Trial Outcomes & Findings for COVID-19 Protection After Transplant Pilot Study (NCT NCT04969263)
NCT ID: NCT04969263
Last Updated: 2025-07-30
Results Overview
The proportion of participants who achieve an antibody response \>50 U/mL after the third dose of vaccine using the Roche Elecsys® anti-RBD assay is considered to show positive response to the intervention, negative response otherwise.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Outcome was measured at 30 days after study intervention (dose 3 vaccination)
Results posted on
2025-07-30
Participant Flow
Participant milestones
| Measure |
All Participants: Anti-RBD Negative or Low at Study Entry
recipients who have failed to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine.
|
|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
All Participants: Anti-RBD Negative or Low at Study Entry
recipients who have failed to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Physician decision due to both medical and non-medical considerations
|
1
|
Baseline Characteristics
COVID-19 Protection After Transplant Pilot Study
Baseline characteristics by cohort
| Measure |
Anti-RBD Negative or Low at Study Entry
n=81 Participants
recipients who have failed to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
44 Participants
n=5 Participants
|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=5 Participants
|
|
Antibody response after 2-dose series of mRNA COVID-19 vaccine
Anti-RBD negative
|
39 Participants
n=5 Participants
|
|
Antibody response after 2-dose series of mRNA COVID-19 vaccine
Anti-RBD low
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Outcome was measured at 30 days after study intervention (dose 3 vaccination)Population: All individuals who receive the intervention and have antibody response measured at 30 days after the intervention will be included in the analysis of the primary outcome. For secondary and exploratory outcomes, all individuals who receive the intervention and have that outcome measured will be included.
The proportion of participants who achieve an antibody response \>50 U/mL after the third dose of vaccine using the Roche Elecsys® anti-RBD assay is considered to show positive response to the intervention, negative response otherwise.
Outcome measures
| Measure |
Anti-RBD Negative or Low at Study Entry
n=81 Participants
The proportion of recipients who have failed to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine.
|
|---|---|
|
Proportion of Recipients Who Achieve an Antibody Response >50 U/mL After the Third Dose of mRNA COVID-19 Vaccine
|
69.1 Percentage of participants with response
Interval 57.9 to 78.9
|
SECONDARY outcome
Timeframe: Through Day 7 Post-Vaccination (Dose 3)Safety measure status post third dose of mRNA vaccine
Outcome measures
| Measure |
Anti-RBD Negative or Low at Study Entry
n=81 Participants
The proportion of recipients who have failed to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine.
|
|---|---|
|
Frequency of/Proportion of Participants With Vaccine Reactogenicity (Local or Systemic) and/or Allergy to the mRNA-Based COVID-19 Vaccine
Overall Events
|
50.6 Proportion of participants as percentage
Interval 39.3 to 61.9
|
|
Frequency of/Proportion of Participants With Vaccine Reactogenicity (Local or Systemic) and/or Allergy to the mRNA-Based COVID-19 Vaccine
Local Reactogenicity
|
45.7 Proportion of participants as percentage
Interval 34.6 to 57.1
|
|
Frequency of/Proportion of Participants With Vaccine Reactogenicity (Local or Systemic) and/or Allergy to the mRNA-Based COVID-19 Vaccine
Systemic Reactogenicity
|
27.2 Proportion of participants as percentage
Interval 17.9 to 38.2
|
|
Frequency of/Proportion of Participants With Vaccine Reactogenicity (Local or Systemic) and/or Allergy to the mRNA-Based COVID-19 Vaccine
Allergic Reaction
|
1.23 Proportion of participants as percentage
Interval 0.03 to 6.69
|
SECONDARY outcome
Timeframe: Through Day 30 Post-Vaccination (Dose 3)Population: The SAE that occurred through Day 30 post-vaccination (dose 3) was a Urinary Tract Infection that was assessed as unrelated to the study vaccine.
Safety measure status post third dose of mRNA vaccine
Outcome measures
| Measure |
Anti-RBD Negative or Low at Study Entry
n=81 Participants
The proportion of recipients who have failed to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine.
|
|---|---|
|
Frequency of/Proportion of Participants With Any Serious Adverse Events (SAEs) Following the Third Dose of an mRNA Vaccine
|
1.23 Proportion of participants as percentage
Interval 0.03 to 6.69
|
SECONDARY outcome
Timeframe: Through Day 60 Post-Vaccination (Dose 3)Safety measure status post third dose of mRNA vaccine
Outcome measures
| Measure |
Anti-RBD Negative or Low at Study Entry
n=81 Participants
The proportion of recipients who have failed to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine.
|
|---|---|
|
Proportion of Participants Treated for Acute Cell-Mediated and/or Antibody-Mediated Allograft Rejection (Clinical or Biopsy Proven)
|
0 Proportion of participants as percentage
Interval 0.0 to 4.5
|
SECONDARY outcome
Timeframe: Through Day 90 Post-Vaccination (Dose 3)Safety measure status post third dose of mRNA vaccine
Outcome measures
| Measure |
Anti-RBD Negative or Low at Study Entry
n=81 Participants
The proportion of recipients who have failed to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine.
|
|---|---|
|
Proportion of Participants Who Develop de Novo Donor-Specific Anti-Human Leukocyte Antigens (HLA) Antibody
|
0 Proportion of participants as percentage
Interval 0.0 to 4.5
|
SECONDARY outcome
Timeframe: Through Day 60 Post-Vaccination (Dose 3)Safety measure status post third dose of mRNA vaccine.
