Trial Outcomes & Findings for Evaluating HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus (NCT NCT03618056)
NCT ID: NCT03618056
Last Updated: 2022-02-07
Results Overview
Assessed by TZM-bl assay
COMPLETED
PHASE1
1 participants
Measured through Month 6.5
2022-02-07
Participant Flow
Participant milestones
| Measure |
AIDSVAX® B/E
Participants will receive 600 mcg/mL of AIDSVAX® B/E at Months 0, 1, and 6.
AIDSVAX® B/E: Administered by intramuscular injection
|
|---|---|
|
Overall Study
STARTED
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1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
AIDSVAX® B/E
n=1 Participants
Participants will receive 600 mcg/mL of AIDSVAX® B/E at Months 0, 1, and 6.
AIDSVAX® B/E: Administered by intramuscular injection
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 6.5Population: Data have not been collected for this Outcome and cannot be reported. This is due to the enrollment of only one participant in this study and the subsequent lack of ability to draw conclusions that would answer the study objectives from data from one participant.
Assessed by TZM-bl assay
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Measured through Month 6.5Population: Data have not been collected for this Outcome and cannot be reported. This is due to the enrollment of only one participant in this study and the subsequent lack of ability to draw conclusions that would answer the study objectives from data from one participant.
Assessed by TZM-bl assay
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Measured through Month 6.5Population: Data have not been collected for this Outcome and cannot be reported. This is due to the enrollment of only one participant in this study and the subsequent lack of ability to draw conclusions that would answer the study objectives from data from one participant.
Assessed by TZM-bl assay
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Measured for seven days through participant's last vaccination at Month 0,1,and 6Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July, 2017. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
AIDSVAX® B/E
n=1 Participants
Participants will receive 600 mcg/mL of AIDSVAX® B/E at Months 0, 1, and 6.
AIDSVAX® B/E: Administered by intramuscular injection
|
|---|---|
|
Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity
Erythema · Severe
|
0 Participants
|
|
Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity
Erythema · Life-threatening
|
0 Participants
|
|
Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity
Induration · Moderate
|
0 Participants
|
|
Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity
Induration · Severe
|
0 Participants
|
|
Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity
Erythema · None
|
0 Participants
|
|
Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity
Erythema · Mild
|
1 Participants
|
|
Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity
Erythema · Moderate
|
0 Participants
|
|
Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity
Induration · None
|
0 Participants
|
|
Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity
Induration · Mild
|
1 Participants
|
|
Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity
Induration · Life-threatening
|
0 Participants
|
|
Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity
Pain/Tenderness · None
|
0 Participants
|
|
Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity
Pain/Tenderness · Mild
|
1 Participants
|
|
Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity
Pain/Tenderness · Moderate
|
0 Participants
|
|
Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity
Pain/Tenderness · Severe
|
0 Participants
|
|
Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity
Pain/Tenderness · Life-threatening
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured for seven days through participant's last vaccination at Month 0,1,and 6Graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July, 2017. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
AIDSVAX® B/E
n=1 Participants
Participants will receive 600 mcg/mL of AIDSVAX® B/E at Months 0, 1, and 6.
AIDSVAX® B/E: Administered by intramuscular injection
|
|---|---|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Fever · Mild
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Fever · Moderate
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Fever · Life-threatening
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Malaise/Fatigue · Severe
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Malaise/Fatigue · Life-threatening
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Myalgia · None
|
1 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Myalgia · Severe
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Myalgia · Life-threatening
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Fever · None
|
1 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Fever · Severe
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Malaise/Fatigue · None
|
1 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Malaise/Fatigue · Mild
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Malaise/Fatigue · Moderate
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Myalgia · Mild
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Myalgia · Moderate
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Headache · None
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Headache · Mild
|
1 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Headache · Moderate
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Headache · Severe
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Headache · Life-threatening
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Nausea · None
|
1 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Nausea · Mild
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Nausea · Moderate
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Nausea · Severe
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Nausea · Life-threatening
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Chills · None
|
1 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Chills · Mild
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Chills · Moderate
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Chills · Severe
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Chills · Life-threatening
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Arthralgia · None
|
1 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Arthralgia · Mild
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Arthralgia · Moderate
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Arthralgia · Severe
|
0 Participants
|
|
Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity
Arthralgia · Life-threatening
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 12AEs categorized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class, and MedDRA Preferred Term. For participants reporting multiple AEs over the time frame, the maximum relationship is counted.
Outcome measures
| Measure |
AIDSVAX® B/E
n=1 Participants
Participants will receive 600 mcg/mL of AIDSVAX® B/E at Months 0, 1, and 6.
AIDSVAX® B/E: Administered by intramuscular injection
|
|---|---|
|
Number of Participants With Adverse Events, by Relationship to the Study Product
Related
|
0 Participants
|
|
Number of Participants With Adverse Events, by Relationship to the Study Product
Not Related
|
1 Participants
|
|
Number of Participants With Adverse Events, by Relationship to the Study Product
No AEs reported
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at all study visits completed in person through Month 12. Per protocol, the assessments were administered at Screening, Day 0 (date of first vaccination), Day 7, Day 14, Day 35, Day 42, Day 84, Day 168, Day 175, Day 182, Day 238, and Day 364.As assessed by Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) and Routine Assessment of Patient Index Data (RAPID3). The SELENA-SLEDAI is used to assess disease activity across nine organ systems within 10 days prior up to and including the day of study visit. The SELENA-SLEDAI is reported as a a weighted composite score with a range from 0 (no evidence of disease; best outcome) to 105 (extremely severe disease). The RAPID3 is a pooled index of the 3 patient-reported American College of Rheumatology rheumatoid arthritis (RA) Core Data Set measures: function, pain, and patient global estimate of status. Each of the 3 individual measures is scored 0 to 10, for a total of 30. Disease severity was classified on the basis of RAPID3 scores: \>12 = high severity; 6.1-12 = moderate; 3.1-6 = low; \< or =3 = near remission (best outcome).
