NCT00189904

Brief Summary

The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

5 active sites

Status
completed

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

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

September 28, 2012

Status Verified

December 1, 2007

First QC Date

September 11, 2005

Last Update Submit

September 27, 2012

Conditions

HIV Infections

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

  • Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study

Secondary Outcomes (2)

  • Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points)

  • ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points)

Interventions

IMVAMUNE (MVA-BN)BIOLOGICAL

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • Male subjects between 18 and 49 years of age or female subjects between 18 and 55 years of age who provided informed consent.
  • Women with negative pregnancy test.
  • Women of childbearing potential must use an acceptable method of contraception.
  • Cardiac enzymes within ULN.
  • White blood cells ≥ 2500/mm3 and \< 11,000/ mm3.
  • Absolute neutrophil count ≥ 1000/mm3.
  • Adequate renal function.
  • Adequate hepatic function.
  • Negative hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
  • Negative antibody test to hepatitis C virus (HCV).
  • Negative urine glucose by dipstick or urinalysis.
  • Normal 12-lead electrocardiogram.
  • Availability for follow-up during the study.
  • Groups 1 and 3 (All vaccinia-naïve subjects) additionally:
  • No history of known or suspected previous smallpox vaccination.
  • +17 more criteria

You may not qualify if:

  • Pregnant or breast-feeding women.
  • Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
  • History of any serious medical condition (other than HIV infection).
  • History of or active autoimmune disease.
  • Known or suspected impairment of immunologic function (other than HIV infection).
  • History of malignancy.
  • History or clinical manifestation of clinically significant and severe haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
  • Clinically significant mental disorder not adequately controlled by medical treatment.
  • Any condition which might interfere with study objectives.
  • History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.
  • History of an immediate family member with onset of ischemic heart disease before age 50.
  • Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool.
  • History of chronic alcohol abuse and/or intravenous drug abuse.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Known previous allergic reaction to immunoglobulins.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Indiana University School of Medicine

Indianapolis, Indiana, 46202-2859, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536-0093, United States

Location

Washington University School of Medicine

St Louis, Missouri, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6073, United States

Location

Vanderbilt AIDS Clinical Trials Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

  • Greenberg RN, Overton ET, Haas DW, Frank I, Goldman M, von Krempelhuber A, Virgin G, Badeker N, Vollmar J, Chaplin P. Safety, immunogenicity, and surrogate markers of clinical efficacy for modified vaccinia Ankara as a smallpox vaccine in HIV-infected subjects. J Infect Dis. 2013 Mar 1;207(5):749-58. doi: 10.1093/infdis/jis753. Epub 2012 Dec 7.

    PMID: 23225902DERIVED

MeSH Terms

Conditions

HIV Infections

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 Diseases

Study Officials

  • Richard N Greenberg, M.D.

    University of Kentucky School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Start

July 1, 2005

Last Updated

September 28, 2012

Record last verified: 2007-12

Locations

US(5)