Immunogenicity of Co-administration of Measles and Japanese Encephalitis Vaccines

Summary

Japanese encephalitis (JE) is the leading cause of viral neurological disease and disability in Asia. A live attenuated vaccine (LJEV) manufactured in China has several advantages over other JE vaccines such as one dose schedule, using for infants, and the cheaper cost. Because the LJEV has been prequalified by the World Health Organization (WHO) in 2013, it will likely be used in other countries, and possibly co-administered with the first dose of measles-containing vaccine (MCV) to ensure early protection and reduce additional vaccination visits.

The evidence for immunogenicity and safety of co-administration of LJEV with MCV is limited. Only one study conducted in the Philippines examining the co-administration of MCV with LJEV among 9 months infants, the results showed the proportion of achieved sero-protection against measles following MCV (96%) was slightly lower than in the MCV-only group (100%), and the measles antibody titres were also slightly lower in the co-administration group. Due to limited evidence available, the WHO position paper of measles vaccines has encouraged further investigation on the possible impact of co-administration of LJEV on measles vaccine effectiveness.

In China, Measles-Rubella combined vaccine (MR) and LJEV is given at 8 months of age nationally. Considering China is reaching towards the goal of measles elimination, it will be important to conduct a study to compare the immunogenicity of MR administered alone or with LJEV, and also evaluate the safety and tolerability of LJEV administered with MR among 8 months infants.

This study is a prospective, randomized, open-label, multi-center study enrolling infants aged 8 months. Basic demographic information of the infant will be taken and blood samples will be collected at enrollment (baseline) and at 6weeks following administration of MR, the measles antibodies will be measured, and compare seroconversion rates to assess for non-inferiority. All infants will be monitored for adverse events after MR.

Conditions

• Measles
• Rubella
• Japanese Encephalitis

Interventions

BIOLOGICAL

Measles-Rubella combined vaccine(MR)

0.5ml for each dose,be administered by single use syringe subcutaneously in the lower part of the deltoid area of lateral arm.

BIOLOGICAL

Japanese Encephalitis alive vaccine(JE)

0.5ml for each dose be administered by single use syringe subcutaneously in the lower part of the deltoid area of lateral arm.

Sponsors & Collaborators

• Centers for Disease Control and Prevention

  collaborator FED

• Zhejiang Provincial Center for Disease Control and Prevention

  collaborator OTHER_GOV

• Hubei Provincial Center for Disease Control and Prevention

  collaborator OTHER

• Centers for Disease Control and Prevention, China

  lead OTHER_GOV

Principal Investigators

• Huaqing Wang, MD, PhD · Centers for Disease Control and Prevention, China

• Zhijie AN, MD, MPH · Centers for Disease Control and Prevention, China

• Zijian Feng, MD, MPH · Centers for Disease Control and Prevention, China

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Months

Max Age

9 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2016-06-30

Completion

2016-06-30

Countries

• China

Study Locations