Search for Correlates of Protective Immunity Conferred by Anthrax Vaccine

doi:10.1128/IAI.69.5.2888-2893.2001

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Infection and Immunity, May 2001, p. 2888-2893, Vol. 69, No. 5
0019-9567/01/$04.00+0 DOI: 10.1128/IAI.69.5.2888-2893.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Search for Correlates of Protective Immunity Conferred by Anthrax Vaccine

Shaul Reuveny,¹ Moshe D. White,¹ Yaakov Y. Adar,¹ Yaron Kafri,¹ Zeev Altboum,² Yehusha Gozes,² David Kobiler,² Avigdor Shafferman,³ and Baruch Velan³^,^*

Departments of Biotechnology,¹ Infectious Diseases,² and Biochemistry and Molecular Genetics,³ Israel Institute for Biological Research, Ness-Ziona 74100, Israel

Received 30 November 2000/Returned for modification 3 January 2001/Accepted 30 January 2001

Vaccination by anthrax protective antigen (PA)-based vaccines requires multiple immunization, underlying the need to developmore efficacious vaccines or alternative vaccination regimens.In spite of the vast use of PA-based vaccines, the definitionof a marker for protective immunity is still lacking. Here wedescribe studies designed to help define such markers. To thisend we have immunized guinea pigs by different methods and monitoredthe immune response and the corresponding extent of protectionagainst a lethal challenge with anthrax spores. Active immunizationwas performed by a single injection using one of two methods:(i) vaccination with decreasing amounts of PA and (ii) vaccinationwith constant amounts of PA that had been thermally inactivatedfor increasing periods. In both studies a direct correlation betweensurvival and neutralizing-antibody titer was found (r² = 0.92 and 0.95, respectively). Most significantly, in the twoprotocols a similar neutralizing-antibody titer range provided50% protection. Furthermore, in a complementary study involvingpassive transfer of PA hyperimmune sera to naive animals, a similarcorrelation between neutralizing-antibody titers and protectionwas found. In all three immunization studies, neutralization titersof at least 300 were sufficient to confer protection against adose of 40 50% lethal doses (LD₅₀) of virulent anthrax sporesof the Vollum strain. Such consistency in the correlation of protectiveimmunity with anti-PA antibody titers was not observed for antibodytiters determined by an enzyme-linked immunosorbent assay. Takentogether, these results clearly demonstrate that neutralizingantibodies to PA constitute a major component of the protectiveimmunity against anthrax and suggest that this parameter couldbe used as a surrogate marker forprotection.

^* Corresponding author: Mailing address: P.O. Box 19, 74100 Ness-Ziona, Israel. Phone: 972-8-9381518. Fax: 972-8-9401404. E-mail:baruch{at}iibr.gov.il.

Infection and Immunity, May 2001, p. 2888-2893, Vol. 69, No. 5
0019-9567/01/$04.00+0 DOI: 10.1128/IAI.69.5.2888-2893.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

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