnam. Not yet recruiting at 3 sites in 2 countries. Open to female participants aged 18 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by National Institute of Hygiene and Epidemiology, Vietnam · Phase 2, Interventional, and Prevention
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:
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
This study's planned enrollment of 300 is above the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →National Institute of Hygiene and Epidemiology, Vietnam is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Exclusion criteria
Participants meeting any of the following criteria will be excluded from the trial:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
HPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58
Also known as: Gardasil 9
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).
Time frame: 7 months from the first doses
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: at least 19 months after the first dose
Plan to share: No — Individual participant data will not be shared. Results will be reported as grouped data
Start is estimated for Dec 2024; primary completion for Oct 2026, 22 months later.
Of 41 phase 2 interventional studies under Papillomavirus Infections, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 77. This study's planned 22 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Human Papillomavirus Recombinant Vaccine nonavalent
National Institute of Hygiene and Epidemiology, Vietnam