PANHPVAX, Study of a New HPV Vaccine in Healthy Volunteers
ConditionHPV
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorGerman Cancer Research Center
About this trial
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.
Eligibility criteria
Qualifiers
Written, personally signed and dated informed consent to participate in the trial prior to any trial-related interventions,
Understanding, ability, and willingness to fully comply with trial interventions and restrictions,
Age 18-45 years (y) inclusive at the time of consent,
Males or females of child-bearing potential who are willing to use a highly effective method of contraception during the treatment and for 4 weeks after each vaccination with the IMP, or women not of child-bearing potential (WNCBP), or individuals who are convincingly sexually abstinent. Highly effective methods of contraception are described in section 7.6.9,
Disqualifiers
Clinically significant or relevant abnormalities as assessed by the investigator in the medical history, or findings from physical examination, or laboratory evaluation that may require treatment or make the participant unlikely to fully complete the trial, or any condition that presents undue risk from the IMP or trial interventions,
Any acute or chronic illness expected to influence the immune response to vaccination,
Immunoglobulin administration in the past 3 months prior to first immunization,
Any known history of severe anaphylactic reactions to drugs or vaccinations, or any known history to allergies against the excipients of the investigational medicinal product (IMP),
Trial design
Treatments tested in this trial
- Vaccination with PANHPVAX 10µg
- Vaccination with PANHPVAX 40µg
- Vaccination with PANHPVAX 100µg
Treatment groups
45 Participants
are divided into 3 treatment groupsSponsors and collaborators
German Cancer Research Center
Lead sponsor
University Hospital Heidelberg
Collaborator
National Center for Tumor Diseases, Heidelberg
Collaborator
Source ClinicalTrials.gov