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

INTERVENTION: 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. CONDITION: Influenza PRIMARY OUTCOME: 1. To evaluate the impact of the time between dosaging of a two component vaccination system on the safety effect. Ampligen, an immunostimulant, will be evaluated in conjunction with influenza vaccination. ; The first stage (Stage I) is a prospective study ; 2. Safety will be measured by the collection of adverse events and the review of laboratory parameters ; 3. The immunization effect will be measured by the Haemagglutinnation Inhibition Antibody assay and Seroconversion. SECONDARY OUTCOME: 1. The second stage is to evaluate the safety response to the vaccine. ; 2. Safety assessment: ; Vaccination site ; ‐ Induration greater than 50 mm present at 72 hours post vaccination ; ‐Pain present at 72 hours ; ‐ Tenderness present at 72 hours ; ‐ Ecchymosis ; Test agent site ; ‐ Induration greater than 50 mm present at 72 hours post vaccination ; ‐ Pain present at 72 hours ; ‐ Ecchymosis ; Temperature higher than 38 degrees celcius for 24 hours ; Malaise ; Shivering/Rigors ; Chemistry panel ; Urinalysis ; Haematology panel ; ECG ; 3. Collection of adverse events and review ; 4. Referring to the test agent Ampligen 'Registered trade mark'. INCLUSION CRITERIA: 1. Healthy Normals 2. Age range 60‐80 years old 3. Ability to provide written informed consent indicating awareness of the investigational nature of this study 4. Documentation during baseline history, examination and testing that each subject is active and healthy 5. Failure to get the current flu vaccination prior to entry to the study