Phase 4
Completed N=539
COVID-19 Vaccination of Immunodeficient Persons (COVAXID)
Source: ClinicalTrials.gov NCT04780659 ↗Enrolled (actual)
539
Serious AEs
4.3%
Results posted
Dec 2025
Primary outcomePrimary: 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
◆ Published Evidence
Established
42citations · ~11 / year
NK cell frequencies, function and correlates to vaccine outcome in BNT162b2 mRNA anti-SARS-CoV-2 vaccinated healthy and immunocompromised individuals.
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.
Linked Publications (4)
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NK cell frequencies, function and correlates to vaccine outcome in BNT162b2 mRNA anti-SARS-CoV-2 vaccinated healthy and immunocompromised individuals.
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Salivary IgG to SARS-CoV-2 indicates seroconversion and correlates to serum neutralization in mRNA-vaccinated immunocompromised individuals.
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Real-world assessment of immunogenicity in immunocompromised individuals following SARS-CoV-2 mRNA vaccination: a one-year follow-up of the prospective clinical trial COVAXID.
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Real-world assessment of immunogenicity in immunocompromised individuals following SARS-CoV-2 mRNA vaccination: a two-year follow-up of the prospective clinical trial COVAXID.
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 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 | — |
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
or
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
Data sourced from ClinicalTrials.gov (NCT04780659) and the linked publication. 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. Informational only — not medical advice.