Outcome measures
| Measure |
Anti-RBD Negative or Low at Study Entry
n=81 Participants
The proportion of recipients who have failed to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine.
|
|---|---|
|
Proportion of Participants With Graft Loss
|
0 Proportion of participants as percentage
Interval 0.0 to 4.5
|
SECONDARY outcome
Timeframe: Through Day 60 Post-Vaccination (Dose 3)Safety measure status post third dose of mRNA vaccine.
Outcome measures
| Measure |
Anti-RBD Negative or Low at Study Entry
n=81 Participants
The proportion of recipients who have failed to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine.
|
|---|---|
|
Occurrence of Death Among Participants
|
0 Proportion of participants as percentage
Interval 0.0 to 4.5
|
Adverse Events
Anti-RBD Negative or Low at Study Entry
Serious events: 12 serious events
Other events: 57 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Anti-RBD Negative or Low at Study Entry
n=81 participants at risk
recipients who have failed (negative or low) to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine.
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.2%
1/81 • Number of events 1 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
General disorders
Death
|
1.2%
1/81 • Number of events 1 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
General disorders
Oedema peripheral
|
1.2%
1/81 • Number of events 1 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Infections and infestations
COVID-19
|
2.5%
2/81 • Number of events 2 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Infections and infestations
Pneumonia
|
1.2%
1/81 • Number of events 1 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Infections and infestations
Diverticulitis
|
1.2%
1/81 • Number of events 1 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.2%
1/81 • Number of events 1 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Renal and urinary disorders
Pyelonephritis
|
1.2%
1/81 • Number of events 1 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Renal and urinary disorders
Urinary tract infection
|
2.5%
2/81 • Number of events 2 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Renal and urinary disorders
Urinary retention
|
1.2%
1/81 • Number of events 1 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.2%
1/81 • Number of events 1 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
Other adverse events
| Measure |
Anti-RBD Negative or Low at Study Entry
n=81 participants at risk
recipients who have failed (negative or low) to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine.
|
|---|---|
|
Injury, poisoning and procedural complications
Vaccination complication
|
39.5%
32/81 • Number of events 34 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
General disorders
Fatigue
|
22.2%
18/81 • Number of events 19 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Nervous system disorders
Headache
|
11.1%
9/81 • Number of events 10 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Investigations
Lymphocyte count decreased
|
11.1%
9/81 • Number of events 9 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Investigations
Creatinine urine increased
|
8.6%
7/81 • Number of events 7 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Blood and lymphatic system disorders
Anemia
|
7.4%
6/81 • Number of events 7 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Gastrointestinal disorders
Diarrhea
|
7.4%
6/81 • Number of events 6 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Metabolism and nutrition disorders
Hyperkaliemia
|
7.4%
6/81 • Number of events 6 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.4%
6/81 • Number of events 6 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Investigations
White blood cell count decreased
|
6.2%
5/81 • Number of events 5 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Infections and infestations
Urinary tract infection
|
4.9%
4/81 • Number of events 4 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
4/81 • Number of events 4 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Metabolism and nutrition disorders
Blood Bicarbonate decreased
|
3.7%
3/81 • Number of events 3 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.7%
3/81 • Number of events 3 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Vascular disorders
Dizziness
|
3.7%
3/81 • Number of events 3 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
General disorders
Injection site erythema
|
3.7%
3/81 • Number of events 3 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.7%
3/81 • Number of events 3 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Vascular disorders
Contusion
|
2.5%
2/81 • Number of events 2 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.5%
2/81 • Number of events 2 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
2/81 • Number of events 2 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
General disorders
Pain
|
2.5%
2/81 • Number of events 2 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
|
General disorders
Pyrexia
|
2.5%
2/81 • Number of events 2 • AEs are reported for 30 days post vaccine and SAEs for 6 months post vaccine.
Adverse Events temporally associated (24 hours) with the research blood draws and nasopharyngeal swabs will be collected from the time of the screening visit until a participant completes study participation. Adverse Events as defined in Section 12.2.1 in the protocol will be collected for 30 days following COVID-19 vaccine administration. Serious Adverse Events will be collected for 6 months following vaccine administration. No reported Serious Adverse Events were related to the vaccine.
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place