Status:
RECRUITING
PANHPVAX, Study of a New HPV Vaccine in Healthy Volunteers
Lead Sponsor:
German Cancer Research Center
Collaborating Sponsors:
University Hospital Heidelberg
National Center for Tumor Diseases, Heidelberg
Conditions:
HPV
Eligibility:
All Genders
18-45 years
Phase:
EARLY_PHASE1
Brief 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 papill...
Detailed Description
Infections with one of 15 human papillomavirus (HPV) types are considered the main risk factor for the development of certain anogenital cancers. In addition, these HPV types are also suspected to be ...
Eligibility Criteria
Inclusion
- 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,
- No current desire to have children, and
- Consent not to be vaccinated with a commercially available HPV vaccine during the trial until the end-of-study visit.
Exclusion
- 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),
- Clinically relevant findings in any of the following investigations at screening (SCR) I. Hemoglobin (Hb) \< 12 g/dl (males) or \< 11 g/dl (females), II. Estimated Creatinine clearance (eCrCl) \< 60 ml/min (Cockcroft-Gault), III. Total bilirubin \> upper limit of normal (ULN) x 1.2; In case of suspected Gilbert´s disease: total bilirubin ≤ ULN x 3 is acceptable , IV. Alanine aminotransferase (ALT) \> ULN x 1.1, V. Aspartate aminotransferase (AST) \> ULN x 1.2,
- Use of an IMP within 30 d prior to the expected date of receiving the first dose of IMP or active enrolment in another drug or vaccine clinical trial,
- Use of any medication (prescription medication, non-prescription medication including herbal preparations) with active ingredients (except hormonal contraception, iodine, and thyroid hormones) within a period of less than 5 times the respective elimination half-life (t1/2) with regard to the expected date of the first dose of IMP. This does not apply to topical preparations if no relevant systemic exposure is expected,
- Known prior vaccination against HPV,
- Any vaccination within the 28 days (d) prior to the expected Visit 1,
- A positive human immunodeficiency virus (HIV) or hepatitis C (HCV) antibody screen, or positive result for Hepatitis-B-Surface-Antigen (HBsAg),
- A positive result in the drug screening test at SCR, and
- Pregnancy or breast feeding.
Key Trial Info
Start Date :
November 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05208710
Start Date
November 7 2022
End Date
December 1 2027
Last Update
December 19 2025
Active Locations (1)
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1
University Hospital Department of Clinical Pharmacology and Pharmacoepidemiology
Heidelberg, Germany, 69120