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

NCT04824638 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2026-04-03

No results posted yet for this study

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

Interventions

BIOLOGICAL

3 doses of BNT162b2 vaccine

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

BIOLOGICAL

2 dose of BNT162b2 vaccine

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

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • LEFEBVRE Maeva, MDPhD · CIC1413, Hôtel Dieu - CHU Nantes

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2021-06-30
Completion
2023-12-02

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04824638 on ClinicalTrials.gov