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A Phase 1 Study of PV-001 9-valent Human Papillomavirus(HPV) Vaccine

NCT07081334 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-07-23

No results posted yet for this study

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

Conditions

  • HPV Infections

Interventions

BIOLOGICAL

PV-001

9-valent vaccine containing antigens for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58

BIOLOGICAL

PEV-001

PEV-001 is a formulation of the PV-001 vaccine that excludes the HPV antigens and contains only aluminum phosphate.

Sponsors & Collaborators

  • POSVAX

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-17
Primary Completion
2024-04-29
Completion
2025-01-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07081334 on ClinicalTrials.gov