drugset / Trial / NCT05208710
PANHPVAX, Study of a New HPV Vaccine in Healthy Volunteers
Phase 0
Recruiting
45 enrolled
German Cancer Research Center
National Center for Tumor Diseases, Heidelberg · collabUniversity Hospital Heidelberg · collab
Non-randomizedSequentialOpen-labelPrevention
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.
Timeline
- Start
- 2022-11-07
- Primary completion
- 2027-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PANHPVAX | Vaccine | 10 ug | Intramuscular |
| Subject | PANHPVAX | Vaccine | 40 ug | Intramuscular |
| Subject | PANHPVAX | Vaccine | 100 ug | Intramuscular |
| Subject | cyclic di-adenosine monophosphate | Oligonucleotide (other) | 0 ug | Intramuscular |
| Subject | cyclic di-adenosine monophosphate | Oligonucleotide (other) | 7.5 ug | Intramuscular |
| Subject | cyclic di-adenosine monophosphate | Oligonucleotide (other) | 15 ug | Intramuscular |