At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 353 enrolled

Drug / intervention

Vaccinia virus: ACAM2000 smallpox vaccine +1 morebiological

Likely dose

ACAM2000 at doses ranging from 1.0×10⁻⁸ to 5.0×10⁻⁶ PFU/ml (Group 1-4) or Dryvax 1.0×10⁻⁸ PFU/ml (Group 5)AI-extracted

Key inclusion· 4

✓18 years or older (adults)
✓Never previously vaccinated against smallpox
✓Females: not pregnant/lactating and willing to use effective contraception for 30 days post-vaccination
✓Available for entire study duration and compliant with all requirements

Key exclusion· 13

✕Military service prior to 1989 (possible prior vaccination exposure)
✕Smallpox vaccination within 10 years
✕Children ≤1 year old in household or close contact
✕Known or suspected HIV infection, primary immunodeficiency, leukemia, lymphoma, or current radiation/immunosuppressive/anti-neoplastic therapy

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

Search/NCT00053495

NCT00053495Phase 2Completed

Compare CT.gov

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

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

In Brief

A Phase 2 clinical trial evaluating Vaccinia virus: ACAM2000 smallpox vaccine and vaccinia virus (calf lymph): Dryvax for Smallpox. Completed, enrolled 353 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSmallpox

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJan 2003

First PostedJan 2003

Primary CompletionJun 2003

Study CompletionNov 2003

TodayJul 2026

First PostedJan 31, 2003

Enrollment StartJan 1, 2003

Primary CompletionJun 1, 2003

Study CompletionNov 1, 2003

TodayJul 2, 2026

Enrollment to primary: 5 monthsPosted 23.4 years ago

Interventions

Vaccinia virus: ACAM2000 smallpox vaccinebiological

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

vaccinia virus (calf lymph): Dryvaxbiological

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