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VAX014
A Phase II Placebo-controlled, Randomized Clinical Trial Evaluating the Safety of LC16m8, a modified Vaccinia Vaccine, in Healthy, Vaccinia-naïve Volunteers
Sponsor: VaxGen
Study Drug: LC16M8
Medical Monitor: Lucille
CRA: Partial
Central IRB:
Central Lab:
Site #:
Investigator #:
4000 Subjects/ Sites = Subjects per Site ; 3000 will receive LC16m8 and 1000 will receive Placebo in a 3:1 Ratio
IC
Age: 18 years & older and born after 1970
ALT <1.5x
Serum Creatinine ? 1.5x
EC
No h/o Smallpox Vaccination or evidence of Vaccine Site Scar
HIV, Hepatitis B or C
Immunosuppression (including HIV), or close contact with an immunosuppressed individual
Autoimmune disease, Spleenectomy or receiving Immunoglobulin or other blood products 60 days before
Any immunosuppressive therapy including RT 30 days before or prior to study completion
Atopic Dermatitis or Eczema
Presence of (or close contact or sharing a household with) a skin condition with extensive breaks in the skin such as burns, impetigo, contact dermatitis, or zoster not likely to heal by the day of vaccination.
Darier's Disease (Keratosis follicularis) or close contact with Darier’s Disease. Keratosis follicularis is a slowly progressive autosomal dominant disorder of keratinization characterised by pinkish-to-tan papules that coalesce to form plaques. These lesions become darker over time and commonly fuse, forming papillomatous and warty malodorous growths.
Prednisone, especially doses of 20 mgm per day for more than 2 weeks
Close Contact with Children under 1 year old
Known cardiac disease
Three or more of the following cardiac risk factors: HTN, DM, Smoking, Hypercholesterolemia, + FH of Heart Disease at age 50 or earlier in a first-degree relative, or Obesity defined as BMI >30.
Live Vaccine exposures 30 days before or after
Subunit or killed vaccines 14 days before or after
VAX014
V1 D -60 Lab, ICF Pre-Randomization EKG
V2 D 0 Lab, Immunization
V3 D 7 +/- 1
V4 D 10 +/- 1 Lab EKG
V5 D 14 +/- 1 Lab
V6 D 30 +/- 3 Lab
V7 D 180 +/- 7 Lab EKG