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

Study acronym: RIFT-SSA
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Miquel Angel Pavon Ribas to Institut d'Investigació Biomèdica de Bellvitgev2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07303751
Lead Sponsor Institut d'Investigació Biomèdica de Bellvitge
Conditions
(from sponsor)		 HPV, High-risk HPV (Any Strain), Human Papillomavirus (HPV) Infections
Related terms Infections, Papillomavirus Infections, Squamous Intraepithelial Lesions of the Cervix, Uterine Cervical Neoplasms
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov