Trial Outcomes & Findings for Perturbing of HIV Reservoir With Immune Stimulation (NCT NCT02707692)
NCT ID: NCT02707692
Last Updated: 2022-08-24
Results Overview
CD4+ T cell-associated HIV RNA was measured before vaccination on Day 0 and again on Day 7. The Day-0 measure of CD4+ T cell-associated HIV RNA transcription was subtracted from the Day-7 measure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Day 0 and Day 7
Results posted on
2022-08-24
Participant Flow
Recruitment dates: 2016 to 2020 Recruitment location: Conducted in HIV clinics and at clinical trial site, UC San Diego AntiViral Research Center in San Diego, CA
Participants had a wash out period of no less than 4 weeks between vaccination series. Participants were excluded from the study before randomization and study assignments if their HIV viral loads were detectable from blood samples collected at screening.
Participant milestones
| Measure |
Pneumococcal, Then Influenza, Then Placebo Vaccination
Participants first received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of saline (placebo).
|
Pneumococcal, Then Placebo, Then Influenza Vaccination
Participants first received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of saline (placebo). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK).
|
Influenza, Then Pneumococcal, Then Placebo Vaccination
Participants first received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of saline (placebo).
|
Influenza, Then Placebo, Then Pneumococcal Vaccination
Participants first received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of saline (placebo). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®).
|
Placebo, Then Pneumococcal, Then Influenza Vaccination
Participants first received a 0.5 mL injection of saline (placebo). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK).
|
Placebo, Then Influenza, Then Pneumococcal Vaccination
Participants first received a 0.5 mL injection of saline (placebo). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®).
|
|---|---|---|---|---|---|---|
|
Cycle 1 (30 Days)
STARTED
|
9
|
9
|
9
|
9
|
9
|
9
|
|
Cycle 1 (30 Days)
COMPLETED
|
8
|
6
|
8
|
9
|
8
|
8
|
|
Cycle 1 (30 Days)
NOT COMPLETED
|
1
|
3
|
1
|
0
|
1
|
1
|
|
Washout Between Cycles 1 and 2 (>=6 Wks)
STARTED
|
8
|
6
|
9
|
9
|
8
|
8
|
|
Washout Between Cycles 1 and 2 (>=6 Wks)
COMPLETED
|
7
|
6
|
9
|
8
|
7
|
8
|
|
Washout Between Cycles 1 and 2 (>=6 Wks)
NOT COMPLETED
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Cycle 2 (30 Days)
STARTED
|
7
|
6
|
9
|
8
|
7
|
8
|
|
Cycle 2 (30 Days)
COMPLETED
|
6
|
6
|
9
|
7
|
4
|
7
|
|
Cycle 2 (30 Days)
NOT COMPLETED
|
1
|
0
|
0
|
1
|
3
|
1
|
|
Washout Between Cycles 2 and 3 (>=6 Wks)
STARTED
|
7
|
6
|
9
|
7
|
6
|
7
|
|
Washout Between Cycles 2 and 3 (>=6 Wks)
COMPLETED
|
7
|
6
|
9
|
5
|
6
|
6
|
|
Washout Between Cycles 2 and 3 (>=6 Wks)
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
1
|
|
Cycle 3 (30 Days)
STARTED
|
7
|
6
|
9
|
5
|
6
|
6
|
|
Cycle 3 (30 Days)
COMPLETED
|
5
|
5
|
9
|
5
|
5
|
5
|
|
Cycle 3 (30 Days)
NOT COMPLETED
|
2
|
1
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The CD4 count was not ascertained for one participant in Arm 5 ("Placebo, then Pneumococcal, then Influenza vaccination").
Baseline characteristics by cohort
| Measure |
Pneumococcal, Then Influenza, Then Placebo Vaccination
n=9 Participants
Participants first received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of saline (placebo).
|
Pneumococcal, Then Placebo, Then Influenza Vaccination
n=9 Participants
Participants first received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of saline (placebo). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK).
|
Influenza, Then Pneumococcal, Then Placebo Vaccination
n=9 Participants
Participants first received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of saline (placebo).
|
Influenza, Then Placebo, Then Pneumococcal Vaccination
n=9 Participants
Participants first received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of saline (placebo). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®).
|
Placebo, Then Pneumococcal, Then Influenza Vaccination
n=9 Participants
Participants first received a 0.5 mL injection of saline (placebo). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK).
|
Placebo, Then Influenza, Then Pneumococcal Vaccination
n=9 Participants
Participants first received a 0.5 mL injection of saline (placebo). After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK). After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®).
