Format

Send to

Choose Destination
Vaccine. 2015 May 15;33(21):2470-6. doi: 10.1016/j.vaccine.2015.03.071. Epub 2015 Apr 5.

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

Author information

1
Tunnell Contracting, Serving the Mission of: Health and Human Services (HHS)/Assistant Secretary for Preparedness and Response(ASPR)/Biomedical Advanced Research and Development Authority(BARDA), Thomas P. O'Neill Federal Building (FOB8), 200 C Street, SW, Washington, DC 20024. Electronic address: james.king@hhs.gov.
2
Health and Human Services (HHS)/Assistant Secretary for Preparedness and Response(ASPR)/Biomedical Advanced Research and Development Authority(BARDA), United States.
3
MPIR Laboratory, MVPD/DBD/NCIRD, Centers for Disease Control & Prevention, MS-D01, Bldg. 23, Room 8-161, 1600 Clifton Road, Atlanta, GA 30333, United States.
4
Tunnell Contracting, Serving the Mission of: Health and Human Services (HHS)/Assistant Secretary for Preparedness and Response(ASPR)/Biomedical Advanced Research and Development Authority(BARDA), Thomas P. O'Neill Federal Building (FOB8), 200 C Street, SW, Washington, DC 20024.
5
GAP Solutions Inc. Supporting the Mission of Health and Human Services (HHS)/Assistant Secretary for Preparedness and Response(ASPR)/Biomedical Advanced Research and Development Authority(BARDA), United States.

Abstract

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.

KEYWORDS:

Anthrax vaccine; Children; Pediatric medical countermeasure research; Presidential Ethics Committee

PMID:
25850022
DOI:
10.1016/j.vaccine.2015.03.071
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center