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Article ; Online: Phase II, randomized, double-blind, placebo-controlled, multicenter study to investigate the immunogenicity and safety of a West Nile virus vaccine in healthy adults.

Biedenbender, Rex / Bevilacqua, Joan / Gregg, Anne M / Watson, Mike / Dayan, Gustavo

2010 Volume 203, Issue 1, Page(s) 75–84

Abstract: Background: ChimeriVax-WN02 is a live, attenuated chimeric vaccine for protection against West Nile virus. This Phase II, randomized, double-blind, placebo-controlled, multicenter study assessed the immunogenicity, viremia, and safety of the ChimeriVax- ... ...

Abstract	Background: ChimeriVax-WN02 is a live, attenuated chimeric vaccine for protection against West Nile virus. This Phase II, randomized, double-blind, placebo-controlled, multicenter study assessed the immunogenicity, viremia, and safety of the ChimeriVax-WN02 vaccine. Methods: The 2-part study included adults in general good health. In part 1, subjects aged 18-40 years were randomized to 1 of 4 treatment groups: ChimeriVax-WN02 3.7- × -10(5) plaque-forming units (PFU), 3.7 × 10(4) PFU, 3.7 × 10(3) PFU, or placebo. In part 2, subjects aged 41-64 and ≥ 65 years were randomized to receive ChimeriVax-WN02 3.7 × 10(5) PFU or placebo. Results: In both part 1 and part 2, seroconversion was achieved at day 28 by >96% of subjects in active treatment groups. In part 1, neutralizing antibody titers at day 28 were higher and viremia levels lower with the highest dose, whereas the adverse event profile was similar between the dose groups. In part 2, antibody titers and viremia levels were higher in subjects aged ≥ 65 years, and more subjects in the 41-64 years cohort experienced adverse events. Conclusions: The ChimeriVax-WN02 vaccine was highly immunogenic in younger adults and the elderly, and it was well tolerated at all dose levels and in all age groups investigated. Clinical Trials.gov identifier: NCT00442169.
MeSH term(s)	Adolescent ; Adult ; Aged ; Antibodies, Neutralizing/blood ; Antibodies, Viral/blood ; Double-Blind Method ; Female ; Human Experimentation ; Humans ; Male ; Middle Aged ; Placebos/administration & dosage ; Vaccines, Attenuated/adverse effects ; Vaccines, Attenuated/immunology ; Viremia ; West Nile Virus Vaccines/adverse effects ; West Nile Virus Vaccines/immunology ; Young Adult
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral ; ChimeriVax ; Placebos ; Vaccines, Attenuated ; West Nile Virus Vaccines
Language	English
Publishing date	2010-12-09
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	3019-3
ISSN	1537-6613 ; 0022-1899
ISSN (online)	1537-6613
ISSN	0022-1899
DOI	10.1093/infdis/jiq003
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Arsenic in drinking water: the public health implications of monitoring technologies

Gregg, Anne M

Abstract: In the 1970s many countries around the world reduced the incidences of waterborne disease by switching drinking water sources from bacterial laden surface waters to groundwater wells. In doing this, however, millions of people became exposed to arsenic ( ... ...

Abstract	In the 1970s many countries around the world reduced the incidences of waterborne disease by switching drinking water sources from bacterial laden surface waters to groundwater wells. In doing this, however, millions of people became exposed to arsenic (As) through drinking water. Over the years chronic exposure to arsenic has led to multiple serious health problems. A critical step toward assessing and limiting human exposure is to evaluate the concentration of arsenic. Field test kits provide a practical means for such evaluation; however, the reliability of field test kits has come into question. This project reviews the methods and technologies available for monitoring arsenic in drinking water. Third party performance data were used to evaluate the reliability of a representative subset of technologies from a public health perspective. Sensitivity, specificity, rates of false positives, and rates of false negatives were calculated, along with summarizing other data on linearity and ease of use characteristics. The technologies were evaluated according to a set of public health relevant criteria. The Merck Doubling Kit met or exceeded the most criteria. The evaluation provides some evidence that human health is being protected with the use of arsenic field test kits; however, there is room for improvement and a need for continuous efforts to lower the method detection limit to a health based level.
Language	english
Document type	Article
Database	AGRIS - International Information System for the Agricultural Sciences and Technology

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