Dose Escalation Trial of CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Healthy Volunteers

NCT07113106 | Active Not Recruiting Phase 1 DMC

• 2 other identifiers: 2024-516767-92-01ANRS0640s LKV-PAN-01 (PANCOV)
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 7

Brief Summary

The clinical trial is a phase1/2a, open-label, dose-escalating, multicentre trial evaluating the safety and immunogenicity of the CD40.Pan.CoV vaccine, adjuvanted or not, as a booster injection in adult participants in France. 48 participants divided into 4 cohorts will be included in the trial. Primary objectives are the following:

• To determine the safety and reactogenicity of different doses (0.25 mg and 1 mg) of a booster of a CD40.Pan.CoV vaccine, adjuvanted or not, in healthy volunteers between Day 0 and Month1
• To determine the humoral immune response (neutralizing antibody titers) induced by different doses (0.25 mg and 1 mg) of a booster of a CD40.Pan.CoV vaccine, adjuvanted or not, at Month1 after administration

Conditions

Healthy Volunteers

Keywords

a phase 1/2a, dose-escalating; Adult healthy volunteers; CD40.Pan.CoV vaccine adjuvanted or not; COVID19 vaccine; Safety and immunogenicity evaluation

Outcome Measures

Primary Outcomes (2)

• Safety primary outcome

  • Proportion of participants without any grade 3 or 4 solicited local/systemic or unsolicited AEs after the vaccine administration and considered to be related or possibly related to IMP administration

  From Day 0 (injection) to Month 1

• Immunogenicity primary outcome

  Geometric mean titers of neutralizing antibodies against the original strain D614G and the relevant circulating variants measured

  from Day 0 (vaccine injection) to Month 1

Secondary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  From Day 0 to the end of the follow-up (Month 6)

• Immune response capacity (Immunogenicity)

  From Day 0 to Month 6

Study Arms (4)

Cohort 1

EXPERIMENTAL

Injection of Low dose CD40.Pan.CoV vaccine non adjuvanted

Biological: CD40.Pan.CoV Low dose(0.25mg)

Cohort 2

EXPERIMENTAL

Injection of LD CD40.Pan.CoV vaccine adjuvanted

Biological: CD40.Pan.CoV Low dose (0,25mg) adjuvanted with Hiltonol®

Cohort 3

EXPERIMENTAL

Injectionin of High dose CD40.Pan.CoV vaccine non adjuvanted

Biological: CD40.Pan.CoV High dose (1mg)

Cohort 4

EXPERIMENTAL

Injection of HD CD40.Pan.CoV vaccine adjuvanted

Biological: CD40.Pan.CoV High dose (1mg) adjuvanted with Hiltonol®

Interventions

CD40.Pan.CoV Low dose(0.25mg) BIOLOGICAL

SC Injection in deltoid of Low dose (LD; 0.25 mg) CD40.Pan.CoV vaccine non adjuvanted at Day 0.

Cohort 1

CD40.Pan.CoV Low dose (0,25mg) adjuvanted with Hiltonol® BIOLOGICAL

SC injection in deltoid of LD (0.25 mg) CD40.Pan.CoV vaccine Hiltonol® adjuvanted at Day 0.

Cohort 2

CD40.Pan.CoV High dose (1mg) BIOLOGICAL

SC injectionin deltoid of High dose (HD; 1mg) CD40.Pan.CoV vaccine non adjuvanted at Day 0.

Cohort 3

CD40.Pan.CoV High dose (1mg) adjuvanted with Hiltonol® BIOLOGICAL

SC injection in deltoid of HD (1mg) CD40.Pan.CoV vaccine Hiltonol® adjuvanted at Day 0.

