Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 7:07 AM
Study NCT ID:
NCT07081334
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2025-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of PV-001 9-valent Human Papillomavirus(HPV) Vaccine
Sponsor:
POSVAX
Organization:
Study Overview
Official Title:
Phase 1 Study to Assess the Safety and Exploratory Immunogenicity of PV-001
Status:
COMPLETED
Status Verified Date:
2025-07
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:
HPV
Brief Summary:
Study Title:
Evaluation of the Safety and Immunogenicity of a Third Dose of PV-001 in Healthy Women Aged 19-45
Objective:
To assess the safety and antibody response of a third dose of PV-001 in healthy adult female participants.
Key Questions Is PV-001 safe? What adverse events may occur after vaccination? Does PV-001 produce an effective immune response?
Participant Activities :
Three clinic visits for screening and vaccination Blood samples collected on a set schedule Monitoring for side effects after vaccination
Evaluation of the Safety and Immunogenicity of a Third Dose of PV-001 in Healthy Women Aged 19-45
Objective:
To assess the safety and antibody response of a third dose of PV-001 in healthy adult female participants.
Key Questions Is PV-001 safe? What adverse events may occur after vaccination? Does PV-001 produce an effective immune response?
Participant Activities :
Three clinic visits for screening and vaccination Blood samples collected on a set schedule Monitoring for side effects after vaccination
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?:
None
Is an FDA AA801 Violation?: