Covid19 Clinical Trial
— CoVaccOfficial title:
CoVacc - Immune Response to Vaccination Against Covid-19, an Open Multicenter Phase IV Study
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.
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Consents to participate in the study - Age = 18 years Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Mälarsjukhuset | Eskilstuna | |
Sweden | Karlstad Central hospital | Karlstad | |
Sweden | Örebro University hospital | Örebro | |
Sweden | Östersund hospital | Östersund | |
Sweden | Umeå University hospital | Umeå |
Lead Sponsor | Collaborator |
---|---|
Umeå University | Örebro Läns Landsting, Region Jämtland Härjedalen, Region Västerbotten, Sormland County Council, Sweden, Värmland County Council, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | Levels of markers for immune response after infection and vaccination against COVID-19 in COVID-naive versus COVID experienced individuals. | Levels of markers for cellular and serological immune response after COVID-19 vaccination e.g. specific antibodies, T- and B-cell memory. | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05047692 -
Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04395768 -
International ALLIANCE Study of Therapies to Prevent Progression of COVID-19
|
Phase 2 | |
Terminated |
NCT04555096 -
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
|
Phase 2 | |
Completed |
NCT04508777 -
COVID SAFE: COVID-19 Screening Assessment for Exposure
|
||
Completed |
NCT04506268 -
COVID-19 SAFE Enrollment
|
N/A | |
Completed |
NCT04961541 -
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04546737 -
Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients
|
N/A | |
Terminated |
NCT04581915 -
PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19
|
Phase 2/Phase 3 | |
Completed |
NCT04494646 -
BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
|
Phase 2 | |
Not yet recruiting |
NCT04543006 -
Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
|
N/A | |
Terminated |
NCT04542993 -
Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
|
Phase 2 | |
Completed |
NCT04532294 -
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
|
Phase 1 | |
Completed |
NCT04537663 -
Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults
|
Phase 4 | |
Not yet recruiting |
NCT04527211 -
Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel
|
Phase 3 | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04387292 -
Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
|
N/A | |
Not yet recruiting |
NCT05038449 -
Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19
|
N/A | |
Completed |
NCT04979858 -
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
|
N/A | |
Completed |
NCT04610502 -
Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients
|
Phase 2 | |
Active, not recruiting |
NCT06042855 -
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
|
Phase 3 |