COVID-19Phase 1/2NCT06255626
Safety and Immunogenicity of a Sub-unit Protein CD40.RBDv Bivalent COVID-19 Vaccine, Adjuvanted or Not, as a Booster in Volunteers.
A Phase 1/2 study testing CD40.RBDv vaccin (SARS-Cov2 Vaccin) in people with COVID-19, run by ANRS, Emerging Infectious Diseases at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- CD40.RBDv vaccin (SARS-Cov2 Vaccin)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 2 sitesFrance
- Study dates
- 27 May 2024to Sep 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hopital Henri Mondor
Créteil, 94000
Jean Daniel Lelièvre, MD
- Recruiting
Hôpital Cochin
Paris, 75014
Odile Launay, MD
About this study
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.
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
Read the 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)
- Conditions
- COVID-19
- Being tested
- CD40.RBDv vaccin (SARS-Cov2 Vaccin)
- Keywords
- Vaccine, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD40.RBDv vaccin (SARS-Cov2 Vaccin)Drug
Also called COVID-19 mRNA vaccine
1 or 2 injection(s) of CD40.RBDv vaccine (or mRNA vaccine 1 injection (5:1))
| Study group | Role | What they receive |
|---|---|---|
| 1-CD40.RBDv non adjuvanted or mRNA vaccine (5:1 ratio) | Experimental | Low dose (LD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio). If randomized to receive LD CD40.RBDv vaccine non adjuvanted in part 1, the subject will be randomised a second time to receive LD CD40.RBDv vaccine non adjuvanted (1:1) in part 2.
Following a substancial amendment the randomization to mRNA vaccine has been removed from study design Receives: Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin) |
| 2-CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio) | Experimental | LD CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio) If randomized to receive LD CD40.RBDv vaccine adjuvanted in part 1, the subject will be randomised a second time to receive LD CD40.RBDv vaccine adjuvanted (1:1) in part 2.
Following a substancial amendment the randomization to mRNA vaccine has been removed from study design Receives: Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin) |
| 3-High dose (HD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio) | Experimental | High dose (HD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio) If randomized to receive HD CD40.RBDv vaccine non adjuvanted in part 1, the subject will be randomised a second time to receive HD CD40.RBDv vaccine non adjuvanted (1:1) in part 2.
Following a substancial amendment the randomization to mRNA vaccine has been removed from study design Receives: Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin) |
| 4-High dose (HD) CD40.RBDv vaccine adjuvanted or mRNA vaccine | Experimental | HD CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio) If randomized to receive HD CD40.RBDv vaccine adjuvanted in part 1, the subject will be randomised a second time to receive HD CD40.RBDv vaccine adjuvanted (1:1) in part 2.
Following a substancial amendment the randomization to mRNA vaccine has been removed from study design Receives: Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
These proportions of participants will be described with its 95% two-sided confidence interval.
Measured: Month 3
Neutralization antibodies titers (anti-RBD) against the original strain D614G and the relevant strain circulating at time of the study Month 1
The primary immunogenecity endpoint is the neutralization antibodies titers (anti -RBD) against the original strain D614G and the relevant strain circulating at time of the study Month 1 after each dose The geometric mean titers (GMTs) with 95% confidence intervals (CIs) will be calculated at baseline and at Month 1 after each dose.
Measured: Month 1
Secondary outcomes (11)
Number of volunteers with solicited local and systemic Adverse Reactions (ARs)
The original verbatim terms used by investigators to identify adverse events in the eCRF will be mapped to preferred terms using the MedDRA dictionary. The adverse events will then be grouped by MedDRA preferred terms into frequency tables according to system organ class. All reported adverse events, as well as adverse events judged by the investigator as at least possibly related to study vaccine, will be summarized according to system organ class and preferred term within system organ class and by interval of study observation. When an adverse event occurs more than once for a participants, the maximal severity and strongest relationship to the vaccine group will be chosen.
Measured: Day 8
Number of volunteers with Adverse Events (AEs) other than solicited adverse events
The original verbatim terms used by investigators to identify adverse events in the eCRF will be mapped to preferred terms using the MedDRA dictionary. The adverse events will then be grouped by MedDRA preferred terms into frequency tables according to system organ class. All reported adverse events, as well as adverse events judged by the investigator as at least possibly related to study vaccine, will be summarized according to system organ class and preferred term within system organ class and by interval of study observation. When an adverse event occurs more than once for a participants, the maximal severity and strongest relationship to the vaccine group will be chosen.
