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COVID-19 Vaccination of Immunodeficient Persons (COVAXID) (COVAXID)

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ClinicalTrials.gov Identifier: NCT04780659
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Soo Aleman, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: Comirnaty (COVID-19, mRNA vaccine) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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.
Other Names:
  • tozinameran
  • Pfizer mRNA vaccine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  1. Previous or ongoing Coronavirus Disease-19 (COVID-19).
  2. 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.
  3. 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
  4. Pregnancy or breast feeding.
  5. Hypersensitivity to the active substance or to any of the excipients contained in the vaccine
  6. Individuals who cannot understand the informed consent.
  7. Individuals who for other reasons are considered by investigators as not suitable for inclusion

Information from the National Library of Medicine

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


Contacts
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Contact: Soo Aleman, MD, PhD +46 72 595 7225 soo.aleman@sll.se
Contact: Lena Dillner, MD, PhD +46 70 085 6871 lena.dillner@sll.se

Locations
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Sweden
Karolinska University Hospital Recruiting
Stockholm, Huddinge, Sweden, 14186
Contact: Soo Aleman, MD    + 46 8 58 58 0000    soo.aleman@sll.se   
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
Investigators
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Principal Investigator: Soo Aleman, MD, PhD Karolinska University Hospital, ME Infectious Diseases
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Responsible Party: Soo Aleman, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04780659    
Other Study ID Numbers: 2021-000175-37
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Within one year after study end.
Access Criteria: Published in EudraCT and national COVID-19 data portal (SciLifeLab Data Centre)
URL: https://eudract.ema.europa.eu/index.html

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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
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs