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Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria vaccine : randomized phase 1b trial in semi-immune adults & children

Cech, Patrick Georges and Aebi, Thomas and Abdallah, Mwanajaa Shomari and Mpina, Maxmillian and Machunda, Ester Barnabas and Westerfeld, Nicole and Stoffel, Sabine Alexandra and Zurbriggen, Rinaldo and Pluschke, Gerd and Tanner, Marcel and Daubenberger, Claudia and Genton, Blaise and Abdulla, Salim. (2011) Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria vaccine : randomized phase 1b trial in semi-immune adults & children. PLoS one, Vol. 6, H. 7 , e22273.

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Official URL: http://edoc.unibas.ch/dok/A6002388

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Abstract

BACKGROUND: This trial was conducted to evaluate the safety and immunogenicity of two virosome formulated malaria peptidomimetics derived from Plasmodium falciparum AMA-1 and CSP in malaria semi-immune adults and children. METHODS: The design was a prospective randomized, double-blind, controlled, age-deescalating study with two immunizations. 10 adults and 40 children (aged 5-9 years) living in a malaria endemic area were immunized with PEV3B or virosomal influenza vaccine Inflexal(R)V on day 0 and 90. RESULTS: No serious or severe adverse events (AEs) related to the vaccines were observed. The only local solicited AE reported was pain at injection site, which affected more children in the Inflexal(R)V group compared to the PEV3B group (p = 0.014). In the PEV3B group, IgG ELISA endpoint titers specific for the AMA-1 and CSP peptide antigens were significantly higher for most time points compared to the Inflexal(R)V control group. Across all time points after first immunization the average ratio of endpoint titers to baseline values in PEV3B subjects ranged from 4 to 15 in adults and from 4 to 66 in children. As an exploratory outcome, we found that the incidence rate of clinical malaria episodes in children vaccinees was half the rate of the control children between study days 30 and 365 (0.0035 episodes per day at risk for PEV3B vs. 0.0069 for Inflexal(R)V; RR = 0.50 [95%-CI: 0.29-0.88], p = 0.02). CONCLUSION: These findings provide a strong basis for the further development of multivalent virosomal malaria peptide vaccines. TRIAL REGISTRATION: ClinicalTrials.gov NCT00513669
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Medical Parasitology and Infection Biology > Molecular Immunology (Pluschke)
03 Faculty of Medicine > Departement Public Health > Sozial- und Präventivmedizin > Malaria Vaccines (Tanner)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Former Units within Swiss TPH > Malaria Vaccines (Tanner)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Epidemiology and Public Health (EPH) > Health Interventions > Malaria Interventions (Lengeler)
UniBasel Contributors:Daubenberger, Claudia and Pluschke, Gerd and Genton, Blaise and Tanner, Marcel
Item Type:Article, refereed
Bibsysno:Link to catalogue
Publisher:PubMed Central
ISSN:1932-6203
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:08 Nov 2012 16:22
Deposited On:08 Nov 2012 16:10

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