Measured: Day 1 to Months 3 after each dose
Number of volunteers with Serious Adverse Events (SAEs), grade 3 and grade 4
The original verbatim terms used by investigators to identify adverse events in the eCRF will be mapped to preferred terms using the MedDRA dictionary. The adverse events will then be grouped by MedDRA preferred terms into frequency tables according to system organ class. All reported adverse events, as well as adverse events judged by the investigator as at least possibly related to study vaccine, will be summarized according to system organ class and preferred term within system organ class and by interval of study observation. When an adverse event occurs more than once for a participants, the maximal severity and strongest relationship to the vaccine group will be chosen.
Measured: Day 1 to Months 3 after each dose
Number of volunteers with events leading to discontinuation of the vaccine regimen
The original verbatim terms used by investigators to identify adverse events in the eCRF will be mapped to preferred terms using the MedDRA dictionary. The adverse events will then be grouped by MedDRA preferred terms into frequency tables according to system organ class. All reported adverse events, as well as adverse events judged by the investigator as at least possibly related to study vaccine, will be summarized according to system organ class and preferred term within system organ class and by interval of study observation. When an adverse event occurs more than once for a participants, the maximal severity and strongest relationship to the vaccine group will be chosen.
Separate summaries will be produced for the following categories:
- Serious adverse events
- Adverse events that are possibly or probably related to vaccine
- Adverse event leading to withdrawal from the study
- After any vaccination and by vaccination
Measured: Through study completion, an average of 15 months
Seroconversion rate defined by an increase of 4 folds between day1 (baseline before vaccination) and Month 1 in anti-RBD IgG binding titers
- The seroconversion rate defined by an increase of 4 folds between day1 (baseline before vaccination) and Month 1 in anti-RBD IgG binding titers will be described with its 95% two-sided confidence interval.
Measured: Month 1
To assess the cross-neutralization against the most relevant VOCs at the time of the study
- To assess the cross-neutralization against the most relevant VOCs, The geometric mean titers (GMTs) with 95% confidence intervals (CIs) will be calculated at each timepoint.
Measured: Day 1 (before each vaccination) day 8, day 14 and M1 after each vaccination, M3, M6, M12 (ie. 12 months after 1st dose and 9 months after 2nd dose) and M15 (ie. 15 months after 1st dose and 12 months after 2nd dose)
To analyze the correlation between the magnitude of CD4+ specific T cell responses and levels of IgG specific responses
- Correlation between the magnitude of CD4+ specific T cell responses and levels of igG specific responses will be estimated at each timepoint using Pearson or Spearman correlation coefficients, depending on variables distribution.
Measured: Day 1 (before each vaccination) day 14 after each vaccination, M3, M6, M12 (ie. 12 months after 1st dose and 9 months after 2nd dose) and M15 (ie. 15 months after 1st dose and 12 months after 2nd dose)
To characterize the vaccine efficacy by evaluating the number of COVID-19 infections (PCR+) and severity (based on CDC definition) in participants throughout the study follow-up.
- Number of COVID-19 infections (PCR+) and severity (based on CDC definition) throughout the study follow-up.
Measured: Through study completion, an average of 15 months
To evaluate the Cytokine expression patterns of CD4 and CD8 T cells as measured by intracellular cytokine staining assay
- Cytokine expression patterns of CD4 and CD8 T cells, measured by intracellular cytokine staining assay, will be described at each timepoint.
Measured: Day 1 (before each vaccination) day 14 after each vaccination, M3, M6, M12 (ie. 12 months after 1st dose and 9 months after 2nd dose) and M15 (ie. 15 months after 1st dose and 12 months after 2nd dose)
Percentages of T cells producing at least one cytokine after in vitro stimulation
- Recall memory T cell responses, following in vitro restimulation (Epimax technology) on residual samples and depending on the results obtained in the analysis of intracellular cytokine staining assay, will be described.
Measured: Through study completion, an average of 15 months
Concentration (pg/mL) of cytokines produced by stimulated PBMC
- Cytokines produced by stimulated PBMC (Luminex assay) on samples evaluated by Epimax technology will be described.
