COVID-19 Vaccination of Immunodeficient Persons (COVAXID) (COVAXID)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04780659|
Recruitment Status : Active, not recruiting
First Posted : March 3, 2021
Last Update Posted : September 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Biological: Comirnaty (COVID-19, mRNA vaccine)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||540 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunological Responses After Vaccination for COVID-19 With the Messenger Ribonucleic Acid (mRNA) Vaccine Comirnaty in Immunosuppressed and Immunocompetent Individuals. An Open and Non-randomized, Phase IV Multicenter Study|
|Actual Study Start Date :||February 23, 2021|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Vaccination with Comirnaty according to standard of care treatment
All study participants will receive Comirnaty according to current approval.
Biological: Comirnaty (COVID-19, mRNA vaccine)
Comirnaty will be administered two times, one at Day 0 and the second dose at Day 21.
- Assessment of seroconversion, defined as development of immunoglobulin G (IgG) antibodies against Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) after vaccination of 2 doses in seronegative individuals. [ Time Frame: 2 weeks after second dose of vaccine. ]Proportion (95% confidence interval, CI) seroconverting to positive response to SARS-CoV-2 IgG serology test after two doses of vaccine, measured 2 weeks after second dose of vaccine.
- Assessment of any Adverse Events (AE) of the given vaccine [Safety and tolerability]. [ Time Frame: Duration of 0-14 days after each given vaccine dose. ]Proportion (95% CI) of study objects experiencing AE including reactogenicity, Serious Adverse Events (SAE), and Suspected Unexpected Serious Adverse Reaction (SUSAR).
- Frequency of SARS-CoV-2 infection documented by positive polymerase chain reaction (PCR) test. [ Time Frame: Day 0 - 6 months. ]Proportion (95% CI) of study objects with SARS-CoV-2 infection.
- Assessment of humoral and cellular immune responses in blood and saliva. [ Time Frame: Day 0- 6 months. ]Description of humoral and cellular immune responses in blood and saliva at baseline, and at time points day 0 (first vaccine dose), day 10 after first dose, day 21 (second vaccine dose), and 2 weeks, 3 months and 6 months after the second vaccine dose.
- Assessment of escape mutations of sequencing SARS-CoV-2 at breakthrough infection. [ Time Frame: Day 0-6 months. ]Genomic sequencing of SARS-CoV-2 at breakthrough infection.
- Assessment of graft versus host disease in allogenic stem cell transplanted persons after given vaccine. [ Time Frame: Day 0-6 months. ]Number of occurrence or worsening of graft versus host disease in allogenic stem cell transplanted persons after given vaccine will be described.
- Assessment of biopsy verified rejection in solid organ transplanted persons after given vaccine. [ Time Frame: Day 0-6 months. ]Number of occurrence of biopsy verified rejection in solid organ transplanted persons after given vaccine.
- Assessment of viremia, defined as HIV ribonucleic acid (RNA) > 50 copies/milliliter after vaccination in HIV infected persons. [ Time Frame: Day 0-6 months. ]Number of HIV infected persons with HIV ribonucleic acid (RNA) > 50 copies/milliliter after vaccination.
- Assessment of HIV deoxyribonucleic acid (DNA) levels after given vaccine in HIV infected persons. [ Time Frame: Day 0-6 months. ]HIV DNA levels at baseline, and 3 and 6 months after second dose of vaccine.
- Assessment of oral and gut microbiota in immunosuppressed and controls, in relation to immune response to vaccination. [ Time Frame: Day 0-6 months. ]Description of oral and fecal microbiota at baseline and association to immune responses.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780659
|Karolinska University Hospital|
|Stockholm, Huddinge, Sweden, 14186|
|Principal Investigator:||Soo Aleman, MD, PhD||Karolinska University Hospital, ME Infectious Diseases|