Cohort 4

Eligibility Criteria

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

You may qualify if:

• Age ≥18 and \<65 years at the day of screening.
• Able to understand and comply with planned trial procedures and willing to be available for all trial-required procedures, visits and calls for the duration of the trial.
• Voluntarily signed written informed consent before performance of any trial-related screening procedures.
• Being covered by the Health Insurance.
• Agree to be registered in the French Health Ministry computerized file.
• In healthy condition or with stable health status which is defined as an existing disease that has not required a significant change in treatment or hospitalization for worsening before enrolment, and for which neither a significant change in treatment or hospitalization for worsening is expected in the near future.
• Subject who has normal biological values:
• ALT, AST, and alkaline phosphatase \< 1.25 x ULN (Liver function)
• Creatinine \< 1.1 x ULN of the laboratory
• Hemoglobin ≥ 11.0 g/dL for females and ≥ 13.0 g/dL for males
• Platelets = 125,000 to 550,000/mm3
• White blood cell count = 3,300 to 12,000 cells/mm3
• Total lymphocyte count ≥ 800 cells/mm3 Biological parameters outside of these values should be reviewed by the clinician who should specify the clinically significance. Results considered non-clinically significant by the clinician are accepted.
• Virology assessment:
• Negative Hepatitis B surface antigen (HBsAg)

You may not qualify if:

• Immunosuppressive medications received within the last three months before IMP administration or within 6 months for chemotherapies. (Not excluded: \[1\] corticosteroid nasal spray; \[2\] topical corticosteroids for mild, uncomplicated dermatitis; or \[3\] a single course of oral/parenteral corticosteroids at doses \< 2 mg/kg/day and length of therapy \< 11 days with completion at least 30 days prior to enrolment). The scheduled use of these treatments up to 6 months after the injection also represents a contraindication.
• Immunoglobulins and/or monoclonal antibodies within 90 days before IMP administration. The scheduled use of these treatments up to 6 months after the injection also represents a contraindication.
• Blood products, including convalescent plasma, within 120 days before IMP administration. The scheduled use of these treatments up to 6 months after the injection also represents a contraindication.
• Any medical condition that could impair the immune response: clinically significant medical condition (like cancer), clinical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
• A process that would affect the immune response;
• A process that would require medication that affects the immune response;
• Any contraindication to repeated injections or blood draws;
• A condition that requires active medical intervention or monitoring to avert grave danger to the participant's health or well-being during the trial period;
• A condition or process for which signs or symptoms could be confused with reactions to vaccine;
• Intent to participate in another trial of an investigational research agent within 4 weeks prior to the enrolment visit or until the end of follow-up.
• Under tutorship, guardianship, or deprived of liberty by a juridical or administrative decision.
• Pregnancy or breastfeeding that is currently ongoing, or positive pregnancy test at screening visit and the day of the vaccination.
• History of severe adverse events following vaccine administration including anaphylactic reaction and associated symptoms such as rash, breathing problems, angioedema, and abdominal pain, or a history of allergic reaction that could be triggered by a component of the SARS-CoV-2 vaccine at the time of the vaccine injection (Not excluded: a participant who had a non-anaphylactic adverse reaction to pertussis vaccine as a child).
• Any bleeding disorder considered as a contraindication due to a previous phlebotomy, or receipt of anticoagulants.
• A condition that requires active medical intervention or monitoring to avert grave danger to asthma other than mild, well-controlled asthma (symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report). Exclude a subject who:

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Unité Mixte de Service 54 Methods and Applied Research for Trials (UMS 54 MART): collaborator

Study Sites (7)

Centre de Recherche Clinique CHU de Caen Normandie

Caen, 14033, France

Location

CIC 1405 CHU Clermont Ferrand

Clermont-Ferrand, 63000, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CIC 1403 CHU de Lille

Lille, 59037, France

Location

CIC 1413 CHU de Nantes

Nantes, 44093, France

Location

CIC 1417 Cochin-Pasteur Hôpital Cochin

Paris, 75014, France

Location

CIC 1427 Hôpital St Louis

Paris, 75475, France

Location

MeSH Terms

Interventions

poly ICLC

Study Design

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

Model Details: Phase I/IIa multicenter dose-escalation trial to evaluate the safety and immunogenicity of the CD40.Pan.CoV vaccine, adjuvanted or not, as a booster in adult participants

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: August 8, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): October 8, 2026
• Study Completion (Estimated): June 25, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

FR (7)