HPVPhase 2RIFT-SSANCT07303751
Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV
A Phase 2 study testing Nonavalent HPV vaccine (9vHPV) in people with HPV and High-risk HPV (Any Strain), run by Institut d'Investigació Biomèdica de Bellvitge at 1 site in Sierra Leone.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 29 years, women only
- Conditions the study is for
- HPV, High-risk HPV (Any Strain), Human Papillomavirus (HPV) Infections
- What is being tested?
- Nonavalent HPV vaccine (9vHPV)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSierra Leone
- Study dates
- 1 Feb 2026to 1 Feb 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 29 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Born female
- Aged between 18-29 years old;
- Living in Kambia district (or neighbouring district if included) without plans to move away in the next 12 months;
- Willing to participate in the study and have signed the informed consent form;
- In good health as determined by a medical history (a physical examination will be conducted if necessary according to the clinician's judgement);
- Willing to be tested for HIV;
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- Are HIV negative at the screening visit;
- Not pregnant;
- Able to pass a Test of Understanding (TOU);
- Willing to provide cervical, urine and blood samples;
- Agree to be vaccinated with a single dose of Gardasil9® if randomised to the vaccine arm at Day 0;
- Have no visible suspicious cervical lesions on examination.
- Agree to a pregnancy test at screening and before any HPV vaccination.
Who cannot join
- They have been previously vaccinated against HPV;
- They have a chronic condition, such as autoimmune conditions, degenerative diseases, neurologic or genetic diseases among others;
- They are HIV positive or immunocompromised;
- They are pregnant or planning to get pregnant in the next 12 months;
- They are less than three months post-partum or currently breastfeeding;
- They are allergic to one of the vaccine components or to latex;
- They are sexually active and are not using, or are not willing to use, an effective birth control method from D-14 until 60 days after the last vaccine dose
- The nurse or clinician determining the eligibility, in agreement with principal investigator, considers that there is a reason that precludes participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elena Ruiz Puig contact
Sierra Leone1 site
Kambia Research Centre
Freetown
Daniel Tindanbil, +232-33634212, Daniel.Tindanbil@lshtm.ac.uk
About this study
Official title: HPV Vaccination and Infectivity Reduction in HPV-positive Women
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.
- Being tested
- Nonavalent HPV vaccine (9vHPV)
- Keywords
- Cervical cancer, Cervical Intraepithelial Neoplasia Grade I/ II/ III (CIN I/II/III), Squamous Intraepithelial Lesions of the Cervix, High/ Low Grade, Human Papillomavirus (HPV) Infections, High-risk HPV, HPV-16/ 18, HPV DNA Tests, HPV Vaccines, HPV Nonavalent Vaccine, Gardasil-9, 9vHPV
- Medical subject headings
- Papillomavirus Infections, Infections, Uterine Cervical Neoplasms, Squamous Intraepithelial Lesions of the Cervix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonavalent HPV vaccine (9vHPV)Biological
Also called Gardasil-9™
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
| Study group | Role | What they receive |
|---|---|---|
| Intervantional Arm | Experimental | Women randomisied on this arm will receive their first dose at Month 0 (M0). Receives: Biological: Nonavalent HPV vaccine (9vHPV) |
| Control Arm | No intervention | Women randomised on this arm will not to be vaccinated at Month 0 (M0). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®).
Measured: 7 months
Secondary outcomes (4)
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®).
Measured: 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®).
Measured: 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
Measured: 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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for HPVStudies 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
- Model description
- This is randomized trial with two arms. First arm will receive one dose of the nonavalent vaccine and the second unvaccined arm will serve as a control.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miquel Angel Pavon Ribas, Institut d'Investigació Biomèdica de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303751
- Sponsor's protocol ID
- INV-074218
- Acronym
- RIFT-SSA
- Status last verified
- Feb 2026
- First submitted
- 20 Nov 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hooper R, Forbes A, Hemming K, Takeda A, Beresford L. Analysis of cluster randomised trials with an assessment of outcome at baseline. BMJ. 2018 Mar 20;360:k1121. doi: 10.1136/bmj.k1121. No abstract available.
PubMed 29559436Houlihan CF, Baisley K, Bravo IG, Kapiga S, de Sanjose S, Changalucha J, Ross DA, Hayes RJ, Watson-Jones D. Rapid acquisition of HPV around the time of sexual debut in adolescent girls in Tanzania. Int J Epidemiol. 2016 Jun;45(3):762-73. doi: 10.1093/ije/dyv367. Epub 2016 Mar 4.
PubMed 26944311Centers for Disease Control and Prevention. (2025, 6 de marzo). Human Papillomavirus (HPV) Vaccine Safety. https://www.cdc.gov/vaccine-safety/vaccines/hpv.html
Watson-Jones D, Baisley K, Brown J, Kavishe B, Andreasen A, Changalucha J, Mayaud P, Kapiga S, Gumodoka B, Hayes RJ, de Sanjose S. High prevalence and incidence of human papillomavirus in a cohort of healthy young African female subjects. Sex Transm Infect. 2013 Aug;89(5):358-65. doi: 10.1136/sextrans-2012-050685. Epub 2013 Mar 13.
