Trial Outcomes & Findings for Safety and Immunogenicity of AERAS-402 in HIV-infected, Bacillus Calmette-Guerin (BCG)-Vaccinated Adults (NCT NCT01017536)

Last Updated: 2016-09-09

Results Overview

Assess the effect of AERAS-402 on the CD4+ lymphocyte count after 6 months in HIV-infected, BCG-vaccinated adult subjects with no evidence of active tuberculosis (TB disease) Change in cells/mm\^3 pre-vaccination to Study Day 182

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

CD4+ counts from samples collected on Study days 0 and 182.

Results posted on

2016-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.	Investigational Vaccine AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
Overall Study STARTED	13	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity of AERAS-402 in HIV-infected, Bacillus Calmette-Guerin (BCG)-Vaccinated Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=13 Participants Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.	Investigational Vaccine n=13 Participants AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.	Total n=26 Participants Total of all reporting groups
Age, Continuous	30.8 years STANDARD_DEVIATION 6.49 • n=99 Participants	30.5 years STANDARD_DEVIATION 5.88 • n=107 Participants	30.7 years STANDARD_DEVIATION 6.07 • n=206 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=99 Participants	13 Participants n=107 Participants	26 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	12 Participants n=107 Participants	23 Participants n=206 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Region of Enrollment South Africa	13 participants n=99 Participants	13 participants n=107 Participants	26 participants n=206 Participants

PRIMARY outcome

Timeframe: CD4+ counts from samples collected on Study days 0 and 182.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.	Investigational Vaccine n=13 Participants AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
CD4+ Lymphocyte Count	-136.0 cells/mm^3 Interval -205.0 to 1.0	-107.0 cells/mm^3 Interval -274.0 to -31.0

SECONDARY outcome

Timeframe: 6 months (day 182) post Study Day 0 vaccination.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.	Investigational Vaccine n=13 Participants AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
Change in HIV Viral Load in HIV-infected, BCG-vaccinated Adult Subjects Before and After Administration of AERAS-402 (From Day 1 to Day 182)	-0.163 Change in copies/mL over time Interval -0.274 to 0.336	-0.011 Change in copies/mL over time Interval -0.357 to 0.281

SECONDARY outcome

Timeframe: Study days 28 and 56

Population: percentage of CD4 or CD8 T-cell response

Intracellular cytokine staining (ICS) assay immune response was expressed as the percentage of CD4+ and CD8+ T cells producing any one of three cytokines (IFN-γ, TNF-α, or IL-2) or any combination of the three cytokines simultaneously after stimulation with Ag85A, Ag85B, and TB10.4 peptide pools.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.	Investigational Vaccine n=13 Participants AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease CD4+ Ag85A response at study day 28	0.0103 percentage of T-cell response Interval 0.0 to 0.023	0.0908 percentage of T-cell response Interval 0.0242 to 0.1357
Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease CD4+ Ag85A response at study day 56	0.0199 percentage of T-cell response Interval 0.0 to 0.0307	0.1248 percentage of T-cell response Interval 0.0537 to 0.2184
Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease CD4+ Ag85B response at study day 28	0.0011 percentage of T-cell response Interval 0.0 to 0.0166	0.0819 percentage of T-cell response Interval 0.0338 to 0.1069
Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease CD4+ Ag85B response at study day 56	0.0083 percentage of T-cell response Interval 0.0 to 0.0277	0.0769 percentage of T-cell response Interval 0.0426 to 0.1463
Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease CD4+ TB10.4 response at study day 28	0.0196 percentage of T-cell response Interval 0.0027 to 0.0494	0.0364 percentage of T-cell response Interval 0.0133 to 0.0463
Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease CD4+ TB10.4 response at study day 56	0.0281 percentage of T-cell response Interval 0.007 to 0.0444	0.0443 percentage of T-cell response Interval 0.0223 to 0.1435
Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease CD8+ Ag85A response at study day 28	0.0002 percentage of T-cell response Interval 0.0 to 0.0019	0.0127 percentage of T-cell response Interval 0.0019 to 0.0462
Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease CD8+ Ag85A response at study day 56	0.0027 percentage of T-cell response Interval 0.0 to 0.0204	0.0300 percentage of T-cell response Interval 0.004 to 0.0824
Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease CD8+ Ag85B response at study day 28	0.0000 percentage of T-cell response Interval 0.0 to 0.01	0.0317 percentage of T-cell response Interval 0.0 to 0.114
Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease CD8+ Ag85B response at study day 56	0.0040 percentage of T-cell response Interval 0.0 to 0.0179	0.0846 percentage of T-cell response Interval 0.0113 to 0.1818
Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease CD8+ TB10.4 response at study day 28	0.0000 percentage of T-cell response Interval 0.0 to 0.0034	0.0000 percentage of T-cell response Interval 0.0 to 0.0112
Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease CD8+ TB10.4 response at study day 56	0.0051 percentage of T-cell response Interval 0.0 to 0.0157	0.0094 percentage of T-cell response Interval 0.0 to 0.0404

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Investigational Vaccine

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=13 participants at risk Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.	Investigational Vaccine n=13 participants at risk AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
Infections and infestations Lower respiratory tract infection	7.7% 1/13 • Number of events 1 Systematic Assessment of AEs by Diary Card, regular laboratory and investigator assessments. As well as subject-reported events.	0.00% 0/13 Systematic Assessment of AEs by Diary Card, regular laboratory and investigator assessments. As well as subject-reported events.
Injury, poisoning and procedural complications Joint injury	0.00% 0/13 Systematic Assessment of AEs by Diary Card, regular laboratory and investigator assessments. As well as subject-reported events.	7.7% 1/13 • Number of events 1 Systematic Assessment of AEs by Diary Card, regular laboratory and investigator assessments. As well as subject-reported events.

Other adverse events

Additional Information

Bernard Landry

Aeras

Phone: 301-547-2900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place