Effect of reduced dose schedules and intramuscular injection of anthrax vaccine adsorbed on immunological response and safety profile: A randomized trial

• Published in: Vaccine Vol. 32; no. 8; pp. 1019 - 1028
• Main Authors: Wright, Jennifer G, Plikaytis, Brian D, Rose, Charles E, Parker, Scott D, Babcock, Janiine, Keitel, Wendy, El Sahly, Hana, Poland, Gregory A, Jacobson, Robert M, Keyserling, Harry L, Semenova, Vera A, Li, Han, Schiffer, Jarad, Dababneh, Hanan, Martin, Sandra K, Martin, Stacey W, Marano, Nina, Messonnier, Nancy E, Quinn, Conrad P
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 12.02.2014; Elsevier; Elsevier Limited
• Subjects: Adult; Adverse events; Allergy and Immunology; Anthrax - prevention & control; Anthrax vaccines; Anthrax Vaccines - administration & dosage; Antibodies, Bacterial - blood; Antibody Formation; Applied microbiology; Bacillus anthracis; Bacterial vaccines; Bacteriology; Biological and medical sciences; Disease control; Double-Blind Method; Drug dosages; Female; Fundamental and applied biological sciences. Psychology; Humans; Immunization, Secondary; Immunoglobulin G - blood; Injection; Injections; Injections, Intramuscular; Licenses; Male; Microbiology; Middle Aged; Miscellaneous; Studies; Vaccination; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Bacillus anthracis; FDA; CDC; United States Army Medical Materiel Agency; Vaccination; subcutaneous; Anthrax vaccines; Centers for Disease Control and Prevention; Adverse events; protective antigen; intramuscularly; SQ; Food and Drug Administration; lethal toxin; Anthrax Vaccine Research Program; Good Clinical Practices; USAMMA; IM; AE; adverse event; Investigational New Drug; AVA; Department of Defense; AVRP; PA; LTx; GCP; Bacterial vaccines; DoD; anthrax vaccine adsorbed; IND; Toxicity; Vaccine; Bacillaceae; Infection; Bacillales; Anthrax; Bacteriosis; Bacteria
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2013.10.039

Highlights • Anthrax vaccine adsorbed (AVA) is the only US licensed anthrax vaccine. • AVA administered intramuscularly results in a lower proportion of injection site adverse events compared to subcutaneous administration. • Immunological priming is complete upon administration of 3 IM doses of AVA at months 0, 1, and 6. • Longer time periods between booster doses achieve higher antibody responses than shorter time periods (12 months). • Establishment of immunological memory and potent anamnestic responses indicate significant potential to reduce the booster schedule.