A Phase 2 interventional study of Nonavalent HPV vaccine (9vHPV) in HPV, High-risk HPV (Any Strain) and Human Papillomavirus (HPV) Infections, sponsored by Institut d'Investigació Biomèdica de Bellvitge. Not yet recruiting at 1 site in Sierra Leone. Open to female participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Institut d'Investigació Biomèdica de Bellvitge · Phase 2, Interventional, and Prevention
This is a randomized, open-label trial, to assess whether a single dose of HPV nonavalent vaccine, administered to HIV uninfected, unvaccinated women with high risk HPV16/18/31/33/45/52 or 58 can decrease the infectivity of shed HPV viruses.
Our hypothesis is that vaccination will have little or no impact on HPV sample positivity by DNA PCR since the viral particles will continue to be produced and released, but that particles will be neutralized by vaccine-induced antibodies, thereby reducing their infective capacity. Cervical samples will be collected at randomisation and at 6 months, to compare infectivity of shed HPV viruses.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
This study's planned enrollment of 80 is below the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →Institut d'Investigació Biomèdica de Bellvitge is the lead sponsor of 19 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women randomisied on this arm will receive their first dose at Month 0 (M0).
Biological: Nonavalent HPV vaccine (9vHPV)
Women randomised on this arm will not to be vaccinated at Month 0 (M0).
Nonavalent HPV vaccine (9vHPV/ Gardasil-9™). Sterile suspension, 0.5 ml dose, intramuscular, prepared from the highly purified viruslike particles (VLPs) of the major capsid L1 protein from 9 HPV types: 6/11/16/18/31/33/45/52/58. 9vHPV is currently indicated in the EU in individuals from 9 years of age for the prevention of diseases caused by vaccine's 9 HPV types: genital warts (HPV6 and 11) and premalignant lesions and cancers affecting the cervix, vulva, vagina and anus (HPV16, 18, 31, 22, 45, 52 and 58). It was authorized for marketing in the EU on June 9th, 201
Also known as: Gardasil-9™
The difference in infective capacity of cervical HPV virions at 6 months, between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).
To analyse the differences in the HPV neutralization capacity of HPV 16, 18, 31, 33, 45, 52, 58 vaccine-induced antibodies in serum and cervical samples at month 6 between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).
Time frame: 7 months
The difference in the HPV neutralization capacity of vaccine-induced antibodies in serum and cervical samples at 6 months, between HPV-positive unvaccinated women with HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine
To analyse the differences in the HPV neutralization capacity of HPV 16, 18, 31, 33, 45, 52, 58 vaccine-induced antibodies in serum and cervical samples at month 6 between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).
Time frame: 7 months
The difference in HPV viral load in cervical samples at 6 months, between HPV-positive unvaccinated women with HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).
To analyse the differences in the HPV viral load in cervical samples at 6 months between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).
Time frame: 7 months
Neutralising antibodies infective capacity of HPV virions and HPV viral load in urine samples
To analyse urine samples at month 6 to detect neutralizing antibodies to HPV 16, 18, 31, 33, 45, 52, 58, and the infective capacity of HPV 16, 18, 31, 33, 45, 52, 58 virions and to measure HPV 16, 18, 31, 33, 45, 52, 58 viral load
Time frame: 7 months
The difference in infectivity reduction and vaccine induced antibodies among different HPV types.
To analyse differences in infectivity reduction and vaccine induced antibodies among different HPV types included in the 9-valent vaccine.
Time frame: 7 months
Plan to share: No
Start is estimated for Feb 2026; primary completion for Feb 2027, 12 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 12 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 Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Human Papillomavirus Recombinant Vaccine nonavalent
Institut d'Investigació Biomèdica de Bellvitge