ACTIVE_NOT_RECRUITING

COVID-19 Vaccine Responses in PIDD Subjects

Talk to us

Conditions

X-linked AgammaglobulinemiaXLAPrimary Immune DeficiencyCVIDCommon Variable ImmunodeficiencyPrimary Antibody DeficienciesSecondary HypogammaglobulinemiaSARS CoV 2 InfectionCOVID-19

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of our study is to assess the cellular immune responses of participants with antibody deficiency disease before and after immunization with SARS-CoV-2 mRNA vaccines.

Official Title

Vaccine-induced SARS-CoV-2-specific T Cell Responses in Patients With Primary Immune Deficiency Disease

Quick Facts

Study Start:2021-09-30
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05321407

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of antibody deficiency with confirmatory lab or genetic testing
  2. 2. Stable on immunoglobulin replacement therapy
  3. 3. Age \>6 months and able to provide consent, or assent with parental consent if \<18 years
  4. 4. Willing and able to receive the Pfizer BioNTech BNT162b2 mRNA or the Moderna mRNA-1273 vaccines
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

John Sleasman, MD
PRINCIPAL_INVESTIGATOR
Duke University
Kristina De Paris, PhD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

University of South Florida
Saint Petersburg, Florida, 33701
United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Duke University
Durham, North Carolina, 27708
United States

Collaborators and Investigators

Sponsor: Duke University

  • John Sleasman, MD, PRINCIPAL_INVESTIGATOR, Duke University
  • Kristina De Paris, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-30
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2021-09-30
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • X-linked Agammaglobulinemia
  • Primary Immune Deficiency
  • Common Variable Immunodeficiency
  • SARS CoV 2 Infection
  • Primary Antibody Deficiencies
  • COVID-19
  • Secondary Hypogammaglobulinemia

Additional Relevant MeSH Terms

  • X-linked Agammaglobulinemia
  • XLA
  • Primary Immune Deficiency
  • CVID
  • Common Variable Immunodeficiency
  • Primary Antibody Deficiencies
  • Secondary Hypogammaglobulinemia