James C King1, Yonghong Gao2, Conrad P Quinn3, Thomas M Dreier4, Cabrini Vianney5, Eric M Espeland2. 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.
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.
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