Selected article for: "clinical trial and randomized phase"
Author: Lundstrom, Kenneth
Title: Alphavirus-Based Vaccines
  • Document date: 2014_6_16
    • ID: 07iwwsfz_25
    Snippet: A human phase II, randomized, double-blind, placebo-controlled, safety and immunogenicity study was conducted in 73 healthy adult volunteers on a serially passaged, plaque-purified, live CHIK vaccine [115] . A single subcutaneous injection of the CHIK vaccine was administered to 59 volunteers, and 14 individuals received placebo. There were no adverse events, except for transient arthralgia in five individuals receiving the CHIK vaccine. Of the 5.....
    Document: A human phase II, randomized, double-blind, placebo-controlled, safety and immunogenicity study was conducted in 73 healthy adult volunteers on a serially passaged, plaque-purified, live CHIK vaccine [115] . A single subcutaneous injection of the CHIK vaccine was administered to 59 volunteers, and 14 individuals received placebo. There were no adverse events, except for transient arthralgia in five individuals receiving the CHIK vaccine. Of the 58 evaluable vaccinated individuals, 57 (98%) developed CHIK neutralizing antibodies by Day 28 and 85% still remained seropositive one year later. None of the individuals who received placebo were seropositive. In another vaccine-related alphavirus phase I randomized, double-blind clinical trial for cytomegalovirus (CMV), a two-component vaccine expressing CMV gB or pp65/1E1 fusion protein was administered intramuscularly or subcutaneously in CMV seronegative adult volunteers [25] . The vaccination showed only mild to moderate local reactions and no clinically important changes. It induced neutralizing antibody and multifunctional T-cell responses against CMV antigens.

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