Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 11:30 AM
Study NCT ID:
NCT07303751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-11
First Post:
2025-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV
Sponsor:
Institut d'Investigació Biomèdica de Bellvitge
Organization:
Study Overview
Official Title:
HPV Vaccination and Infectivity Reduction in HPV-positive Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIFT-SSA
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: