Evaluation of Post-vaccination Anti-SARS-CoV-2 Serological Response in Health Care Workers With a History of COVID-19. (VACCICOVID)

December 30, 2021 updated by: Groupe Hospitalier Paris Saint Joseph

Since the beginning of 2020, a major pandemic due to the new emerging coronavirus (SARS-CoV-2) has been spreading around the world. Today, the hope to contain this pandemic lies in the development and use of vaccines directed against this virus. Different strategies aim to maximize the early impact of vaccination in a context where few doses are available.

In early January 2021, large-scale vaccination began in France, first for populations at risk of severe COVID-19, but also for healthcare workers over 50 years of age or with an underlying pathology, and then for all voluntary healthcare workers.

Study Overview

Status

Completed

Conditions

Detailed Description

The question of vaccination of patients with a history of recent or late SARS-CoV-2 infection has rapidly become a major issue. Currently, French recommendations call for a single dose in the cohort that has been cured of COVID-19 for six months. In addition, the use of anti-SARS-Cov2 serology may be of interest because the presence of antibodies indicates recent or past contact with SARS-CoV-2. However, serological testing is not included in the vaccination decision strategy.

The goal of the investigators is to provide data on the immune response induced by SARS-CoV-2 vaccines in a real-world setting to support this choice. Given the absence of recommendations concerning the realization of the anti-SARS-CoV-2 serology, it will be proposed to all the nursing staff of the Groupe Hospitalier Paris Saint Joseph at the time of their vaccination, a serological screening.

The investigators will evaluate the dynamics of antibody production against the SARS-CoV-2 Spike protein after the first and second dose of vaccine (conventional prime-boost strategy recommended) in healthcare workers with or without a history of COVID-19.

Study Type

Observational

Enrollment (Actual)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe hospitalier Paris saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will be carried out on the data of health care workers referred for vaccination to the Occupational Medicine Department and having received anti-SARS-CoV-2 serology at Day 21 post injection between 01/01/2021 and 31/03/2021, i.e. approximately 100 patients in total

Description

Inclusion Criteria:

  • Health care workers of the Paris Saint Joseph Hospital Group whose age ≥ 18 years
  • French-speaking
  • Health care workers who have received the BNT162b2 mRNA vaccine (COMIRNATY, Pfizer/BioNTech).

Exclusion Criteria:

  • Health care workers under guardianship or curatorship
  • Health care workers under court protection
  • Health care workers who object to the use of their data for this research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the level of serological response after the first and second vaccine doses in health care workers with and without a history of COVID-19.
Time Frame: Day 28
Evolution of of anti-SARS-CoV-2 antibody level at D21-28 post-first dose and at D21-28 post-second dose in healthcare workers with and without a history of COVID-19.
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: PEAN DE PONFILLY Gauthier, Groupe hospitalier Paris saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2021

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

November 3, 2021

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

December 30, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VACCICOVID

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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