This study is NOT currently recruiting participants.
Number
000384-I
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 3 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Non-English Speaking
Keywords
Adaptive immunity; clinical epidemiology; SARS-CoV-2; Coronavirus; Natural History
Recruitment Keyword(s)
None
Condition(s)
Immunodeficiencies; immune dysregulations
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Allergy and Infectious Diseases
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.
--Back to Top--
INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet the following criteria: 1. Aged 3 years and older. 2. 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. 3. Must meet the definition of affected participant or control participant: a. 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. b. 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. 4. Ability to provide informed consent. 5. Willing to have blood samples stored for future research. 6. Able to proficiently speak, read, and write English. EXCLUSION CRITERIA: Individuals meeting any of the following criteria will be excluded from study participation: 1. Receipt of any other vaccine within 14 days prior to screening. 2. Planned non-COVID-19 vaccination within 28 days after COVID-19 vaccination(s). 3. Any condition that, in the opinion of the investigator, contraindicates participation in this study (e.g. specific autoinflammatory diseases, interferonopathies). 4. Self-reported history of HIV.
In order to be eligible to participate in this study, an individual must meet the following criteria:
1. Aged 3 years and older.
2. 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.
3. Must meet the definition of affected participant or control participant:
a. 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.
b. 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.
4. Ability to provide informed consent.
5. Willing to have blood samples stored for future research.
6. Able to proficiently speak, read, and write English.
EXCLUSION CRITERIA:
Individuals meeting any of the following criteria will be excluded from study participation:
1. Receipt of any other vaccine within 14 days prior to screening.
2. Planned non-COVID-19 vaccination within 28 days after COVID-19 vaccination(s).
3. Any condition that, in the opinion of the investigator, contraindicates participation in this study (e.g. specific autoinflammatory diseases, interferonopathies).
4. Self-reported history of HIV.
Principal Investigator
Referral Contact
For more information: