Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria vaccine: randomized phase 1b trial in semi-immune adults & children.
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.The design was a prospective randomized, double-blind, controlled, age-deescalating study...
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2011-01-01
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| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC3142124?pdf=render |
| _version_ | 1819099968781156352 |
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| author | Patrick Georges Cech Thomas Aebi Mwanajaa Shomari Abdallah Maxmillian Mpina Ester Barnabas Machunda Nicole Westerfeld Sabine Alexandra Stoffel Rinaldo Zurbriggen Gerd Pluschke Marcel Tanner Claudia Daubenberger Blaise Genton Salim Abdulla |
| author_facet | Patrick Georges Cech Thomas Aebi Mwanajaa Shomari Abdallah Maxmillian Mpina Ester Barnabas Machunda Nicole Westerfeld Sabine Alexandra Stoffel Rinaldo Zurbriggen Gerd Pluschke Marcel Tanner Claudia Daubenberger Blaise Genton Salim Abdulla |
| author_sort | Patrick Georges Cech |
| collection | DOAJ |
| description | 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.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.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).These findings provide a strong basis for the further development of multivalent virosomal malaria peptide vaccines.ClinicalTrials.gov NCT00513669. |
| first_indexed | 2024-12-22T00:55:19Z |
| format | Article |
| id | doaj.art-5c1e302c45db4532a841b6ffee7f25e1 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-22T00:55:19Z |
| publishDate | 2011-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-5c1e302c45db4532a841b6ffee7f25e12022-12-21T18:44:19ZengPublic Library of Science (PLoS)PLoS ONE1932-62032011-01-0167e2227310.1371/journal.pone.0022273Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria vaccine: randomized phase 1b trial in semi-immune adults & children.Patrick Georges CechThomas AebiMwanajaa Shomari AbdallahMaxmillian MpinaEster Barnabas MachundaNicole WesterfeldSabine Alexandra StoffelRinaldo ZurbriggenGerd PluschkeMarcel TannerClaudia DaubenbergerBlaise GentonSalim AbdullaThis 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.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.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).These findings provide a strong basis for the further development of multivalent virosomal malaria peptide vaccines.ClinicalTrials.gov NCT00513669.http://europepmc.org/articles/PMC3142124?pdf=render |
| spellingShingle | Patrick Georges Cech Thomas Aebi Mwanajaa Shomari Abdallah Maxmillian Mpina Ester Barnabas Machunda Nicole Westerfeld Sabine Alexandra Stoffel Rinaldo Zurbriggen Gerd Pluschke Marcel Tanner Claudia Daubenberger Blaise Genton Salim Abdulla Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria vaccine: randomized phase 1b trial in semi-immune adults & children. PLoS ONE |
| title | Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria vaccine: randomized phase 1b trial in semi-immune adults & children. |
| title_full | Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria vaccine: randomized phase 1b trial in semi-immune adults & children. |
| title_fullStr | Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria vaccine: randomized phase 1b trial in semi-immune adults & children. |
| title_full_unstemmed | Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria vaccine: randomized phase 1b trial in semi-immune adults & children. |
| title_short | Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria vaccine: randomized phase 1b trial in semi-immune adults & children. |
| title_sort | virosome formulated plasmodium falciparum ama 1 csp derived peptides as malaria vaccine randomized phase 1b trial in semi immune adults children |
| url | http://europepmc.org/articles/PMC3142124?pdf=render |
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