NCT04920357

Brief Summary

The study investigates the immune response after vaccination in individuals with and without pre-existing immunity to Coronavirus disease (COVID) -19. The participants are followed and sampled up to 4 years after vaccination. Blood samples are collected at different timepoints to analyze immune response. The aim is to investigate the level of specific antibodies to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) yearly, up to 4 years after vaccination.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

May 31, 2021

Last Update Submit

June 8, 2021

Conditions

Vaccination; InfectionCovid19

Keywords

Immune responseImmunoglobulin G

Outcome Measures

Primary Outcomes (2)

  • Change in levels of specific IgG antibody against SARS-CoV-2 after vaccination over time.

    Levels of specific IgG antibody against SARS-CoV-2 will be measured as optical density, OD in a specific Spike-protein IgG ELISA at each time-point.

    1 and 6 months, 1, 2, 3, and 4 years after vaccination.

  • Change in proportion of participants with detectable specific IgG antibodies after vaccination over time.

    Immune response will be measured as the proportion of participants (in % of all vaccinated individuals) with detectable specific IgG antibodies after vaccination at each time-point (in months after vaccination).

    1 and 6 months, 1, 2, 3, and 4 years after vaccination

Secondary Outcomes (1)

  • Levels of markers for immune response after infection and vaccination against COVID-19 in COVID-naive versus COVID experienced individuals.

    Change of markers for cellular and serological immune response over time measured at 1 and 6 months, 1, 2, 3, and 4 years after vaccination

Study Arms (2)

Post-COVID-19

Persons with a verified previous COVID-19 infection

Drug: Vaccination

COVID-19 naive

Persons that have no history of COVID-19

Drug: Vaccination

Interventions

VaccinationDRUG

Persons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study.

COVID-19 naivePost-COVID-19

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with and without pre-existing immunity to Covid-19 that are vaccinated in the national and regional vaccine campaign.

You may qualify if:

  • Consents to participate in the study
  • Age ≥ 18 years

You may not qualify if:

  • Age \<18 years
  • Incapable of giving informed consent
  • Contraindication to vaccination
  • Severe disease
  • Ongoing treatment that is judged to affect the vaccine response (Does not include Rituximab which is allowed after individual consideration). Steroids \> 15 mg orally per day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Mälarsjukhuset

Eskilstuna, 633 49, Sweden

RECRUITING

Karlstad Central hospital

Karlstad, 651 85, Sweden

RECRUITING

Örebro University hospital

Örebro, 701 85, Sweden

RECRUITING

Östersund hospital

Östersund, 831 83, Sweden

RECRUITING

Umeå University hospital

Umeå, 901 85, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Periferal blood mononuclear cells (PBMC), plasma and sera.

MeSH Terms

Conditions

InfectionsCOVID-19

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Clas Ahlm, Prof

    Umeå University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clas Ahlm, Prof

CONTACT

+46-(0)70-3172965clas.ahlm@umu.se

Mattias Forsell, Assoc Prof

CONTACT

+46-(0)73-0211221mattias.forsell@umu.se

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 9, 2021

Study Start

March 31, 2021

Primary Completion

March 31, 2022

Study Completion

December 31, 2024

Last Updated

June 9, 2021

Record last verified: 2021-06

Locations

SE(5)