Official Title
A Phase 1/2 Multicenter, Randomized Study of the Safety and Immunogenicity of a Sub-unit Protein CD40.RBDv Bivalent COVID-19 Vaccine, Adjuvanted or Not, as a Booster in Volunteers.
Brief Summary

The goal of this clinical trial, on healthy volunteers, is to learn more about safety andreactogenicity 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 vaccine or a single injection of approved mRNA vaccine

Detailed Description

Phase 1/2a randomized, multicentre trial with four cohorts of two arms in two parts.

Part 1:

Cohort 1: Low dose (LD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio)

Cohort 2: LD CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio)

Cohort 3: High dose (HD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio)

Cohort 4: SC injection of HD CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio)

A substancial amendment (January 2025) has removed the randomisation to mRNA vaccine from
the study design

Go-criterion for opening enrolment within cohorts are detailed into the protocol.

Part 2 at Month 3 :

Group 1: Volunteers who received mRNA vaccine in Part 1 will not receive any vaccine

Group 2: Volunteers who received a first dose of CD40.RBDv vaccine (adjuvanted or not) in
Part 1 but randomized (1:1) to receive no further dose of vaccine in Part 2.

Group 3: Volunteers who received a first dose of CD40.RBDv vaccine (adjuvanted or not) in
Part 1 and randomized (1:1) to receive an additional dose of CD40.RBDv vaccine
(adjuvanted or not)

Recruiting
COVID-19

Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin)

1 or 2 injection(s) of CD40.RBDv vaccine (or mRNA vaccine 1 injection (5:1))
Other Name: COVID-19 mRNA vaccine

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
vaccination(s) with the last boost at least 6 months prior to the inclusion in the
study

- Subjects has adequate organ functions, evidenced by normal ALT, AST, and alkaline
phosphatase

- Normal haematology lab values

- Negative virology assessment

- Normal Urine testing

- Volunteers must meet the eligibility criteria in the approved package labelling of
the active comparator

- For women of childbearing potential: use of an effective contraceptive method and
negative pregnancy test. For male participants, use of an effective method of
contraception with their partner

Exclusion Criteria:

- Acute febrile infection within the previous 72 hours and/or presenting symptoms
suggestive of COVID-19 or SARS CoV 2 infection within the previous 28 days

- Immunosuppressive medications received within last three months before first IMP
administration or within 6 months for chemotherapies

- Immunoglobulins within 90 days before first IMP administration

- Blood products within 120 days before first IMP administration

- Any medical condition, such as cancer, that might impair the immune response

- Use of any experimental therapy

- Intent to participate in another study of an investigational research agent within 4
weeks prior to the enrolment visit or until the end of the study

- Currently pregnant or breastfeeding

- History of severe adverse events following vaccine administration

- Any bleeding disorder considered as a contraindication to an intramuscular injection

- A condition that requires active medical intervention or monitoring to avert grave
danger to Asthma other than mild, well-controlled asthma.

- Hypertension

- BMI ≥ 40 kg/m2; ≤ 18 kg/m2; or BMI ≥ 35 kg/m2 with 2 or more of the following: age >
45, current smoker, known hyperlipidemia, blood pressure is defined as consistently
≥ 140 mm Hg systolic and ≥ 90 mm Hg diastolic

- Malignancy

- Asplenia

- Seizure disorder

- History of hereditary angioedema acquired angioedema, or idiopathic angioedema

- History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with
permanent sequelae, clinically significant arrhythmia (including arrhythmia
requiring medication, treatment, or clinical follow-up

- History of autoimmune disease

- Any medical, occupational, or other condition that, in the judgment of the
investigator, would interfere with or serve as a contraindication to protocol
adherence

- Psychiatric condition that precludes compliance with the protocol.

- Live attenuated vaccines received within 30 days before first IMP administration or
scheduled within 28 days after one of the last injection according to the protocol

- Vaccines that are not live attenuated vaccines and were received within 21 days
prior to first IMP administration

- Allergy treatment with antigen injections within 30 days before first IMP
administration and until the end of the study

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 84 Years
Countries
France
Locations

Hopital Henri Mondor
Créteil, France

Hôpital Cochin
Paris, France

Contacts

Yves Levy, MD
+33149814442
yves.levy@aphp.fr

Not Provided

ANRS, Emerging Infectious Diseases
NCT Number
Keywords
Vaccine
Covid-19
MeSH Terms
COVID-19
Vaccines