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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Biological: Comirnaty (COVID-19, mRNA vaccine)

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.

• Study Type: Interventional
• Enrollment (Actual): 539
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Huddinge
    • Stockholm, Huddinge, Sweden, 14186
      • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Any Adverse Events (AE) of the Given Vaccine.	Proportion (95% CI) who experience adverse events, with AE/SAE/SUSAR (after dose 1)	Duration of 0-14 days after the first vaccine dose.
Assessment of Any Adverse Events (AE) of the Given Vaccine.	Proportion (95% CI) who experience adverse events, with AE/SAE/SUSAR (after dose 2)	Duration of 0-14 days after the second vaccine dose.
Frequency Who Experience Local and Systemic Reactions	Number and proportion (95% CI) who experience local and systemic reactions (after dose 1)	After the first vaccin dose
Frequency Who Experience Local and Systemic Reactions	Number and proportion (95% CI) who experience local and systemic reactions (after dose 2)	After the second vaccin dose
Frequency of SARS-CoV-2 Infection Documented by PCR Test.	Proportion (95% CI) diagnosed with a new SARS-CoV-2 infection confirmed by a positive PCR test	0 - 6 months

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Karolinska Institutet
• Investigators: Principal Investigator: Soo Aleman, MD, PhD, Karolinska University Hospital, ME Infectious Diseases

Publications and helpful links

General Publications

• 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.
• 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.
• Chen P, Bergman P, Blennow O, Hansson L, Mielke S, Nowak P, Gao Y, Soderdahl G, Osterborg A, Smith CIE, Vesterbacka J, Wullimann D, Cuapio A, Akber M, Bogdanovic G, Muschiol S, Aberg M, Lore K, Chen MS, Ljungman P, Buggert M, Aleman S, Ljunggren HG. 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. EBioMedicine. 2024 Nov;109:105385. doi: 10.1016/j.ebiom.2024.105385. Epub 2024 Oct 11.
• Chen P, Bergman P, Blennow O, Hansson L, Mielke S, Nowak P, Soderdahl G, Osterborg A, Smith CIE, Vesterbacka J, Wullimann D, Cuapio A, Akber M, Bogdanovic G, Muschiol S, Aberg M, Lore K, Sallberg Chen M, Buggert M, Ljungman P, Aleman S, Ljunggren HG. 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. EBioMedicine. 2023 Aug;94:104700. doi: 10.1016/j.ebiom.2023.104700. Epub 2023 Jul 13.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): May 8, 2024

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; COVID-19 Vaccines; Antigens; Vaccines, Acellular; Vaccines, Subunit; BNT162 Vaccine; mRNA Vaccines
• Other Study ID Numbers: 2021-000175-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• 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