Smallpox Vaccine Clinical Study Now Enrolling at Avail Clinical Research Near Orlando, Florida; Accepting Healthy M/F Age 18-40
Summary
As mass vaccination programs halted more than 30 years ago, it is estimated that the majority of the world population has no existing immunity to smallpox, and as such, the release of this highly contagious virus would have devastating effects.Electrocardiogram (ECG) without clinically significant findings (e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two premature ventricular contractions in a row, ST elevation consistent with ischemia) For information about how to participate in a Vaccine Clinical Trial, visit Avail Clinical Research or contact them directly at (386) 310-1334.For more information about participating in this Vaccine Clinical Trial, please visit our website or contact us directly at (386) 310-1334.Background & Scientific RationaleDespite the fact that the World Health Organization (WHO) officially declared successful global eradication of smallpox in 1980, the existence of variola stockpiles and the threat of bioterrorism demands to maintain immunity to smallpox through vaccination.After the events of September 11th, 2001, concern over the use of bioweapons as agents of terrorism increased.As mass vaccination programs halted more than 30 years ago, it is estimated that the majority of the world population has no existing immunity to smallpox, and as such, the release of this highly contagious virus would have devastating effects.As a consequence, there is an urgent need for a safe and efficacious vaccine to protect the public against smallpox.Primary Objective-To assess the consistency of three consecutively produced IMVAMUNE® lots.Secondary Objective-To assess uncommon adverse reactions, in particular any cardiac sign and symptom indicating a case of myo-/pericarditis, and to compare the frequency of those reactions against placebo.-To collect vaccinia-specific humoral immune response data.Inclusion Criteria1.Electrocardiogram (ECG) without clinically significant findings (e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two premature ventricular contractions in a row, ST elevation consistent with ischemia)For information about how to participate in a Vaccine Clinical Trial, visit Avail Clinical Research or contact them directly at (386) 310-1334.