PubMed 23486859Centers for Disease Control and Prevention. (2024, 9 de julio). HPV Vaccine Safety and Effectiveness Data. https://www.cdc.gov/hpv/hcp/vaccination-considerations/safety-and-effectiveness-data.html
Chow EP, Read TR, Wigan R, Donovan B, Chen MY, Bradshaw CS, Fairley CK. Ongoing decline in genital warts among young heterosexuals 7 years after the Australian human papillomavirus (HPV) vaccination programme. Sex Transm Infect. 2015 May;91(3):214-9. doi: 10.1136/sextrans-2014-051813. Epub 2014 Oct 10.
PubMed 25305210Whitworth HS, Mounier-Jack S, Choi EM, Gallagher KE, Howard N, Kelly H, Mbwanji G, Kreimer AR, Basu P, Barnabas R, Drolet M, Brisson M, Watson-Jones D. Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to multidose vaccination regimens or no vaccination: An updated systematic review of evidence from clinical trials. Vaccine X. 2024 Apr 16;19:100486. doi: 10.1016/j.jvacx.2024.100486. eCollection 2024 Aug.
PubMed 38873638Kamolratanakul S, Pitisuttithum P. Human Papillomavirus Vaccine Efficacy and Effectiveness against Cancer. Vaccines (Basel). 2021 Nov 30;9(12):1413. doi: 10.3390/vaccines9121413.
PubMed 34960159Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Teblick L, Lipovac M, Molenberghs F, Delputte P, De Vos WH, Vorsters A. HPV-specific antibodies in female genital tract secretions captured via first-void urine retain their neutralizing capacity. Hum Vaccin Immunother. 2024 Dec 31;20(1):2330168. doi: 10.1080/21645515.2024.2330168. Epub 2024 Apr 3.
PubMed 38567541Smahelova J, Hamsikova E, Ludvikova V, Vydrova J, Traboulsi J, Vencalek O, Lukes P, Tachezy R. Outcomes After Human Papillomavirus Vaccination in Patients With Recurrent Respiratory Papillomatosis: A Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Jul 1;148(7):654-661. doi: 10.1001/jamaoto.2022.1190.
PubMed 35653138Wenande E, Hastrup A, Wiegell S, Philipsen PA, Thomsen NB, Demehri S, Kjaer SK, Haedersdal M. Human Papillomavirus Vaccination and Actinic Keratosis Burden: The VAXAK Randomized Clinical Trial. JAMA Dermatol. 2025 Jun 1;161(6):605-614. doi: 10.1001/jamadermatol.2025.0531.
PubMed 40047786Drolet M, Benard E, Perez N, Brisson M; HPV Vaccination Impact Study Group. Population-level impact and herd effects following the introduction of human papillomavirus vaccination programmes: updated systematic review and meta-analysis. Lancet. 2019 Aug 10;394(10197):497-509. doi: 10.1016/S0140-6736(19)30298-3. Epub 2019 Jun 26.
PubMed 31255301
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Vaccination and Infectivity Reduction in HPV-positive Women
- ClinicalTrials.gov ID
- NCT07303751
- Acronym / sponsor ID
- RIFT-SSA / INV-074218
- Keywords
- Cervical cancer, Cervical Intraepithelial Neoplasia Grade I/ II/ III (CIN I/II/III), Squamous Intraepithelial Lesions of the Cervix, High/ Low Grade, Human Papillomavirus (HPV) Infections, High-risk HPV, HPV-16/ 18, HPV DNA Tests, HPV Vaccines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de BellvitgeUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 26 Dec 2025 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is randomized trial with two arms. First arm will receive one dose of the nonavalent vaccine and the second unvaccined arm will serve as a control.
| Arm | Type | Receives |
|---|---|---|
| Intervantional Arm | Experimental | Biological: Nonavalent HPV vaccine (9vHPV)Women randomisied on this arm will receive their first dose at Month 0 (M0). |
| Control Arm | No intervention | –Women randomised on this arm will not to be vaccinated at Month 0 (M0). |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Born female
- Aged between 18-29 years old;
- Living in Kambia district (or neighbouring district if included) without plans to move away in the next 12 months;
- Willing to participate in the study and have signed the informed consent form;
- In good health as determined by a medical history (a physical examination will be conducted if necessary according to the clinician's judgement);
Key exclusion criteria (8 listed)
- They have been previously vaccinated against HPV;
- They have a chronic condition, such as autoimmune conditions, degenerative diseases, neurologic or genetic diseases among others;
- They are HIV positive or immunocompromised;
- They are pregnant or planning to get pregnant in the next 12 months;
- They are less than three months post-partum or currently breastfeeding;
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 |
|---|---|---|
| Nonavalent HPV vaccine (9vHPV)Also: Gardasil-9™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 | Biological | Intervantional Arm |
Primary outcome
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®).
