Trial of Additional Measles Vaccine to Reduce Child Mortality

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bandim Health Project
Sponsor:
Collaborators:
Centre de Recherche en Sante de Nouna, Burkina Faso
Navrongo Health Research Centre, Ghana
Heidelberg University
National Institute for Public Health and the Environment, RIVM, Holland
Information provided by (Responsible Party):
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT01644721
First received: July 17, 2012
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

Background: All observational studies and a few randomised controlled trials (RCT) suggest that early measles vaccine (MV), in particular an early two-dose strategy, has a much better effect on overall mortality than later MV. These results suggest that MV has a non-measles related beneficial effect on child survival.

Objective: To evaluate in a two-site RCT the effect on child survival and other health indicators of a two-dose measles vaccination schedule by providing an additional dose of Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard measles vaccine at 9 months of age. The trials are planned in Guinea-Bissau and Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site separately and a 32% reduction overall. Based on the results from the RCT, the investigators will assess the cost-effectiveness of the intervention.

Design, Guinea-Bissau: Newborns are followed through the Health and Demographic Surveillance System (HDSS) of the Bandim Health Project. Information on routine and campaign vaccinations will be collected regularly through home visits and health centre registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3), the children will be eligible for enrollment in the trial if they are not severely ill. Eligible children will be invited to take part in the trial. Provided parental informed consent is given, the children will be randomised to MV at 4 and 9 months of age or only at 9 months. Cost estimates will be based on consumption of services and average cost per unit. The incremental cost effectiveness ratio will be calculated.

Sample size, follow-up and analyses: To detect a 40% reduction in overall mortality at each site the investigators intend to enroll at least 3,750 children in Guinea-Bissau. The children will be followed for survival and hospitalisations to 3 years of age or to the end of the study after three years. The investigators will analyse the effects by site and combined; by sex and season; possible interactions with other interventions like campaigns with drugs, vaccines or micronutrients will be explored.

Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of maternal antibody levels on subsequent antibody responses to MV. The children will be followed to 24 months of age and samples collected at 4, 9 and 24 months of age.


Condition Intervention Phase
Measles Vaccine
Biological: Early measles vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Two-site Randomised Trial of an Additional Measles Vaccine at 4 Months of Age to Reduce Child Mortality in Rural Areas of Burkina Faso and Guinea-Bissau

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Mortality [ Time Frame: 4 months - 3 years ] [ Designated as safety issue: No ]
    Overall mortality from 4 months to 3 years by sex and age at enrolment


Secondary Outcome Measures:
  • Mortality [ Time Frame: 4 to 9 months of age and from 9 months to 3 years of age ] [ Designated as safety issue: No ]
    Mortality from 4 to 9 months of age and from 9 months to 3 years of age

  • Morbidity [ Time Frame: 4 months - 3 years of age ] [ Designated as safety issue: No ]
    Hospital admissions, consultations, specific morbidity and measles infection

  • Growth
  • Antibody titres

Other Outcome Measures:
  • Immunological markers
    Provided funding becomes available


Estimated Enrollment: 3750
Study Start Date: July 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early measles vaccine
An additional measles vaccine at 4 months of age, at least 28 days after the third dose of pentavalent vaccine
Biological: Early measles vaccine
Standard Edmonston-Zagreb measles vaccine
No Intervention: Control
Follows the normal vaccination schedule

  Eligibility

Ages Eligible for Study:   4 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Children who

  • received the third dose of pentavalent vaccine at least 28 days before enrolment
  • are between 4 and 6 months old
  • belong to households of the existing HDSS

Exclusion Criteria:

Children

  • with serious malformation
  • who are severely sick (needing hospitalisation)
  • with high fever (>38.5 C axillary temperature)
  • who are severely malnourished (mid-upper-arm-circumference (MUAC) < 110 mm and/or bilateral peripheral oedema)
  • who have received neonatal vitamin A supplementation
  • whose parents/guardians state that they intend to permanently move out of the study area before the child reaches 9 months of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644721

Contacts
Contact: Cesario Martins, MD, PhD c.martins@bandim.org
Contact: Amabelia Rodrigues, PhD a.rodrigues@bandim.org

Locations
Guinea-Bissau
Bandim Health Project Recruiting
Bissau, Guinea-Bissau
Contact: Cesario Martins, MD, PhD       c.martins@bandim.org   
Contact: Amabelia Rodrigues, PhD       a.rodrigues@bandim.org   
Sponsors and Collaborators
Bandim Health Project
Centre de Recherche en Sante de Nouna, Burkina Faso
Navrongo Health Research Centre, Ghana
Heidelberg University
National Institute for Public Health and the Environment, RIVM, Holland
Investigators
Principal Investigator: Cesario Martins, MD,PhD Bandim Health Project
Principal Investigator: Amabelia Rodrigues, DMSc Bandim Health Project
Study Director: Peter Aaby, DMSc Bandim Health Project
  More Information

Publications:
Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT01644721     History of Changes
Other Study ID Numbers: OPTIMUNISE_BHP_early MV
Study First Received: July 17, 2012
Last Updated: August 6, 2014
Health Authority: Guinea-Bissau: Ministry of Health
Denmark: Ethics Committee

Keywords provided by Bandim Health Project:
Child mortality
Measles vaccine
Non-specific effects

Additional relevant MeSH terms:
Measles
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 27, 2014