N/A
N=308
COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations
Immunodeficiencies · Immune Dysregulations
Bottom Line
View on ClinicalTrials.gov: NCT04852276 ↗Enrolled (actual)
308
Serious AEs
—
Results posted
Oct 2024
Primary outcome: Primary: Change in S and Receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody Titer From Baseline Depending on Vaccine Manufacturer and Platform — 0.447333; 2.10678; 0.83819; 2.8153 ug/ml
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 3+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in S and Receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody Titer From Baseline Depending on Vaccine Manufacturer and Platform |
0.447333; 2.10678; 0.83819; 2.8153 | — |
| SECONDARY Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers |
31; 6; 134; 45; 85; 26 | — |
Summary
Background:
The immune system defends the body against disease and infection. Immune deficiencies are health conditions that decrease the strength of this response. Vaccines stimulate the immune system to create a defense against a specific type of germ. Researchers want to compare immune system responses to COVID-19 vaccines in people with and without immune deficiencies.
Objective:
To learn about how people with immune deficiencies respond to COVID-19 vaccines.
Eligibility:
People age 3 and older with an immune deficiency who plan to get a COVID-19 vaccine. Healthy volunteers are also needed.
Design:
Participants will be pre-screened for eligibility, including COVID-19 vaccination history and immune status.
Participants will give a blood sample before they get their first COVID-19 vaccine. Blood will be drawn from an arm vein using a needle. Blood can be drawn at the NIH, at a local doctor's office, or at a laboratory. It may also be drawn through a fingerstick at home. Participants will also complete 2 online surveys about their health and COVID-19 history. Additional surveys are optional.
Participants will give a second blood sample 2 to 4 weeks after they get the vaccine. They will complete 2 surveys about changes in their health and side effects from the vaccine.
If participants get another COVID-19 vaccine dose, they will repeat the blood draw and surveys 3 to 4 weeks later.
Participants may give 3 optional blood samples in the 24 months after their last vaccine. They may also give saliva samples every 2 weeks while they are in the study for 6 months following their last vaccine.
Participation will last from 1 month to 2 years after the participant's last vaccine.
Eligibility Criteria
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet the following criteria:
- Aged 3 years and older.
- Must be eligible to receive (based on official FDA authorization or approval) and scheduled to receive or have already received a COVID-19 vaccine outside of this facility.
- Must meet the definition of affected participant or control participant:
- Affected participants must have evidence of a primary or secondary immune deficiency or dysregulation under another NIAID protocol or as documented by an outside physician.
- Control participants are healthy volunteers that do not have evidence of a primary or secondary immune deficiency or dysregulation and may include unaffected relatives of affected participants.
- Ability to provide informed consent.
- Willing to have blood samples stored for future research.
- Able to proficiently speak, read, and write English.
EXCLUSION CRITERIA
Individuals meeting any of the following criteria will be excluded from study participation:
- Receipt of any other vaccine within 14 days prior to screening.
- Planned non-COVID-19 vaccination within 28 days after COVID-19 vaccination(s).
- Any condition that, in the opinion of the investigator, contraindicates participation in this study (e.g. specific autoinflammatory diseases, interferonopathies).
- Self-reported history of HIV.
Data sourced from ClinicalTrials.gov (NCT04852276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.