Clinical and vaccine immunology : CVI
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Clin. Vaccine Immunol. · Dec 2010
Randomized Controlled Trial Multicenter StudySafety and immunogenicity of a novel Staphylococcus aureus vaccine: results from the first study of the vaccine dose range in humans.
Merck V710 is a novel vaccine containing the conserved Staphylococcus aureus iron surface determinant B shown to be protective in animal models. A phase I, multicenter, double-blind study of the dose range was conducted to assess the immunogenicity and safety of an adjuvanted liquid formulation of V710. A total of 124 adults (18 to 55 years of age) were randomized 1:1:1:1 to receive one 0.5-ml intramuscular injection of V710 (5 μg, 30 μg, or 90 μg) or saline placebo. ⋯ No immediate reactions or serious adverse events were reported. In this first study of V710 in humans, a single 30-μg or 90-μg dose was more immunogenic than the 5-μg dose or placebo. Immune responses were evident by 10 to 14 days after vaccination in most responders.
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Clin. Vaccine Immunol. · Oct 2009
Multicenter StudyKinetic patterns of Candida albicans germ tube antibody in critically ill patients: influence on mortality.
The influence of kinetic patterns of Candida albicans germ tube antibodies (CAGTA) on mortality was analyzed in six intensive care units. Statistically significant lower mortality rates were found in patients with patterns of increasing CAGTA titers who had been treated with antifungal agents. Thus, antifungal treatment should be considered when CAGTA titers are increasing in critically ill patients.
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Clin. Vaccine Immunol. · Feb 2008
Randomized Controlled Trial Multicenter Study Comparative StudyA double-blind, randomized, controlled, multicenter safety and immunogenicity study of a refrigerator-stable formulation of Zostavax.
The vaccine Zostavax has been shown to prevent herpes zoster (HZ) and postherpetic neuralgia and is recommended for individuals > or =60 years of age. This study compared the safety and the immunogenicity of a refrigerator-stable formulation (Zostavax refrigerated) with those of the current formulation (Zostavax frozen) in subjects > or =50 years of age. Subjects with a negative history for HZ were randomized 1:1 to receive one dose of either formulation. ⋯ The frequencies of injection-site AEs during follow-up were 35.6% and 46.4% in the refrigerated and the frozen formulation groups, respectively, and were generally mild. The frequencies of systemic AEs were similar in the two groups, and those of vaccine-related AEs were approximately 6% in both groups. The refrigerator-stable formulation of Zostavax has an acceptable safety profile and is as immunogenic as the frozen formulation; thus, the vaccine may be used in clinical settings where freezer availability is limited.