gms | German Medical Science

10. Kongress für Infektionskrankheiten und Tropenmedizin (KIT 2010)

Deutsche Gesellschaft für Infektiologie,
Deutsche AIDS-Gesellschaft,
Deutsche Gesellschaft für Tropenmedizin und Internationale Gesundheit,
Paul-Ehrlich-Gesellschaft für Chemotherapie

23.06. - 26.06.2010, Köln

Phase 1b randomized controlled double blind trial to evaluate the safety and immunogenicity of GMZ2 malaria vaccine candidate in healthy Gabonese children aged 1 to 5 years

Phase 1b randomisierte kontrollierte doppelblinde Studie zur Sicherheit und Immunogenität des Malaria-Impfstoffkandidats GMZ2 an gesunden Kindern in Gabun im Alter von 1–5 Jahren

Meeting Abstract

  • S. Bélard - Medical Research Unit, Albert Schweitzer Hospital, Lambaréné, Gabon; University Hospital of Freiburg, Centre for Paediatrics and Adolescent Medicine, Freiburg, Germany
  • S. Issifou - Medical Research Unit, Albert Schweitzer Hospital, Lambaréné, Gabon
  • N. Ramadhani - African Malaria Network Trust, Dar es Salaam, Tanzania
  • P.G. Kremsner - Medical Research Unit, Albert Schweitzer Hospital, Lambaréné, Gabon; University of Tübingen, Germany
  • B. Mordmüller - Medical Research Unit, Albert Schweitzer Hospital, Lambaréné, Gabon; University of Tübingen, Germany

10. Kongress für Infektionskrankheiten und Tropenmedizin (KIT 2010). Köln, 23.-26.06.2010. Düsseldorf: German Medical Science GMS Publishing House; 2010. DocP84

DOI: 10.3205/10kit139, URN: urn:nbn:de:0183-10kit1397

Published: June 2, 2010

© 2010 Bélard et al.
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Outline

Text

Background: Malaria is still a major health thread in Sub-Saharan Africa. An effective vaccine could be a sustainable control measure easy to integrate into health infrastructures such as the extended program on immunization. The malaria vaccine candidate GMZ2 is a recombinant fusion protein of conserved parts of Plasmodium falciparum Glutamate Rich Protein (GLURP) and Merozoite Surface Protein 3 (MSP3), and is adjuvanted with aluminium hydroxide. In clinical trials GMZ2 showed immunogenicity and good safety in adults. Subsequently, GMZ2 was to be evaluated in children, the target population.

Methods: Primary objective was to evaluate the safety and reactogenicity of three doses of 30 and 100 µg GMZ2 in comparison with three doses of the control vaccine (rabies) in healthy Gabonese children aged 1–5 years. Secondary objective was to assess the humoral response to the vaccine antigens by measuring total IgG and IgG subclasses by ELISA and antigen-specific memory B-cells by ELISPOT. Follow-up was carried out for 1 year.

Results: The study was performed in Gabon from September 2008 to November 2009. 30 healthy children aged 1-5 years were enrolled and all received either three doses of 30 µg or 100 µg GMZ2 or rabies vaccine with monthly intervals. Induration was the most prevalent solicited local reaction, followed by pain and swelling. All local reactions were of mild intensity and resolved after 14 days. The most frequent solicited systemic reactions were loss of appetite and fever up to grade 3 (>39°C) intensity, which was related to concomitant diseases. No vaccine related serious adverse event occurred. Unsolicited adverse events were of mild or moderate intensity and not related to study vaccines. GMZ2 vaccine induced an increase of IgG against GMZ2, GLURP and MSP3, this effect was most pronounced for GMZ2 and GLURP. Immunogenicity was shown by a clear difference in specific IgG elevation in the two GMZ2 vaccine regimens versus the control vaccine.

Conclusion: The clinical and biological results suggest that three doses of 30µg and 100µg GMZ2 malaria vaccine candidate, administered in monthly intervals, are safe and well tolerated by children from malaria endemic Central Africa. Observed immunogenicity has now to be evaluated in phase II trials for protection against morbidity due to infection by P. falciparum.