Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in HIV Infected Patients

September 27, 2012 updated by: Bavarian Nordic

A Multicenter, Open-label Phase I/II Study to Evaluate Safety and Immunogenicity of MVA-BN® Smallpox Vaccine in HIV Infected Subjects (CD4 Counts >350 / µl) and Healthy Subjects With and Without Previous Smallpox Vaccination

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
151

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202-2859
        • Indiana University School of Medicine
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0093
        • University of Kentucky Medical Center
    • Missouri
      • St.Louis, Missouri, United States
        • Washington University School of Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-6073
        • University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt AIDS Clinical Trials Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • No detectable vaccinia scar.
  • No military service prior to 1989 or after January 2003.

Groups 2 and 4 (All previously vaccinated subjects) additionally:

  • History of at least one previous smallpox vaccination
  • Time since most current smallpox vaccination > 10 years.

Groups 1 and 2 (All HIV Infected subjects) additionally:

  • Documented HIV-1 infection
  • Plasma HIV-1 RNA level < 400 copies/mL at screening.
  • CD4 cells ≥ 350/µL
  • Haemoglobin ≥ 9.0 g/dL.
  • Platelets ≥ 100,000/mm3.
  • AST (SGOT), ALT (SGPT) and alkaline phosphatase ≤ 3 x ULN

Groups 3 and 4 (All Healthy subjects) additionally:

  • Negative ELISA for HIV.
  • Haemoglobin >11 g/dL.
  • Platelets ≥ 140,000/mm3.
  • AST (SGOT), ALT (SGPT) and alkaline phosphatase without clinically significant findings

Exclusion Criteria:

  • 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.
  • Known allergies to cidofovir or probenecid.
  • History of anaphylaxis or severe allergic reaction.
  • Acute disease (illness with or without a fever) at the time of enrollment.
  • Temperature >100.4°F at the time of enrollment.
  • Subjects undergoing treatment for tuberculosis infection or disease.
  • Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior or after study vaccination.
  • Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior or after study vaccination.
  • Chronic administration of immuno-suppressant or immune-modifying drugs.
  • Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
  • Administration or planned administration of immunoglobulins and/or any blood products.
  • Use of any investigational or non-registered drug or vaccine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bavarian Nordic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard N Greenberg, M.D., University Of Kentucky School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • POX-MVA-010
  • HHSN266200400072C (NIAID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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