Dose Escalation Trial of CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Healthy V… (NCT07113106) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Dose Escalation Trial of CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Healthy Volunteers
France48 participantsStarted 2025-06-18
Plain-language 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
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety primary outcome
Timeframe: From Day 0 (injection) to Month 1
2
Immunogenicity primary outcome
Timeframe: from Day 0 (vaccine injection) to Month 1
. Subject who has received : 2 doses of COVID-19 vaccine with a history of COVID-19 infection or at least 3 doses of COVID-19 vaccine (including at least 1 booster of mRNA vaccination). The last dose should be at least 6 months prior to the inclusion.
. Subject who has normal biological values:
Exclusion criteria
. Acute febrile infection (body temperature ≥ 38.0°C) within the previous 72 hours and/or presenting symptoms suggestive of COVID-19 or SARS-CoV-2 infection within the previous 28 days or having been in contact with an infected individual for the last 14 days before the inclusion visit.
. 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:
. 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.