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NCT Number: NCT07303751

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

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.

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Key information

Conditions

HPV Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female High-risk HPV (Any Strain) Human Papillomavirus (HPV) Infections Infections Morphological and Microscopic Findings Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Squamous Intraepithelial Lesions Squamous Intraepithelial Lesions of the Cervix Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nonavalent HPV vaccine (9vHPV)

Biological

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™

Primary outcomes

  1. 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®).

Secondary outcomes

  1. 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®).

  2. 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®).

  3. 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

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Ruiz Puig

CONTACT

[email protected]

Miquel Àngel Pavón Ribas PhD

CONTACT

[email protected]

+34932607123

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Bellvitge

Other

Registry information

Official study title

HPV Vaccination and Infectivity Reduction in HPV-positive Women

Acronym: RIFT-SSA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 26, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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