Immunogenicity of Co-administration of Measles and Japanese Encephalitis Vaccines

NCT02643433 | Completed Phase 4

• 1 other identifier: 201518
• Study Type: interventional
• Target: 1,043
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Immunogenicity; Coadministration; Measles; Rubella; Japanese encephalitis; Vaccine

Outcome Measures

Primary Outcomes (1)

• Seroconversion rate for measles

  Compare the seroconversion rate of measles antibody between the two groups

  6 weeks after vaccination (day 42-48)

Secondary Outcomes (2)

• Seroconversion rate for rubella

  6 weeks after vaccination (day 42-48)

• Adverse Events Following Immunization

  Within 6 weeks after vaccination

Study Arms (2)

MR and JE coadministration group

EXPERIMENTAL

Infants aged 8 months are vaccinated measles-rubella combined vaccine (MR) and Japanese Encephalitis alive vaccine (JE) in different sites at same time.

Biological: Measles-Rubella combined vaccine(MR); Biological: Japanese Encephalitis alive vaccine(JE)

MR administration alone group

ACTIVE COMPARATOR

Infants aged 8 months are vaccinated measles-rubella combined vaccine alone

Biological: Measles-Rubella combined vaccine(MR)

Interventions

Measles-Rubella combined vaccine(MR) BIOLOGICAL

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

MR administration alone group; MR and JE coadministration group

Japanese Encephalitis alive vaccine(JE) BIOLOGICAL

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

MR and JE coadministration group

Eligibility Criteria

• Age: 8 Months - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants between 8 months and 8 months plus two weeks of age;
• Complete vaccination of national immunization schedule before 8 months;
• Healthy infants;
• Live in the study county with good compliance who can participate in the entire observation period.

You may not qualify if:

• Previous history of measles, rubella, or JE;
• Previously received vaccines containing measles/rubella or JE components;
• Contraindications to the study vaccines;
• Received blood products or immunosuppressive treatments within last 3 months;
• Received any live attenuated vaccines within the last 4 weeks, or any inactivated vaccines within 2 weeks;
• Guardian refuses to participate in the study.

Sponsors & Collaborators

• Centers for Disease Control and Prevention, China: lead
• Centers for Disease Control and Prevention: collaborator
• Zhejiang Provincial Center for Disease Control and Prevention: collaborator
• Hubei Provincial Center for Disease Control and Prevention: collaborator

Study Sites (2)

Hebei Provincial Center for Disease Control and Prevention

Shijiazhuang, Hebei, China

Location

Zhejiang Provincial Center for Disease Control and Prevention

Hangzhou, Zhejiang, China

Location

Related Publications (3)

• Gatchalian S, Yao Y, Zhou B, Zhang L, Yoksan S, Kelly K, Neuzil KM, Yaich M, Jacobson J. Comparison of the immunogenicity and safety of measles vaccine administered alone or with live, attenuated Japanese encephalitis SA 14-14-2 vaccine in Philippine infants. Vaccine. 2008 Apr 24;26(18):2234-41. doi: 10.1016/j.vaccine.2008.02.042. Epub 2008 Mar 18.

  PMID: 18394765 BACKGROUND

• Measles vaccines: WHO position paper. Wkly Epidemiol Rec. 2009 Aug 28;84(35):349-60. No abstract available. English, French.

  PMID: 19714924 BACKGROUND

• Li Y, Chu SY, Yue C, Wannemuehler K, Xie S, Zhang F, Wang Y, Zhang Y, Ma R, Li Y, Zuo Z, Rodewald L, Xiao Q, Feng Z, Wang H, An Z. Immunogenicity and safety of measles-rubella vaccine co-administered with attenuated Japanese encephalitis SA 14-14-2 vaccine in infants aged 8 months in China: a non-inferiority randomised controlled trial. Lancet Infect Dis. 2019 Apr;19(4):402-409. doi: 10.1016/S1473-3099(18)30650-9. Epub 2019 Mar 1.

  PMID: 30833160 DERIVED

MeSH Terms

Conditions

Measles; Rubella; Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Rubivirus Infections; Togaviridae Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Huaqing Wang, MD, PhD

  Centers for Disease Control and Prevention, China

  PRINCIPAL INVESTIGATOR

• Zhijie AN, MD, MPH

  Centers for Disease Control and Prevention, China

  STUDY DIRECTOR

• Zijian Feng, MD, MPH

  Centers for Disease Control and Prevention, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, National Immunization Program, China CDC

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: December 31, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 1, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)