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Protocol Details

Analysis of the Immune Response to COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000384-I

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 12
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women and Fetuses;
Non-English Speaking

Special Instructions

Currently Not Provided

Keywords

Adaptive immunity;
clinical epidemiology;
SARS-CoV-2;
Coronavirus

Recruitment Keyword(s)

None

Condition(s)

Immunodeficiencies;
immune dysregulations

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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 12 and older with an immune deficiency who plan to get a COVID-19 vaccine. Healthy volunteers are also needed.

Design:

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.

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Eligibility

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet the following criteria:

1. Aged 12 years and older.

2. 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.

3. Ability to provide informed consent.

4. Willing to have blood samples stored for future research.

5. 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. Self-reported pregnancy, breast feeding, or intention to initiate a pregnancy before day 28 after study vaccination.

4. Any condition that, in the opinion of the investigator, contraindicates participation in this study (e.g. specific autoinflammatory diseases, interferonopathies).

5. Self-reported history of HIV.


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Citations:

Szczawinska-Poplonyk A, Breborowicz A, Samara H, Ossowska L, Dworacki G. Impaired Antigen-Specific Immune Response to Vaccines in Children with Antibody Production Defects. Clin Vaccine Immunol. 2015 Aug;22(8):875-82. doi: 10.1128/CVI.00148-15. Epub 2015 May 27. PMID: 26018535; PMCID: PMC4519726.

Bonilla FA. Vaccines in Patients with Primary Immune Deficiency. Immunol Allergy Clin North Am. 2020 Aug;40(3):421-435. doi: 10.1016/j.iac.2020.03.004. PMID: 32654690.

Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, McCullough MP, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott A, Flach B, Doria-Rose NA, Corbett KS, Morabito KM, O'Dell S, Schmidt SD, Swanson PA 2nd, Padilla M, Mascola JR, Neuzil KM, Bennett H, Sun W, Peters E, Makowski M, Albert J, Cross K, Buchanan W, Pikaart-Tautges R, Ledgerwood JE, Graham BS, Beigel JH; mRNA-1273 Study Group. An mRNA Vaccine against SARS-CoV-2 - Preliminary Report. N Engl J Med. 2020 Nov 12;383(20):1920-1931. doi: 10.1056/NEJMoa2022483. Epub 2020 Jul 14. PMID: 32663912; PMCID: PMC7377258.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Emily E. Ricotta, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)



Emily E. Ricotta, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
BG 5601FL RM 7D18
5601 FISHERS LN
ROCKVILLE MD 20852
(301) 761-7784
NIAIDCovidVaccineStudy@niaid.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT04852276

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