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

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Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MVA Smallpox Vaccine

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, Smallpox, MVA

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Alabama at Birmingham
AltaMed Health Services Corporation
Quest Clinical Research
University of Miami AIDS Clinical Research Unit
University of Miami School of Medicine
University of Hawaii

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

placebo

Arm Description

Outcomes

Primary Outcome Measures

Safety

Secondary Outcome Measures

Immunogenicity

Full Information

NCT ID

NCT00282581

First Posted

January 26, 2006

Last Updated

January 17, 2014

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00282581

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Terminated

Why Stopped

Senior managemnt decision

Study Start Date

October 2006 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Smallpox

Keywords

HIV, Smallpox, MVA

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

MVA Smallpox Vaccine

Other Intervention Name(s)

placebo

Intervention Description

0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.

Primary Outcome Measure Information:

Title

Safety

Time Frame

Study Completion

Secondary Outcome Measure Information:

Title

Immunogenicity

Time Frame

Study Completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: