RecruitingEarly Phase 1NCT07605520

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.

Sponsor

ANRS, Emerging Infectious Diseases

Enrollment

48 participants

Start Date

May 13, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Adults

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CD40.Pan.CoV vaccine adjuvanted with Hiltonol®, a biological treatment called CD40.RBDv vaccine adjuvanted with Hiltonol®, and others for people with healthy adults. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALCD40.RBDv vaccine adjuvanted with Hiltonol®

used 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.

BIOLOGICALCD40.Pan.CoV vaccine adjuvanted with Hiltonol®

used 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.

BIOLOGICALComirnaty® vaccine

administered 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.

BIOLOGICALNuvaxovid™ vaccine

administered 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.

Locations(3)

Hôpital Henri Mondor

Créteil, France

CIC 1417 - Hôpital Cochin

Paris, France

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07605520

Related Trials

The Effect of Low or High Dietary Fiber Diet on Volatile Organic Compounds in Exhaled Breath of Healthy Individuals

NCT075946001 location

A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fasting Conditions

NCT075876971 location