Phase 4 N=539 Prevention

COVID-19 Vaccination of Immunodeficient Persons (COVAXID)

Covid19

Bottom Line

View on ClinicalTrials.gov: NCT04780659 ↗

Enrolled (actual)

539

Serious AEs

4.3%

Results posted

Dec 2025

Primary outcome: 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. — 280; 78; 108; 0 Participants — p=< 0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Comirnaty (COVID-19, mRNA vaccine) (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Karolinska University Hospital
Primary completion: Oct 2021

Outcome Measures

Outcome	Result	p-value
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.	280; 78; 108; 0	< 0.05 sig
SECONDARY Assessment of Any Adverse Events (AE) of the Given Vaccine.	87; 5; 13; 0; 0; 0	—
SECONDARY Assessment of Any Adverse Events (AE) of the Given Vaccine.	87; 5; 13; 0; 0; 0	—
SECONDARY Frequency Who Experience Local and Systemic Reactions	337; 74; 85; 13	< 0.05 sig
SECONDARY Frequency Who Experience Local and Systemic Reactions	337; 74; 85; 13	< 0.05 sig
SECONDARY Frequency of SARS-CoV-2 Infection Documented by PCR Test.	18; 2; 370; 76	—

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.

Eligibility Criteria

Inclusion Criteria

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

2b. In the opinion of the investigator, individuals without immunosuppressive disease or treatment without significant co-morbidity

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04780659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.