Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV (RIFT-SSA)

February 9, 2026 updated by: Miquel Angel Pavon Ribas, Institut d'Investigació Biomèdica de Bellvitge

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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;
  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervantional Arm
Women randomisied on this arm will receive their first dose at Month 0 (M0).
Biological: Nonavalent HPV vaccine (9vHPV)
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
Other Names:
  • Gardasil-9™
No Intervention: Control Arm
Women randomised on this arm will not to be vaccinated at Month 0 (M0).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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®).
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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®).
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
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®).
7 months
Neutralising antibodies infective capacity of HPV virions and HPV viral load in urine samples
Time Frame: 7 months
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
7 months
The difference in infectivity reduction and vaccine induced antibodies among different HPV types.
Time Frame: 7 months
To analyse differences in infectivity reduction and vaccine induced antibodies among different HPV types included in the 9-valent vaccine.
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut d'Investigació Biomèdica de Bellvitge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INV-074218

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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