A Phase 4 interventional study of Nonavalent HPV vaccine (9vHPV/Gardasil-9™). in Cervical Intraepithelial Neoplasia Grade I/ II/ III (CIN I/II/III), Human Papillomavirus (HPV) Infections and High-risk HPV, sponsored by Miquel Angel Pavon Ribas. Recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Miquel Angel Pavon Ribas · Phase 4, Interventional, and Prevention
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Among 21 studies in Papillomavirus Infections with a site in Spain — 6 open to participants now, 8 under way, 1 of them phase 3. Papillomavirus Infections · Spain.
Among the 21 studies in Papillomavirus Infections with a site in Spain, this one is the 15th largest by planned enrollment of the 16 interventional ones that give a count, is one of 2 that started in 2022, is one of 4 in phase 4, and was the 14th registered.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
Browse Papillomavirus Infections studies →6 of the 21 studies in Papillomavirus Infections with a site in Spain are open now. Recruiting first, the newest first:
Catalysis SL · Sites in Spain
Ages 30–65 · Women only
Talia Sainz Costa · Sites in Spain
Ages 9–18 · Healthy volunteers
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Sites in Spain
Ages 18–79 · Men only
Marengo Therapeutics, Inc. · Sites in Spain, United States, Canada and 1 more country
Ages 18+
Hifas da Terra S.L. · Sites in Spain
Ages 30–50 · Women only
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 85 Papillomavirus Infections studies recruiting now, 38 (45%) set no upper age limit and 42 (49%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2022.
This study's planned enrollment of 69 is below the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.
Median enrollment 182 across the 16 interventional studies, 384 across the 5 observational. Of the 11 that completed or were terminated, 4 (36%) have results posted.
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15 of 21 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Miquel Angel Pavon Ribas as lead sponsor.
Miquel Angel Pavon Ribas has 1 study filed under Papillomavirus Infections — fewer than ten, so there is no comparison to draw.
3 of the studies in Papillomavirus Infections with a site in Spain that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04199689Phase 3Merck Sharp & Dohme LLCEfficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049) | 2027-01-15 |
| NCT05334706Miquel Angel Pavon RibasA Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV-Positive Women After Vaccination With 9vHPV (RIFT-HPV) | 2026-12 |
| NCT05592626Marengo Therapeutics, Inc.A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors | 2027-09 |
Add all 3 to your calendar (.ics) → With an account.
Among the 21 studies in Papillomavirus Infections with a site in Spain, from their registry updates:
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This is a non-randomized, open label study to assess the reduction of Human Papillomavirus (HPV) infectivity and transmission in women positive for HPV16 and/or 18 in a cervical, oral and anal sample and vaccinated with 9vHPV/Gardasil-9™.
The primary objective of the study is to demonstrate that vaccination with a 3-dose regimen of 9vHPV will reduce viral infectivity in HPV 16/18/16+18-positive women. This objective rests upon the hypothesis that, since vaccination with 9vHPV triggers the production of type-specific HPV antibodies which are exudated to the cervical and other infected mucosae, these antibodies adhere to and neutralize newly produced HPV 16/18 viral particles also present in the mucosae, thus reducing HPV's infective capacity and transmission to sexual partners.
Secondary objectives of the study are:
The main endpoint of the study is the evaluation of the HPV infective capacity in cervical, anal and oral samples from HPV 16, 18 or 16+18-positive women, using a cellular assay that models in-vitro the cervical mucosa. In brief, the specific HPV biomarker E1\^E4 is measured in HaCaT keratinocytes after being cultured with study samples and thus, exposed to HPV16/18 viral particles. A reduction in E1\^E4 expression is expected for keratinocytes exposed to samples taken after vaccination with 9vHPV, since the specific HPV antibodies also present in these samples would bind HPV viral particles and prevent infection of cultured keratinocytes.
Other endpoints included in the study are:
A minimum of 39 and 30 women will be enrolled in two different study population cohorts, respectively:
Candidates to participate in the study are selected according to the HPV DNA test result in a cervical sample taken in their routine cervical cancer screening visit or in their routine gynaecological follow-up visit.
