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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00282581
• Other study ID #: H-249-004
• Status: Terminated
• Phase: Phase 1
• First received: January 26, 2006
• Last updated: January 17, 2014
• Start date: October 2006
• Est. completion date: July 2007

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Adults at least 18 years old and who were born after 1971 who have never had a smallpox vaccination or exposure to a vaccinia-containing product

• Subjects must test positive for HIV infection

• Subjects must be in good general health except for HIV infection, including no AIDS-defining illnesses.

• Female Subjects must not be pregnant or lactating, and all subjects must agree to practice birth control

• subjects must be clinically stable for 6 months prior to study enrollment.

Exclusion Criteria:

• Subjects with a known or suspected history of immunodeficiency (with the exception of HIV infection)

• Subjects with history or prior exposure to a vaccinia-containing product

• subjects with current radiation treatment or use of immunosuppressive or antineoplastic drugs (with exceptions)

• Subjects with concomitant illnesses associated with impairment of immunologic function.

• subjects with dementia

• Subjects with malignancy.

• Subjects with a known history of Cardiac disease, or who have risk factors for ischemic coronary disease, or other abnormalities

• Current or past history of eczema

• known allergies to any component of MVA, including eggs or egg products, or allergies to blood products

• females must not be pregnant and using approved contraceptives.

• Morbid obesity

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Smallpox

Intervention

Biological:
• MVA Smallpox Vaccine
0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Hawaii	Honolulu	Hawaii
United States	AltaMed Health Services Corporation	Los Angeles	California
United States	University of Miami AIDS Clinical Research Unit	Miami	Florida
United States	University of Miami School of Medicine	Miami	Florida
United States	Quest Clinical Research	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		Study Completion	Yes
Secondary	Immunogenicity		Study Completion	No

External Links

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