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.
Summary
The SOLVE-01 trial is a study evaluating four SARS-CoV-2 vaccines as booster injections: two experimental vaccines (CD40.RBDv and CD40.Pan.CoV, both combined with the Hiltonol® adjuvant) and two authorised vaccines (Comirnaty® and NuvaxovidTM). This trial is designed for healthy adults aged 18 to 65 at the time of signing the informed consent form. The main objectives of this trial are: * to evaluate the safety of the two experimental vaccines, * to determine the antibody response induced by the vaccines and its durability. Participants will: * Receive one injection of vaccine and two intradermal skin tests * Come to the hospital 10 visits for medical exams and blood and saliva sample collection * Keep a diary of their symptoms and the treatments taken
Timeline
- Start
- 2026-05-13
- Primary completion
- 2028-05
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | BNT162b2 | Messenger RNA (mRNA) | — | Intramuscular |
| Subject | CD40.Pan.CoV | Vaccine | 1 mg | Subcutaneous |
| Subject | CD40.RBDv | Vaccine | 1 mg | Subcutaneous |
| Comparator | Nuvaxovid | Vaccine | — | Intramuscular |
| Background | Hiltonol | Other / unclassified | 1 mg | Subcutaneous |
Indications
No indication recorded.