NCT00282581

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1 hiv-infections

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_1 hiv-infections

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

9 months

First QC Date

January 26, 2006

Last Update Submit

January 17, 2014

Conditions

HIV InfectionsSmallpox

Keywords

HIVSmallpoxMVA

Outcome Measures

Primary Outcomes (1)

  • Safety

    Study Completion

Secondary Outcomes (1)

  • Immunogenicity

    Study Completion

Study Arms (1)

placebo

PLACEBO COMPARATOR
Biological: MVA Smallpox Vaccine

Interventions

MVA Smallpox VaccineBIOLOGICAL

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

Also known as: placebo
placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-2050, United States

Location

AltaMed Health Services Corporation

Los Angeles, California, 90022, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

University of Miami AIDS Clinical Research Unit

Miami, Florida, 33136, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

University of Hawaii

Honolulu, Hawaii, 96816, United States

Location

Related Links

MeSH Terms

Conditions

HIV InfectionsSmallpox

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPoxviridae InfectionsDNA Virus Infections

Study Officials

  • Margaret Fischl, MD

    University of Miami AIDS clinical research unit

    PRINCIPAL INVESTIGATOR

  • Rafael E Campo, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

  • Cecilia Shikuma, MD

    University of Hawaii- Honolulu

    PRINCIPAL INVESTIGATOR

  • Daniel Pearce, DO

    AltaMed Health Services, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Jacob Lalezari, MD

    Quest Clinical Research, San Francisco

    PRINCIPAL INVESTIGATOR

  • Scott D Parker, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 27, 2006

Study Start

October 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

US(6)