Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers

• ClinicalTrials.gov Identifier: NCT01001988
• Recruitment Status: Completed
• First Posted: October 27, 2009
• Results First Posted: November 29, 2017
• Last Update Posted: November 29, 2017
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Conditions: Encephalitis; Japanese Encephalitis
• Interventions: Other: Blood sample; Biological: JE-CV administered in Study JEC02
• Enrollment: 596

Participant Flow

Recruitment Details	Study participants were enrolled at 3 sites in Thailand and 2 sites in the Philippines.
Pre-assignment Details	A total of 596 participants received a single dose of JE-CV in JEC02 and came to Visit 1 (Year 1) in JEC05; 585 participants were included in the Per Protocol Analysis set.

Arm/Group Title	Study Group
Arm/Group Description	Participants received a single dose of JE-CV in Study JEC02 (NCT00735644)
Period Title: Overall Study
Started	596
Completed	479
Not Completed	117
Reason Not Completed
Protocol Violation	84
Withdrawal by Subject	18
Lost to Follow-up	15

Baseline Characteristics

Arm/Group Title		Study Group
Arm/Group Description		Participants received a single dose of JE-CV in Study JEC02
Overall Number of Baseline Participants		585
Baseline Analysis Population Description		The baseline analysis population includes all participants in the Per Protocol Analysis Set at Year 1 of JEC05
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	585 participants
	<=18 years	585 100.0%
	Between 18 and 65 years	0 0.0%
	>=65 years	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Months
	Number Analyzed	585 participants
		26.2 (1.86)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	585 participants
	Female	272 46.5%
	Male	313 53.5%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	585 participants
Philippines		229
Thailand		356

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV
Description	Seroprotection was defined as the proportion of participants with Japanese encephalitis virus neutralizing antibody titers ≥10 1/dil as measured by a JE 50% plaque reduction neutralization test (PRNT50).
Time Frame	Day 0 (pre-vaccination) from study JEC02, Day 28 post-vaccination from study JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination

Outcome Measure Data

Analysis Population Description

Seroprotection was analyzed in the Per Protocol Analysis Set.

Arm/Group Title		Study Group
Arm/Group Description:		Participants received a single dose of Japanese encephalitis chimeric virus vaccine (JE-CV) in Study JEC02 (NCT00735644)
Overall Number of Participants Analyzed		585
Measure Type: Number; Unit of Measure: Percentage of participants
Day 0 (pre-vaccination)	Number Analyzed	583 participants
		2.6
Day 28 post-vaccination	Number Analyzed	574 participants
		100.0
Year 1 post-vaccination	Number Analyzed	584 participants
		88.2
Year 2 post-vaccination	Number Analyzed	541 participants
		90.0
Year 3 post-vaccination	Number Analyzed	505 participants
		93.1
Year 4 post-vaccination	Number Analyzed	484 participants
		87.6
Year 5 post-vaccination	Number Analyzed	478 participants
		85.4

2. Primary Outcome

Title	Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV
Description	Geometric mean titers of Japanese encephalitis virus antibodies were assessed using the PRNT50 test.
Time Frame	Day 0 (pre-vaccination) from JEC02, Day 28 post-vaccination from JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination

Outcome Measure Data

Analysis Population Description

Geometric mean titers were assessed in the Per Protocol Analysis Set.

Arm/Group Title		Study Group
Arm/Group Description:		Participants received a single dose of Japanese encephalitis chimeric virus vaccine (JE-CV) in Study JEC02 (NCT00735644)
Overall Number of Participants Analyzed		585
Geometric Mean (95% Confidence Interval); Unit of Measure: Titers (1/dil)
Day 0 (pre-vaccination)	Number Analyzed	583 participants
		5.13; (5.06 to 5.21)
Day 28 post-vaccination	Number Analyzed	574 participants
		252; (224 to 284)
Year 1 post-vaccination	Number Analyzed	584 participants
		76.8; (67.4 to 87.6)
Year 2 post-vaccination	Number Analyzed	541 participants
		81.4; (71.7 to 92.6)
Year 3 post-vaccination	Number Analyzed	505 participants
		132; (114 to 153)
Year 4 post-vaccination	Number Analyzed	484 participants
		85.8; (74.7 to 98.6)
Year 5 post-vaccination	Number Analyzed	478 participants
		63.3; (54.8 to 73.0)

Adverse Events

Time Frame	Safety data were not collected in this trial as no vaccine was administered. Only serious adverse events (SAEs) related to the vaccination in study JEC02 were collected. Overall, no related SAEs (including death) were reported from 6 months to 5 years post-vaccination in JEC02.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Study Group
Arm/Group Description	Participants received a single dose of JE-CV in Study JEC02 (NCT00735644)
All-Cause Mortality
	Study Group
	Affected / at Risk (%)
Total	0/591 (0.00%)
Serious Adverse Events
	Study Group
	Affected / at Risk (%)
Total	0/591 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Study Group
	Affected / at Risk (%)
Total	0/591 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Medical Director
• Organization: Sanofi Pasteur
• Phone: 800-633-1610
• EMail: RegistryContactUS@sanofi.com

• Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
• ClinicalTrials.gov Identifier: NCT01001988
• Other Study ID Numbers: JEC05; U1111-1112-2127 ( Other Identifier: WHO )
• First Submitted: October 23, 2009
• First Posted: October 27, 2009
• Results First Submitted: September 18, 2017
• Results First Posted: November 29, 2017
• Last Update Posted: November 29, 2017