Measured: Through study completion, an average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start27 May 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Vaccine Research Institute (VRI), France, EnnoDc (previously known as LinKinVax)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255626
- Sponsor's protocol ID
- ANRS0407s - LKV.Cov40
- Other IDs
- 2023-504594-20-00, 2023
- Status last verified
- Apr 2025
- First submitted
- 8 Feb 2024
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06255626
- Acronym / sponsor ID
- ANRS0407s - LKV.Cov40
- Conditions
- COVID-19
- Keywords
- Vaccine, COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Vaccine Research Institute (VRI), France, EnnoDc (previously known as LinKinVax)
- Study start
- 27 May 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1-CD40.RBDv non adjuvanted or mRNA vaccine (5:1 ratio) | Experimental | Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin)Low dose (LD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio). If randomized to receive LD CD40.RBDv vaccine non adjuvanted in part 1, the subject will be randomised a second time to receive LD CD40.RBDv vaccine non adjuvanted (1:1) in part 2. Following a substancial amendment the randomization to mRNA vaccine has been removed from study design |
| 2-CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio) | Experimental | Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin)LD CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio) If randomized to receive LD CD40.RBDv vaccine adjuvanted in part 1, the subject will be randomised a second time to receive LD CD40.RBDv vaccine adjuvanted (1:1) in part 2. Following a substancial amendment the randomization to mRNA vaccine has been removed from study design |
| 3-High dose (HD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio) | Experimental | Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin)High dose (HD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio) If randomized to receive HD CD40.RBDv vaccine non adjuvanted in part 1, the subject will be randomised a second time to receive HD CD40.RBDv vaccine non adjuvanted (1:1) in part 2. Following a substancial amendment the randomization to mRNA vaccine has been removed from study design |
| 4-High dose (HD) CD40.RBDv vaccine adjuvanted or mRNA vaccine | Experimental | Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin)HD CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio) If randomized to receive HD CD40.RBDv vaccine adjuvanted in part 1, the subject will be randomised a second time to receive HD CD40.RBDv vaccine adjuvanted (1:1) in part 2. Following a substancial amendment the randomization to mRNA vaccine has been removed from study design |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD40.RBDv vaccin (SARS-Cov2 Vaccin)Also: COVID-19 mRNA vaccine1 or 2 injection(s) of CD40.RBDv vaccine (or mRNA vaccine 1 injection (5:1)) | Drug | 1-CD40.RBDv non adjuvanted or mRNA vaccine (5:1 ratio), 2-CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio), 3-High dose (HD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio), 4-High dose (HD) CD40.RBDv vaccine adjuvanted or mRNA vaccine |
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
Time frame: Month 3
These proportions of participants will be described with its 95% two-sided confidence interval.
Neutralization antibodies titers (anti-RBD) against the original strain D614G and the relevant strain circulating at time of the study Month 1
Time frame: Month 1
The primary immunogenecity endpoint is the neutralization antibodies titers (anti -RBD) against the original strain D614G and the relevant strain circulating at time of the study Month 1 after each dose The geometric mean titers (GMTs) with 95% confidence intervals (CIs) will be calculated at baseline and at Month 1 after each dose.
11 secondary outcomes
Number of volunteers with solicited local and systemic Adverse Reactions (ARs)
Time frame: Day 8
Number of volunteers with Adverse Events (AEs) other than solicited adverse events
Time frame: Day 1 to Months 3 after each dose
Number of volunteers with Serious Adverse Events (SAEs), grade 3 and grade 4
Time frame: Day 1 to Months 3 after each dose
Number of volunteers with events leading to discontinuation of the vaccine regimen
Time frame: Through study completion, an average of 15 months
Seroconversion rate defined by an increase of 4 folds between day1 (baseline before vaccination) and Month 1 in anti-RBD IgG binding titers
Time frame: Month 1
To assess the cross-neutralization against the most relevant VOCs at the time of the study
Time frame: Day 1 (before each vaccination) day 8, day 14 and M1 after each vaccination, M3, M6, M12 (ie. 12 months after 1st dose and 9 months after 2nd dose) and M15 (ie. 15 months after 1st dose and 12 months after 2nd dose)
To analyze the correlation between the magnitude of CD4+ specific T cell responses and levels of IgG specific responses
Time frame: Day 1 (before each vaccination) day 14 after each vaccination, M3, M6, M12 (ie. 12 months after 1st dose and 9 months after 2nd dose) and M15 (ie. 15 months after 1st dose and 12 months after 2nd dose)
To characterize the vaccine efficacy by evaluating the number of COVID-19 infections (PCR+) and severity (based on CDC definition) in participants throughout the study follow-up.
Time frame: Through study completion, an average of 15 months
To evaluate the Cytokine expression patterns of CD4 and CD8 T cells as measured by intracellular cytokine staining assay
Time frame: Day 1 (before each vaccination) day 14 after each vaccination, M3, M6, M12 (ie. 12 months after 1st dose and 9 months after 2nd dose) and M15 (ie. 15 months after 1st dose and 12 months after 2nd dose)
Percentages of T cells producing at least one cytokine after in vitro stimulation
Time frame: Through study completion, an average of 15 months
Concentration (pg/mL) of cytokines produced by stimulated PBMC
Time frame: Through study completion, an average of 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD40.RBDv vaccin (SARS-Cov2 Vaccin) in people with COVID-19, run by ANRS, Emerging Infectious Diseases at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yves Levy, MD (+33149814442, yves.levy@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.