Time frame: 7 months
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®).
4 secondary outcomes
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
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®).
Time frame: 7 months
Neutralising antibodies infective capacity of HPV virions and HPV viral load in urine samples
Time frame: 7 months
The difference in infectivity reduction and vaccine induced antibodies among different HPV types.
Time frame: 7 months
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 11 Feb 2026.
- Background: PubMed 29559436Hooper R, Forbes A, Hemming K, Takeda A, Beresford L. Analysis of cluster randomised trials with an assessment of outcome at baseline. BMJ. 2018 Mar 20;360:k1121. doi: 10.1136/bmj.k1121. No abstract available.
- Background: PubMed 26944311Houlihan CF, Baisley K, Bravo IG, Kapiga S, de Sanjose S, Changalucha J, Ross DA, Hayes RJ, Watson-Jones D. Rapid acquisition of HPV around the time of sexual debut in adolescent girls in Tanzania. Int J Epidemiol. 2016 Jun;45(3):762-73. doi: 10.1093/ije/dyv367. Epub 2016 Mar 4.
- BackgroundCenters for Disease Control and Prevention. (2025, 6 de marzo). Human Papillomavirus (HPV) Vaccine Safety. https://www.cdc.gov/vaccine-safety/vaccines/hpv.html
- Background: PubMed 23486859Watson-Jones D, Baisley K, Brown J, Kavishe B, Andreasen A, Changalucha J, Mayaud P, Kapiga S, Gumodoka B, Hayes RJ, de Sanjose S. High prevalence and incidence of human papillomavirus in a cohort of healthy young African female subjects. Sex Transm Infect. 2013 Aug;89(5):358-65. doi: 10.1136/sextrans-2012-050685. Epub 2013 Mar 13.
- BackgroundCenters for Disease Control and Prevention. (2024, 9 de julio). HPV Vaccine Safety and Effectiveness Data. https://www.cdc.gov/hpv/hcp/vaccination-considerations/safety-and-effectiveness-data.html
- Background: PubMed 25305210Chow EP, Read TR, Wigan R, Donovan B, Chen MY, Bradshaw CS, Fairley CK. Ongoing decline in genital warts among young heterosexuals 7 years after the Australian human papillomavirus (HPV) vaccination programme. Sex Transm Infect. 2015 May;91(3):214-9. doi: 10.1136/sextrans-2014-051813. Epub 2014 Oct 10.
- Background: PubMed 38873638Whitworth HS, Mounier-Jack S, Choi EM, Gallagher KE, Howard N, Kelly H, Mbwanji G, Kreimer AR, Basu P, Barnabas R, Drolet M, Brisson M, Watson-Jones D. Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to multidose vaccination regimens or no vaccination: An updated systematic review of evidence from clinical trials. Vaccine X. 2024 Apr 16;19:100486. doi: 10.1016/j.jvacx.2024.100486. eCollection 2024 Aug.
- Background: PubMed 34960159Kamolratanakul S, Pitisuttithum P. Human Papillomavirus Vaccine Efficacy and Effectiveness against Cancer. Vaccines (Basel). 2021 Nov 30;9(12):1413. doi: 10.3390/vaccines9121413.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 38567541Teblick L, Lipovac M, Molenberghs F, Delputte P, De Vos WH, Vorsters A. HPV-specific antibodies in female genital tract secretions captured via first-void urine retain their neutralizing capacity. Hum Vaccin Immunother. 2024 Dec 31;20(1):2330168. doi: 10.1080/21645515.2024.2330168. Epub 2024 Apr 3.
- Background: PubMed 35653138Smahelova J, Hamsikova E, Ludvikova V, Vydrova J, Traboulsi J, Vencalek O, Lukes P, Tachezy R. Outcomes After Human Papillomavirus Vaccination in Patients With Recurrent Respiratory Papillomatosis: A Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Jul 1;148(7):654-661. doi: 10.1001/jamaoto.2022.1190.
- Background: PubMed 40047786Wenande E, Hastrup A, Wiegell S, Philipsen PA, Thomsen NB, Demehri S, Kjaer SK, Haedersdal M. Human Papillomavirus Vaccination and Actinic Keratosis Burden: The VAXAK Randomized Clinical Trial. JAMA Dermatol. 2025 Jun 1;161(6):605-614. doi: 10.1001/jamadermatol.2025.0531.
- Individual participant dataSharing planned: No
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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.
Elena Ruiz Puig contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nonavalent HPV vaccine (9vHPV) in people with HPV and High-risk HPV (Any Strain), run by Institut d'Investigació Biomèdica de Bellvitge at 1 site in Sierra Leone.
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 13 inclusion and 8 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 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sierra Leone. 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 Miquel Àngel Pavón Ribas PhD (+34932607123, mpavon@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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®). (time frame: 7 months). 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 NCT07303751, which also lists 13 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 11 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.