CoVacc - Immune response to vaccination against Covid-19

Phase 1

• Conditions: Individuals with and without pre-existing immunity to Covid-19.; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-000683-30-SE
• Lead Sponsor: meå university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-23
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Consents to participate in the study
• Age = 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 750

Exclusion Criteria

• Age <18 years
• Incapable of giving informed consent (does not apply to participants in the elderly study)
• Contraindication to vaccination
• Severe disease (assessed to affect the subjects ability to complete the study)
• Ongoing treatment that is judged to affect the vaccine response (Does not include inhaled steroids and nasal sprays, as well as tablet cortisone =15mg / day. Rituximab treatment is not an exclusion criterion.)
Participants in the elderly study:
The exclusion criteria described in the protocol above for CoVacc will not apply to the sub-study called The Elderly Study, this clinical research study in which people with severe illness and people who lack their own decision-making ability can be included. Data on chronic diseases or drugs will not be collected

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does antibody development to SARS-CoV-2 S protein differ after vaccination between those who have had a previous SARS-CoV-2 infection compared to Covid-19 naive individuals?;Primary end point(s): Investigate the level of specific antibodies to SARS-CoV-2 yearly, up to four years after vaccination.;Timepoint(s) of evaluation of this end point: 1, 2, 3, 4 year after vaccination;Secondary Objective: Better understanding of how the human immune system reacts when exposed to foreign protein antigen measured as antibody level in serum, plasma and mucosa as well as at the cellular and genetic level.<br>The secondary issues are those that are general to understanding how the human immune system works in both infection and vaccination.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Analyzes to investigate how the human immune system reacts to Covid 19 vaccine.;Timepoint(s) of evaluation of this end point: Before and after each dose of vaccine. Thereafter the following times after vaccination: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years and 4 years.