PANHPVAX, Study of a New HPV Vaccine in Healthy Volunteers
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
German Cancer Research Center
45 participants
Nov 7, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria12
- 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.
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Interventions
Escalated dosages of c-di AMP (0, 7,5, 15µg) added groupwise to 10µg antigen
Escalated dosages of c-di AMP (0, 7,5, 15µg) added groupwise to 40µg antigen
Escalated dosages of c-di AMP (0, 7,5, 15µg) added groupwise to 100µg antigen
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05208710