None listed
Conditions
Brief 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.
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
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.
Sponsors
Hemispherx Biopharama Inc
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Healthy volunteers
Yes
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
Exclusion criteria
1. Inability to return to scheduled treatment and assessments 2. Chronic or intercurrent acute medical disorder or disease such as: - unexplained abnormal ESR or C-reactive protein - rheumatoid arthritis - lupus - other autoimmune disease - obstructive airway diseases whether reversible (asthma) or Chronie Obstructive Pulmonary Disease (COPD) - diabetes - allergies to eggs, antibiotics, mercury containing products or vaccines history of anaphylaxis 3. Therapy with: - immunomodulatory drugs (including gamma globulin, systemic steriods, interferons) - antivirals (including acyclovir, AZT and/or antiviral nucleoside analogues) - investigational drugs within the past 6 weeks
Outcome results
None listed