VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV

NCT01158157 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-03-18

Study results available
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Summary

The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).

Conditions

  • Smallpox Vaccine Adverse Reaction

Interventions

BIOLOGICAL

ACAM2000

Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.

Sponsors & Collaborators

Principal Investigators

  • Ronald Brown, MD · Cangene Plasma Resources, Mid-Florida

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-13
Primary Completion
2012-02-14
Completion
2012-02-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01158157 on ClinicalTrials.gov