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COVID-19 Vaccination of Immunodeficient Persons (COVAXID)

NCT04780659 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 539

Last updated 2025-12-04

Study results available
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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

Interventions

BIOLOGICAL

Comirnaty (COVID-19, mRNA vaccine)

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

Sponsors & Collaborators

Principal Investigators

  • Soo Aleman, MD, PhD · Karolinska University Hospital, ME Infectious Diseases

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-23
Primary Completion
2021-10-15
Completion
2024-05-08

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04780659 on ClinicalTrials.gov