Back to resultsCOVID-19 Vaccination of Immunodeficient Persons (COVAXID) (COVAXID)
Primary Purpose
Covid19
Status
Active
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Comirnaty (COVID-19, mRNA vaccine)
Sponsored by
About this trial
This is an interventional prevention trial for Covid19
Eligibility Criteria
Inclusion Criteria:
1. Individuals ≥18 years old
2a. In the opinion of the investigator, individuals with immunosuppressive disease who meet one of the following criteria:
- Primary immunodeficiency
- Human immunodeficiency virus (HIV)-infection
- Allogeneic stem cell transplantation / Chimeric antigen receptor (CAR T cell) therapy
- Solid organ transplant
- Chronic lymphatic leukemia
or
2b. In the opinion of the investigator, individuals without immunosuppressive disease or treatment without significant co-morbidity
3. Provision of signed informed consent to participate in the study
Exclusion Criteria:
- Previous or ongoing Coronavirus Disease-19 (COVID-19).
- Coagulation disorders, other conditions associated with prolonged bleeding time or anticoagulant treatments, which according to the investigator contraindicate intramuscular injection. Conditions which can be corrected with measures such as platelet concentrate treatments, coagulation factors or other measures for people responsible for anticoagulants are not exclusion criteria.
- Planned to receive another vaccine within 14 days before the first dose of the study vaccine, or during the period from the first dose of the study vaccine up to 14 days after the second dose of the study vaccine, and vaccination with another vaccine which in the investigator's opinion cannot be planned outside these time periods
- Pregnancy or breast feeding.
- Hypersensitivity to the active substance or to any of the excipients contained in the vaccine
- Individuals who cannot understand the informed consent.
- Individuals who for other reasons are considered by investigators as not suitable for inclusion
Sites / Locations
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vaccination with Comirnaty according to standard of care treatment
Arm Description
All study participants will receive Comirnaty according to current approval.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Assessment of any Adverse Events (AE) of the given vaccine [Safety and tolerability].
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.
Proportion (95% CI) of study objects with SARS-CoV-2 infection.
Assessment of humoral and cellular immune responses in blood and saliva.
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.
Genomic sequencing of SARS-CoV-2 at breakthrough infection.
Assessment of graft versus host disease in allogenic stem cell transplanted persons after given vaccine.
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.
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.
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.
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.
Description of oral and fecal microbiota at baseline and association to immune responses.
Full Information
NCT ID
NCT04780659
First Posted
February 19, 2021
Last Updated
September 1, 2023
Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT04780659
Brief Title
COVID-19 Vaccination of Immunodeficient Persons (COVAXID)
Acronym
COVAXID
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is designed as an open, non-randomized, phase IV cohort study in which the mRNA vaccine Comirnaty will be given in two doses. Analyses will be performed on blood and saliva, investigating humoral and cellular vaccine responses. Occurence of local or systemic reactogenicity will be evaluated, as well as adverse events. The study will include persons with primary or secondary immunosuppressive disorders, as well as immunocompetent persons, with the aim of investigating if the immune responses after given Comirnaty mRNA vaccine against COVID-19.
Detailed Description
In this study with 450 patients with primary or secondary immunosuppressive disorders (patients with primary immunodeficiency, HIV infected patients, patients with allogenic stem cell transplantation/CAR T cell treated, solid organ transplanted, and patients with chronic lymphatic leukemia) from Karolinska University Hospital, and healthy controls of 90 individuals for comparison, we will investigate the safety and the immune responses after mRNA vaccination with Comirnaty after two doses, under 6 months of time for each participant. The study is In collaboration with research groups at Karolinska Institutet and SciLifeLab, with planned in-depth detailed analyses of antibody responses as well as cellular responses. The study has obtained permission from Swedish Medical Agency and Swedish Ethical Review Authority.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
540 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaccination with Comirnaty according to standard of care treatment
Arm Type
Experimental
Arm Description
All study participants will receive Comirnaty according to current approval.
Intervention Type
Biological
Intervention Name(s)
Comirnaty (COVID-19, mRNA vaccine)
Other Intervention Name(s)
tozinameran, Pfizer mRNA vaccine
Intervention Description
Comirnaty will be administered two times, one at Day 0 and the second dose at Day 21.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2 weeks after second dose of vaccine.
Secondary Outcome Measure Information:
Title
Assessment of any Adverse Events (AE) of the given vaccine [Safety and tolerability].
Description
Proportion (95% CI) of study objects experiencing AE including reactogenicity, Serious Adverse Events (SAE), and Suspected Unexpected Serious Adverse Reaction (SUSAR).
Time Frame
Duration of 0-14 days after each given vaccine dose.
Title
Frequency of SARS-CoV-2 infection documented by positive polymerase chain reaction (PCR) test.
Description
Proportion (95% CI) of study objects with SARS-CoV-2 infection.
Time Frame
Day 0 - 6 months.
Title
Assessment of humoral and cellular immune responses in blood and saliva.
Description
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.
Time Frame
Day 0- 6 months.
Title
Assessment of escape mutations of sequencing SARS-CoV-2 at breakthrough infection.
Description
Genomic sequencing of SARS-CoV-2 at breakthrough infection.
