Clinical trial NCT00282581: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: HIV Infections
Smallpox
Keywords: HIV
Smallpox
MVA
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-01-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Safety
timeFrame: Study Completion
Secondary outcomes:
measure: Immunogenicity
timeFrame: Study Completion
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: AltaMed Health Services Corporation
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Miami
country: United States
facility: University of Miami AIDS Clinical Research Unit
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Honolulu
country: United States
facility: University of Hawaii
state: Hawaii
Study officials:
affiliation: University of Miami AIDS clinical research unit
name: Margaret Fischl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Rafael E Campo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Hawaii- Honolulu
name: Cecilia Shikuma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AltaMed Health Services, Los Angeles
name: Daniel Pearce, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Quest Clinical Research, San Francisco
name: Jacob Lalezari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Scott D Parker, MD
role: PRINCIPAL_INVESTIGATOR
References: