Trial Outcomes & Findings for COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations (NCT NCT04852276)
NCT ID: NCT04852276
Last Updated: 2024-10-01
Results Overview
To characterize the immune response to coronavirus disease 2019 (COVID-19) vaccination among immunodeficient and immune dysregulated individuals compared to healthy volunteers
Recruitment status
COMPLETED
Target enrollment
308 participants
Primary outcome timeframe
Baseline, post dose 1 (14-21 days), and post dose 2 (21-28 days), depending on vaccine manufacturer and platform
Results posted on
2024-10-01
Participant Flow
April 2021 through December 2022. Immune deficient individuals were recruited from NIAID protocols evaluating immune deficiencies, referred from physicians, or self-referred. Healthy adult volunteers were recruited through various avenues. Healthy relatives of immunodeficient participants were recruited for participation as controls if they met enrollment criteria.
Participant milestones
| Measure |
Immune Deficient/Disordered
Immune Deficient/Disordered participants must have evidence of a primary or secondary immune deficiency or dysregulation under another NIAID protocol or as documented by an outside physician.
|
Healthy Control
Healthy volunteers do not have evidence of a primary or secondary immune deficiency or dysregulation and may include unaffected relatives of affected participants.
|
|---|---|---|
|
Overall Study
STARTED
|
235
|
73
|
|
Overall Study
COMPLETED
|
192
|
58
|
|
Overall Study
NOT COMPLETED
|
43
|
15
|
Reasons for withdrawal
| Measure |
Immune Deficient/Disordered
Immune Deficient/Disordered participants must have evidence of a primary or secondary immune deficiency or dysregulation under another NIAID protocol or as documented by an outside physician.
|
Healthy Control
Healthy volunteers do not have evidence of a primary or secondary immune deficiency or dysregulation and may include unaffected relatives of affected participants.
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
15
|
9
|
|
Overall Study
Withdrawal by Subject
|
26
|
6
|
Baseline Characteristics
COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations
Baseline characteristics by cohort
| Measure |
Immune Deficient/Disordered
n=235 Participants
Immune Deficient/Disordered participants must have evidence of a primary or secondary immune deficiency or dysregulation under another NIAID protocol or as documented by an outside physician.
|
Healthy Control
n=73 Participants
Healthy volunteers do not have evidence of a primary or secondary immune deficiency or dysregulation and may include unaffected relatives of affected participants.
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
31 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
172 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 19 • n=5 Participants
|
42 years
STANDARD_DEVIATION 19 • n=7 Participants
|
43 years
STANDARD_DEVIATION 19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
212 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
204 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
233 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Antibody deficiency
|
54 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Primary immune regulatory disorder
|
56 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Combined immunodeficiency
|
13 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Other inborn error of immunity
|
42 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Other immune disorder
|
70 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Healthy volunteer
|
0 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, post dose 1 (14-21 days), and post dose 2 (21-28 days), depending on vaccine manufacturer and platformPopulation: Analysis for these endpoints consisted only of participants who were enrolled and had provided samples at baseline and post-dose 1 or post-dose 1 and post-dose 2.
To characterize the immune response to coronavirus disease 2019 (COVID-19) vaccination among immunodeficient and immune dysregulated individuals compared to healthy volunteers
Outcome measures
| Measure |
Immune Deficient/Disordered
n=95 Participants
Immune Deficient/Disordered participants must have evidence of a primary or secondary immune deficiency or dysregulation under another NIAID protocol or as documented by an outside physician.
|
Healthy Control
n=27 Participants
Healthy volunteers do not have evidence of a primary or secondary immune deficiency or dysregulation and may include unaffected relatives of affected participants.
|
|---|---|---|
|
Change in S and Receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody Titer From Baseline Depending on Vaccine Manufacturer and Platform
Change in anti-S titer from Post-dose 1 to Post-dose 2
|
0.83819 ug/ml
Standard Deviation 8.953689
|
2.8153 ug/ml
Standard Deviation 5.749115
|
|
Change in S and Receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody Titer From Baseline Depending on Vaccine Manufacturer and Platform
Change in anti-S titer from Baseline to Post-dose 1
|
0.447333 ug/ml
Standard Deviation 1.118685
|
2.10678 ug/ml
Standard Deviation 4.048595
|
SECONDARY outcome
Timeframe: Baseline up to a maximum of 24 monthsPopulation: Analysis consisted of participants who returned each relevant survey on vaccine-associated events.
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, moderate, and severe vaccine-associated side effects will not sum to the total number of surveys completed.
Outcome measures
| Measure |
Immune Deficient/Disordered
n=212 Participants
Immune Deficient/Disordered participants must have evidence of a primary or secondary immune deficiency or dysregulation under another NIAID protocol or as documented by an outside physician.
|
Healthy Control
n=60 Participants
Healthy volunteers do not have evidence of a primary or secondary immune deficiency or dysregulation and may include unaffected relatives of affected participants.
|
|---|---|---|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 1 : No vaccine-associated side effects
|
31 participants
|
6 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 1 : Mild vaccine-associated side effects
|
134 participants
|
45 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 1 : Moderate vaccine-associated side effects
|
85 participants
|
26 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 1 : Severe vaccine-associated side effects
|
19 participants
|
9 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 1 : Total Volunteers completing dose survey
|
187 participants
|
57 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 2 : No vaccine-associated side effects
|
28 participants
|
8 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 2 : Mild vaccine-associated side effects
|
143 participants
|
43 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 2 : Moderate vaccine-associated side effects
|
88 participants
|
24 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 2 : Severe vaccine-associated side effects
|
16 participants
|
6 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 2 : Total Volunteers completing dose survey
|
189 participants
|
53 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 3 : No vaccine-associated side effects
|
16 participants
|
7 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 3 : Mild vaccine-associated side effects
|
120 participants
|
22 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 3 : Moderate vaccine-associated side effects
|
55 participants
|
9 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 3 : Severe vaccine-associated side effects
|
19 participants
|
1 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 3 : Total Volunteers completing dose survey
|
148 participants
|
29 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 4 : No vaccine-associated side effects
|
7 participants
|
0 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 4 : Mild vaccine-associated side effects
|
44 participants
|
6 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 4 : Moderate vaccine-associated side effects
|
18 participants
|
1 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 4 : Severe vaccine-associated side effects
|
3 participants
|
0 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 4 : Total Volunteers completing dose survey
|
60 participants
|
6 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 5 : Mild vaccine-associated side effects
|
4 participants
|
0 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 5 : Moderate vaccine-associated side effects
|
1 participants
|
0 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 5 : Severe vaccine-associated side effects
|
1 participants
|
0 participants
|
|
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Vaccine-associated side-effects after dose 5 : Total Volunteers completing dose survey
|
4 participants
|
0 participants
|
Adverse Events
Immune Deficient/Disordered
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Healthy Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Emily Ricotta, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 240-550-3474
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place