Clinical trial NCT04934215: Evaluation of Post-vaccination Anti-SARS-CoV-2 Serological Response in Health Care Workers With a History of COVID-19.
Official title: Evaluation of Post-vaccination Anti-SARS-CoV-2 Serological Response in Health Care Workers With a History of COVID-19.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS CoV 2 Infection
Vaccination Reaction
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: PEAN DE PONFILLY Gauthier
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.