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 13.4 • n=9 Participants
|
42.9 years
STANDARD_DEVIATION 9.5 • n=9 Participants
|
42.2 years
STANDARD_DEVIATION 13.4 • n=9 Participants
|
44.3 years
STANDARD_DEVIATION 10.2 • n=9 Participants
|
46.9 years
STANDARD_DEVIATION 10.1 • n=9 Participants
|
48.0 years
STANDARD_DEVIATION 10.9 • n=9 Participants
|
45.0 years
STANDARD_DEVIATION 11.0 • n=54 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
6 Participants
n=9 Participants
|
8 Participants
n=9 Participants
|
8 Participants
n=9 Participants
|
8 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
8 Participants
n=9 Participants
|
45 Participants
n=54 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
3 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
6 Participants
n=54 Participants
|
|
Sex/Gender, Customized
Gender · Trans or non-binary
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
27 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
6 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
27 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
8 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
6 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
42 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=54 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
9 participants
n=9 Participants
|
9 participants
n=9 Participants
|
9 participants
n=9 Participants
|
9 participants
n=9 Participants
|
9 participants
n=9 Participants
|
54 participants
n=54 Participants
|
|
Virologically suppressed
Suppressed (< 50 copies/ml)
|
9 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
8 Participants
n=9 Participants
|
8 Participants
n=9 Participants
|
52 Participants
n=54 Participants
|
|
Virologically suppressed
Viremic (>= 50 copies/ml)
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=54 Participants
|
|
Virologically suppressed
Unknown
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=54 Participants
|
|
CD4 Counts
|
785.4 cells/microliters
STANDARD_DEVIATION 248.5 • n=9 Participants • The CD4 count was not ascertained for one participant in Arm 5 ("Placebo, then Pneumococcal, then Influenza vaccination").
|
814.9 cells/microliters
STANDARD_DEVIATION 267.9 • n=9 Participants • The CD4 count was not ascertained for one participant in Arm 5 ("Placebo, then Pneumococcal, then Influenza vaccination").
|
798.4 cells/microliters
STANDARD_DEVIATION 280.0 • n=9 Participants • The CD4 count was not ascertained for one participant in Arm 5 ("Placebo, then Pneumococcal, then Influenza vaccination").
|
724.4 cells/microliters
STANDARD_DEVIATION 256.7 • n=9 Participants • The CD4 count was not ascertained for one participant in Arm 5 ("Placebo, then Pneumococcal, then Influenza vaccination").
|
753.8 cells/microliters
STANDARD_DEVIATION 242.4 • n=8 Participants • The CD4 count was not ascertained for one participant in Arm 5 ("Placebo, then Pneumococcal, then Influenza vaccination").
|
639.9 cells/microliters
STANDARD_DEVIATION 222.1 • n=9 Participants • The CD4 count was not ascertained for one participant in Arm 5 ("Placebo, then Pneumococcal, then Influenza vaccination").
|
752.8 cells/microliters
STANDARD_DEVIATION 248.6 • n=53 Participants • The CD4 count was not ascertained for one participant in Arm 5 ("Placebo, then Pneumococcal, then Influenza vaccination").
|
PRIMARY outcome
Timeframe: Day 0 and Day 7Population: Within each cycle, all participants who received the vaccination and completed the Day-7 visit were included in the analysis.
CD4+ T cell-associated HIV RNA was measured before vaccination on Day 0 and again on Day 7. The Day-0 measure of CD4+ T cell-associated HIV RNA transcription was subtracted from the Day-7 measure.
Outcome measures
| Measure |
Pneumococcal Vaccine
n=42 Participants
Participants received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®) and a 0.5 mL of saline (placebo) with at least 6 weeks of washout between injections, in random order.
|
Influenza Vaccine
n=44 Participants
Participants received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK) and a 0.5 mL of saline (placebo) with at least 6 weeks of washout between injections, in random order.
|
Placebo
n=45 Participants
Participants received a 0.5 mL injection of saline (placebo).
|
|---|---|---|---|
|
Change From Vaccination (Day 0) in Mean CD4+ T Cell-associated HIV RNA Transcription at Day 7
|
-471.8 HIV RNA copies per million cell
Standard Deviation 2998.0
|
-45.9 HIV RNA copies per million cell
Standard Deviation 243.2
|
332.3 HIV RNA copies per million cell
Standard Deviation 2266.4
|
Adverse Events
Pneumococal Vaccine
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Influenza Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pneumococal Vaccine
n=45 participants at risk
Participants received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®).
|
Influenza Vaccine
n=45 participants at risk
Participants received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK).
|
Placebo
n=48 participants at risk
Participants received a 0.5 mL injection of saline (placebo).
|
|---|---|---|---|
|
Gastrointestinal disorders
Elevated ALT/AST
|
2.2%
1/45 • Number of events 1 • From baseline until the end of Cycle 3 (up to 417 days on study)
|
0.00%
0/45 • From baseline until the end of Cycle 3 (up to 417 days on study)
|
0.00%
0/48 • From baseline until the end of Cycle 3 (up to 417 days on study)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place