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

NCT04934215 | Completed

• 1 other identifier: VACCICOVID
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SARS CoV 2 Infection; Vaccination Reaction

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (3)

• Marot S, Malet I, Leducq V, Zafilaza K, Sterlin D, Planas D, Gothland A, Jary A, Dorgham K, Bruel T; Sorbonne Universite SARS-CoV-2 Neutralizing Antibodies Study Group; Burrel S, Boutolleau D, Schwartz O, Gorochov G, Calvez V, Marcelin AG. Rapid decline of neutralizing antibodies against SARS-CoV-2 among infected healthcare workers. Nat Commun. 2021 Feb 8;12(1):844. doi: 10.1038/s41467-021-21111-9.

  PMID: 33558507 BACKGROUND

• Dan JM, Mateus J, Kato Y, Hastie KM, Yu ED, Faliti CE, Grifoni A, Ramirez SI, Haupt S, Frazier A, Nakao C, Rayaprolu V, Rawlings SA, Peters B, Krammer F, Simon V, Saphire EO, Smith DM, Weiskopf D, Sette A, Crotty S. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection. Science. 2021 Feb 5;371(6529):eabf4063. doi: 10.1126/science.abf4063. Epub 2021 Jan 6.

  PMID: 33408181 BACKGROUND

• Pean De Ponfilly G, Pilmis B, El Kaibi I, Castreau N, Laplanche S, Le Monnier A. Is the second dose of vaccination useful in previously SARS-CoV-2-infected healthcare workers? Infect Dis Now. 2021 Nov;51(8):673-675. doi: 10.1016/j.idnow.2021.07.001. Epub 2021 Jul 6.

  PMID: 34242841 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• PEAN DE PONFILLY Gauthier

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 22, 2021
• Study Start: July 28, 2021
• Primary Completion: August 30, 2021
• Study Completion: November 3, 2021
• Last Updated: January 21, 2022

Record last verified: 2021-12

Locations

FR (1)