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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Vaccination with PANHPVAX 10µg
Biological/VaccineEscalated dosages of c-di AMP (0, 7,5, 15µg) added groupwise to 10µg antigen
Vaccination with PANHPVAX 40µg
Biological/VaccineEscalated dosages of c-di AMP (0, 7,5, 15µg) added groupwise to 40µg antigen
Vaccination with PANHPVAX 100µg
Biological/VaccineEscalated dosages of c-di AMP (0, 7,5, 15µg) added groupwise to 100µg antigen
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: PANHPVAX 10µgExperimental treatment 1 intervention
Group B: PANHPVAX 40µgExperimental treatment 1 intervention
Group C: PANHPVAX 100µgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Frequency and severity of local and systemic reactions
Frequency and severity of local and systemic reactions (solicited vaccination reactions) of ascending doses of the vaccine after each vaccination until day 29.
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
German Cancer Research Center
Lead sponsor
University Hospital Heidelberg
Collaborator
National Center for Tumor Diseases, Heidelberg
Collaborator
Source ClinicalTrials.gov