Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults

Status Completed

Clinical Trial Summary

The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age and previously vaccinated against smallpox.

Clinical Trial Description

Specifically, the objectives of this study are to: 1. Compare the safety and tolerability of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age and previously vaccinated to smallpox. 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 four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age by comparing: 1. the proportion of subjects at each dose level who develop a major cutaneous reaction 2. 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 ACAM2000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age, with a history of smallpox vaccination. ;

Study Design

Related Conditions & MeSH terms

Smallpox

Clinical Trial Details

NCT number	NCT00053482
Study type	Interventional
Source	Emergent BioSolutions
Contact
Status	Completed
Phase	Phase 2
Start date	January 2003
Completion date	October 2003

View Details

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