Active — Not RecruitingNot Applicable

COVID-19 Vaccine Responses in PIDD Subjects

United States100 participantsStarted 2021-09-30

Plain-language summary

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.

Who can participate

Age range6 Months

SexALL

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Inclusion criteria

✓. Diagnosis of antibody deficiency with confirmatory lab or genetic testing
✓. Stable on immunoglobulin replacement therapy
✓. Age \>6 months and able to provide consent, or assent with parental consent if \<18 years
✓. Willing and able to receive the Pfizer BioNTech BNT162b2 mRNA or the Moderna mRNA-1273 vaccines

What they're measuring

Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 wild-type peptides (measured as a percentage of total T cells).

Timeframe: 2 years

Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 alpha variant peptides (measured as a percentage of total T cells).

Timeframe: 2 years

Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 beta variant peptides (measured as a percentage of total T cells).

Timeframe: 2 years

Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 delta variant peptides (measured as a percentage of total T cells).

Timeframe: 2 years

Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 omicron variant peptides (measured as a percentage of total T cells).

Timeframe: 2 years

Trial details

NCT IDNCT05321407

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More X-linked Agammaglobulinemia trials