PMID- 25850022
OWN - NLM
STAT- MEDLINE
DCOM- 20160119
LR  - 20220716
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Print)
IS  - 0264-410X (Linking)
VI  - 33
IP  - 21
DP  - 2015 May 15
TI  - Evaluation of anthrax vaccine safety in 18 to 20 year olds: A first step towards 
      age de-escalation studies in adolescents.
PG  - 2470-6
LID - S0264-410X(15)00390-4 [pii]
LID - 10.1016/j.vaccine.2015.03.071 [doi]
AB  - BACKGROUND/OBJECTIVES: Anthrax vaccine adsorbed (AVA, BioThrax((R))) 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.
CI  - Copyright (c) 2015 Elsevier Ltd. All rights reserved.
FAU - King, James C Jr
AU  - King JC Jr
AD  - 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.
FAU - Gao, Yonghong
AU  - Gao Y
AD  - Health and Human Services (HHS)/Assistant Secretary for Preparedness and 
      Response(ASPR)/Biomedical Advanced Research and Development Authority(BARDA), 
      United States.
FAU - Quinn, Conrad P
AU  - Quinn CP
AD  - 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.
FAU - Dreier, Thomas M
AU  - Dreier TM
AD  - 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.
FAU - Vianney, Cabrini
AU  - Vianney C
AD  - 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.
FAU - Espeland, Eric M
AU  - Espeland EM
AD  - Health and Human Services (HHS)/Assistant Secretary for Preparedness and 
      Response(ASPR)/Biomedical Advanced Research and Development Authority(BARDA), 
      United States.
LA  - eng
GR  - CC999999/ImCDC/Intramural CDC HHS/United States
GR  - HHS100200700037C/PHS HHS/United States
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20150405
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Anthrax Vaccines)
RN  - 0 (Antibodies, Bacterial)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Age Factors
MH  - Anthrax/*prevention & control
MH  - Anthrax Vaccines/administration & dosage/*adverse effects/immunology
MH  - Antibodies, Bacterial/blood
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/*pathology
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Retrospective Studies
MH  - Young Adult
PMC - PMC9024341
MID - NIHMS1798621
OTO - NOTNLM
OT  - Anthrax vaccine
OT  - Children
OT  - Pediatric medical countermeasure research
OT  - Presidential Ethics Committee
COIS- Conflict of interest statement The authors also do not have any conflict of 
      interest to disclose.
EDAT- 2015/04/08 06:00
MHDA- 2016/01/20 06:00
PMCR- 2022/04/22
CRDT- 2015/04/08 06:00
PHST- 2014/10/08 00:00 [received]
PHST- 2015/03/02 00:00 [revised]
PHST- 2015/03/24 00:00 [accepted]
PHST- 2015/04/08 06:00 [entrez]
PHST- 2015/04/08 06:00 [pubmed]
PHST- 2016/01/20 06:00 [medline]
PHST- 2022/04/22 00:00 [pmc-release]
AID - S0264-410X(15)00390-4 [pii]
AID - 10.1016/j.vaccine.2015.03.071 [doi]
PST - ppublish
SO  - Vaccine. 2015 May 15;33(21):2470-6. doi: 10.1016/j.vaccine.2015.03.071. Epub 2015 
      Apr 5.