COVID-19 Vaccination of Immunodeficient Persons (COVAXID)

Covid19 Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04780659
• Other study ID #: 2021-000175-37
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 23, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 540
• Est. completion date: December 31, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• Comirnaty (COVID-19, mRNA vaccine)
Comirnaty will be administered two times, one at Day 0 and the second dose at Day 21.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm	Huddinge

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks after second dose of vaccine.
Secondary	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).	Duration of 0-14 days after each given vaccine dose.
Secondary	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.	Day 0 - 6 months.
Secondary	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.	Day 0- 6 months.
Secondary	Assessment of escape mutations of sequencing SARS-CoV-2 at breakthrough infection.	Genomic sequencing of SARS-CoV-2 at breakthrough infection.	Day 0-6 months.
Secondary	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.	Day 0-6 months.
Secondary	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.	Day 0-6 months.
Secondary	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.	Day 0-6 months.
Secondary	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.	Day 0-6 months.
Secondary	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.	Day 0-6 months.