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NCT Number: NCT04706390

Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination

The ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by no population-based immunity to the severe acute respiratory disease coronavirus 2 (SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigate the pandemic. Currently, two COVID-19 vaccines are available for vaccination in Europe through conditional marketing authorisation granted by the European Medicines Agency and further vaccine will be licensed. These vaccines have shown good vaccine efficacy in phase 3 vaccine trials. We will recruit subjects who will be prioritised for vaccination with the primary aim of comparing the immune responses after COVID-19 vaccination and natural SARS-CoV-2 infection. In Western Norway we have recruited cohorts of health care workers and patients infected with SARS-CoV-2 and will extend to COVID-19 vaccinees. Demographic, clinical data and repeated blood samples will be collected to evaluate the complications and kinetics, duration and breadth of the immune responses comparing natural infection to vaccination.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The primary aim of this study is

  • To compare immune responses after natural SARS-CoV-2 infection and COVID-19 vaccination The secondary aims are
  • To compare the duration and breadth of antibody responses between natural infection and vaccination.
  • To investigate the duration and breadth of B and T cellular responses between natural infection and vaccination.
  • To evaluate the short and long term complications after natural infection and vaccination.
  • To find out if previous infection skews the immune response after vaccination.
  • To study reinfection after natural infection and vaccination.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subjects prioritized by national vaccination program

Exclusion criteria

  • Children
  • unable or unwilling to provide informed consent

Treatment and study plan

COVID-19 vaccine

Biological

vaccination

Primary outcomes

  1. immune responses

    Time frame: 2 months to 3 years

    spike antibody response to SARS-CoV-2

Secondary outcomes

  1. Duration and breadth of B- cell responses

    Time frame: 2 months to 3 years

    compare serological and memory B cells after vaccination to natural infection

  2. Duration and breadth of T cell responses

    Time frame: 2 months to 3 years

    compare T cell responses after vaccination to natural infection

Study contacts

Contact information is provided by the study sponsor or research team.

Nina Langeland, MD

CONTACT

[email protected]

+4741616450

Rebecca J Cox, PhD

CONTACT

[email protected]

+4745242974

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • Haukeland University Hospital

Registry information

Acronym: COVID19vac-1

Important dates

Study start
2021
Primary completion
2024
Study completion
2030
First posted
Jan 12, 2021
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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