NCT07113106

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

A Phase 1/2a Multicenter Trial to Evaluate the Safety and Immunogenicity of the CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Participants

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Detailed description

The ongoing COVID-19 pandemic continues to present a challenge to global public health and the response to the pandemic has been complicated by the rapid evolution of the virus. Even though vaccinations have reduced severe cases, the constant appearance of new variants has decreased the effectiveness of current vaccinations. The development of more effective vaccines is therefore becoming necessary. Two main concerns leave open scientific and policy questions regarding the optimal use and further development of COVID-19 vaccines and represent public health challenges and preventing the morbidity/mortality related to SARS-CoV-2 (re) infections. First, the continuous appearance of SARS-CoV-2 variants causing virus escape from vaccine and/or natural infection, humoral responses and second the durability of vaccine-induced protective immunity from infection. Although certain data are reassuring with the current vaccines - in particular the conservation of the T response against variants - it is clear that vaccines incorporating additional T-cell antigens, acting in synergy with antibodies, may prove beneficial in preventing both infection and serious diseases induced by SARS-CoV-2 variants and future coronaviruses, and would avoid the need for annual or bi-annual renewal of current vaccines. From this perspective, the CD40.Pan.CoV will be assessed in this trial.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	CD40.Pan.CoV Low dose(0.25mg)	SC Injection in deltoid of Low dose (LD; 0.25 mg) CD40.Pan.CoV vaccine non adjuvanted at Day 0.
BIOLOGICAL	CD40.Pan.CoV Low dose (0,25mg) adjuvanted with Hiltonol®	SC injection in deltoid of LD (0.25 mg) CD40.Pan.CoV vaccine Hiltonol® adjuvanted at Day 0.
BIOLOGICAL	CD40.Pan.CoV High dose (1mg)	SC injectionin deltoid of High dose (HD; 1mg) CD40.Pan.CoV vaccine non adjuvanted at Day 0.
BIOLOGICAL	CD40.Pan.CoV High dose (1mg) adjuvanted with Hiltonol®	SC injection in deltoid of HD (1mg) CD40.Pan.CoV vaccine Hiltonol® adjuvanted at Day 0.

Timeline

• Start date: 2025-06-18
• Primary completion: 2026-06-25
• Completion: 2027-06-25
• First posted: 2025-08-08
• Last updated: 2026-04-01

Locations

7 sites across 1 country: France