Analysis of the Immune Response to COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04852276|
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : May 17, 2021
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 16 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|
The novel human severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) causes coronavirus disease (COVID-19). This acute respiratory syndrome is associated with activation of the innate immune system and a hyper-inflammatory response which can lead to life-threatening symptoms. There are a number of primary immunodeficiencies (PIDs) that prevent complete activation of innate immune cells or other pro-inflammatory mediators, as well as secondary immune deficiencies that evoke the same dysfunctional immune response. Because the extent to which these individuals experience COVID-19 is unknown, vaccination against SARS-CoV-2 is critical.
In December 2020, the FDA announced Emergency Use Authorization for two mRNA-based SARS-CoV-2 vaccines. While evaluation of the immune response to these vaccines in healthy volunteers is ongoing, no large-scale characterization of the immune response in immunodeficient individuals has been undertaken. This prospective cohort study will assess and describe the baseline and post-vaccination immune response in individuals with select immune deficiencies compared to healthy volunteers who receive a COVID-19 vaccine, as well as any adverse events (AEs) experienced after either dose. All required study visits for this protocol may be conducted remotely; in-person visits at the NIH are optional. Subjects who have not yet been vaccinated will undergo baseline blood sampling using finger stick microsampler kits and/or venous blood draw within 7 days prior to receiving the vaccine. Additional samples will be collected approximately 21 days after dose 1 and approximately 28 days after dose 2 (if applicable). Optional samples may be collected at 6, 12, and 24 months post-vaccination. If a subsequent booster dose is received while a participant is still on study, blood will again be drawn approximately 28 days after the booster dose. Participants who are able to attend in-person visits at NIH will have optional on-site blood draws 1 and 3 days after doses 1 and 2 (as applicable). Research evaluations will include baseline severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) antibody titers to the spike (S), nucleocapsid (N), and receptor binding domain (RBD) proteins, to assess pre-vaccination SARS-CoV-2 exposure and evaluate responses to vaccination. Additional immune markers of interest may include presence of autoantibodies, transcriptomic profiling, T-cell receptor (TCR) repertoire, among others. Participants who only submit finger stick home microsampler kits at the timepoints listed above will be evaluated for SARS-CoV-2 antibody titers and autoantibodies only. All subjects will be asked at baseline about prior COVID-19 diagnosis, symptoms, and severity, and will be asked additional questions at follow-up timepoints about vaccine AEs using standardized questionnaires.
The goal of this protocol is to gain a comprehensive understanding of the variety of immune responses in immunodeficient individuals.
|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 email@example.com|
|Principal Investigator:||Emily E Ricotta, Ph.D.||National Institute of Allergy and Infectious Diseases (NIAID)|