Clinical trial · Interventional
Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV
HPV Vaccination and Infectivity Reduction in HPV-positive Women
NCT07303751CI-TRIAL-00103001RIFT-SSAnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-risk HPV (Any Strain) | — | UNRESOLVED | — |
| HPV | — | UNRESOLVED | — |
| Human Papillomavirus (HPV) Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nonavalent HPV vaccine (9vHPV) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervantional Arm
- description
- Women randomisied on this arm will receive their first dose at Month 0 (M0).
- interventionNames
- Biological: Nonavalent HPV vaccine (9vHPV)
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- Women randomised on this arm will not to be vaccinated at Month 0 (M0).
Primary outcomes (1)
- 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®).
- timeFrame
- 7 months
- description
- 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®).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 29 Years
Show eligibility criteria text
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.
References
Publications (13)
- BACKGROUNDHooper 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. PMID 29559436
- BACKGROUNDHoulihan 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. PMID 26944311
- BACKGROUNDCenters for Disease Control and Prevention. (2025, 6 de marzo). Human Papillomavirus (HPV) Vaccine Safety. https://www.cdc.gov/vaccine-safety/vaccines/hpv.html
- BACKGROUNDWatson-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. PMID 23486859
- 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
- BACKGROUNDChow 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. PMID 25305210
- BACKGROUNDWhitworth 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.