National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
3 and older, any sex, with Immunodeficiencies or Immune Dysregulations. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in S and Receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody Titer From Baseline Depending on Vaccine Manufacturer and PlatformPrimary· Baseline, post dose 1 (14-21 days), and post dose 2 (21-28 days), 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
Change in anti-S titer from Baseline to Post-dose 1
Group
Value
95% CI
Immune Deficient/Disordered
0.447333
± 1.118685
Healthy Control
2.10678
± 4.048595
Change in anti-S titer from Post-dose 1 to Post-dose 2
Group
Value
95% CI
Immune Deficient/Disordered
0.83819
± 8.953689
Healthy Control
2.8153
± 5.749115
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy VolunteersSecondary· Baseline up to a maximum of 24 months
To characterize the COVID-19 vaccine-associated adverse events among immunodeficient and immune dysregulated individuals compared to healthy volunteers.
Note on terminology: "No vaccine-associated side effects" means participants reported zero symptoms or reactions after vaccination. A "mild vaccine-associated side effect" means a participant reported any symptom/reaction and reported is as "mild" on the scale of "mild", "moderate", or "severe". A participant could have reported several mild symptom/reactions and several moderate or severe symptoms/reactions. Therefore, the number of mild, mo
Vaccine-associated side-effects after dose 1 : No vaccine-associated side effects
Group
Value
95% CI
Immune Deficient/Disordered
31
Healthy Control
6
Vaccine-associated side-effects after dose 1 : Mild vaccine-associated side effects
Group
Value
95% CI
Immune Deficient/Disordered
134
Healthy Control
45
Vaccine-associated side-effects after dose 1 : Moderate vaccine-associated side effects
Group
Value
95% CI
Immune Deficient/Disordered
85
Healthy Control
26
Vaccine-associated side-effects after dose 1 : Severe vaccine-associated side effects
Group
Value
95% CI
Immune Deficient/Disordered
19
Healthy Control
9
Vaccine-associated side-effects after dose 1 : Total Volunteers completing dose survey
Group
Value
95% CI
Immune Deficient/Disordered
187
Healthy Control
57
Vaccine-associated side-effects after dose 2 : No vaccine-associated side effects
Group
Value
95% CI
Immune Deficient/Disordered
28
Healthy Control
8
Vaccine-associated side-effects after dose 2 : Mild vaccine-associated side effects
Group
Value
95% CI
Immune Deficient/Disordered
143
Healthy Control
43
Vaccine-associated side-effects after dose 2 : Moderate vaccine-associated side effects
Group
Value
95% CI
Immune Deficient/Disordered
88
Healthy Control
24
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS)
· Phase 1
· not yet recruiting
NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of
· Phase 1, PHASE2
· not yet recruiting
NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 1 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04852276.