Short summary

To conduct a cluster randomized controlled trial of a Measles Vaccination Campaign's effect on general child morbidity and mortality among children aged 9-59 months in Rural Guinea-Bissau within a context of limited measles infection. Children in the intervention group will receive a Measles Vaccination Campaign and children in the control group will not receive a Measles Vaccination Campaign.

Rationale

Studies from the Bandim Health Project in Guinea-Bissau, West Africa, and other low-income countries suggest that the measles vaccine reduces child mortality to an extent that cannot be ascribed to prevention of the measles infection itself; this live vaccine seems to have beneficial effects on general child mortality, also called beneficial non-specific effects. In an epidemiological review commissioned by the World Health Organization's Strategic Advisory Group of Experts on Immunizations, it was concluded that: "There was consistent evidence of a beneficial effect of measles vaccine (...)" and the group has called for more research on this topic. To our knowledge, no randomized trial has studied the effect of a Measles Vaccination Campaign on general child morbidity and mortality. Through beneficial non-specific effects of a Measles Vaccination Campaign, the general infectious pressure may be lowered. Furthermore, a repeated measles vaccine dose may boost the resistance against causes related to general mortality. Thus, if we examine the effect of the measles vaccine provided as a Measles Vaccination Campaign in a randomized trial, we will be able to measure the effect of a Measles Vaccination Campaign on general mortality and morbidity, as well as explore if the effect varies with prior measles vaccination status. 

Description of the cohort

Children aged 9-59 months living with registered families in the Bandim Health Project's Rural Health and Demographic Surveillance System will be eligible to enter our trial. Children will be excluded from our trial if they fulfill one of the following criteria: the child has a temperature >39°C or is overtly ill, the child has a mid-upper-arm-circumference <110 mm, the child has experienced an allergic reaction after a prior vaccination.

Data and biological material

The Bandim Health Project has been following a random sample of Guinea-Bissau's rural population through a Health and Demographic Surveillance System since the 1990's. The system assesses the effects of child health interventions on general child morbidity and mortality through continuous registrations of health status and interventions received by  children aged 0-59 months.

In 1990, 100 geographical clusters were randomly selected using methods recommended by the World Health Organization's Expanded Programme on Immunization for Surveys of Immunization Coverage. In 2006, additional 82 clusters were added to cover all Guinea-Bissau's nine health regions (Biombo, Oio, Cacheu, Gabu, Bafata, Quinara, Tombali, Bolama, Bubaque). Thus, 182 clusters with women of fertile age and more than 18,000 children below the age of 5 years are now under surveillance.

Every six months, mobile teams consisting of nurses and field workers visit all villages in all clusters. In the households, field workers register information on health interventions received and health status (mortality, hospital admissions and nutritional status) of all followed children through structured interviews. New children are added to the cohort by registering migrating children and new pregnancies. Prior to a first registration, mothers/guardians or pregnant women are requested for an oral consent. This setting will be the implementation platform for the RECAMP trial. 

Collaborating researchers and departments

The Bandim Health Project's Rural Health and Demographic Surveillance System

• Associate Professor Ane Bærent Fisker, MD, PhD

• Anthropologist and professor Peter Aaby
• PhD student Anshu Varma
• Statistician Aksel Georg Jensen, PhD

The Research Center for Vitamins and Vaccines in Denmark

• Professor Christine Stabell Benn, MD

• Epidemiologist Amabelia Rodrigues, PhD

Statens Seruminstitut, København

• Sanne Marie Thysen, MD