Actively Recruiting
PANHPVAX, Study of a New HPV Vaccine in Healthy Volunteers
Led by German Cancer Research Center · Updated on 2025-12-19
45
Participants Needed
1
Research Sites
264 weeks
Total Duration
On this page
Sponsors
G
German Cancer Research Center
Lead Sponsor
U
University Hospital Heidelberg
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
PANHPVAX, Study of a New HPV Vaccine in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written, signed informed consent before any trial procedures
- Ability and willingness to follow all trial interventions and restrictions
- Age between 18 and 45 years at consent
- Male or female of child-bearing potential willing to use effective contraception during treatment and for 4 weeks after each vaccination, or women not of child-bearing potential, or individuals convincingly sexually abstinent
- No current desire to have children
- Agree not to receive any commercial HPV vaccine during the trial until the end-of-study visit
You will not qualify if you...
- Significant medical abnormalities, acute or chronic illnesses affecting immune response, or conditions posing undue risk
- Immunoglobulin treatment within 3 months before first vaccination
- History of severe allergic reactions to drugs, vaccines, or vaccine components
- Abnormal lab results including low hemoglobin, low creatinine clearance, elevated bilirubin, ALT, or AST above defined limits
- Use of investigational medicinal product within 30 days before first dose or participation in another drug/vaccine trial
- Recent medication use with active ingredients except hormonal contraception, iodine, or thyroid hormones within specified elimination half-life
- Previous HPV vaccination
- Vaccination within 28 days before first study visit
- Positive HIV, hepatitis B, or hepatitis C tests
- Positive drug screening test at screening
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Department of Clinical Pharmacology and Pharmacoepidemiology
Heidelberg, Germany, 69120
Actively Recruiting
Research Team
M
Markus Kratzmann, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here