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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
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
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)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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
    • SAEs

  7. SARS-CoV-2 infection [ Time Frame: study period ]
    Occurrence of confirmed SARS-CoV-2 infection.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18 to 45 years old or at least 65 years old,
  2. Healthy adults or stable medical condition for adults with pre-existing medical conditions. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment, nor expected to require any significant change in therapy or hospitalization for worsening disease in foreseeable future.
  3. Group 1: Healthy adults with no previous history of SARS COV2 infection (PCR-, antigenic test- or chest TDM- or serology SARS-CoV-2-) Group 2: Healthy adults with history of infection with SARS COV 2 (PCR+, antigenic test+ or chest TDM+ or serology SARS-CoV-2+ of more than 6 months)
  4. A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

    • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile. OR
    • Is of childbearing potential and agrees to use an effective contraceptive method from at least 4 weeks prior to vaccination until at least 4 weeks after the last vaccination. A participant of childbearing potential must have a negative blood pregnancy test at enrolment visit.
  5. Understands and agrees to comply with the study procedures (visits, phone calls) based on Investigator judgement
  6. Written and informed consent signed by the person and the investigator (no later than the day of pre-inclusion and prior to any examination realized in the frame of the trial) (article L1122-1-1 of the Public Health Code)
  7. Affiliated or beneficiary of a social security scheme (article L1121-11 of the Public Health Code) (AME is not a social security scheme)
  8. who agrees to be registered in the national file of persons who lend themselves to biomedical research (article L1121-16 of the Public Health Code).

Exclusion Criteria:

  1. Participant is ill or febrile (body temperature ≥ 38.0°C) within 72 prior hours or and/or symptoms suggestive of COVID-19 or being contact subject within the past 14 days at enrolment visit.

    (Ill or febrile participants may be re-scheduled within the trial inclusion period when no longer presenting symptoms, except if condition is COVID19)

  2. Participants with positive PCR, antigenic test or chest TDM or serology to SARS-CoV-2 at the enrolment visit, only for the group1.
  3. Participants who already received another anti-SARS-CoV-2-vaccine
  4. Participants who received BCG given within the last year.
  5. Use of immunosuppressive drugs like e.g. corticosteroids at a dosage > 10mg equivalent prednisone /day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies
  6. Received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion.
  7. Received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine 4 weeks after the last injection.
  8. History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, laryngeal oedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-SARS-CoV-2-vaccine.
  9. History of severe allergic event
  10. Known HIV, active HCV or HBV infection
  11. Any pathological condition, such as cancer, which may be susceptible of reducing immunity response
  12. Any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy
  13. The use of investigational Ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study
  14. Any condition which in the opinion of the investigator may interfere with the aim of the study
  15. Pregnant or breastfeeding or positive pregnancy blood test at enrolment visit.
  16. An immediate family member or household member of study staff.
  17. Participation in another investigational clinical study (Jardé 1 or Jardé 2) within 4 weeks before the enrolment visit or still in an exclusion period from another clinical trial or participation in another investigational clinical study planned before the study completion.
  18. People under legal protection measure (tutorship, curatorship or safeguard measures)

Information from the National Library of Medicine

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


Contacts
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Contact: DESAINT Corinne, PhD 33 145 59 52 01 corinne.desaint@aphp.fr
Contact: LEVIER Axel 33 1 53946036 axel.levier@inserm.fr

Locations
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France
CIC1412, CHRU Brest Recruiting
Brest, France, 29609
Principal Investigator: ANSART Séverine, PUPH         
Centre de Recherche Clinique, CHU Côte de Nacre Recruiting
Caen, France, 14000
Principal Investigator: VERDON Renaud, PUPH         
CIC 1405 , CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Principal Investigator: LAURICHESSE Henri, PUPH         
CIC1430, Hôpital Henri Mondor Not yet recruiting
Creteil, France, 94000
Principal Investigator: LELIEVRE Jean-Daniel, PUPH         
CIC1413 , Hôtel Dieu - CHU Nantes Recruiting
Nantes, France, 44093
Principal Investigator: LEFEBVRE Maeva, PH         
Service des maladies infectieuses, CHU de Caremeau Recruiting
Nîmes, France, 30029
Principal Investigator: LOUBET Paul, PH         
CIC1417, hôpital Cochin Recruiting
Paris, France, 75 679
Principal Investigator: Launay Odile         
CIC 1427, Hopital Saint-Louis Recruiting
Paris, France, 75010
Principal Investigator: KILADJIAN Jean-Jacques, PUPH         
URCI, Hôpital Lyon Sud Recruiting
Pierre-Bénite, France, 69310
Principal Investigator: NICOLAS Jean-François, PUPH         
CIC1434, Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Principal Investigator: MUTTER catherine, PH         
CIC1415, CHRU Tours Hôpital Bretonneau Recruiting
Tours, France, 37044
Principal Investigator: MAAKAROUN-VERMESS Zoha, PH         
Sponsors and Collaborators
ANRS, Emerging Infectious Diseases
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: LEFEBVRE Maeva, MDPhD CIC1413, Hôtel Dieu - CHU Nantes
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Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT04824638    
Other Study ID Numbers: ANRS0002S
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ANRS, Emerging Infectious Diseases:
BNT162b2 vaccine
elderly
SARS CoV-2 infected participants
Additional relevant MeSH terms:
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Infection
Vaccines
Immunologic Factors
Physiological Effects of Drugs