Trial Outcomes & Findings for SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine (NCT NCT04952402)
NCT ID: NCT04952402
Last Updated: 2023-05-24
Results Overview
NAb level was measured by using both 50% neutralizing dilution titers (ND50) and 80% neutralizing titers (ND80). A higher NAb level corresponds to a stronger immune response. For ND50 values less than lower limit of quantification (LLQ), we impute with 10 (which is ½ LLQ of 20). For ND50 values exceeding the upper limit of quantification (ULQ), we impute with 20,000 (a value suggested by the immunology lab, which is 2 times the ULQ of 10,000). For ND80, we impute similarly with 10 and 20,000. We carry forward the Day 56 NAb measurement if the Day 140 measurement is not reported.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
43 participants
Primary outcome timeframe
Measured 140 days after the first dose of the vaccine
Results posted on
2023-05-24
Participant Flow
Participants were enrolled from July 9, 2021 to December 16, 2021 at six clinical research sites in the U.S.
For participant flow, ACTIV-2/A5401 participants regardless of the exposure (select active therapy or Camostat or placebo) are considered as one cohort, and COVID-naïve participants are considered as the second cohort.
Participant milestones
| Measure |
Cohort: ACTIV-2/A5401
Participants of the ACTIV-2/A5401 randomized trial who received a select investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV, BMS 096414+BMS 986413 subcutaneous, Camostat Oral) or its corresponding comparator (Placebo).
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
Cohort: COVID-19 Naïve
Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants).
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
25
|
|
Overall Study
Completed Two-dose Vaccine Series
|
18
|
25
|
|
Overall Study
COMPLETED
|
17
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Cohort: ACTIV-2/A5401
Participants of the ACTIV-2/A5401 randomized trial who received a select investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV, BMS 096414+BMS 986413 subcutaneous, Camostat Oral) or its corresponding comparator (Placebo).
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
Cohort: COVID-19 Naïve
Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants).
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Lack Of Venous Access
|
0
|
1
|
Baseline Characteristics
8 participants in the ACTV-2/A5401 cohort did not have BMI information collected.
Baseline characteristics by cohort
| Measure |
Cohort: ACTIV-2/A5401
n=18 Participants
Participants of the ACTIV-2/A5401 randomized trial who received a select investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV, BMS 096414+BMS 986413 subcutaneous, Camostat Oral) or its corresponding comparator (Placebo).
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
Cohort: COVID-19 Naïve
n=25 Participants
Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants).
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
n=18 Participants
|
32 years
n=25 Participants
|
32 years
n=43 Participants
|
|
Sex/Gender, Customized
Female
|
9 Participants
n=18 Participants
|
16 Participants
n=25 Participants
|
25 Participants
n=43 Participants
|
|
Sex/Gender, Customized
Gender Queer
|
0 Participants
n=18 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=43 Participants
|
|
Sex/Gender, Customized
Male
|
9 Participants
n=18 Participants
|
8 Participants
n=25 Participants
|
17 Participants
n=43 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=18 Participants
|
17 Participants
n=25 Participants
|
26 Participants
n=43 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=18 Participants
|
8 Participants
n=25 Participants
|
17 Participants
n=43 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=18 Participants
|
6 Participants
n=25 Participants
|
12 Participants
n=43 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=18 Participants
|
19 Participants
n=25 Participants
|
31 Participants
n=43 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=43 Participants
|
|
Race/Ethnicity, Customized
Race · Black Or African American
|
1 Participants
n=18 Participants
|
18 Participants
n=25 Participants
|
19 Participants
n=43 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
17 Participants
n=18 Participants
|
7 Participants
n=25 Participants
|
24 Participants
n=43 Participants
|
|
Body Mass Index
|
40 kg/m^2
n=10 Participants • 8 participants in the ACTV-2/A5401 cohort did not have BMI information collected.
|
24 kg/m^2
n=25 Participants • 8 participants in the ACTV-2/A5401 cohort did not have BMI information collected.
|
27 kg/m^2
n=35 Participants • 8 participants in the ACTV-2/A5401 cohort did not have BMI information collected.
|
PRIMARY outcome
Timeframe: Measured 140 days after the first dose of the vaccinePopulation: The analysis population includes all participants who received at least the first dose of an mRNA-based COVID-19 vaccine and who provided a specimen sample at either Day 56 or Day 140 (One COVID-19 naïve participant who was not able to provide specimen at any study visits was excluded).
NAb level was measured by using both 50% neutralizing dilution titers (ND50) and 80% neutralizing titers (ND80). A higher NAb level corresponds to a stronger immune response. For ND50 values less than lower limit of quantification (LLQ), we impute with 10 (which is ½ LLQ of 20). For ND50 values exceeding the upper limit of quantification (ULQ), we impute with 20,000 (a value suggested by the immunology lab, which is 2 times the ULQ of 10,000). For ND80, we impute similarly with 10 and 20,000. We carry forward the Day 56 NAb measurement if the Day 140 measurement is not reported.