Time Frame
Day 0-6 months.
Title
Assessment of graft versus host disease in allogenic stem cell transplanted persons after given vaccine.
Description
Number of occurrence or worsening of graft versus host disease in allogenic stem cell transplanted persons after given vaccine will be described.
Time Frame
Day 0-6 months.
Title
Assessment of biopsy verified rejection in solid organ transplanted persons after given vaccine.
Description
Number of occurrence of biopsy verified rejection in solid organ transplanted persons after given vaccine.
Time Frame
Day 0-6 months.
Title
Assessment of viremia, defined as HIV ribonucleic acid (RNA) > 50 copies/milliliter after vaccination in HIV infected persons.
Description
Number of HIV infected persons with HIV ribonucleic acid (RNA) > 50 copies/milliliter after vaccination.
Time Frame
Day 0-6 months.
Title
Assessment of HIV deoxyribonucleic acid (DNA) levels after given vaccine in HIV infected persons.
Description
HIV DNA levels at baseline, and 3 and 6 months after second dose of vaccine.
Time Frame
Day 0-6 months.
Title
Assessment of oral and gut microbiota in immunosuppressed and controls, in relation to immune response to vaccination.
Description
Description of oral and fecal microbiota at baseline and association to immune responses.
Time Frame
Day 0-6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Individuals ≥18 years old
2a. In the opinion of the investigator, individuals with immunosuppressive disease who meet one of the following criteria:
Primary immunodeficiency
Human immunodeficiency virus (HIV)-infection
Allogeneic stem cell transplantation / Chimeric antigen receptor (CAR T cell) therapy
Solid organ transplant
Chronic lymphatic leukemia
or
2b. In the opinion of the investigator, individuals without immunosuppressive disease or treatment without significant co-morbidity
3. Provision of signed informed consent to participate in the study
Exclusion Criteria:
Previous or ongoing Coronavirus Disease-19 (COVID-19).
Coagulation disorders, other conditions associated with prolonged bleeding time or anticoagulant treatments, which according to the investigator contraindicate intramuscular injection. Conditions which can be corrected with measures such as platelet concentrate treatments, coagulation factors or other measures for people responsible for anticoagulants are not exclusion criteria.
Planned to receive another vaccine within 14 days before the first dose of the study vaccine, or during the period from the first dose of the study vaccine up to 14 days after the second dose of the study vaccine, and vaccination with another vaccine which in the investigator's opinion cannot be planned outside these time periods
Pregnancy or breast feeding.
Hypersensitivity to the active substance or to any of the excipients contained in the vaccine
Individuals who cannot understand the informed consent.
Individuals who for other reasons are considered by investigators as not suitable for inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo Aleman, MD, PhD
Organizational Affiliation
Karolinska University Hospital, ME Infectious Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
State/Province
Huddinge
ZIP/Postal Code
14186
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Will submit data to European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) and share data result. Will share research results and data through national COVID-19 data portal, operated by SciLifeLab Data Centre, Sweden.
IPD Sharing Time Frame
Within one year after study end.
IPD Sharing Access Criteria
Published in EudraCT and national COVID-19 data portal (SciLifeLab Data Centre)
IPD Sharing URL
https://eudract.ema.europa.eu/index.html
Citations:
PubMed Identifier
35135470
Citation
Cuapio A, Boulouis C, Filipovic I, Wullimann D, Kammann T, Parrot T, Chen P, Akber M, Gao Y, Hammer Q, Strunz B, Perez Potti A, Rivera Ballesteros O, Lange J, Muvva JR, Bergman P, Blennow O, Hansson L, Mielke S, Nowak P, Soderdahl G, Osterborg A, Smith CIE, Bogdanovic G, Muschiol S, Hellgren F, Lore K, Sobkowiak MJ, Gabarrini G, Healy K, Sallberg Chen M, Alici E, Bjorkstrom NK, Buggert M, Ljungman P, Sandberg JK, Aleman S, Ljunggren HG. NK cell frequencies, function and correlates to vaccine outcome in BNT162b2 mRNA anti-SARS-CoV-2 vaccinated healthy and immunocompromised individuals. Mol Med. 2022 Feb 8;28(1):20. doi: 10.1186/s10020-022-00443-2.
Results Reference
derived
PubMed Identifier
35075450
Citation
Healy K, Pin E, Chen P, Soderdahl G, Nowak P, Mielke S, Hansson L, Bergman P, Smith CIE, Ljungman P, Valentini D, Blennow O, Osterborg A, Gabarrini G, Al-Manei K, Alkharaan H, Sobkowiak MJ, Yousef J, Mravinacova S, Cuapio A, Xu X, Akber M, Lore K, Hellstrom C, Muschiol S, Bogdanovic G, Buggert M, Ljunggren HG, Hober S, Nilsson P, Aleman S, Sallberg Chen M. Salivary IgG to SARS-CoV-2 indicates seroconversion and correlates to serum neutralization in mRNA-vaccinated immunocompromised individuals. Med. 2022 Feb 11;3(2):137-153.e3. doi: 10.1016/j.medj.2022.01.001. Epub 2022 Jan 20.
Results Reference
derived
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COVID-19 Vaccination of Immunodeficient Persons (COVAXID)
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