Evaluation of anthrax vaccine safety in 18 to 20 year olds: A first step towards age de-escalation studies in adolescents✩

Details

• Alternative Title:
  Vaccine
• Personal Author:
  King, James C. ; Gao, Yonghong ; Quinn, Conrad P. ; Dreier, Thomas M. ; Vianney, Cabrini ; Espeland, Eric M.
• Description:
  Background/objectives: ; Anthrax vaccine adsorbed (AVA, BioThrax®) is recommended for post-exposure prophylaxis administration for the US population in response to large-scale Bacillus anthracis spore exposure. However, no information exists on AVA use in children and ethical barriers exist to performing pre-event pediatric AVA studies. A Presidential Ethics Commission proposed a potential pathway for such studies utilizing an age de-escalation process comparing safety and immunogenicity data from 18 to 20 year-olds to older adults and if acceptable proceeding to evaluations in younger adolescents. We conducted exploratory summary re-analyses of existing databases from 18 to 20 year-olds (n = 74) compared to adults aged 21 to 29 years (n = 243) who participated in four previous US government funded AVA studies. ; Methods: ; Data extracted from studies included elicited local injection-site and systemic adverse events (AEs) following AVA doses given subcutaneously at 0, 2, and 4 weeks. Additionally, proportions of subjects with ≥4-fold antibody rises from baseline to post-second and post-third AVA doses (seroresponse) were obtained. ; Results: ; Rates of any elicited local AEs were not significantly different between younger and older age groups for local events (79.2% vs. 83.8%, P = 0.120) or systemic events (45.4% vs. 50.5%, P = 0.188). Robust and similar proportions of seroresponses to vaccination were observed in both age groups. ; Conclusions: ; AVA was safe and immunogenic in 18 to 20 year-olds compared to 21 to 29 year-olds. These results provide initial information to anthrax and pediatric specialists if AVA studies in adolescents are required.
• Subjects:
  • Article
  • Pediatric medical countermeasure research
  • Anthrax vaccine
  • Presidential Ethics Committee
  • Children
  • Adolescent
  • Adult
  • Age Factors
  • Anthrax
  • Anthrax Vaccines
  More +
• Source:
  Vaccine. 33(21):2470-2476
• Pubmed ID:
  25850022
• Pubmed Central ID:
  PMC9024341
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/ ; HHS100200700037C/PHS HHSUnited States/
• Volume:
  33
• Issue:
  21
• Download URL:
  https://stacks.cdc.gov/view/cdc/116648/cdc_116648_DS1.pdf
• File Type:
  [PDF - 352.69 KB]
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:6539c709e28cacb6fb7a4cd3bd01ef6014772e03ff43b4795029cf5d06ce6412