NCT02816554

Brief Summary

A dose escalating study with 3 different dosing regimens of the studied vaccine (JECEVAX- VABIOTECH-Vietnam) and a licensed vaccine (JEVAX-VABIOTECH-Vietnam) is conducted in Vietnamese children, aged 9 to 24 months to assess the safety and immunogenicity. Two hundred children are enrolled and randomly assigned into 4 groups (50 children/group), each of which receive 2 doses of study / control vaccine subcutaneously, at 10-12 days interval. Safety issues included immediate reaction at the site of injection and systemic reaction within 30 min of administration, solicited and unsolicited adverse events occurs from the first dose to 30 days after second dose; SAE (from start of first dose to 30 days after second dose), blood cell count, urea, ALT, AST. Immunogenicity outcomes include seroconversion of neutralizing antibodies (blood samples are taken prior to 1st dose and 20-22 days post 2nd dose).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

5 months

First QC Date

June 23, 2016

Last Update Submit

June 24, 2016

Conditions

Japanese Encephalitis

Keywords

Japanese EncephalitisJECEVAXVietnam

Outcome Measures

Primary Outcomes (2)

  • Number of participants with treatment-related adverse events during study period.

    Number of participants with solicited and unsolicited adverse events after each dose of vaccine: immediately injection site and systemic AEs after vaccination (within 30 min), solicited and unsolicited AEs within 7 days after each dose, unsolicited AEs from day 8 after dose 1 to date of dose 2 and from day 8 after dose 2 to day 30 post 2nd dose, as assessed by CTCAE v.4.0.

    Up to 30 days after 2nd dose

  • Number of participants have sero-conversion at 20-22 days post 2nd dose (compared to pre-vaccination)

    Sero-conversion rate of each JECEVAX regimen and JEVAX at 20-22 days after 2 doses of vaccines

    Up to 20-22 days after the 2nd dose

Secondary Outcomes (2)

  • Number of participants with treatment-related SAE during study period

    Up to 30 days after the 2nd dose

  • Number of participants with abnormal laboratory value.

    Up to 20-22 days after the 2nd dose.

Study Arms (4)

JECEVAX-1

EXPERIMENTAL

JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1.0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12days

Biological: JECEVAX-1

JECEVAX-0.8

EXPERIMENTAL

JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days

Biological: JECEVAX-0.8

JECEVAX-0.5

EXPERIMENTAL

JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days

Biological: JECEVAX-0.5

JEVAX

ACTIVE COMPARATOR

JEVAX - VABIOTECH Vietnam Liquid form Composition: 1,0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days

Biological: JEVAX

Interventions

JEVAXBIOLOGICAL

JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 10-12 days interval

JEVAX
JECEVAX-1BIOLOGICAL

JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days

Also known as: JECEVAX-HI
JECEVAX-1
JECEVAX-0.8BIOLOGICAL

JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days

Also known as: JECVAX-MED
JECEVAX-0.8
JECEVAX-0.5BIOLOGICAL

JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days

Also known as: JECEVAX-LOW
JECEVAX-0.5

Eligibility Criteria

Age9 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children of both sexes, 9-24 months of age;
  • Have not been vaccinated with JE vaccine;
  • Not have any chronic disease;
  • Parents/legal guardians agree to participate their children in this study and sign the informed consent.

You may not qualify if:

  • Currently has chronic diseases (cardiovascular, liver and spleen related etc);
  • Currently has acute diseases;
  • Use (orally or injection) with corticosteroid containing drug (\>1 mg / kg dose);
  • Use of immunocompromised treatment within 4 weeks of enrollment;
  • Being immunocompromised and autoimmune diseases (HIV, lupus);
  • The family history of immunocompromised;
  • History of febrile seizure;
  • Allergic to any vaccine component;
  • Fever (\>38 Celsius degree) within 3 days before vaccination or at enrollment;
  • Malnourished (3rd grade or above);
  • Blood disorder;
  • Use of vaccines which have not been licenced 7 days before enrolment in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

District Health Center

Thanh Sơn, Phu Tho, Vietnam

Location

Phu Tho Preventive Medicine Center

Việt Trì, Phu Tho, Vietnam

Location

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesMosquito-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Study Officials

  • Thiem D Vu, MD., PhD.

    National Institute of Hygiene and Epidemiology, Vietnam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Department of Epidemiology

Study Record Dates

First Submitted

June 23, 2016

First Posted

June 28, 2016

Study Start

April 1, 2015

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

June 28, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Individual data with identification removed are to be available for Ethical committee, Ministry of Health and National Foundation of Science and Technology Development to avoid misuse of data. Public shared data will be in the form of summarised tables and figures.

Locations

VN(2)