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 range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this study is specifically looking at T cell responses rather than antibody responses in people with conditions like XLA or CVID who can't make normal amounts of antibodies, can you help me understand whether my immune system is likely to have any meaningful T cell response to the COVID-19 vaccine at all?
2This trial is no longer enrolling new participants — does that mean results might be available soon, and could those findings change your recommendations about how many COVID-19 vaccine doses I should be getting given my primary immune deficiency?
3The study is measuring T cell responses to multiple COVID-19 variants including omicron, alpha, and delta — based on what's known so far in patients like me with antibody deficiencies, should I still be getting updated COVID-19 boosters even if my antibody levels don't rise after vaccination?
4Because this is a Phase NA observational study focused on measuring immune responses rather than testing a new treatment, does participating or having data like this available change anything about how you would currently manage my COVID-19 protection, such as recommending prophylactic medications or other precautions?
5Given that my condition involves secondary hypogammaglobulinemia or a primary antibody deficiency, are there other studies or emerging findings I should know about that look at whether T cell immunity alone provides meaningful real-world protection against severe COVID-19 for patients like me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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