Trial Outcomes & Findings for Targeted Investigation of Microbiome Elimination (NCT NCT05177328)

Last Updated: 2024-11-12

Results Overview

Measured as the time needed for coagulase negative staphylococcus species (CoNS) colony-forming unit (CFU) to drop below baseline density measured before application of ShA9 + 100 CFU/cm2 (time to CoNS elimination). Baseline CoNS density was defined as the CoNS (CFU/cm2) result from the sample taken prior to treatment application during the Treatment Visit (Day 0). The primary endpoint was assessed based on samples from lesional skin from the arm (left or right) that received active treatment (ShA9) among SA+ participants. The event is CoNS elimination. Participants who did not experience CoNS elimination were right-censored. The median survival time (hours) was estimated using Kaplan Meier techniques. The 95% confidence interval for median survival time was estimated based on a log-log transformation of the survivor function.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

21 participants

Primary outcome timeframe

Day 0 to Day 24

Results posted on

2024-11-12

Participant Flow

Enrollment was open JUL 2022-OCT 2023. Participants were recruited in person or via phone. Those who met recruitment criteria were invited to an in-clinic Screening Visit where informed consent was given and full eligibility assessed. Those meeting eligibility requirements began a pre-treatment phase for \~7 days before the Day 0 clinic visit.

21 participants were enrolled during the recruitment period. Enrolled participants were those who signed informed consent and met all eligibility criteria. 17 of the enrolled participants were randomized and received study therapy. 4 of the enrolled participants discontinued prior to randomization and did not receive study therapy.

Unit of analysis: arms

Participant milestones

Participant milestones
Measure	All Randomized Participants All randomized participants includes participants that were randomized to receive either an application of ShA9 to the dominant ventral arm and placebo to the non-dominant ventral arm, or an application of ShA9 to the non-dominant ventral arm and placebo to the dominant ventral arm.
Overall Study STARTED	17 34
Overall Study Received ShA9 on Dominant Ventral Arm/Placebo on Non-Dominant Ventral Arm	9 18
Overall Study Received ShA9 on Non-Dominant Ventral Arm/Placebo on Dominant Ventral Arm	8 16
Overall Study COMPLETED	17 34
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Targeted Investigation of Microbiome Elimination

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Population n=17 Participants The safety population includes all participants who were enrolled and received any amount of Staphylococcus hominis A9 (ShA9)/placebo.
Age, Continuous	24.9 years STANDARD_DEVIATION 9.30 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants
Staphylococcus aureus (SA) Status SA Positive	10 Participants n=5 Participants
Staphylococcus aureus (SA) Status SA Negative	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 to Day 24

Outcome measures

Outcome measures
Measure	mITT, SA+ Participants n=10 Participants The modified intent-to-treat (mITT) population includes all participants who were enrolled and received any amount of study product (ShA9 or placebo). The analysis of the primary endpoint is subset to the mITT participants who were SA+ at baseline \[based on samples obtained prior to treatment application during the Treatment Visit (Day 0)\]. Out of the 10 participants who were analyzed, the number of participants who were censored equals 0.
The Duration of ShA9 Survival on the Lesional Ventral Arm Skin of Atopic Dermatitis (AD) Participants Positive for S. Aureus (AD SA+).	37.0 Hours Interval 0.25 to 240.0

SECONDARY outcome

Timeframe: Day 0 to Day 24

Measured as the time needed for coagulase negative staphylococcus species (CoNS) colony-forming unit (CFU) to drop below baseline density measured before application of ShA9 + 100 CFU/cm2 (time to CoNS elimination). Baseline CoNS density was defined as the CoNS (CFU/cm2) result from the sample taken prior to treatment application during the Treatment Visit (Day 0). This secondary endpoint was assessed based on samples from non-lesional skin from the arm (left or right) that received active treatment (ShA9) among SA+ participants. The event is CoNS elimination. Participants who did not experience CoNS elimination were right-censored. The median survival time (hours) was estimated using Kaplan Meier techniques. The 95% confidence interval for median survival time was estimated based on a log-log transformation of the survivor function.

