New HPV vaccine tested 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

This study is testing a new HPV vaccine in healthy adults aged 18-45 to see if it can safely boost their immune response against different types of HPV that can cause cancer.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: German Cancer Research Center (Academic / other)
• Locations: 1 site (Heidelberg)
• Trial ID: NCT05208710 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy individuals aged 18-45 who are willing to comply with trial protocols and contraception requirements.

Not a fit: Patients with significant health issues or those currently desiring to conceive may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide enhanced protection against HPV-related cancers and infections.

How similar studies have performed: While there are existing HPV vaccines, this approach using L2 antigens and cyclic di-AMP is novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Heidelberg

• 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.

Conditions HPV; HPV Vaccines; Cyclic-di AMP; First in Human