Safety and Immunogenicity of a Sub-unit Protein CD40.RBDv Bivalent COVID-19 Vaccine, Adjuvanted or Not, as a Booster in Volunteers.
Recruiting
Phase 1Phase 2Interventional 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.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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 vaccine or a single injection of approved mRNA vaccine
Trial Locations
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Facility
City
State
Country
Status
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…
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
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