Ability of ELISA and a toxin neutralization assay to detect changes in immunogenicity of a recombinant Bacillus anthracis protective antigen vaccine upon storage

Rocío I. Domínguez-Castillo; Anita Verma; Juan C. Amador-Molina; Lev Sirota; Juan L. Arciniega

doi:10.1016/j.biologicals.2012.10.002

Ability of ELISA and a toxin neutralization assay to detect changes in immunogenicity of a recombinant Bacillus anthracis protective antigen vaccine upon storage

Rocío I. Domínguez-Castillo, Anita Verma, Juan C. Amador-Molina, Lev Sirota, Juan L. Arciniega

Research output: Contribution to journal › Article › peer-review

5 Scopus citations

Abstract

We examined the capability of a mouse immunogenicity assay to detect improper storage of a recombinant protective antigen (rPA)-based anthrax vaccine formulated with an aluminum adjuvant, using ELISA and a toxin neutralization assay (TNA) to measure the antibody response to rPA. The vaccine was stored at 4 °C, room temperature (RT) or 37 °C for one, four and eight weeks and used for immunization, along with freshly prepared vaccine. Results showed that, contrary to ELISA, TNA is suitable to detect a loss of immunogenicity of the rPA vaccine following its exposure to RT for a period of eight weeks and to 37 °C for a period as short as 1 week.

Original language	English (US)
Pages (from-to)	111-114
Number of pages	4
Journal	Biologicals
Volume	41
Issue number	2
DOIs	https://doi.org/10.1016/j.biologicals.2012.10.002
State	Published - Mar 2013
Externally published	Yes

Keywords

ELISA
Potency test
RPA-based anthrax vaccine
TNA

ASJC Scopus subject areas

Biotechnology
Bioengineering
Applied Microbiology and Biotechnology
General Immunology and Microbiology
Pharmacology

Access to Document

10.1016/j.biologicals.2012.10.002

Cite this

@article{368786faaede41509c65fbf19d72ac99,

title = "Ability of ELISA and a toxin neutralization assay to detect changes in immunogenicity of a recombinant Bacillus anthracis protective antigen vaccine upon storage",

abstract = "We examined the capability of a mouse immunogenicity assay to detect improper storage of a recombinant protective antigen (rPA)-based anthrax vaccine formulated with an aluminum adjuvant, using ELISA and a toxin neutralization assay (TNA) to measure the antibody response to rPA. The vaccine was stored at 4 °C, room temperature (RT) or 37 °C for one, four and eight weeks and used for immunization, along with freshly prepared vaccine. Results showed that, contrary to ELISA, TNA is suitable to detect a loss of immunogenicity of the rPA vaccine following its exposure to RT for a period of eight weeks and to 37 °C for a period as short as 1 week.",

keywords = "ELISA, Potency test, RPA-based anthrax vaccine, TNA",

author = "Dom{\'i}nguez-Castillo, {Roc{\'i}o I.} and Anita Verma and Amador-Molina, {Juan C.} and Lev Sirota and Arciniega, {Juan L.}",

note = "Funding Information: This project was supported in part by the Biomedical Advanced Research Development Authority (BARDA) and for an appointment (JC A-M) to the Research Participation Program at the Center for Biologics Evaluation and Research administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and the U.S. Food and Drug Administration. The following reagents were obtained from the NIH Biodefense and Emerging Infections Research Resources Repository, NIAID, NIH: anthrax PA, recombinant from Bacillus anthracis, NR-140 and from E. coli, NR-164; anthrax LF, recombinant from Bacillus anthracis, NR-142; and J774A.1 monocyte/macrophage (mouse) working cell bank, NR-28. ",

year = "2013",

month = mar,

doi = "10.1016/j.biologicals.2012.10.002",

language = "English (US)",

volume = "41",

pages = "111--114",

journal = "Biologicals",

issn = "1045-1056",

publisher = "Academic Press Inc.",

number = "2",

}

TY - JOUR

T1 - Ability of ELISA and a toxin neutralization assay to detect changes in immunogenicity of a recombinant Bacillus anthracis protective antigen vaccine upon storage

AU - Domínguez-Castillo, Rocío I.

AU - Verma, Anita

AU - Amador-Molina, Juan C.

AU - Sirota, Lev

AU - Arciniega, Juan L.

N1 - Funding Information: This project was supported in part by the Biomedical Advanced Research Development Authority (BARDA) and for an appointment (JC A-M) to the Research Participation Program at the Center for Biologics Evaluation and Research administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and the U.S. Food and Drug Administration. The following reagents were obtained from the NIH Biodefense and Emerging Infections Research Resources Repository, NIAID, NIH: anthrax PA, recombinant from Bacillus anthracis, NR-140 and from E. coli, NR-164; anthrax LF, recombinant from Bacillus anthracis, NR-142; and J774A.1 monocyte/macrophage (mouse) working cell bank, NR-28.

PY - 2013/3

Y1 - 2013/3

N2 - We examined the capability of a mouse immunogenicity assay to detect improper storage of a recombinant protective antigen (rPA)-based anthrax vaccine formulated with an aluminum adjuvant, using ELISA and a toxin neutralization assay (TNA) to measure the antibody response to rPA. The vaccine was stored at 4 °C, room temperature (RT) or 37 °C for one, four and eight weeks and used for immunization, along with freshly prepared vaccine. Results showed that, contrary to ELISA, TNA is suitable to detect a loss of immunogenicity of the rPA vaccine following its exposure to RT for a period of eight weeks and to 37 °C for a period as short as 1 week.

AB - We examined the capability of a mouse immunogenicity assay to detect improper storage of a recombinant protective antigen (rPA)-based anthrax vaccine formulated with an aluminum adjuvant, using ELISA and a toxin neutralization assay (TNA) to measure the antibody response to rPA. The vaccine was stored at 4 °C, room temperature (RT) or 37 °C for one, four and eight weeks and used for immunization, along with freshly prepared vaccine. Results showed that, contrary to ELISA, TNA is suitable to detect a loss of immunogenicity of the rPA vaccine following its exposure to RT for a period of eight weeks and to 37 °C for a period as short as 1 week.

KW - ELISA

KW - Potency test

KW - RPA-based anthrax vaccine

KW - TNA

UR - http://www.scopus.com/inward/record.url?scp=84875249020&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84875249020&partnerID=8YFLogxK

U2 - 10.1016/j.biologicals.2012.10.002

DO - 10.1016/j.biologicals.2012.10.002

M3 - Article

C2 - 23137818

AN - SCOPUS:84875249020

SN - 1045-1056

VL - 41

SP - 111

EP - 114

JO - Biologicals

JF - Biologicals

IS - 2

ER -

Ability of ELISA and a toxin neutralization assay to detect changes in immunogenicity of a recombinant Bacillus anthracis protective antigen vaccine upon storage

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this