Outcome measures
| Measure |
ACTIV-2/A5401 Investigational Therapy Except Camostat
n=8 Participants
Participants of ACTIV-2/A5401 who received an investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV or BMS 096414+BMS 986413 subcutaneous).
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
ACTIV-2/A5401 Placebo or Camostat
n=10 Participants
Participants of ACTIV-2/A5401 who received placebo or Camostat.
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
COVID-19 Naïve
n=24 Participants
Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants)
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
|
|---|---|---|---|
|
Neutralizing Antibody (NAb) Level
50% neutralizing dilution titers (ND50)
|
2242.47 titer
Interval 688.55 to 7303.29
|
2695.21 titer
Interval 1005.71 to 7222.88
|
2196.74 titer
Interval 970.88 to 4970.42
|
|
Neutralizing Antibody (NAb) Level
80% neutralizing dilution titers (ND80)
|
888.80 titer
Interval 222.6 to 3548.78
|
972.43 titer
Interval 358.67 to 2636.46
|
794.90 titer
Interval 364.34 to 1734.27
|
SECONDARY outcome
Timeframe: Measured before the first dose of the vaccine, and 56 days after the first dose of the vaccinePopulation: The analysis population includes all participants who received at least the first dose of an mRNA-based COVID-19 vaccine and who provided a specimen sample at both Day 0 and Day 56.
Relative change is defined as the ratio of post-vaccine NAb level/pre-vaccine NAb level. A ratio greater than one indicates an increase of NAb response. For ND50 values less than lower limit of quantification (LLQ), we impute with 10 (which is ½ LLQ of 20). For ND50 values exceeding the upper limit of quantification (ULQ), we impute with 20,000 (a value suggested by the immunology lab, which is 2 times the ULQ of 10,000). For ND80, we impute similarly with 10 and 20,000.
Outcome measures
| Measure |
ACTIV-2/A5401 Investigational Therapy Except Camostat
n=3 Participants
Participants of ACTIV-2/A5401 who received an investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV or BMS 096414+BMS 986413 subcutaneous).
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
ACTIV-2/A5401 Placebo or Camostat
n=2 Participants
Participants of ACTIV-2/A5401 who received placebo or Camostat.
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
COVID-19 Naïve
n=21 Participants
Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants)
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
|
|---|---|---|---|
|
Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine
50% neutralizing dilution titers (ND50)
|
6.85 ratio
Interval 0.05 to 982.6
|
21.63 ratio
Interval 0.0 to 1842965.87
|
50.80 ratio
Interval 16.66 to 154.86
|
|
Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine
80% neutralizing dilution titers (ND80)
|
8.31 ratio
Interval 0.01 to 5138.2
|
40.86 ratio
Interval 0.18 to 9051.19
|
33.05 ratio
Interval 12.19 to 89.59
|
SECONDARY outcome
Timeframe: From first dose of the vaccine through 140 days after the first dose of the vaccinePopulation: The analysis population includes all participants who received at least the first dose of an mRNA-based COVID-19 vaccine.
An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. A serious adverse event (SAE) is defined as any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1).
Outcome measures
| Measure |
ACTIV-2/A5401 Investigational Therapy Except Camostat
n=8 Participants
Participants of ACTIV-2/A5401 who received an investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV or BMS 096414+BMS 986413 subcutaneous).
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
ACTIV-2/A5401 Placebo or Camostat
n=10 Participants
Participants of ACTIV-2/A5401 who received placebo or Camostat.
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
COVID-19 Naïve
n=25 Participants
Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants)
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
|
|---|---|---|---|
|
Proportion of Participants With New Grade 3 or Higher AE, or SAE, or AE Leading to Change or Discontinuation in Vaccine Receipt
|
0.13 proportion of participants
Interval 0.0 to 0.53
|
0.00 proportion of participants
Interval 0.0 to 0.31
|
0.00 proportion of participants
Interval 0.0 to 0.14
|
SECONDARY outcome
Timeframe: From first dose of the vaccine through 56 days after the first dose of the vaccinePopulation: The analysis population includes all participants who received at least the first dose of an mRNA-based COVID-19 vaccine.
Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1).
Outcome measures
| Measure |
ACTIV-2/A5401 Investigational Therapy Except Camostat
n=8 Participants
Participants of ACTIV-2/A5401 who received an investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV or BMS 096414+BMS 986413 subcutaneous).
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
ACTIV-2/A5401 Placebo or Camostat
n=10 Participants
Participants of ACTIV-2/A5401 who received placebo or Camostat.
