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Evaluate Tolerability of a Multi-envelope, Prime-boost HIV Vaccine in Healthy Adults

Primary Purpose

HIV Infections

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EnvDNA, PolyEnv1, EnvPro
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Vaccine, Prevention, HIV, AIDS, Human Immunodeficiency Virus, HIV Seronegativity, HIV Preventive Vaccine

Eligibility Criteria

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

Inclusion Criteria:

  • Healthy adults; age > 18 years, born after 1972 if born in U.S.
  • Informed consent
  • Normal history and physical exam
  • HIV-1 negative as documented by ELISA and Western blot analysis within 30 days prior to immunization

  • Normal laboratory values within 60 days prior to immunization defined as:

    • hemoglobin greater than or equal to 12.0 gm/dl for females and greater than or equal to 14.0 gm/dl for males
    • White blood cell count > 3500 cells/mm3
    • Platelet count 150,000 - 550,000 cells/mm3
    • Absolute CD4+ count > 400 cells/mm3
    • AST and ALT within normal institutional limits
    • Serum creatinine within normal institutional limits
  • Normal CPK-MB (creatine kinase isoenzyme MB) and troponin I within 30 days prior to immunization
  • Normal ECG within 30 days prior to immunization
  • No evidence of smallpox vaccination (born in the U.S. after 1972 with no typical scar on the deltoid, ankle, thigh or between the scapulae and no history of vaccination in personal immunization record)
  • No entry into military service before 1990

  • Fewer than 3 of the following:

    • Current cigarette smoker
    • History of high cholesterol
    • History of diabetes or high blood sugar
    • High blood pressure
    • Heart disease before age 50 in parent or sibling
  • Not planning to become pregnant during study vaccinations and for 3 months after last vaccination
  • Vaccinia virus seronegative

Exclusion Criteria:

  • History of immunosuppressive illness, chronic illness (e.g. asthma, bleeding diathesis, etc) or use of any immunosuppressive medications (e.g. steroids)
  • History of neurological disorder
  • Receiving therapy or prophylaxis for tuberculosis
  • Known allergy to the antibiotic kanamycin
  • History of eczema, atopic dermatitis and other acute, chronic or exfoliative conditions
  • Household contact with persons with eczema or other exfoliative skin conditions
  • Pregnant or nursing women
  • Household contact with persons with immunodeficiency (including eczema or use of immunosuppressive medications)
  • Household contact with persons less than 12 months of age
  • Household contact with pregnant women
  • History of cardiac disease such as previous myocardial infarction, angina, congestive heart failure, or cardiomyopathy
  • Any member of the Investigator's laboratory program
  • Participation in previous HIV vaccine trial

Sites / Locations

  • St. Jude Children's Research Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the tolerability and safety of the multi-envelope vaccine regimen.

Secondary Outcome Measures

To characterize the kinetics, duration and magnitude of the HIV-envelope specific immune responses elicited by the multi-envelope vaccine regimen.

