CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 357 enrolled
Drug / intervention
ACAM2000 Smallpox Vaccine +1 morebiological
Likely dose
ACAM2000 at doses ranging from 1.0×10⁻⁸ to 5.0×10⁻⁶ PFU/ml (Groups 1-4), or Dryvax 1.0×10⁻⁸ PFU/ml (Group 5)AI-extracted
Key inclusion· 3
  • ✓History of previous smallpox vaccination more than 10 years prior to screening with documented vaccination scar
  • ✓Females must not be pregnant or lactating and must use effective birth control for 30 days after vaccination
  • ✓Agreement to be available for entire study and comply with all requirements
Key exclusion· 12
  • ✕Children ≤1 year of age in household or close contact
  • ✕Smallpox vaccination within the past 10 years
  • ✕Known or suspected HIV infection, primary immunodeficiency, leukemia, lymphoma, or current immunosuppressive/anti-neoplastic therapy
  • ✕Household member or intimate contact with HIV, immunodeficiency, leukemia, lymphoma, or on immunosuppressive therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00053482
NCT00053482Phase 2Completed
CompareCT.gov

The Effect of Dose on Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination

Emergent BioSolutions·interventional·Posted Jan 31, 2003·Updated Mar 18, 2024

In Brief

A Phase 2 clinical trial evaluating ACAM2000 Smallpox Vaccine and Vaccinia virus (calf lymph) smallpox vaccine: Dryvax® for Smallpox. Completed, enrolled 357 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmallpox
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 31, 2003
Enrollment StartJan 1, 2003
Primary CompletionApr 1, 2003
Study CompletionOct 1, 2003
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 23.4 years ago

Interventions

ACAM2000 Smallpox Vaccinebiological

Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml

Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®biological

Group 5 dose: 1.0x10-8th PFU/ml