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Evaluation of diphtheria - and tetanus-toxin neutralizing anibody activity in human and animal sera

Objective

* To investigate the nature of the reported absence of correlation between in vitro toxin neutralization assays and in vivo neutralization tests for diphtheria (and to a lesser extent tetanus) antibodies and to develop a practical solution for this phenomenon.
* To improve research and development capacity in vaccine quality control laboratories of public sector vaccine producers in two developing countries (Indonesia and Vietnam).
* To ensure quality in immunization programmes and local vaccine production by developing and making available scientifically validated test systems that can be used in developing countries.
Expected Outcome

* Understanding of the factors which have an effect on the mechanism of toxin neutralization.
* Recommendations to regulatory authorities on the selection and standardization of in vitro toxin neutralization tests.
* Research training to 2 Bio Farma and 2 IVAC staff workers for a period of 4 months each.
* The organization of a workshop on the immunological aspects of diphtheria toxin neutralization and antiserum production.
* Improved horse immunization schedules and the introduction of plasmaphoresis for the production of anti-D serum.
* Establisment of anti-diphtheria serumpanels from 4 different species
* Study of kinetics of neutralization test systems for diphtheria in in vitro tests (Vero cell test, ToBI, Double antigen ELISA, DELFIA) and in vivo tests (skin test in guinea pigs) using high, intermediate and low doses of toxin.
* Standardization of one or two selected in vitro toxin neutralization test systems, with established validity for the in vivo neutralization mechanism.
* Improve horse hyper-immunization schedules and introduction of plasmaphoresis.
* Provide research training to staff at RIVM (two from Vietnam and two from Indonesia) and implement/improve in vitro techniques in Vietnam and in Indonesia.
* Hold two project meetings: one at the onset of the project and one at mid-term, to upgrade research training.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

Rijksinstituut voor Volksgezondheid en Milieuhygiène
Address
9,Antonie Van Leeuwenhoeklaan
3720 BA Bilthoven
Netherlands

Participants (3)

Bio Farma
Indonesia
Address
28,Jl. Pasteur
40161 Bandung
Institute of Vaccines and Biological Substances
Vietnam
Address
9,Pasteur Street
58 Nha Trang
Statens Serum Institut
Denmark
Address
5,Artillerivej
2300 Kobenhavn A