Trial Outcomes & Findings for MVA85A Aerosol vs Intramuscular Vaccination in Adults With Latent Mycobacterium Tuberculosis (M. tb) Infection (NCT NCT02532036)
NCT ID: NCT02532036
Last Updated: 2020-08-31
Results Overview
Actively and passively collected data on adverse events via diary card for 14 days after vaccination and at each visit over 6 months.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
2 participants
Primary outcome timeframe
Up to Day 168
Results posted on
2020-08-31
Participant Flow
Participant milestones
| Measure |
Starter Group
Receive 1x10\^7 pfu aerosol inhaled MVA85A at day 0.
|
Group A
Receive 5x10\^7 pfu aerosol inhaled MVA85A
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Starter Group
n=2 Participants
Received 1x10\^7 pfu aerosol inhaled MVA85A at day 0.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Up to Day 168Actively and passively collected data on adverse events via diary card for 14 days after vaccination and at each visit over 6 months.
Outcome measures
| Measure |
Starter Group
n=2 Participants
Receive 1x10\^7 pfu aerosol inhaled MVA85.
|
|---|---|
|
Adverse Events (AE)
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Day 168Evaluation of ex-vivo ELISpot and intracellular cytokine staining in blood and bronchoalveolar lavage (BAL) samples.
Outcome measures
Outcome data not reported
Adverse Events
Starter Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Starter Group
n=2 participants at risk
Received 1x10\^7 pfu aerosol inhaled MVA85A at day 0.
|
|---|---|
|
Investigations
radiological changes
|
50.0%
1/2 • Number of events 1 • All AEs occurring for 6 months following the vaccination that were observed by the investigator or reported by the volunteer, whether or not attributed to study medication, were recorded by volunteers on electronic diary cards or by staff on CRFs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place