Outpatient studies of the safety and immunogenicity of an auxotrophic Escherichia coli K-12-Shigella flexneri 2a hybrid vaccine candidate, EcSf2a-2

David N. Taylor; Douglas F. Phillip; Michael Zapor; Andrew Trofa; Lillian Van de Verg; Antoinette Hartman; Natalie Bendiuk; John W. Newland; Samuel B. Formal; Jerald C. Sadoff; Thomas L. Hale

doi:10.1016/0264-410X(94)90318-2

Outpatient studies of the safety and immunogenicity of an auxotrophic Escherichia coli K-12-Shigella flexneri 2a hybrid vaccine candidate, EcSf2a-2

David N. Taylor, Douglas F. Phillip, Michael Zapor, Andrew Trofa, Lillian Van de Verg, Antoinette Hartman, Natalie Bendiuk, John W. Newland, Samuel B. Formal, Jerald C. Sadoff, Thomas L. Hale

Bloomberg School of Public Health

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

9 Scopus citations

Abstract

A phase II study was conducted in 244 volunteers at Fort Ord, CA, to determine the safety and immunogenicity of EcSf2a-2, a live, oral Shigella vaccine constructed by transfer of genes from Shigella flexneri to Escherichia coli K-12. In this placebo-controlled study, four doses of vaccine ranging from 2.3 to 9.0 × 10⁸ colony-forming units were given on days 0, 3, 14 and 17. Vaccine shedding occurred from 1 to 3 days after each dose. The vaccine was well tolerated at every dose tested. Significant levels of IgA, IgG or IgM antibody-secreting cells (ASC) recognizing S. flexneri 2a lipopolysaccharide (LPS) were found in 94% of a volunteer subset tested 7 days after the first dose of EcSf2a-2. Seven days after the third dose, ASC were detected less often (57%), and were mainly IgA. Significant rises in serum antibody to LPS were detected in 37% of vaccine recipients.

Original language	English (US)
Pages (from-to)	565-568
Number of pages	4
Journal	Vaccine
Volume	12
Issue number	6
DOIs	https://doi.org/10.1016/0264-410X(94)90318-2
State	Published - May 1994

Keywords

ELISA
Escherichia coli-Shigella hybrid vaccine
antibody-secreting cells
mucosal immunization
phase II study

ASJC Scopus subject areas

Molecular Medicine
General Immunology and Microbiology
General Veterinary
Public Health, Environmental and Occupational Health
Infectious Diseases

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10.1016/0264-410X(94)90318-2

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Taylor, D. N., Phillip, D. F., Zapor, M., Trofa, A., Van de Verg, L., Hartman, A., Bendiuk, N., Newland, J. W., Formal, S. B., Sadoff, J. C., & Hale, T. L. (1994). Outpatient studies of the safety and immunogenicity of an auxotrophic Escherichia coli K-12-Shigella flexneri 2a hybrid vaccine candidate, EcSf2a-2. Vaccine, 12(6), 565-568. https://doi.org/10.1016/0264-410X(94)90318-2

Taylor, DN, Phillip, DF, Zapor, M, Trofa, A, Van de Verg, L, Hartman, A, Bendiuk, N, Newland, JW, Formal, SB, Sadoff, JC & Hale, TL 1994, 'Outpatient studies of the safety and immunogenicity of an auxotrophic Escherichia coli K-12-Shigella flexneri 2a hybrid vaccine candidate, EcSf2a-2', Vaccine, vol. 12, no. 6, pp. 565-568. https://doi.org/10.1016/0264-410X(94)90318-2

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title = "Outpatient studies of the safety and immunogenicity of an auxotrophic Escherichia coli K-12-Shigella flexneri 2a hybrid vaccine candidate, EcSf2a-2",

abstract = "A phase II study was conducted in 244 volunteers at Fort Ord, CA, to determine the safety and immunogenicity of EcSf2a-2, a live, oral Shigella vaccine constructed by transfer of genes from Shigella flexneri to Escherichia coli K-12. In this placebo-controlled study, four doses of vaccine ranging from 2.3 to 9.0 × 108 colony-forming units were given on days 0, 3, 14 and 17. Vaccine shedding occurred from 1 to 3 days after each dose. The vaccine was well tolerated at every dose tested. Significant levels of IgA, IgG or IgM antibody-secreting cells (ASC) recognizing S. flexneri 2a lipopolysaccharide (LPS) were found in 94% of a volunteer subset tested 7 days after the first dose of EcSf2a-2. Seven days after the third dose, ASC were detected less often (57%), and were mainly IgA. Significant rises in serum antibody to LPS were detected in 37% of vaccine recipients.",

keywords = "ELISA, Escherichia coli-Shigella hybrid vaccine, antibody-secreting cells, mucosal immunization, phase II study",

author = "Taylor, {David N.} and Phillip, {Douglas F.} and Michael Zapor and Andrew Trofa and {Van de Verg}, Lillian and Antoinette Hartman and Natalie Bendiuk and Newland, {John W.} and Formal, {Samuel B.} and Sadoff, {Jerald C.} and Hale, {Thomas L.}",

year = "1994",

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doi = "10.1016/0264-410X(94)90318-2",

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AU - Zapor, Michael

AU - Trofa, Andrew

AU - Van de Verg, Lillian

AU - Hartman, Antoinette

AU - Bendiuk, Natalie

AU - Newland, John W.

AU - Formal, Samuel B.

AU - Sadoff, Jerald C.

AU - Hale, Thomas L.

PY - 1994/5

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N2 - A phase II study was conducted in 244 volunteers at Fort Ord, CA, to determine the safety and immunogenicity of EcSf2a-2, a live, oral Shigella vaccine constructed by transfer of genes from Shigella flexneri to Escherichia coli K-12. In this placebo-controlled study, four doses of vaccine ranging from 2.3 to 9.0 × 108 colony-forming units were given on days 0, 3, 14 and 17. Vaccine shedding occurred from 1 to 3 days after each dose. The vaccine was well tolerated at every dose tested. Significant levels of IgA, IgG or IgM antibody-secreting cells (ASC) recognizing S. flexneri 2a lipopolysaccharide (LPS) were found in 94% of a volunteer subset tested 7 days after the first dose of EcSf2a-2. Seven days after the third dose, ASC were detected less often (57%), and were mainly IgA. Significant rises in serum antibody to LPS were detected in 37% of vaccine recipients.

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KW - ELISA

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KW - antibody-secreting cells

KW - mucosal immunization

KW - phase II study

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Outpatient studies of the safety and immunogenicity of an auxotrophic Escherichia coli K-12-Shigella flexneri 2a hybrid vaccine candidate, EcSf2a-2

Abstract

Keywords

ASJC Scopus subject areas

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