Trial Outcomes & Findings for A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2 (NCT NCT01656200)

Results Overview

Interferon gamma (IFNγ) spot forming cells (SFC)/million peripheral blood mononuclear cells (PBMC) at week 2 (peak response)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

Week 1, week 2, week 4, week 8, 6 months

Results posted on

2019-04-26

Participant Flow

Participant milestones

Participant milestones
Measure	Vaccine Single dose live attenuated Japanese encephalitis vaccine SA14-14-2 Live attenuated Japanese encephalitis vaccine SA14-14-2: Live attenuated Japanese encephalitis vaccine SA14-14-2
Overall Study STARTED	17
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Vaccine Single dose live attenuated Japanese encephalitis vaccine SA14-14-2 Live attenuated Japanese encephalitis vaccine SA14-14-2: Live attenuated Japanese encephalitis vaccine SA14-14-2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaccine n=17 Participants Single dose live attenuated Japanese encephalitis vaccine SA14-14-2 Live attenuated Japanese encephalitis vaccine SA14-14-2: Live attenuated Japanese encephalitis vaccine SA14-14-2
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	25 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment India	17 Count of participants n=5 Participants

PRIMARY outcome

Timeframe: Week 1, week 2, week 4, week 8, 6 months

Population: 15 participants had data available at the two week time point. 1 withdrew beforehand, 1 declined to donate thew two week blood sample.

Interferon gamma (IFNγ) spot forming cells (SFC)/million peripheral blood mononuclear cells (PBMC) at week 2 (peak response)

Outcome measures

Outcome measures
Measure	Vaccine n=15 Participants Single dose live attenuated Japanese encephalitis vaccine SA14-14-2 Live attenuated Japanese encephalitis vaccine SA14-14-2: Live attenuated Japanese encephalitis vaccine SA14-14-2
Change of T Lymphocyte Responses to Live Attenuated JE SA-14-14-2 Vaccine at Week 2.	34 IFNγ SFC/million PBMC Interval 0.0 to 537.0

SECONDARY outcome

Timeframe: 4 weeks

Population: 1 participant withdrew before the 4 week time point, for another the sample was not available for analysis.

Neutralizing antibody titres (measured by 50% Plaque reduction neutralisation titre (PRNT50)) at 4 weeks post vaccination

Outcome measures

Outcome measures
Measure	Vaccine n=15 Participants Single dose live attenuated Japanese encephalitis vaccine SA14-14-2 Live attenuated Japanese encephalitis vaccine SA14-14-2: Live attenuated Japanese encephalitis vaccine SA14-14-2
Neutralizing Antibody Titres to Live Attenuated JE SA-14-14-2 Vaccine at Week 4 Post Vaccination.	18.5 Neutralising antibody titres Interval 0.0 to 1188.0

SECONDARY outcome

Timeframe: one month

Outcome measures

Outcome measures
Measure	Vaccine n=17 Participants Single dose live attenuated Japanese encephalitis vaccine SA14-14-2 Live attenuated Japanese encephalitis vaccine SA14-14-2: Live attenuated Japanese encephalitis vaccine SA14-14-2
Number of Participants Reporting Adverse Events (Graded in Severity 1-4).	3 Participants

Adverse Events

Vaccine

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	Vaccine n=17 participants at risk Single dose live attenuated Japanese encephalitis vaccine SA14-14-2 Live attenuated Japanese encephalitis vaccine SA14-14-2: Live attenuated Japanese encephalitis vaccine SA14-14-2
General disorders Fever, headache, myalgia, sore throat	5.9% 1/17 • Number of events 1
Respiratory, thoracic and mediastinal disorders Fever, dry cough	5.9% 1/17 • Number of events 1
Nervous system disorders Dizziness, Headache	5.9% 1/17 • Number of events 1
General disorders Fever	5.9% 1/17 • Number of events 1
Nervous system disorders Dizziness for 2-3 seconds a time	5.9% 1/17 • Number of events 1
General disorders Fever, myalgia	5.9% 1/17 • Number of events 1

Additional Information

Dr Lance Turtle

University of Liverpool

Phone: +44 151 795 9626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place