Outcome measures

Outcome measures
Measure	mITT, SA+ Participants n=10 Participants The modified intent-to-treat (mITT) population includes all participants who were enrolled and received any amount of study product (ShA9 or placebo). The analysis of the primary endpoint is subset to the mITT participants who were SA+ at baseline \[based on samples obtained prior to treatment application during the Treatment Visit (Day 0)\]. Out of the 10 participants who were analyzed, the number of participants who were censored equals 0.
The Duration of ShA9 Survival on the Non-lesional Ventral Arm Skin of Atopic Dermatitis (AD) Participants Positive for S. Aureus (AD SA+).	6.0 Hours Interval 0.25 to 24.0

SECONDARY outcome

Timeframe: Day 0 to Day 31

For this study, an adverse event included any untoward or unfavorable medical occurrence associated with the study treatment regimen or study mandated procedures. An adverse event was considered 'serious' if, in the view of the investigator or Sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	mITT, SA+ Participants n=17 Participants The modified intent-to-treat (mITT) population includes all participants who were enrolled and received any amount of study product (ShA9 or placebo). The analysis of the primary endpoint is subset to the mITT participants who were SA+ at baseline \[based on samples obtained prior to treatment application during the Treatment Visit (Day 0)\]. Out of the 10 participants who were analyzed, the number of participants who were censored equals 0.
The Count of Serious Treatment-emergent Adverse Events Per Participant.	0 Serious TEAEs per participant Standard Deviation 0

SECONDARY outcome

Timeframe: Day 0 to Day 31

Outcome measures

Outcome measures
Measure	mITT, SA+ Participants n=17 Participants The modified intent-to-treat (mITT) population includes all participants who were enrolled and received any amount of study product (ShA9 or placebo). The analysis of the primary endpoint is subset to the mITT participants who were SA+ at baseline \[based on samples obtained prior to treatment application during the Treatment Visit (Day 0)\]. Out of the 10 participants who were analyzed, the number of participants who were censored equals 0.
The Count of Non-serious Treatment-emergent Adverse Events Per Participant.	0.24 Non-serious TEAEs per participant Standard Deviation 0.752

Adverse Events

ShA9-Treated Ventral Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo-Treated Ventral Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Systemic

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Overall

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ShA9-Treated Ventral Arm n=17 participants at risk Treatment-emergent adverse events involving the ShA9-treated ventral arm among participants included in the safety population.	Placebo-Treated Ventral Arm n=17 participants at risk Treatment-emergent adverse events involving the placebo-treated ventral arm among participants included in the safety population.	Systemic n=21 participants at risk Systemic adverse events among all enrolled participants.	Overall n=21 participants at risk All adverse events for enrolled participants.
Infections and infestations COVID-19	0.00% 0/17 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.	0.00% 0/17 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.	4.8% 1/21 • Number of events 1 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.	4.8% 1/21 • Number of events 1 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.
Psychiatric disorders Bipolar II disorder	0.00% 0/17 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.	0.00% 0/17 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.	4.8% 1/21 • Number of events 1 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.	4.8% 1/21 • Number of events 1 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.
Skin and subcutaneous tissue disorders Dermatitis atopic	5.9% 1/17 • Number of events 1 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.	5.9% 1/17 • Number of events 1 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.	4.8% 1/21 • Number of events 1 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.	4.8% 1/21 • Number of events 1 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.
Skin and subcutaneous tissue disorders Eczema	5.9% 1/17 • Number of events 1 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.	5.9% 1/17 • Number of events 1 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.	4.8% 1/21 • Number of events 1 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.	9.5% 2/21 • Number of events 2 • Screening through Day 31 Adverse events (AEs) were collected from Screening-Day 31. AEs included any untoward/unfavorable medical occurrence associated with study treatment or study mandated procedures. AEs are reported for enrolled subjects. Treatment-emergent AEs were summarized by involvement of ShA9 or placebo-treated arm. AEs involving both arms were counted in both arm summaries. AEs involving both arms and other body parts were also counted as systemic. AEs occurring prior to treatment were considered systemic.

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place