BCG Immunology Study: Protective immunity following neonatal BCG vaccination
Malawi, 2007 - 2010
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MWI-MEIRU-BIS-2007-v1
BCG Immunology Study: Protective immunity following neonatal BCG vaccination
| Name | Country code |
|---|---|
| Malawi | MWI |
Clinical Trial
Tuberculosis (TB) has been declared a global emergency by the WHO and remains a major public health problem worldwide, with more than 8 million new cases and over 2 million deaths each year. Bacille Calmette-Guerin (BCG) vaccination protects young children from disseminated forms of TB when given to infants, and many developing countries, including Malawi, follow the extended programme for immunization (EPI) recommendation that it be given at birth or first contact with health services. Although BCG vaccination protects against childhood forms of TB, it does not protect young adults against pulmonary TB in endemic settings. Waning of T cell memory and exposure to environmental mycobacteria in these populations have been proposed to explain the partial failure of BCG. A number of immunisation strategies were being investigated that were designed to enhance protection induced by BCG vaccination. A key aspect of such studies was to investigate new immunological markers that are predictive of protective immunity from TB.
The aim of this study was to characterise antigen-specific T cell responses to a range of novel mycobacterial antigens 3, 12 and 36 months after BCG vaccination to identify likely new markers of protection.
This was done prospectively by following BCG-vaccinated children over a period of three years. In parallel we also evaluated immune responses to environmental mycobacteria and the effect of environmental mycobacterial exposure on the induction of BCG-specific immune responses in young children.
Samples were collected from peripheral blood for antigen-specific immunoassays, and RNA and serum stored for analyses of host biomarkers of protection following vaccination.
This study was part of a multi-centre study involving other sites in South Africa and the UK, using reagents generated by collaborators in Germany, Netherlands and Denmark. The results of this study were to enable the definition of immune correlates that will aid the development of new TB vaccines that will be more effective than BCG in an African setting.
NHSRC approval number: 484
Individual
Version
2020-05-11
Scope
Woman's education and occupation, Father of this pregnancy, Marital Status, This pregnancy, Reproductive history, Last birth to now, Child residence and survival, Contraception, TB case finding, BCG scar survey, medical help during this pregnancy, EXAMINATION, SAMPLES COLLECTED, POSTNATAL CHECK, FEEDING PRACTICES,
BABY VACCINATION RECORD
| Topic | Vocabulary |
|---|---|
| Tuberculosis | MeSH |
| Tuberculosis Vaccines | MeSH |
| BCG Vaccine | MeSH |
| Biomarkers | MeSH |
| Immunology | MeSH |
| Malawi | MeSH |
Coverage
Chilumba Karonga
Infants vaccinated with BCG within one week of birth, followed up for 12 months
Producers and sponsors
| Name | Affiliation |
|---|---|
| Dr Kate Watkins, Immunologist, | Karonga Prevention Study, Chilumba, Malawi |
| Name | Affiliation | Role |
|---|---|---|
| Mr Hazzie Mvula, Paediatric Clinical Officer | Karonga Prevention Study, Chilumba, Malawi | Co-Investigator |
| Professor Hazel Dockrell, Professor of Immunology | London School of Hygiene and Tropical Medicine, UK | Co-Investigator |
| Ms Maeve Lalor, Research Assistant | London School of Hygiene and Tropical Medicine, UK | Co-Investigator |
| Dr Nuala McGrath, Field Director & Epidemiologist | London School of Hygiene and Tropical Medicine, UK | Co-Investigator |
| Dr Neil French, Director | London School of Hygiene and Tropical Medicine, UK | Co-Investigator |
| Dr Amelia (Mia) Crampin, Epidemiologist | London School of Hygiene and Tropical Medicine, UK | Co-Investigator |
| Name | Abbreviation |
|---|---|
| Wellcome Trust, UK | WT |
| Name |
|---|
| MEIRU Core datamanagement team |
Data collection
| Start | End |
|---|---|
| 2007-02-19 | 2010-08-17 |
- Face-to-face [f2f]
| Name | Abbreviation |
|---|---|
| Malawi Epidemiology and Intervention Research Unit | MEIRU |
Data Access
| Name |
|---|
| Malawi Epidemiology and Intervention Research Unit |
These data are made available for licensed access under the following conditions:
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Data and other material provided by MEIRU will not be redistributed or sold to other individuals, institutions or organisations without MEIRU's written agreement.
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In the case of multi-centre datasets, data originating from a single contributing member centre of the collaboration may not be analysed or reported on in isolation without the express permission of the member centre concerned.
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No attempt will be made to re-identify respondents, and there will be no use of the identity of any person or establishment discovered inadvertently. Any such discovery will be reported immediately to MEIRU.
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No attempt will be made to produce links between datasets provided by MEIRU or between MEIRU data and other datasets that could identify individuals.
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Any books, articles, conference papers, theses, dissertations, reports or other publications employing data obtained from MEIRU will cite the source, in line with the citation requirement provided with the dataset.
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An electronic copy of all publications based on the requested data will be sent to MEIRU.
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MEIRU, MEIRU research collaborators and the relevant funding agencies bear no responsibility for the data's use or interpretation or inferences based upon it.
Metadata production
DDI-MWI-MEIRU-BIS-2007-v1
| Name | Abbreviation | Affiliation | Role |
|---|---|---|---|
| Themba Chirwa | TC | MEIRU | Metadata Editing and Entry Officer |
| Elizabeth Nancy Munthali | ENM | MEIRU | Metadata supervisor |
| Chifundo Kanjala | CK | MEIRU | Documentation planning and supervision |
| Estelle McLean | EM | LSHTM | Production of the documentation used to create this DDI document |
2020-05-11
Metadata version
Version 1 (May 2020)