COVID-19 Vaccination of Immunodeficient Persons (COVAXID)

NCT ID: NCT04780659

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 539 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2024-05-08

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.

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.

Conditions

Covid19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vaccination with Comirnaty according to standard of care treatment

All study participants will receive Comirnaty according to current approval.

Group Type: EXPERIMENTAL

Comirnaty (COVID-19, mRNA vaccine)

Intervention Type: BIOLOGICAL

Comirnaty will be administered two times, one at Day 0 and the second dose at Day 21.

Interventions

Comirnaty (COVID-19, mRNA vaccine)

Comirnaty will be administered two times, one at Day 0 and the second dose at Day 21.

Intervention Type: BIOLOGICAL

Other Intervention Names

tozinameran; Pfizer mRNA vaccine

Eligibility 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).

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soo Aleman

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soo Aleman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital, ME Infectious Diseases

Locations

Karolinska University Hospital

Stockholm, Huddinge, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 39395230 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37453361 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35135470 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35075450 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021-000175-37

Identifier Type: -

Identifier Source: org_study_id