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RECRUITING
NCT05208710
EARLY_PHASE1

PANHPVAX, Study of a New HPV Vaccine in Healthy Volunteers

Sponsor: German Cancer Research Center

View on ClinicalTrials.gov

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.

Official title: A First-in-human, Phase I, Single-center, Open-label, Dose-escalation Trial in Healthy Volunteers to Assess Safety, Tolerability, and Immunogenicity of PANHPVAX, a Vaccine Targeting Human Papilloma L2 Antigen Formulated With Cyclic Di-AMP

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2022-11-07

Completion Date

2027-12

Last Updated

2025-12-19

Healthy Volunteers

Yes

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

Locations (1)

University Hospital Department of Clinical Pharmacology and Pharmacoepidemiology

Heidelberg, Germany