There is no control group in this study: all participants are expected to complete all the per-protocol procedures in a total of 4 study visits within an average of 7 months' duration: Visit 1/ Day1, Visit 2/Month 2, Visit 3/Month 6, and Visit 4/Month 7.
The study procedures are the following:
Regarding data analysis for primary objective assessment, differences in the infectivity rate before (Day 1/ Visit 1) and after vaccination with 3 doses of 9vHPV (Month 7/ Visit 4) will be compared in cervical, anal and oral samples using non-parametric Wilcoxon signed rank test. The same assessment will be done in 1- or 2-dose vaccination scenario.
Antibody production before and after vaccination will be summarized for each of the 9vHPV-covered HPV types.
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.
have no apparent cervical lesion (Cohort 1). have a CIN1/2 lesion which is eligible for conservative treatment (cohort 1). have HPV 16 and/or HPV 18 positive anal test with non-apparent anal lesions or with anal lesions eligible for conservative treatment (Cohort 2).
have HPV 16 and/or HPV 18 positive cervical test with vulvar premalignant lesion or condylomas, associated to HPV infection (Cohort 2).
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.
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.
Single arm, vaccination with 9vHPV in a 3-dose regimen (Day 1, Month 2, Month 6).
Biological: Nonavalent HPV vaccine (9vHPV/Gardasil-9™).
Sterile suspension, 0.5 ml dose, intramuscular administration in a 3 dose-regimen (Day 1, Month 2, Month 6), prepared from the highly purified virus-like 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, 2015.
To demonstrate that vaccination with a 3-dose regimen of 9vHPV will change viral infectivity in cervical, anal and oral samples from HPV 16/18/16+18-positive women.
In-vitro infectivity evaluation of cervical, anal, and oral samples collected before and after 9vHPV vaccination, by expression of E1\^E4 HPV biomarker in HaCaT keratinocytes.
Time frame: 7 month
Detection of HPV 6/11/16/18/31/33/45/52/58 L1 antibodies in cervical, anal and oral samples collected before and after 9vHPV vaccination, using ELISA and cLIA.
This endpoint will allow to associate the reduction in viral infectivity with the presence of neutralizing antibodies.
Time frame: 7 month
HPV16/18 virion detection in cervical, anal and oral samples collected before and after 9vHPV vaccination.
HPV16/18 virion detection will be carried out using ELISA and electronic microscopy in cervical, anal and oral samples collected before and after 9vHPV vaccination.
Time frame: 7 month
HPV DNA detection in cervical, anal and oral samples collected before and after 9vHPV vaccination.
HPV DNA detection will be performed using Anyplex HPV28 in cervical, anal and oral samples collected before and after 9vHPV vaccination.
Time frame: 7 month
HPV DNA genotyping in cervical, anal and oral samples collected before and after 9vHPV vaccination.
HPV DNA genotyping will be performed using Anyplex HPV28 in cervical, anal and oral samples collected before and after 9vHPV vaccination.
Time frame: 7 month
To determine HPV antibody titration before and after vaccination for each of the 9vHPV-covered HPV types (6, 11, 16, 18, 31, 33, 45, 52, and 58).
To determine HPV 6/11/16/18/31/33/45/52/58 L1 antibody titration in serum samples collected before and after 9vHPV vaccination, using ELISA for types 16 and 18 in samples from RIFT-HPV 1 and 2 study cohorts, using cLIA for all 9vHPV-covered types except 16 and 18, in samples from RIFT-HPV 1 study cohort.
Time frame: 7 month
To demonstrate viral infectivity change in cervical, oral and anal samples from HPV 16/18/16+18-positive women after vaccination with 1-dose or 2-dose regimen of 9vHPV.
In-vitro infectivity evaluation of cervical, anal, and oral samples collected before and after 9vHPV vaccination with 1st dose and 2nd dose, by expression of E1\^E4 HPV biomarker in HaCaT keratinocytes.
Time frame: 7 month
Plan to share: No
Started Sep 2022 (actual). Primary completion is estimated for Dec 2026, 51 months after the start.
Of 28 phase 4 interventional studies under Papillomavirus Infections, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 92. This study's planned 51 months is below that.
How these figures are worked out, and which studies are left out of them.
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