Outcome measures
| Measure |
AIDSVAX® B/E
n=1 Participants
Participants will receive 600 mcg/mL of AIDSVAX® B/E at Months 0, 1, and 6.
AIDSVAX® B/E: Administered by intramuscular injection
|
|---|---|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
SELENA-SLEDAI score 0 at Day 42
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
SELENA-SLEDAI score 0 at Day 168
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
SELENA-SLEDAI score 0 at Day 364
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
Rapid 3 Score of Near Remission (NR) at Day 1
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
Rapid 3 Score of Near Remission (NR) at Day 7
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
Rapid 3 Score of Near Remission (NR) at Day 168
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
Rapid 3 Score of Near Remission (NR) at Day 175
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
Rapid 3 Score not assessed at Day 238
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
SELENA-SLEDAI score 0 at screening
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
SELENA-SLEDAI score 0 at Day 0
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
SELENA-SLEDAI score 0 at Day 7
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
SELENA-SLEDAI score 0 at Day 14
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
SELENA-SLEDAI score 0 at Day 28
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
SELENA-SLEDAI score 0 at Day 35
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
SELENA-SLEDAI score 0 at Day 84
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
SELENA-SLEDAI score 0 at Day 175
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
SELENA-SLEDAI score 0 at Day 182
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
SELENA-SLEDAI score not done at Day 238
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
Rapid 3 Score of Near Remission (NR) at screening
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
Rapid 3 Score of Near Remission (NR) at Day 14
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
Rapid 3 Score of Near Remission (NR) at Day 21
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
Rapid 3 Score of Near Remission (NR) at Day 35
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
Rapid 3 Score of Near Remission (NR) at Day 42
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
Rapid 3 Score of Near Remission (NR) at Day 84
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
Rapid 3 Score of Near Remission (NR) at Day 182
|
1 Participants
|
|
Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day
Rapid 3 Score of Near Remission (NR) at Day 365
|
1 Participants
|
SECONDARY outcome
Timeframe: Measured through Month 6.5Population: Data have not been collected for this Outcome and cannot be reported. This is due to the enrollment of only one participant in this study and the subsequent lack of ability to draw conclusions that would answer the study objectives from data from one participant.
Measured by flow cytometry
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through Month 6.5Population: Data have not been collected for this Outcome and cannot be reported. This is due to the enrollment of only one participant in this study and the subsequent lack of ability to draw conclusions that would answer the study objectives from data from one participant.
Measured by flow cytometry
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through Month 6.5Population: Data have not been collected for this Outcome and cannot be reported. This is due to the enrollment of only one participant in this study and the subsequent lack of ability to draw conclusions that would answer the study objectives from data from one participant.
Assessed by TZM-bl assay
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through Month 6.25Population: Data have not been collected for this Outcome and cannot be reported. This is due to the enrollment of only one participant in this study and the subsequent lack of ability to draw conclusions that would answer the study objectives from data from one participant.
Assessed by serum cytokine analysis and B and T cell phenotyping, as well as expression of Treg and Tfh markers
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through Month 6.5Population: Data have not been collected for this Outcome and cannot be reported. This is due to the enrollment of only one participant in this study and the subsequent lack of ability to draw conclusions that would answer the study objectives from data from one participant.
Assessed by Binding Antibody Multiplex Assay (BAMA)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through Month 6.5Population: Data have not been collected for this Outcome and cannot be reported. This is due to the enrollment of only one participant in this study and the subsequent lack of ability to draw conclusions that would answer the study objectives from data from one participant.
Assessed by BAMA
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through Month 6.5Population: Data have not been collected for this Outcome and cannot be reported. This is due to the enrollment of only one participant in this study and the subsequent lack of ability to draw conclusions that would answer the study objectives from data from one participant.
Assessed by epitope mapping of functional and binding antibodies
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through Month 6.5Population: Data have not been collected for this Outcome and cannot be reported. This is due to the enrollment of only one participant in this study and the subsequent lack of ability to draw conclusions that would answer the study objectives from data from one participant.
Measured by intracellular cytokine staining (ICS)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through Month 6.5Population: Data have not been collected for this Outcome and cannot be reported. This is due to the enrollment of only one participant in this study and the subsequent lack of ability to draw conclusions that would answer the study objectives from data from one participant.
Measured by ICS
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through Month 6.5Population: Data have not been collected for this Outcome and cannot be reported. This is due to the enrollment of only one participant in this study and the subsequent lack of ability to draw conclusions that would answer the study objectives from data from one participant.
Measured by ICS
Outcome measures
Outcome data not reported
Adverse Events
AIDSVAX® B/E
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AIDSVAX® B/E
n=1 participants at risk
Participants will receive 600 mcg/mL of AIDSVAX® B/E at Months 0, 1, and 6.
AIDSVAX® B/E: Administered by intramuscular injection
|
|---|---|
|
Infections and infestations
Urinary tract infection
|
100.0%
1/1 • Number of events 1 • Data were collected for 12 months of study participation.
|
Additional Information
Jessica Andriesen
Fred Hutchinson Cancer Research Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place