BNT162b2 Vaccination With 2 Doses in COVID-19 Negative Volunteers and With a Single Dose in COVID-19 Positive Volunteers

NCT04824638 | Completed Phase 2

• 1 other identifier: ANRS0002S
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 11

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.

Conditions

Healthy; Immunization; Infection

Keywords

BNT162b2 vaccine; elderly; SARS CoV-2 infected participants

Outcome Measures

Primary Outcomes (1)

• IgG humoral response to vaccine 28 days post vaccination

  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).

  at Day 57 for patients of the group1 and at Day 29 for patient of the group 2

Secondary Outcomes (8)

• humoral response to vaccine

  Day 1, Day 29, Day 57, Month 6, Month 8, Month 8+3days, Month 8+15days, Month 8+28 days, Month 8+6 month, Month 24

• T cells response to vaccine

  Fluorospot assays : Day 1, Day 29, Day 57, Month 6, Month 8+6months, Month 24 (all participants) and at Month 8, Month 8+28days (participants having received the additional vaccine dose). Phenotyping of antigen specific T-Cells : Day 1 and Month 24

• Mucosal response to vaccine

  Day 1, Day29, Day57, Month6, Month12, Month24 (all participants) [and Month 8, Month 8+28days, Month 8+6months (participants having received the additional vaccine dose)]

• B cell response to vaccine

  Determination of the epitope profiling and B Elispots: Day1, Day57 and Month24. Determination of the B cell repertoire: Day1, Day57 [and Month8, Month8+28days (participants selected for this analysis and having received an additional dose of vaccine]

• predictive determinants of vaccine response

  at screening visit : (Day -6) and at the latest day (Day 0) before the inclusion visit (Day 1)

Study Arms (2)

Group 1: SARS-CoV-2 naive participants

EXPERIMENTAL

participants without antecedent of SARS-CoV-2 infection

Biological: 3 doses of BNT162b2 vaccine

Group 2: Previously SARS CoV-2 infected participants

EXPERIMENTAL

participants with antecedent of SARS-CoV-2 infection (more than 5 months)

Biological: 2 dose of BNT162b2 vaccine

Interventions

3 doses of BNT162b2 vaccine BIOLOGICAL

Administration of BNT162 b2 vaccine (30µg in 0.3mL) at D1 D29 and M8, intramuscularly (participants without antecedent of SARS-CoV-2 infection)

Group 1: SARS-CoV-2 naive participants

2 dose of BNT162b2 vaccine BIOLOGICAL

Administration of BNT162 b2 vaccine (30µg in 0.3mL) at D1 and M8, intramuscularly (participants with antecedent of SARS-CoV-2 infection)

Group 2: Previously SARS CoV-2 infected participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 45 years old or at least 65 years old,
• 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.
• 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.
• Understands and agrees to comply with the study procedures (visits, phone calls) based on Investigator judgement
• Affiliated or beneficiary of a social security scheme (article L1121-11 of the Public Health Code) (AME is not a social security scheme)
• 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).

You may not qualify if:

• 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.
• Participants with positive PCR, antigenic test or chest TDM or serology to SARS-CoV-2 at the enrolment visit, only for the group1.
• Participants who already received another anti-SARS-CoV-2-vaccine
• Participants who received BCG given within the last year.
• 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
• Received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion.
• Received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine within 4 weeks after the last injection.
• 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.
• History of severe allergic event
• Known HIV, active HCV or HBV infection
• Any pathological condition, such as cancer, which may be susceptible of reducing immunity response
• Any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy
• The use of investigational Ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study
• Any condition which in the opinion of the investigator may interfere with the aim of the study
• Pregnant or breastfeeding or positive pregnancy blood test at enrolment visit.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (11)

CIC1412, CHRU Brest

Brest, 29609, France

Location

Centre de Recherche Clinique, CHU Côte de Nacre

Caen, 14000, France

Location

CIC 1405 , CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

CIC1430, Hôpital Henri Mondor

Créteil, 94000, France

Location

CIC1413 , Hôtel Dieu - CHU Nantes

Nantes, 44093, France

Location

Service des maladies infectieuses, CHU de Caremeau

Nîmes, 30029, France

Location

CIC1417, hôpital Cochin

Paris, 75 679, France

Location

CIC 1427, Hopital Saint-Louis

Paris, 75010, France

Location

URCI, Hôpital Lyon Sud

Pierre-Bénite, 69310, France

Location

CIC1434, Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

CIC1415, CHRU Tours Hôpital Bretonneau

Tours, 37044, France

Location

MeSH Terms

Conditions

Infections

Study Officials

• LEFEBVRE Maeva, MDPhD

  CIC1413, Hôtel Dieu - CHU Nantes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants of group 1 will receive two administrations of BNT162b2 at Day1 and Day29 then at Month8 Participants of group 2 will receive one administration of BNT162b2 at Day1, then at Month8

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: April 1, 2021
• Study Start: March 8, 2021
• Primary Completion: June 30, 2021
• Study Completion: December 2, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

FR (11)