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
Male and female subjects aged 18 to 65 years inclusive at the time of the screening visit
Having received at least two doses of COVID-19 mRNA vaccines in the past with the last dose received more than 6 months prior to IMP administration in the trial
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.
For woman of childbearing potential: a negative Beta-HCG blood test measure during the screening visit, and a negative highly sensitive pregnancy urinary test the day of the vaccination visit
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
A process that would affect the immune response;
A process that would require medication that affects the immune response;
Any contraindication to repeated injections or blood draws;
Parallel
CD40.RBDv vaccine adjuvanted with Hiltonol®
Biological/Vaccineused at the dose of 1.0 mg subcutaneously Poly-ICLC adjuvant (Hiltonol) used at a dose of 1.0 mg and will be mixed with CD40.RBDv vaccine just prior to subcutaneous injection at day 0.
CD40.Pan.CoV vaccine adjuvanted with Hiltonol®
Biological/Vaccineused at the dose of 1.0 mg subcutaneously Poly-ICLC adjuvant (Hiltonol) used at a dose of 1.0 mg and will be mixed with CD40.Pan.CoV vaccine just prior to subcutaneous injection at day 0.
Comirnaty® vaccine
Biological/Vaccineadministered intramuscularly at day 0. The version of the Comirnaty® vaccine and the dose will be the one adapted to the variant circulating at the start of trial and authorised by EMA.
Nuvaxovid™ vaccine
Biological/Vaccineadministered intramuscularly at day 0. The version of the Nuvaxovid™ vaccine and the dose will be the one commercialised at the start of trial and authorised by EMA.
Safety_Proportion of participants without any grade 3 or 4 adverse event
Proportion of participants without any grade 3 or 4 solicited local/systemic or unsolicited AEs between Day 0 and Week 4 and considered to be related or possibly related to IMP administration
Immunogenicity_Geometric mean titers of neutralizing antibodies
Geometric mean titers of neutralizing antibodies against the original strain D614G and the relevant circulating variants measured at Week 4 and Week 48
Safety_Number of Solicited local and systemic Adverse Reactions
overall; by grade
Safety_Number of Unsolicited adverse events
overall; by grade; by relationship to the vaccine
Safety_Number of Serious Adverse Events
overall; by grade; by relationship to the vaccine
Immunogenicity_humoral immune response (IgG binding)
Geometric mean titers of IgG binding/neutralizing antibodies titers against the original strain D614G and the relevant circulating variants
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