NCT00053495

Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination

The Effect of Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 29 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.

Detailed description

The objective of this study is to 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 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 four dose levels of ACAM2000 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 four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults 18-29 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 18-29 years of age and naïve to smallpox vaccine.

Conditions

• Smallpox

Interventions

Type	Name	Description
BIOLOGICAL	Vaccinia virus: ACAM2000 smallpox vaccine	Group 1 dose: 1.0x10-8th PFU/ml Group 2 dose: 2.0x10-8th PFU/ml Group 3 dose: 1.0x10-7th PFU/ml Group 4 dose: 5.0x10-6th PFU/ml
BIOLOGICAL	vaccinia virus (calf lymph): Dryvax	Group 5 dose: 1.0x10-8th PFU/ml

Timeline

• Start date: 2003-01-01
• Primary completion: 2003-06-01
• Completion: 2003-11-01
• First posted: 2003-01-31
• Last updated: 2024-03-18
• Results posted: 2011-02-11

Locations

4 sites across 1 country: United States