Trial Outcomes & Findings for Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX (NCT NCT02526550)

Last Updated: 2016-12-07

Results Overview

Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

Day 0 (Baseline) and Day 28 (post-vaccination)

Results posted on

2016-12-07

Participant Flow

This phase IV study was conducted between 01 June 2014 and 04 July 2014 in accordance with ICH GCP. The study was approved by the Siriraj IRB. Written Informed Consent was obtained from all participants' parents or legal guardians before study entry.

Participant milestones

Participant milestones
Measure	Imojev Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Overall Study STARTED	50
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Imojev Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Overall Study Lost to Follow-up	1

Baseline Characteristics

Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imojev n=50 Participants Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Age, Continuous	20.5 months STANDARD_DEVIATION 0.8 • n=93 Participants
Sex: Female, Male Female	27 Participants n=93 Participants
Sex: Female, Male Male	23 Participants n=93 Participants
Region of Enrollment Thailand	50 participants n=93 Participants

PRIMARY outcome

Timeframe: Day 0 (Baseline) and Day 28 (post-vaccination)

Population: Per-protocol analysis

Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).

Outcome measures

Outcome measures
Measure	Imojev n=49 Participants Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination	9144 titers Interval 7365.0 to 11353.0

SECONDARY outcome

Timeframe: Day 0 (Baseline) and Day 28 (post-vaccination)

Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.

Outcome measures

Outcome measures
Measure	Imojev n=49 Participants Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination	100 percentage of participants

SECONDARY outcome

Timeframe: Up to 28 days post booster vaccination

Immediate reactions: any reactions occurred within 30 minutes following vaccination; Solicited injection site reactions: Injection site Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Crying/Irritability, Drowsiness, Low Appetite and Skin Rash; Unsolicited adverse events: any adverse events spontaneously reported by participants regardless the causal relationship of adverse events to vaccine; Serious adverse events: Any adverse events that resulted in any of the following outcomes: death, a life threatening adverse event, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, a congenital anomaly/birth defect, or any important medical events based upon appropriate medical judgment.

Outcome measures

Outcome measures
Measure	Imojev n=49 Participants Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™ Immediate reactions	0 percentage of participants
Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™ Injection site pain	10.2 percentage of participants
Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™ Injection site redness	6.1 percentage of participants
Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™ Injection site swelling	6.1 percentage of participants
Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™ Fever	10.3 percentage of participants
Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™ Crying/Irritability	8.3 percentage of participants
Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™ Drowsiness	10.4 percentage of participants
Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™ Low Appetite	8.2 percentage of participants
Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™ Skin Rash	12.2 percentage of participants
Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™ Unsolicited adverse events	49.0 percentage of participants
Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™ Serious adverse events	0 percentage of participants

Adverse Events

Imojev

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Imojev n=49 participants at risk Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
General disorders Immediate reactions	0.00% 0/49 • 28 days following vaccination Patients' parents/guardians were provided with rulers, digital thermometers, and diary cards to record daily temperature and any solicited local injection site reactions (pain, redness, and swelling) and general symptoms (fever, abnormal crying/irritability, drowsiness, loss of appetite and skin rash) during the 28-day period following each study vaccination. The occurrence of unsolicited (i.e. spontaneously reported) adverse events were recorded for up to 28 days following vaccination.
Skin and subcutaneous tissue disorders Solicited local reactions	12.2% 6/49 • Number of events 11 • 28 days following vaccination Patients' parents/guardians were provided with rulers, digital thermometers, and diary cards to record daily temperature and any solicited local injection site reactions (pain, redness, and swelling) and general symptoms (fever, abnormal crying/irritability, drowsiness, loss of appetite and skin rash) during the 28-day period following each study vaccination. The occurrence of unsolicited (i.e. spontaneously reported) adverse events were recorded for up to 28 days following vaccination.
General disorders Solicited systemic reactions	24.5% 12/49 • Number of events 25 • 28 days following vaccination Patients' parents/guardians were provided with rulers, digital thermometers, and diary cards to record daily temperature and any solicited local injection site reactions (pain, redness, and swelling) and general symptoms (fever, abnormal crying/irritability, drowsiness, loss of appetite and skin rash) during the 28-day period following each study vaccination. The occurrence of unsolicited (i.e. spontaneously reported) adverse events were recorded for up to 28 days following vaccination.
General disorders Unsolicited adverse events	49.0% 24/49 • Number of events 34 • 28 days following vaccination Patients' parents/guardians were provided with rulers, digital thermometers, and diary cards to record daily temperature and any solicited local injection site reactions (pain, redness, and swelling) and general symptoms (fever, abnormal crying/irritability, drowsiness, loss of appetite and skin rash) during the 28-day period following each study vaccination. The occurrence of unsolicited (i.e. spontaneously reported) adverse events were recorded for up to 28 days following vaccination.

Additional Information

Prof.Kulkanya Chokephaibulkit

Siriraj Hospital

Phone: 662 4195695

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place