Phase 3 trial evaluating the immunogenicity and safety of a three-dose BioThrax® regimen for post-exposure prophylaxis in healthy adults
| Autor: | Cynthia Strout, Robert J. Hopkins, Ericka Hunter-Stitt, Brett Pleune, Katya Vert-Wong, Eric Sheldon, Paulina E. Kaptur, Derek Muse, Cris Howard, Matthew Davis |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent medicine.medical_treatment Immunization Secondary Anthrax Vaccines Pharmacology Anthrax Young Adult Internal medicine medicine Humans Post-exposure prophylaxis Adverse effect Aged General Veterinary General Immunology and Microbiology business.industry Immunogenicity Public Health Environmental and Occupational Health Anthrax Vaccine Adsorbed Middle Aged Antibodies Bacterial Antibodies Neutralizing Healthy Volunteers Confidence interval Vaccination Clinical trial Regimen Infectious Diseases Molecular Medicine Female Post-Exposure Prophylaxis business |
| Zdroj: | Vaccine. 32:2217-2224 |
| ISSN: | 0264-410X |
| DOI: | 10.1016/j.vaccine.2014.01.073 |
| Popis: | Background This study was conducted to support licensure of a post-exposure prophylaxis indication for BioThrax ® (anthrax vaccine adsorbed) concurrent with antimicrobials for individuals exposed to aerosolized anthrax spores. Methods The immunogenicity and safety of a three-dose regimen (0, 2, and 4 weeks) of BioThrax administered subcutaneously (SC) were evaluated in 200 healthy adults 18–65 years of age. Toxin-neutralizing antibody (TNA) was expressed as 50% neutralization factor (NF 50 ) at predetermined time points through Day 100. Safety was assessed by physical examinations, vital signs, solicited local and systemic reactions using web-enabled subject diaries, in-clinic solicited reactions, and unsolicited adverse events (AEs). Results The prospectively defined success criteria for the primary and secondary endpoints were met. This required the lower bound of the 95% confidence interval (CI) for the proportion of subjects with a TNA NF 50 value to be greater than 40% at Day 63 (primary), Day 70 (secondary) and Days 63–100 (secondary). At Day 63, 71% of subjects achieved a TNA NF 50 threshold value ≥0.56, with a lower bound of the 95% CI ≥40% (64%). The percentage of subjects achieving a TNA NF 50 threshold value ≥0.56 at Day 70 was 58% (95% CI: 50%, 65%), and the mean value on Days 63–100 (inclusive) was 53% (95% CI: 41%, 55%). The threshold TNA NF 50 value of 0.56 was developed from previous rabbit challenge and human immunogenicity studies. No related serious AEs occurred during the study, and no subjects withdrew from the study because of an AE. Tenderness and pain at the injection site were recorded most often in subject diaries following vaccination. Conclusions BioThrax, administered as three SC doses at 0, 2, and 4 weeks, was well tolerated. The prospectively defined success criteria for TNA levels on Days 63, 70, and 63–100 were achieved. |
| Databáze: | OpenAIRE |
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