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
COVID-19 Naïve
n=25 Participants
Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants)
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
|
|---|---|---|---|
|
Number of Participants With Grade 1 or Higher Allergic Reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of the vaccine through 56 days after the first dose of the vaccinePopulation: The analysis population includes all participants who received at least the first dose of an mRNA-based COVID-19 vaccine.
Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1).
Outcome measures
| Measure |
ACTIV-2/A5401 Investigational Therapy Except Camostat
n=8 Participants
Participants of ACTIV-2/A5401 who received an investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV or BMS 096414+BMS 986413 subcutaneous).
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
ACTIV-2/A5401 Placebo or Camostat
n=10 Participants
Participants of ACTIV-2/A5401 who received placebo or Camostat.
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
COVID-19 Naïve
n=25 Participants
Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants)
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
|
|---|---|---|---|
|
Proportion of Participants With Grade 2 or Higher Injection Site Reaction
|
0.00 proportion of participants
Interval 0.0 to 0.37
|
0.10 proportion of participants
Interval 0.0 to 0.45
|
0.00 proportion of participants
Interval 0.0 to 0.16
|
SECONDARY outcome
Timeframe: Measured before the first dose of the vaccine, and 56 days after the first dose of the vaccinePopulation: The analysis population includes all participants who received at least the first dose of an mRNA-based COVID-19 vaccine and who provided a specimen sample at both Day 0 and Day 56. None of the participants who received Pfizer-BioNTech BNT162b2 COVID-19 vaccine provided a specimen sample at both Day 0 and Day 56.
Relative change is defined as the ratio of post-vaccine NAb level/pre-vaccine NAb level by received vaccine, i.e., Moderna mRNA-1273 versus Pfizer-BioNTech BNT162b2. A ratio greater than one indicates an increase of NAb response for those on Moderna mRNA-1273 versus Pfizer-BioNTech BNT162b2. For ND50 values less than lower limit of quantification (LLQ), we impute with 10 (which is ½ LLQ of 20). For ND50 values exceeding the upper limit of quantification (ULQ), we impute with 20,000 (a value suggested by the immunology lab, which is 2 times the ULQ of 10,000). For ND80, we impute similarly with 10 and 20,000.
Outcome measures
| Measure |
ACTIV-2/A5401 Investigational Therapy Except Camostat
n=26 Participants
Participants of ACTIV-2/A5401 who received an investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV or BMS 096414+BMS 986413 subcutaneous).
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
ACTIV-2/A5401 Placebo or Camostat
Participants of ACTIV-2/A5401 who received placebo or Camostat.
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
COVID-19 Naïve
Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants)
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
|
|---|---|---|---|
|
Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine by Received Vaccine
50% neutralizing dilution titers (ND50)
|
37.75 ratio
Interval 14.48 to 98.43
|
—
|
—
|
|
Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine by Received Vaccine
80% neutralizing dilution titers (ND80)
|
28.65 ratio
Interval 12.05 to 68.13
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the visit 56 days after the first dose of the vaccineTeam re-prioritized the analysis of secondary objectives due to limited accrual and moved this outcome to exploratory.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the visit 56 days after the first dose of the vaccineTeam re-prioritized the analysis of secondary objectives due to limited accrual and moved this outcome to exploratory.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the visit 56 days after the first dose of the vaccineTeam re-prioritized the analysis of secondary objectives due to limited accrual and moved this outcome to exploratory.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At study entry/Day 0 and 56 days after the first vaccine dose.Team re-prioritized the analysis of secondary objectives due to limited accrual and moved this outcome to exploratory.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the visit 56 days after the first dose of the vaccineTeam re-prioritized the analysis of secondary objectives due to limited accrual and moved this outcome to exploratory.
Outcome measures
Outcome data not reported
Adverse Events
ACTIV-2/A5401 Investigational Therapy Except Camostat
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ACTIV-2/A5401 Placebo or Camostat
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
COVID-19 Naïve
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACTIV-2/A5401 Investigational Therapy Except Camostat
n=8 participants at risk
Participants of ACTIV-2/A5401 who received an investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV or BMS 096414+BMS 986413 subcutaneous).
Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
ACTIV-2/A5401 Placebo or Camostat
n=10 participants at risk
Participants of ACTIV-2/A5401 who received placebo or Camostat. Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series.
|
COVID-19 Naïve
n=25 participants at risk
Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants) Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
|
|---|---|---|---|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
General disorders
Fatigue
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
General disorders
Inflammation
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
General disorders
Injection site pain
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
General disorders
Peripheral swelling
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Infections and infestations
COVID-19
|
12.5%
1/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
20.0%
2/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
8.0%
2/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Infections and infestations
Epididymitis
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
1/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
4.0%
1/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
4.0%
1/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
8.0%
2/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
4.0%
1/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Psychiatric disorders
Anxiety disorder
|
12.5%
1/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis perennial
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
10.0%
1/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
0.00%
0/10 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
4.0%
1/25 • From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company
Phone: (301) 628-3348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place