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

ABSTRACT

ConditionCOVID-19

InterventionDrug CD40.RBDv vaccin (SARS-Cov2 Vaccin)

Primary outcome:Proportion of participants without any grade 3 or 4 biological or clinical solicited local/systemic or unsolicited AEs between D1 and Month 3 after each IMP/vaccine administration and considered to be related or possibly related to IMP administration;Neutralization antibodies titers (anti-RBD) against the original strain D614G and the relevant strain circulating at time of the study Month 1

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