Virosome-Formulated Plasmodium falciparum AMA-1 & CSP Derived Peptides as Malaria Vaccine: Randomized Phase 1b Trial in Semi-Immune Adults & Children
| Autor: | Thomas Aebi, Claudia Daubenberger, Ester Barnabas Machunda, Gerd Pluschke, Mwanajaa Shomari Abdallah, Maxmillian Mpina, Salim Abdulla, Patrick G. Cech, Blaise Genton, Sabine A Stoffel, Marcel Tanner, Nicole Westerfeld, Rinaldo Zurbriggen |
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| Rok vydání: | 2011 |
| Předmět: |
Male
efficacy Protozoan Proteins lcsh:Medicine immunogenicity Tanzania Clinical trials vaccine lcsh:Science Child Vaccines Multidisciplinary biology Malaria vaccine Immunogenicity Vaccination Middle Aged peptide Virosome Infectious Diseases Child Preschool Medicine Female Research Article safety Adult medicine.medical_specialty Adolescent Virosomes Influenza vaccine Immunology Plasmodium falciparum Antigens Protozoan Young Adult Phase I Internal medicine Vaccine Development Malaria Vaccines parasitic diseases Parasitic Diseases medicine Humans Adverse effect lcsh:R Immunity Tropical Diseases (Non-Neglected) Membrane Proteins medicine.disease biology.organism_classification Malaria Immunization Humoral Immunity lcsh:Q Clinical Immunology Peptidomimetics Clinical research design |
| Zdroj: | PLoS ONE PLoS ONE, Vol 6, Iss 7, p e22273 (2011) Plos One, vol. 6, no. 7, pp. e22273 |
| ISSN: | 1932-6203 |
| DOI: | 10.1371/journal.pone.0022273 |
| Popis: | 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®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®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®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®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. |
| Databáze: | OpenAIRE |
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