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

NCT04706390 | Recruiting

• 1 other identifier: COVID-19vacc-1
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19

Keywords

Covid19; Vaccine; SARS-CoV-2 antibody

Outcome Measures

Primary Outcomes (1)

• immune responses

  spike antibody response to SARS-CoV-2

  2 months to 3 years

Secondary Outcomes (2)

• Duration and breadth of B- cell responses

  2 months to 3 years

• Duration and breadth of T cell responses

  2 months to 3 years

Study Arms (2)

Health care workers

500-1000 health care workers prioritized for early vaccination

Biological: covid-19 vaccine

prioritized patient populations

2000 individuals in patient populations prioritized for vaccinations

Biological: covid-19 vaccine

Interventions

covid-19 vaccine BIOLOGICAL

vaccination

Health care workers; prioritized patient populations

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Comparator group: patients with natural SARS-CoV-2 infection Vaccine groups: Health care workers and high-risk population groups.

You may qualify if:

• subjects prioritized by national vaccination program

You may not qualify if:

• Children
• unable or unwilling to provide informed consent

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

University of Bergen

Bergen, 5020, Norway

RECRUITING

Related Publications (4)

• Cox RJ, Brokstad KA, Krammer F, Langeland N; Bergen COVID-19 Research Group. Seroconversion in household members of COVID-19 outpatients. Lancet Infect Dis. 2021 Feb;21(2):168. doi: 10.1016/S1473-3099(20)30466-7. Epub 2020 Jun 15. No abstract available.

  PMID: 32553187 BACKGROUND

• Trieu MC, Bansal A, Madsen A, Zhou F, Saevik M, Vahokoski J, Brokstad KA, Krammer F, Tondel C, Mohn KGI, Blomberg B, Langeland N, Cox RJ; Bergen COVID-19 Research Group. SARS-CoV-2-Specific Neutralizing Antibody Responses in Norwegian Health Care Workers After the First Wave of COVID-19 Pandemic: A Prospective Cohort Study. J Infect Dis. 2021 Feb 24;223(4):589-599. doi: 10.1093/infdis/jiaa737.

  PMID: 33247924 BACKGROUND

• Bredholt G, Saevik M, Soyland H, Ueland T, Zhou F, Pathirana R, Madsen A, Vahokoski J, Lartey S, Halvorsen BE, Dahl TB, Trieu MC, Mohn KG, Brokstad KA, Aukrust P, Tondel C, Langeland N, Blomberg B, Cox RJ; Bergen COVID-19 Research Group. Three doses of Sars-CoV-2 mRNA vaccine in older adults result in similar antibody responses but reduced cellular cytokine responses relative to younger adults. Vaccine X. 2024 Sep 25;20:100564. doi: 10.1016/j.jvacx.2024.100564. eCollection 2024 Oct.

  PMID: 39403561 DERIVED

• Hansen L, Brokstad KA, Bansal A, Zhou F, Bredholt G, Onyango TB, Sandnes HH, Elyanow R, Madsen A, Trieu MC, Saevik M, Soyland H, Olofsson JS, Vahokoski J, Ertesvag NU, Fjelltveit EB, Shafiani S, Tondel C, Chapman H, Kaplan I, Mohn KGI, Langeland N, Cox RJ. Durable immune responses after BNT162b2 vaccination in home-dwelling old adults. Vaccine X. 2023 Apr;13:100262. doi: 10.1016/j.jvacx.2023.100262. Epub 2023 Jan 10.

  PMID: 36643855 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood collection including cells.

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Rebecca J Cox, PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca J Cox, PhD

CONTACT

+4745242974; rebecca.cox@uib.no

Nina Langeland, MD

CONTACT

+4741616450; nina.langeland@uib.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 12, 2021
• Study Start: January 12, 2021
• Primary Completion: December 12, 2024
• Study Completion (Estimated): December 12, 2030
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

NO (1)