Actively Recruiting
An Experimental Medicine Multicenter Trial to Evaluate the Safety and Immunogenicity of Experimental Versus Authorized SARS-CoV-2 Vaccine Candidates as a Booster Dose in Healthy Adults Previously Vaccinated With Authorized mRNA SARS-CoV-2 Vaccines
Led by ANRS, Emerging Infectious Diseases · Updated on 2026-06-02
48
Participants Needed
3
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating four different SARS-CoV-2 vaccines as booster shots in healthy adults aged 18 to 65 years who have previously received authorized mRNA COVID-19 vaccines. The trial compares two experimental vaccines, CD40.RBDv and CD40.Pan.CoV, both combined with the Hiltonol® adjuvant, against two authorized vaccines, Comirnaty® and Nuvaxovid™. The study aims to assess the safety of the experimental vaccines and measure the immune response they trigger, including the durability of antibodies over time. Participants will receive a single vaccine injection at day 0, with the experimental vaccines given subcutaneously combined with Hiltonol®, and the authorized vaccines administered intramuscularly. Alongside vaccination, participants will undergo two intradermal skin tests. The trial involves 10 hospital visits for medical examinations and collection of blood and saliva samples to monitor immune responses and safety over a period extending to 48 weeks. During the study, participants will keep a diary to record any symptoms or treatments they experience. Researchers will evaluate multiple safety outcomes, including adverse events shortly after vaccination and throughout the trial. Immunogenicity will be assessed by measuring neutralizing antibodies, T-cell responses, and other immune markers at various time points from day 0 through week 48. Participants commit to follow-up visits and testing according to the study schedule to support comprehensive monitoring of vaccine effects.
CONDITIONS
Brief Title
An Experimental Medicine Multicenter Trial to Evaluate the Safety and Immunogenicity of Experimental Versus Authorized SARS-CoV-2 Vaccine Candidates as a Booster Dose in Healthy Participants Previously Vaccinated With Authorized mRNA SARS-CoV-2 Vaccines.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 65 years at screening
- Received at least two doses of COVID-19 mRNA vaccines, with last dose more than 6 months before study vaccine
- Healthy or stable health status without recent significant treatment changes or hospitalizations
- Negative pregnancy test for women of childbearing potential at screening and vaccination visits
- Women of childbearing potential must use effective contraception from 21 days before enrollment through 4 months after vaccination or not be of reproductive potential
- Heterosexually active males must use effective contraception from vaccination through 4 months after and agree not to donate sperm during this period
- Negative SARS-CoV-2 antigen test at screening and before randomization
- Normal biological test results including hemoglobin, white blood cell count, lymphocytes, platelets, liver and kidney function, and negative HIV, Hepatitis B and C tests
- Willingness to undergo SARS-CoV-2 testing and receive results
- Willingness and availability for follow-up visits during the study
- Signed informed consent before any study procedures
- Registration in French Health Ministry computerized file and health insurance coverage (France only)
You will not qualify if you...
- Fever or symptoms of COVID-19 infection within prior 28 days or recent contact with infected person
- Medical conditions or treatments impairing immune response or contraindicating injections/blood draws
- Current pregnancy or breastfeeding
- Immunodeficiency or active asthma requiring significant treatment
- Type 1 or 2 diabetes including diet-controlled cases
- Thyroid disease requiring medication in last 12 months
- Uncontrolled hypertension or high blood pressure at enrollment
- Hypersensitivity or contraindication to study vaccines
- BMI ≥ 40 kg/m2, or BMI ≥ 35 kg/m2 with additional risk factors
- Bleeding disorders
- Recent or ongoing malignancy with risk of recurrence
- Absence of functional spleen (asplenia)
- Recent seizures or seizure disorder
- History of angioedema
- Significant heart conditions including myocarditis or arrhythmia
- Autoimmune diseases
- Psychiatric conditions interfering with study compliance
- History of serious vaccine reactions including anaphylaxis
- Recent participation in other investigational studies or receipt of experimental vaccines
- Recent live or non-live vaccines within specified windows before study vaccination
- Recent blood or immunoglobulin products
- Current tuberculosis treatment or prophylaxis
- Recent allergy treatments with antigen injections
- Use of immunosuppressive or immunomodulatory medications recently
- Participation in other research with overlapping exclusion periods
- Inability to follow study procedures or legal restrictions
- Planned absence affecting participation during the study period
- Use of prohibited medications up to 6 months after vaccination may also exclude participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 (single vaccination day)
Participants receive one of several booster vaccine candidates administered by injection to evaluate safety and immune response.
1 vaccination visit (in-person)
Duration - Up to 48 weeks after vaccination
Participants are monitored through multiple visits to assess safety, immunogenicity, and adverse events for up to 48 weeks after vaccination.
Multiple visits including Day 1, Day 7, Week 2, Week 4, Week 12, Week 24, Week 36, and Week 48
Trial Site Locations
Total: 3 locations
1
Hôpital Henri Mondor
Créteil, France
Actively Recruiting
2
CIC 1417 - Hôpital Cochin
Paris, France
Actively Recruiting
3
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland
Actively Recruiting
Research Team
Y
Yves LEVY, Pr
G
Giuseppe PANTALEO, Pr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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