PANHPVAX, Study of a New HPV Vaccine in Healthy Volunteers

NCT05208710 | Recruiting Early Phase 1 DMC

• 2 other identifiers: DKFZ-2019-0032021-002584-22
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 papilloma L2 antigens formulated with cdA (adjuvant) as compared to the formulation without cdA.

Conditions

HPV

Keywords

HPV Vaccines; Cyclic-di AMP; First in Human

Outcome Measures

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.

  3 months

Study Arms (3)

PANHPVAX 10µg

EXPERIMENTAL

PANHPVAX 10µg plus c-di AMP in escalating doses

Biological: Vaccination with PANHPVAX 10µg

PANHPVAX 40µg

EXPERIMENTAL

PANHPVAX 40µg plus c-di AMP in escalating doses

Biological: Vaccination with PANHPVAX 40µg

PANHPVAX 100µg

EXPERIMENTAL

PANHPVAX 100µg plus c-di AMP in escalating doses

Biological: Vaccination with PANHPVAX 100µg

Interventions

Vaccination with PANHPVAX 10µg BIOLOGICAL

Escalated dosages of c-di AMP (0, 7,5, 15µg) added groupwise to 10µg antigen

PANHPVAX 10µg

Vaccination with PANHPVAX 40µg BIOLOGICAL

Escalated dosages of c-di AMP (0, 7,5, 15µg) added groupwise to 40µg antigen

PANHPVAX 40µg

Vaccination with PANHPVAX 100µg BIOLOGICAL

Escalated dosages of c-di AMP (0, 7,5, 15µg) added groupwise to 100µg antigen

PANHPVAX 100µg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• German Cancer Research Center: lead
• National Center for Tumor Diseases, Heidelberg: collaborator
• University Hospital Heidelberg: collaborator

Study Sites (1)

University Hospital Department of Clinical Pharmacology and Pharmacoepidemiology

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Interventions

Vaccination

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Antje Blank, Dr.

  Heidelberg University Hospital, Department of Clinical Pharmacology and Pharmacoepidemiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Markus Kratzmann, Dr.

CONTACT

+49 (0)6221 56 32014; markus.kratzmann@nct-heidelberg.de

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 26, 2022
• Study Start: November 7, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-10

Locations

DE (1)