drugset
drugset / Trial / NCT07113106

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

NCT07113106 ↗

Phase 1/2 Active not recruiting 48 enrolled ANRS, Emerging Infectious Diseases Institut National de la Santé Et de la Recherche Médicale, France · collabUnité Mixte de Service 54 Methods and Applied Research for Trials (UMS 54 MART) · collab
Non-randomizedSequentialOpen-labelTreatment

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

Timeline

Start
2025-06-18
Primary completion
2026-10-08
Completion
2027-06-25

Drugs

EvaluationDrugModalityDoseRoute
Subject CD40.Pan.CoV Vaccine 0.25 mg Subcutaneous
Subject CD40.Pan.CoV Vaccine 1 mg Subcutaneous
Subject Hiltonol Other / unclassified — Subcutaneous

Indications

No indication recorded.