Phase I study of safety and immunogenicity of an Escherichia coli-derived recombinant protective antigen (rPA) vaccine to prevent anthrax in adults.
The fatal disease caused by Bacillus anthracis is preventable with a prophylactic vaccine. The currently available anthrax vaccine requires a lengthy immunization schedule, and simpler and more immunogenic options for protection against anthrax are a priority for development. In this report we descr...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2010-11-01
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| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC2974626?pdf=render |
| _version_ | 1811219826621808640 |
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| author | Bruce K Brown Josephine Cox Anita Gillis Thomas C VanCott Mary Marovich Mark Milazzo Tanya Santelli Antonille Lindsay Wieczorek Kelly T McKee Karen Metcalfe Raburn M Mallory Deborah Birx Victoria R Polonis Merlin L Robb |
| author_facet | Bruce K Brown Josephine Cox Anita Gillis Thomas C VanCott Mary Marovich Mark Milazzo Tanya Santelli Antonille Lindsay Wieczorek Kelly T McKee Karen Metcalfe Raburn M Mallory Deborah Birx Victoria R Polonis Merlin L Robb |
| author_sort | Bruce K Brown |
| collection | DOAJ |
| description | The fatal disease caused by Bacillus anthracis is preventable with a prophylactic vaccine. The currently available anthrax vaccine requires a lengthy immunization schedule, and simpler and more immunogenic options for protection against anthrax are a priority for development. In this report we describe a phase I clinical trial testing the safety and immunogenicity of an anthrax vaccine using recombinant Escherichia coli-derived, B. anthracis protective antigen (rPA).A total of 73 healthy adults ages 18-40 were enrolled and 67 received 2 injections separated by 4 weeks of either buffered saline placebo, or rPA formulated with or without 704 µg/ml Alhydrogel® adjuvant in increasing doses (5, 25, 50, 100 µg) of rPA. Participants were followed for one year and safety and immunologic data were assessed. Tenderness and warmth were the most common post-injection site reactions. No serious adverse events related to the vaccine were observed. The most robust humoral immune responses were observed in subjects receiving 50 µg of rPA formulated with Alhydrogel® with a geometric mean concentration of anti-rPA IgG antibodies of 283 µg/ml and a toxin neutralizing geometric 50% reciprocal geometric mean titer of 1061. The highest lymphoproliferative peak cellular response (median Lymphocyte Stimulation Index of 29) was observed in the group receiving 25 µg Alhydrogel®-formulated rPA.The vaccine was safe, well tolerated and stimulated a robust humoral and cellular response after two doses.ClinicalTrials.gov NCT00057525. |
| first_indexed | 2024-04-12T07:32:25Z |
| format | Article |
| id | doaj.art-536b9783e5ae44dbbd58d330690a4703 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-04-12T07:32:25Z |
| publishDate | 2010-11-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-536b9783e5ae44dbbd58d330690a47032022-12-22T03:42:02ZengPublic Library of Science (PLoS)PLoS ONE1932-62032010-11-01511e1384910.1371/journal.pone.0013849Phase I study of safety and immunogenicity of an Escherichia coli-derived recombinant protective antigen (rPA) vaccine to prevent anthrax in adults.Bruce K BrownJosephine CoxAnita GillisThomas C VanCottMary MarovichMark MilazzoTanya Santelli AntonilleLindsay WieczorekKelly T McKeeKaren MetcalfeRaburn M MalloryDeborah BirxVictoria R PolonisMerlin L RobbThe fatal disease caused by Bacillus anthracis is preventable with a prophylactic vaccine. The currently available anthrax vaccine requires a lengthy immunization schedule, and simpler and more immunogenic options for protection against anthrax are a priority for development. In this report we describe a phase I clinical trial testing the safety and immunogenicity of an anthrax vaccine using recombinant Escherichia coli-derived, B. anthracis protective antigen (rPA).A total of 73 healthy adults ages 18-40 were enrolled and 67 received 2 injections separated by 4 weeks of either buffered saline placebo, or rPA formulated with or without 704 µg/ml Alhydrogel® adjuvant in increasing doses (5, 25, 50, 100 µg) of rPA. Participants were followed for one year and safety and immunologic data were assessed. Tenderness and warmth were the most common post-injection site reactions. No serious adverse events related to the vaccine were observed. The most robust humoral immune responses were observed in subjects receiving 50 µg of rPA formulated with Alhydrogel® with a geometric mean concentration of anti-rPA IgG antibodies of 283 µg/ml and a toxin neutralizing geometric 50% reciprocal geometric mean titer of 1061. The highest lymphoproliferative peak cellular response (median Lymphocyte Stimulation Index of 29) was observed in the group receiving 25 µg Alhydrogel®-formulated rPA.The vaccine was safe, well tolerated and stimulated a robust humoral and cellular response after two doses.ClinicalTrials.gov NCT00057525.http://europepmc.org/articles/PMC2974626?pdf=render |
| spellingShingle | Bruce K Brown Josephine Cox Anita Gillis Thomas C VanCott Mary Marovich Mark Milazzo Tanya Santelli Antonille Lindsay Wieczorek Kelly T McKee Karen Metcalfe Raburn M Mallory Deborah Birx Victoria R Polonis Merlin L Robb Phase I study of safety and immunogenicity of an Escherichia coli-derived recombinant protective antigen (rPA) vaccine to prevent anthrax in adults. PLoS ONE |
| title | Phase I study of safety and immunogenicity of an Escherichia coli-derived recombinant protective antigen (rPA) vaccine to prevent anthrax in adults. |
| title_full | Phase I study of safety and immunogenicity of an Escherichia coli-derived recombinant protective antigen (rPA) vaccine to prevent anthrax in adults. |
| title_fullStr | Phase I study of safety and immunogenicity of an Escherichia coli-derived recombinant protective antigen (rPA) vaccine to prevent anthrax in adults. |
| title_full_unstemmed | Phase I study of safety and immunogenicity of an Escherichia coli-derived recombinant protective antigen (rPA) vaccine to prevent anthrax in adults. |
| title_short | Phase I study of safety and immunogenicity of an Escherichia coli-derived recombinant protective antigen (rPA) vaccine to prevent anthrax in adults. |
| title_sort | phase i study of safety and immunogenicity of an escherichia coli derived recombinant protective antigen rpa vaccine to prevent anthrax in adults |
| url | http://europepmc.org/articles/PMC2974626?pdf=render |
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