COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations

NCT04852276 | Completed Results

• 2 other identifiers: 10000384000384-I
• Study Type: observational
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immunodeficiencies; Immune Dysregulations

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in S and Receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody Titer From Baseline Depending on Vaccine Manufacturer and Platform

  To characterize the immune response to coronavirus disease 2019 (COVID-19) vaccination among immunodeficient and immune dysregulated individuals compared to healthy volunteers

  Baseline, post dose 1 (14-21 days), and post dose 2 (21-28 days), depending on vaccine manufacturer and platform

Secondary Outcomes (1)

• Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers

  Baseline up to a maximum of 24 months

Study Arms (2)

Control participants

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

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Immunodeficient individuals will be recruited from NIAID protocols that evaluate primary or secondary immune deficiencies. Potential subjects will be identified by discussion between the study teams and review of medical and research records if necessary. They may also be referred from community practitioners who see this population.Healthy adult volunteers will be recruited through the NIH Clinical Research Volunteer Program, the Office of Patient Recruitment, MMG Patient Recruitment, ResearchMatch, or BuildClinical. Volunteers will also be recruited from existing NIH protocols. Healthy relatives of immunodeficient participants can be recruited for participation as controls if they meet enrollment criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples with DNA

MeSH Terms

Conditions

Immunologic Deficiency Syndromes; Coronavirus Infections

Condition Hierarchy (Ancestors)

Immune System Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Limitations and Caveats

This was a longitudinal observational study; participants could enroll at any point in their vaccine history. While 1 month post-vaccination samples were mandatory, subsequent samples were optional. Vaccination date and information was self-reported and sometimes resulted in delayed sample collection. Medical history, treatment status, and vaccine-associated side effects were self-reported.

Results Point of Contact

• Title: Emily Ricotta, PhD
• Organization: National Institute of Allergy and Infectious Diseases (NIAID)

emily.ricotta@nih.gov

240-550-3474

Study Officials

• Emily E Ricotta, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 21, 2021
• Study Start: April 20, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2023-10-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)