COVID-19 Vaccination of Immunodeficient Persons (COVAXID)

NCT04780659 | Completed Phase 4 Results

• 1 other identifier: 2021-000175-37
• Study Type: interventional
• Target: 539
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assessment of Any Adverse Events (AE) of the Given Vaccine.

  Duration of 0-14 days after the first vaccine dose.

• Assessment of Any Adverse Events (AE) of the Given Vaccine.

  Duration of 0-14 days after the second vaccine dose.

• Frequency Who Experience Local and Systemic Reactions

  After the first vaccin dose

• Frequency Who Experience Local and Systemic Reactions

  After the second vaccin dose

• Frequency of SARS-CoV-2 Infection Documented by PCR Test.

  0 - 6 months

Study Arms (1)

Vaccination with Comirnaty according to standard of care treatment

EXPERIMENTAL

All study participants will receive Comirnaty according to current approval.

Biological: Comirnaty (COVID-19, mRNA vaccine)

Interventions

Comirnaty (COVID-19, mRNA vaccine) BIOLOGICAL

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

Also known as: tozinameran, Pfizer mRNA vaccine

Vaccination with Comirnaty according to standard of care treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Individuals ≥18 years old
• a. 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
• b. 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

You may not qualify if:

• Previous or ongoing Coronavirus Disease-19 (COVID-19).
• 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.

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Huddinge, 14186, Sweden

Location

Related Publications (4)

• 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.

  PMID: 39395230 DERIVED

• 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.

  PMID: 37453361 DERIVED

• 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.

  PMID: 35135470 DERIVED

• 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.

  PMID: 35075450 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine; mRNA Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors; Vaccines, Acellular; Vaccines, Subunit

Results Point of Contact

• Title: Soo Aleman Sponsor representative
• Organization: Karolinska University Hospital

soo.aleman@regionstockholm.se

+46 72595 7225

Study Officials

• Soo Aleman, MD, PhD

  Karolinska University Hospital, ME Infectious Diseases

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 3, 2021
• Study Start: February 23, 2021
• Primary Completion: October 15, 2021
• Study Completion: May 8, 2024
• Last Updated: December 4, 2025
• Results First Posted: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Within one year after study end.
• Access Criteria: Published in EudraCT and national COVID-19 data portal (SciLifeLab Data Centre)

Locations

SE (1)