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NCT06255626 | RECRUITING | COVID-19

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

ANRS, Emerging Infectious Diseases

Brief Summary:

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

Condition or disease

COVID-19

Intervention/treatment

CD40.RBDv vaccin (SARS-Cov2 Vaccin)

Phase

PHASE1

PHASE2

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)

Study Type : INTERVENTIONAL
Estimated Enrollment : 215 participants
Masking : NONE
Masking Description : This is an open label study. Immunological assessors, only, will remain blinded.
Primary Purpose : PREVENTION
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.
Actual Study Start Date : 2024-05-27
Estimated Primary Completion Date : 2025-09
Estimated Study Completion Date : 2025-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 84 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 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
Safety and Immunogenicity of a Sub-unit Protein CD40.RBDv Bivalent COVID-19 Vaccine, Adjuvanted or Not, as a Booster in Volunteers.

Location Details

NCT06255626

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How to Participate

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Locations

RECRUITING

France,

Henri Mondor Hospital

Creteil, France, 94000

RECRUITING

France,

Cochin Hospital

Paris, France, 75014