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

AbstractOBJECTIVE:
We evaluated an alternative administration route, reduced schedule priming series, and increased intervals between booster doses for anthrax vaccine adsorbed (AVA). AVA's originally licensed schedule was 6 subcutaneous (SQ) priming injections administered at months (m) 0, 0.5, 1, 6, 12 and 18 with annual boosters; a simpler schedule is desired.
METHODS:
Through a multicenter randomized, double blind, non-inferiority Phase IV human clinical trial, the originally licensed schedule was compared to four alternative and two placebo schedules. 8-SQ group participants received 6 SQ injections with m30 and m42 "annual" boosters; participants in the 8-IM group received intramuscular (IM) injections according to the same schedule. Reduced schedule groups (7-IM, 5-IM, 4-IM) received IM injections at m0, m1, m6; at least one of the m0.5, m12, m18, m30 vaccine doses were replaced with saline. All reduced schedule groups received a m42 booster. Post-injection blood draws were taken two to four weeks following injection. Non-inferiority of the alternative schedules was compared to the 8-SQ group at m2, m7, and m43. Reactogenicity outcomes were proportions of injection site and systemic adverse events (AEs).
RESULTS:
The 8-IM group's m2 response was non-inferior to the 8-SQ group for the three primary endpoints of anti-protective antigen IgG geometric mean concentration (GMC), geometric mean titer, and proportion of responders with a 4-fold rise in titer. At m7 anti-PA IgG GMCs for the three reduced dosage groups were non-inferior to the 8-SQ group GMCs. At m43, 8-IM, 5-IM, and 4-IM group GMCs were superior to the 8-SQ group. Solicited injection site AEs occurred at lower proportions in the IM group compared to SQ. Route of administration did not influence the occurrence of systemic AEs. A 3 dose IM priming schedule with doses administered at m0, m1, and m6 elicited long term immunological responses and robust immunological memory that was efficiently stimulated by a single booster vaccination at 42 months.
CONCLUSIONS:
A priming series of 3 intramuscular doses administered at m0, m1, and m6 with a triennial booster was non-inferior to more complex schedules for achieving antibody response.
AuthorsJennifer G Wright, Brian D Plikaytis, Charles E Rose, Scott D Parker, Janiine Babcock, Wendy Keitel, Hana El Sahly, Gregory A Poland, Robert M Jacobson, Harry L Keyserling, Vera A Semenova, Han Li, Jarad Schiffer, Hanan Dababneh, Sandra K Martin, Stacey W Martin, Nina Marano, Nancy E Messonnier, Conrad P Quinn
JournalVaccine (Vaccine) Vol. 32 Issue 8 Pg. 1019-28 (Feb 12 2014) ISSN: 1873-2518 [Electronic] Netherlands
PMID24373307 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)
CopyrightPublished by Elsevier Ltd.
Chemical References
  • Anthrax Vaccines
  • Antibodies, Bacterial
  • Immunoglobulin G
Topics
  • Adult
  • Anthrax (prevention & control)
  • Anthrax Vaccines (administration & dosage)
  • Antibodies, Bacterial (blood)
  • Antibody Formation
  • Double-Blind Method
  • Female
  • Humans
  • Immunization, Secondary
  • Immunoglobulin G (blood)
  • Injections, Intramuscular
  • Male
  • Middle Aged

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