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PANHPVAX, Study of a New HPV Vaccine in Healthy Volunteers

NCT05208710 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-12-19

No results posted yet for this study

Summary

First-in-human, phase I, single-center, open-label, dose-escalation trial in healthy volunteers. Investigation of safety and tolerability of ascending doses of PANHPVAX, a vaccine against human papilloma L2 antigens formulated with cdA (adjuvant) as compared to the formulation without cdA.

Conditions

Interventions

BIOLOGICAL

Vaccination with PANHPVAX 10µg

Escalated dosages of c-di AMP (0, 7,5, 15µg) added groupwise to 10µg antigen

BIOLOGICAL

Vaccination with PANHPVAX 40µg

Escalated dosages of c-di AMP (0, 7,5, 15µg) added groupwise to 40µg antigen

BIOLOGICAL

Vaccination with PANHPVAX 100µg

Escalated dosages of c-di AMP (0, 7,5, 15µg) added groupwise to 100µg antigen

Sponsors & Collaborators

  • University Hospital Heidelberg

    collaborator OTHER

  • National Center for Tumor Diseases, Heidelberg

    collaborator OTHER

  • German Cancer Research Center

    lead OTHER

Principal Investigators

  • Antje Blank, Dr. · Heidelberg University Hospital, Department of Clinical Pharmacology and Pharmacoepidemiology

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-07
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT05208710 on ClinicalTrials.gov