BNT162b2 Vaccination With Two Doses in COVID-19 Negative Adult Volunteers and With a Single Dose in COVID-19 Positive Adult Volunteers (CoviCompareP)
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|ClinicalTrials.gov Identifier: NCT04824638|
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
As previously shown, individuals who experienced COVID-19 have developed some protective immunity to reinfection. The magnitude and duration of protection from reinfection conferred by the infection may be weaker after an asymptomatic infection as it is after a symptomatic COVID-19 episode. Moreover, it is known that immunity decreases among older adults compared to younger individuals often referred to as ''immune senescence,'' and leading to a decreased efficacy of vaccination.
This study raises the question of whether a single administration of BNT162b2 in participants with prior SARS-CoV-2 infection leads to sufficient and durable immune response.
We propose to evaluate the level of the single BNT162b2 vaccine dose response according to the severity of the previous SARS-CoV-2 infection in young and elderly participants with the same immunogenicity analyses to assess this response in participants receiving the two-dose vaccination regimen.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Immunization; Infection||Biological: two doses of BNT162b2 vaccine Biological: one dose of BNT162b2 vaccine||Phase 2|
This is a national open phase II trial, assessing the immunogenicity and safety of vaccine candidate Pfizer - BNT162b2 against SARS-CoV-2 in participants with no history of SARS-CoV-2 infection receiving two doses of vaccine and in participants with history SARS-CoV-2 infection of more than 6 months and receiving only one dose of vaccine.
A total of 300 volunteers will be included and vaccinated in 2 groups:
Group 1: Adults with no history of COVID 19 (N=150)
- Sub-group 1A: 18 - 45 years old: 50 volunteers
- Sub-group 1B: 65 - 74 years old: 50 volunteers* (minimum of 45)
- Sub-group 1C: At least 75 years old: 50 volunteers* (minimum of 45)
Group 2: Adults with history of COVID 19 of more than 6 months (N=150)
- Sub-group 2A: 18 - 45 years old: 50 volunteers
- Sub-group 2B: 65 - 74 years old: 50 volunteers* (minimum of 45)
- Sub-group 2C: At least 75 years old: 50 volunteers* (minimum of 45)
Within each subgroup of the group 2, a distribution will be respected including:
- 1/3 volunteers with asymptomatic COVID-19 infection,
- 1/3 volunteers with mild COVID-19 infection (symptomatic but not hospitalized) and
- 1/3 volunteers with severe COVID-19 infection (hospitalization required).
Participants within the group 1 will receive BNT162b2 (Comirnaty®) intramuscularly as a 2-dose series spaced 28 days apart at a dose of 30 µg each.
Participants within the group 2 will receive BNT162b2 intramuscularly as a single dose of 30 µg.
Analyses of humorale and saliva immune responses will be performed in differents centralized laboratories blinded for the trial group, by ELISA at Day -6/D0 (pre-vaccination sample), D29, D57, M6, M12, and M24.
T and B cell analyses will be performed in a sub-group of participants Immunosenescence will be analysed in pre-vaccination samples.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants of group 1 will receive two administrations of BNT162b2 at D1 and D29 Participants of group 2 will receive one administration of BNT162b2 at D1 and D29|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Assessing Immunogenicity and Safety of COVID-19 mRNA Vaccine BNT162b2 in Adult Volunteers With no History of SARS-CoV-2 Infection Administered With Two Doses of Vaccine (D1-D29) and in Adult Volunteers With Documented History of SARS-CoV-2 Infection (of More Than 6 Months) Administered With Only One Dose of Vaccine|
|Actual Study Start Date :||March 8, 2021|
|Estimated Primary Completion Date :||August 8, 2021|
|Estimated Study Completion Date :||December 8, 2023|
Experimental: Group 1: SARS-CoV-2 naive participants
participants without antecedent of SARS-CoV-2 infection
Biological: two doses of BNT162b2 vaccine
Administration of BNT162 b2 vaccine (30µg in 0.3mL) at D1 and D29, intramuscularly (participants without antecedent of SARS-CoV-2 infection)
Experimental: Group 2: Previously SARS CoV-2 infected participants
participants with antecedent of SARS-CoV-2 infection (more than 6 months)
Biological: one dose of BNT162b2 vaccine
Administration of BNT162 b2 vaccine (30µg in 0.3mL) at D1, intramuscularly (participants with antecedent of SARS-CoV-2 infection)
- IgG humoral response to vaccine 28 days post vaccination [ Time Frame: at Day 57 for patients of the group1 and at Day 29 for patient of the group 2 ]Anti SARS-CoV-2 Spike IgG (ELISA test) 28 days after the last injection i.e. at Day 57 in adult volunteers receiving 2 vaccine doses (group 1, without documented history of SARS-CoV-2 infection) and at Day 29 in adult volunteers receiving 1 vaccine dose (group 2, with documented history of SARS-CoV-2 infection).
- humoral response to vaccine [ Time Frame: Day 1, Day 29, Day 57, Month 6, Month 12, Month 24 ]Anti SARS-CoV-2 specific IgG at Day 1, Day 29 (group 1), Day 57 (group 2), as measured via ELISA Anti SARS-CoV-2 IgA and IgM (total and subclasses IgG 1-4) as measured by ELISA at D 1, D29, D57, M6, M12 and M24 Specific neutralizing antibody to SARS-CoV-2 and its variants (classical in vitro neutralisation assay and Pseudo neutralisation assay ) (all participants)
- T cells response to vaccine [ Time Frame: at Day1, Day 29 and Month 6 ]Fluorospot assays (TH1, TH2, TH17, Cytotoxicity) Phenotyping of antigen specific T-Cells via Mass cytometry at D 1 and M6 selected from results of Fluorospot assay
- Mucosal response to vaccine [ Time Frame: at Day 1, Day 29, Day 57, Month 6, Month 12 and Month 24 ]Mucosal SARS-CoV-2 -specific antibody via measure of IgA, IgM and IgG in saliva by specific home-made and commercially available ELISA assays for salivary IgA and IgG (all participants)
- B cell response to vaccine [ Time Frame: at Day 1, Day 57 and Month 12 ]Determination of the epitope profiling and B cell repertoire (stereotype clonotype) of the humoral response
- predictive determinants of vaccine response [ Time Frame: at screening visit ]Pre-existing serology for SARS-CoV-2 or other coronavirus, clinical profile of COVID 19 for group 2, immunosenescence profile, transcriptomic analysis, immune cell phenotype
- Safety of BNT162b2 vaccine [ Time Frame: through 28 days after each dose of vaccine for reactions; throughout the study period for others adverse events ]
All grade adverse reactions:
- Immediate reactogenicity defined as any adverse reactions
- Local and systemic reactogenicity, all grade, measured by solicited adverse reactions
- Unsolicited adverse reactions
Others adverse events:
- Any AEs of grade ≥ 2, .
- AEs leading to withdrawal .
- Medically significant AEs
- SARS-CoV-2 infection [ Time Frame: study period ]Occurrence of confirmed SARS-CoV-2 infection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04824638
|Contact: DESAINT Corinne, PhD||33 145 59 52 email@example.com|
|Contact: LEVIER Axel||33 1 firstname.lastname@example.org|
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