Smallpox Clinical Trial
Official title:
The Effect of Dose On Safety, Tolerability, and Immunogenicity of ACAM1000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination A Phase 2, Randomized, Double-Blind, Dose-Response Study
The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
In addition to assessment of safety parameters, the objective of this study is to determine
the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at
least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox
vaccine. Specifically, the objectives of this study are to:
1. Compare the safety and tolerability of three dose levels of ACAM1000 and a standard
dose of Dryvax® in healthy adults 18-29 years of age and naïve to smallpox vaccine.
Safety and tolerability will be determined by examination of the local cutaneous
reaction, adverse events, physical examinations, vital signs, structured interviews,
and laboratory analysis.
2. Determine the immunogenicity of three dose levels of ACAM1000 and a standard dose of
Dryvax® in healthy adults 18-29 years of age by comparing: (a)the proportion of
subjects at each dose level who develop a major cutaneous reaction; (b)the proportion
of subjects in each treatment group who develop neutralizing antibodies, including the
fold-increase in antibody titer between Baseline and Day 30 sera; and the geometric
mean vaccinia neutralizing antibody titer on Day 30.
3. Determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous
reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve
to smallpox vaccine.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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