A Randomized, Double-blind, Placebo-controlled Study of the Dosaging of AMPLIGEN 'Registered trade mark' (POLY I: POLY C12U), an Immunostimulant, in Conjunction With Influenza Vaccination
A Randomized, Double-blind, Placebo-controlled Study of the Dosaging of AMPLIGEN 'Registered trade mark' (POLY I: POLY C12U), an Immunostimulant, in Conjunction With Influenza Vaccination in active healthy volunteers.
Hemispherx Biopharama Inc
39 participants
Mar 1, 2007
Interventional
Conditions
Summary
The purpose of this study is the evaluate the activity and safety of a new investigational drug called Ampligen 'Registered trade mark' (poly l: poly C12U) in boosting the response to influenza vaccination.
Eligibility
Plain Language Summary
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Interventions
1. Vaccination using AMPLIGEN 'Registered trade mark' to augment the response to influenza vaccination. 2. Three treatment groups (6 patients each) will recieve an intramuscular (IM) injection of the immune stimulant. One of these three groups will recieve the injection 2 hours before the vaccine, another group will recieve the injection of the immune stimulant immediately before the vaccine injection and the third and final group will recieve the injection of the immune stimulant immediately after the vaccine. Dosing: Poly I:poly C12 U (Ampligen 'Registered trade mark') (200mg) and placebo will be supplied as solutions (80ml) ready for injection in identical 100 ml glass bottles. 1ml will be drawn up into a syringe and 2mg injected into the deltoid muscle of the subject's non dominant arm. 3. Patients will be dosed twice over a 6 week period.
Locations(1)
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ACTRN12609000083291