Measles and BCG Vaccines for Mother and Child
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age15-35
SponsorBandim Health Project
About this trial
In Africa, the mortality from infectious diseases remains high. The investigators have discovered that live vaccines such as the BCG vaccine against tuberculosis and the measles vaccine can strengthen resistance to other infections: they have beneficial "non-specific effects". The investigators have now seen signs that these non-specific effects for children are stronger if their mother has been given the same vaccines.
In Africa, BCG vaccine is recommended at birth and measles vaccine at 9 months of age. They are not used beyond childhood.
The investigators will randomize 2400 women to BCG vaccine, measles vaccine, or placebo. The investigators will further randomize their children to an extra early measles vaccine or placebo. The investigators will assess which of the resulting six vaccination schedules are best for women's and children's protection against measles, for the child's immune system, and for general health.
The project will be the first in the world to investigate the importance of vaccinating women with live vaccines.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female women in the fertile age
Non-pregnant
HIV-negative
Living in the BHP HDSS study area
Disqualifiers
Positive pregnancy test
Positive HIV test
Tuberculosis (previous or current)
Immunodeficiency
Trial design
Design model
Factorial
Treatments tested in this trial
BCG vaccine
Biological/VaccineIt is an attenuated live bacterial vaccine. This vaccine is a freeze-dried product that must be reconstituted.
Measles vaccine
Biological/VaccineIt is an attenuated live virus vaccine. This vaccine is a freeze-dried product that must be reconstituted.
Placebo
Other interventionSaline
Treatment groups
2,400 Participants
are divided into 3 treatment groupsGroup A: Measles vaccineExperimental treatment 1 intervention
Group B: BCG vaccineExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of children with maternal measles antibody
Children with maternal measles antibody
Time frame
20 weeks of age2
Proportion of children with maternal measles antibody
Children with maternal measles antibody
Time frame
9 months of age3
Yellow fever viral load after yellow fever vaccine
The level of yellow fever virus in the blood following yellow fever vaccine
Time frame
9 months of ageSecondary outcomes
1
Measles antibody levels in the women
Measles antibody levels in the women
Time frame
4 weeks after MV or BCG vaccine2
Measles antibody levels in children
Measles antibody levels in the children
Time frame
13.5 months of age3
Incidence of morbidity in women after MV or BCG compared with placebo
Diseases occurring post-randomisation in women
Time frame
Up to 12 months following vaccination4
Incidence of morbidity in children subsequently born to BCG, MV or placebo vaccinated mothers
Diseases occurring in children of randomised women
Time frame
Up to age 13.5 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bandim Health Project
Lead sponsor
The University of Western Australia
Collaborator
Université Libre de Bruxelles
Collaborator
Source ClinicalTrials.gov