Phase I dose finding studies of an adjuvanted Clostridium difficile toxoid vaccine

Richard N. Greenberg; Thomas C. Marbury; Ginamarie Foglia; Michel Warny

doi:10.1016/j.vaccine.2012.01.065

Phase I dose finding studies of an adjuvanted Clostridium difficile toxoid vaccine

Richard N. Greenberg
, Thomas C. Marbury
, Ginamarie Foglia
, Michel Warny

Internal Medicine

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

81 Scopus citations

Abstract

Fifty healthy adult (18-55 years) and 48 elderly (≥65 years) volunteers were randomized to receive a candidate Clostridium difficile toxoid vaccine (2 μg, 10 μg, or 50 μg) or placebo on Days 0, 28, and 56. No volunteer receiving placebo seroconverted. For toxin A, seroconversion by Day 56 (post-dose 2) was observed in 100% of volunteers aged 18-55 years in all dose groups and in 50%, 89%, and 100% of elderly participants in the 2 μg, 10 μg, and 50 μg dose groups, respectively. For both age groups, seroconversion for toxin B was lower than toxin A. There were no safety concerns.

Original language	English
Pages (from-to)	2245-2249
Number of pages	5
Journal	Vaccine
Volume	30
Issue number	13
DOIs	https://doi.org/10.1016/j.vaccine.2012.01.065
State	Published - Mar 16 2012

Bibliographical note

Copyright:
Copyright 2012 Elsevier B.V., All rights reserved.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Clostridium difficile
Dose finding
Immunogenicity
Safety
Vaccine

ASJC Scopus subject areas

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

Access to Document

10.1016/j.vaccine.2012.01.065

Cite this

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title = "Phase I dose finding studies of an adjuvanted Clostridium difficile toxoid vaccine",

abstract = "Fifty healthy adult (18-55 years) and 48 elderly (≥65 years) volunteers were randomized to receive a candidate Clostridium difficile toxoid vaccine (2 μg, 10 μg, or 50 μg) or placebo on Days 0, 28, and 56. No volunteer receiving placebo seroconverted. For toxin A, seroconversion by Day 56 (post-dose 2) was observed in 100\% of volunteers aged 18-55 years in all dose groups and in 50\%, 89\%, and 100\% of elderly participants in the 2 μg, 10 μg, and 50 μg dose groups, respectively. For both age groups, seroconversion for toxin B was lower than toxin A. There were no safety concerns.",

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AU - Greenberg, Richard N.

AU - Marbury, Thomas C.

AU - Foglia, Ginamarie

AU - Warny, Michel

PY - 2012/3/16

Y1 - 2012/3/16

N2 - Fifty healthy adult (18-55 years) and 48 elderly (≥65 years) volunteers were randomized to receive a candidate Clostridium difficile toxoid vaccine (2 μg, 10 μg, or 50 μg) or placebo on Days 0, 28, and 56. No volunteer receiving placebo seroconverted. For toxin A, seroconversion by Day 56 (post-dose 2) was observed in 100% of volunteers aged 18-55 years in all dose groups and in 50%, 89%, and 100% of elderly participants in the 2 μg, 10 μg, and 50 μg dose groups, respectively. For both age groups, seroconversion for toxin B was lower than toxin A. There were no safety concerns.

AB - Fifty healthy adult (18-55 years) and 48 elderly (≥65 years) volunteers were randomized to receive a candidate Clostridium difficile toxoid vaccine (2 μg, 10 μg, or 50 μg) or placebo on Days 0, 28, and 56. No volunteer receiving placebo seroconverted. For toxin A, seroconversion by Day 56 (post-dose 2) was observed in 100% of volunteers aged 18-55 years in all dose groups and in 50%, 89%, and 100% of elderly participants in the 2 μg, 10 μg, and 50 μg dose groups, respectively. For both age groups, seroconversion for toxin B was lower than toxin A. There were no safety concerns.

KW - Clostridium difficile

KW - Dose finding

KW - Immunogenicity

KW - Safety

KW - Vaccine

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M3 - Article

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AN - SCOPUS:84857793535

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SP - 2245

EP - 2249

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JF - Vaccine

IS - 13

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Phase I dose finding studies of an adjuvanted Clostridium difficile toxoid vaccine

Abstract

Bibliographical note

UN SDGs

Keywords

ASJC Scopus subject areas

Access to Document

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