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 - NA

Inserm-ANRS0 sites300 target enrollmentFebruary 3, 2021

ConditionsHealthy volunteers MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865 Therapeutic area: Diseases [C] - Virus Diseases [C02]

DrugsComirnaty

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy volunteers
Sponsor: Inserm-ANRS
Enrollment: 300
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 3, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Inserm-ANRS

Eligibility 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 CoV\-2 infection (PCR\-, antigenic test\- or chest TDM\- or serology SARS\-CoV\-2\-)
•Group 2: Healthy adults with history of documented 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\. Person affiliated or beneficiary of a social security scheme (article L1121\-11 of the Public Health Code) (AME is not a social security scheme)

Exclusion Criteria

•1\. Subject 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 inclusion period when no longer presenting symptoms, except if condition is COVID19\)
•2\. Participants with positive serology SARS\-CoV\-2 at the enrolment visit (only for the group 1\)
•3\. Participants who already received another anti\-SARS\-CoV\-2\-vaccine
•4\. Participants who received BCG 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