Full Information

First Posted
February 18, 2008
Last Updated
April 24, 2017
Sponsor
St. Jude Children's Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00623753
Brief Title
Evaluate Tolerability of a Multi-envelope, Prime-boost HIV Vaccine in Healthy Adults
Official Title
Evaluate Tolerability and Safety of Multi-Envelope, Prime-boost HIV Vaccine (DVP) in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Terminated
Study Start Date
May 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Vaccines have been very successful in preventing viral infections such as hepatitis B and the measles. Viral vaccines work by causing a person's immune system to make cells that will work against the virus. Due to the success in treating other viral infections, scientists are trying to develop a vaccine for human immunodeficiency virus (HIV). HIV infection is the cause of acquired immune deficiency syndrome (AIDS). AIDS is one of the most serious viral infections we know. This is a research study to evaluate the safety of a possible vaccine against HIV. Researchers want to determine that a person's immune system can respond to the HIV before he or she is exposed to it. Therefore that person may be able to be protected from infection with HIV.
Detailed Description
This is a research study to find out about the safety of a new potential vaccine regimen against HIV. This potential vaccine regimen consists of a sequence of six vaccine shots that are being studied to see if they can help to protect people from the human immunodeficiency virus (HIV). HIV infection is the cause of AIDS. AIDS is one of the most serious viral infections we know. Twenty million people around the world have already died of AIDS and over 40 million people are currently infected with the virus. This study is being done to help us find an HIV vaccine that works. Vaccines have been very successful in preventing other viral infections, such as hepatitis B, polio, and measles. Viral vaccines work by causing a person's immune system to make antibodies and immune cells against the virus or to "respond" to the virus. Because of the success with other viral infections, scientists are trying to develop a successful vaccine for HIV. If a person's immune system can respond to HIV before he or she is exposed to it, that person may be able to be protected from infection with HIV. The vaccine regimen that will be tested in this study is based on the information that the virus uses to make a small part of the HIV. This small part is called the "envelope" or coating around the virus. Because only the information for this one part of the virus is used in the vaccine, the vaccine cannot cause HIV infection. We make all parts of the vaccine regimen in test tubes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Vaccine, Prevention, HIV, AIDS, Human Immunodeficiency Virus, HIV Seronegativity, HIV Preventive Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
EnvDNA, PolyEnv1, EnvPro
Intervention Description
Description: The vaccine regimen is a series of 6 injections given 28 days apart. EnvDNA is administered intramuscularly as 100 mcg of recombinant DNA in 1.5 mL of PBS as injections #1, 2 and 5. PolyEnv1 is recombinant vaccinia virus administered subcutaneously as 107 pfu in 0.8 mL of PBS as injection #3. EnvPro is administered intramuscularly as 100 mcg of recombinant protein and 500 mcg of aluminum hydroxide (alum) adjuvant in 1.0 mL of PBS as injections #4 and 6.
Primary Outcome Measure Information:
Title
To evaluate the tolerability and safety of the multi-envelope vaccine regimen.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To characterize the kinetics, duration and magnitude of the HIV-envelope specific immune responses elicited by the multi-envelope vaccine regimen.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults; age > 18 years, born after 1972 if born in U.S. Informed consent Normal history and physical exam HIV-1 negative as documented by ELISA and Western blot analysis within 30 days prior to immunization Normal laboratory values within 60 days prior to immunization defined as: hemoglobin greater than or equal to 12.0 gm/dl for females and greater than or equal to 14.0 gm/dl for males White blood cell count > 3500 cells/mm3 Platelet count 150,000 - 550,000 cells/mm3 Absolute CD4+ count > 400 cells/mm3 AST and ALT within normal institutional limits Serum creatinine within normal institutional limits Normal CPK-MB (creatine kinase isoenzyme MB) and troponin I within 30 days prior to immunization Normal ECG within 30 days prior to immunization No evidence of smallpox vaccination (born in the U.S. after 1972 with no typical scar on the deltoid, ankle, thigh or between the scapulae and no history of vaccination in personal immunization record) No entry into military service before 1990 Fewer than 3 of the following: Current cigarette smoker History of high cholesterol History of diabetes or high blood sugar High blood pressure Heart disease before age 50 in parent or sibling Not planning to become pregnant during study vaccinations and for 3 months after last vaccination Vaccinia virus seronegative Exclusion Criteria: History of immunosuppressive illness, chronic illness (e.g. asthma, bleeding diathesis, etc) or use of any immunosuppressive medications (e.g. steroids) History of neurological disorder Receiving therapy or prophylaxis for tuberculosis Known allergy to the antibiotic kanamycin History of eczema, atopic dermatitis and other acute, chronic or exfoliative conditions Household contact with persons with eczema or other exfoliative skin conditions Pregnant or nursing women Household contact with persons with immunodeficiency (including eczema or use of immunosuppressive medications) Household contact with persons less than 12 months of age Household contact with pregnant women History of cardiac disease such as previous myocardial infarction, angina, congestive heart failure, or cardiomyopathy Any member of the Investigator's laboratory program Participation in previous HIV vaccine trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pat Flynn, MD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital

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Evaluate Tolerability of a Multi-envelope, Prime-boost HIV Vaccine in Healthy Adults

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