Analysis of the Immune Response to COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations
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|ClinicalTrials.gov Identifier: NCT04852276|
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : July 7, 2022
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.
To learn about how people with immune deficiencies respond to COVID-19 vaccines.
People age 12 and older with an immune deficiency who plan to get a COVID-19 vaccine. Healthy volunteers are also needed.
Participants will be screened with a medical record review.
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.
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 a second (booster) vaccine, 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.
Participation will last from 1 month to 2 years after the participant s last vaccine.
|Condition or disease|
|Immunodeficiencies Immune Dysregulations|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Analysis of the Immune Response to COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations|
|Actual Study Start Date :||April 20, 2021|
|Estimated Primary Completion Date :||June 30, 2025|
|Estimated Study Completion Date :||June 30, 2025|
Control participants will be healthy volunteers, and may include unaffected relatives of immunodeficient/dysregulated participants
Patients with immunodeficiencies and immune dysregulations
Affected patients with evidence of a primary or secondary immune deficiency or dysregulation
- Change in S and RBD immunoglobulin G (IgG) antibody titer from baseline depending on vaccine manufacturer and platform [ Time Frame: 14-21 days or 21-28 days, depending on vaccine manufacturer and platform ]To characterize the immune response to COVID-19 vaccination among immunodeficient and immune dysregulated individuals compared to healthy volunteers
- Incidence of vaccine-associated AEadverse events experienced by immunodeficient individuals compared to healthy volunteers [ Time Frame: Throughout study ]To characterize the COVID-19 vaccine-associated adverse events among immunodeficient and immune dysregulated individuals compared to healthy volunteers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04852276
|Contact: Emily E Ricotta, Ph.D.||(301) 761-7784||NIAIDCovidVaccineStudy@niaid.nih.gov|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Emily E Ricotta, Ph.D.||National Institute of Allergy and Infectious Diseases (NIAID)|