CD40.RBDv COVID-19 Booster Vaccine Safety Trial

Safety and Immunogenicity of a Sub-unit Protein CD40.RBDv Bivalent COVID-19 Vaccine, Adjuvanted or Not, as a Booster in Volunteers.

Recruiting Phase 1 Phase 2 Interventional Study
COVID-19
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 84
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Prevention
Participants needed
215 (estimated)
Sponsor
ANRS, Emerging Infectious Diseases · Government
Who this trial is looking for

This trial is looking for healthy adults aged 18 to 85 who have received prior COVID-19 vaccinations. Participants will receive either one or two doses of the CD40.RBDv vaccine, or one dose of an approved mRNA vaccine, to help researchers understand the vaccine's safety and immune response.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am a healthy adult aged 18 to 85.
  • I have received a primary series and at least one booster of COVID-19 vaccines.
  • My last COVID-19 booster was at least 6 months ago.
  • I understand and can follow the study procedures.
  • I have normal organ function and lab results.
  • I have a negative COVID-19 test.
  • I use effective contraception if I can become pregnant.

You may not be able to join if

  • I have had a fever or infection in the last 72 hours.
  • I have symptoms of COVID-19 within the last 28 days.
  • I have taken immunosuppressive medications in the last 3 months.
  • I have a medical condition affecting my immune response.
  • I am currently pregnant or breastfeeding.
  • I have a history of severe vaccine side effects.
  • I have hypertension or a BMI over 40.
  • I have a history of autoimmune disease.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
The goal of this clinical trial, on healthy volunteers, is to learn more about safety and reactogenicity of the CD40.RBDv vaccine. The main questions that will be studied are : * Is the CD40.RBDv (adjuvanted or not) safe ? * Does the CD40.RBDv (adjuvanted or not) imply an immunologic response ? Participants will receive, depending on their randomization arm, 1 or 2 injections of the CD40.RBDv va…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Healthy volunteers Age ≥18 and \<85 * Able to understand and comply with planned study procedures and sign an informed consent before performance of any study-related screening procedures * Who has received a primary series of vaccination and ≥ 1 booster(s) of COVID-19 mRNA va…
Contacts

Yves Levy, MD

+33149814442

yves.levy@aphp.fr

CONTACT