New HPV vaccine tested in healthy volunteers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, phase I, single-center, open-label, dose-escalation trial that evaluates the safety and tolerability of the PANHPVAX vaccine, which targets human papillomavirus (HPV) L2 antigens. The study involves administering ascending doses of the vaccine, both with and without an adjuvant called cyclic di-AMP, to healthy volunteers aged 18-45. The goal is to induce a broad immune response against multiple HPV types, which are linked to various cancers. Participants will be monitored for their immune response and any adverse effects following vaccination.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written, personally signed and dated informed consent to participate in the trial prior to any trial-related interventions,
2. Understanding, ability, and willingness to fully comply with trial interventions and restrictions,
3. Age 18-45 years (y) inclusive at the time of consent,
4. 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,
5. No current desire to have children, and
6. Consent not to be vaccinated with a commercially available HPV vaccine during the trial until the end-of-study visit.

Exclusion Criteria:

1. 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,
2. Any acute or chronic illness expected to influence the immune response to vaccination,
3. Immunoglobulin administration in the past 3 months prior to first immunization,
4. 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),
5. 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,
6. 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,
7. 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,
8. Known prior vaccination against HPV,
9. Any vaccination within the 28 days (d) prior to the expected Visit 1,
10. A positive human immunodeficiency virus (HIV) or hepatitis C (HCV) antibody screen, or positive result for Hepatitis-B-Surface-Antigen (HBsAg),
11. A positive result in the drug screening test at SCR, and
12. Pregnancy or breast feeding.

Where it's running

• University Hospital Department of Clinical Pharmacology and Pharmacoepidemiology
  Heidelberg, Germany Recruiting

Study contacts

• Principal investigator: Antje Blank, Dr. — Heidelberg University Hospital, Department of Clinical Pharmacology and Pharmacoepidemiology
• Study coordinator: Markus Kratzmann, Dr.
• Email: markus.kratzmann@nct-heidelberg.de
• Phone: +49 (0)6221 56 32014

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.