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CompletedNCT04934215VACCICOVIDUpdated Jan 21, 2022

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

An observational study in SARS CoV 2 Infection and Vaccination Reaction, sponsored by Fondation Hôpital Saint-Joseph. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-21.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
73
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • SARS CoV 2 Infection
  • Vaccination Reaction

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 73 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
73 participants (actual)
Patient registry
No
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What researchers measure

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.

    Time frame: Day 28

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Study locations

1 site
  • Groupe Hospitalier Paris Saint Joseph
    Paris, Ile-de-France 75014, France
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References and documents

Publications

  • 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. Erratum In: Nat Commun. 2021 May 10;12(1):2824. doi: 10.1038/s41467-021-23128-6. PubMed 33558507 ↗
  • 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. PubMed 33408181 ↗
  • 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. PubMed 34242841 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04934215
Lead sponsor
Fondation Hôpital Saint-Joseph
Responsible party
Sponsor
First posted
Jun 22, 2021
Start date
Jul 28, 2021
Primary completion
Aug 30, 2021
Completion
Nov 3, 2021
Last update
Jan 21, 2022

Study contacts

PEAN DE PONFILLY Gauthier
principal investigator · Fondation Hôpital Saint-Joseph

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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