NCT00282581

Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive

A Phase 1, Double-Blind, Placebo-Controlled Study to Assess the Safety and Immunogenicity of MVA3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Vaccinia-Naive Human Immunodeficiency Virus (HIV)-Seropositive Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with HIV infection

Detailed description

This is a multi-center study 90 HIV-seropositive subjects. There will be an injection of MVA smallpox vaccine or placebo on day 0 and day 28. Subjects will be enrolled and vaccinated in two cohorts according to CD4 cell count levels and number of subjects vaccinated. Excluding the screening period, the study duration will be approximately 56 days with a follow up safety visit at study day 148 and a telephone health status interview at study day 208.

Conditions

• HIV Infections
• Smallpox

Interventions

Type	Name	Description
BIOLOGICAL	MVA Smallpox Vaccine	0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2006-01-27
• Last updated: 2014-01-22

Locations

6 sites across 1 country: United States