Evaluate Tolerability of a Multi-Envelope, Prime-Boost HIV Vaccine in Healthy Adults - Full Text View

Sponsored by:	St. Jude Children's Research Hospital
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00623753

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Biological: EnvDNA, PolyEnv1, EnvPro	Phase I

MedlinePlus related topics: AIDS

Drug Information available for: Aluminum hydroxide Algeldrate Aluminum PANVAC-V Alum, potassium Aluminum sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Single Group Assignment
Official Title:	Evaluate Tolerability and Safety of Multi-Envelope, Prime-Boost HIV Vaccine (DVP) in Healthy Adults

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:

To evaluate the tolerability and safety of the multi-envelope vaccine regimen. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	3
Study Start Date:	May 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Biological: EnvDNA, PolyEnv1, EnvPro 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.

Arms

Assigned Interventions

A: Experimental

Biological: EnvDNA, PolyEnv1, EnvPro

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623753

Locations

United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105

Sponsors and Collaborators

St. Jude Children's Research Hospital

Investigators

Principal Investigator:

Pat Flynn, MD

St. Jude Children's Research Hospital

More Information

St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site

Responsible Party:	St. Jude Children's Research Hospital ( Patricia Flynn, M.D., Principal Investigator )
Study ID Numbers:	DVP-I, IND13042
Study First Received:	February 18, 2008
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00623753
Health Authority:	United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:

Vaccine
Prevention
HIV

AIDS
Human Immunodeficiency Virus
HIV Seronegativity, HIV Preventive Vaccine

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Aluminum sulfate
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Healthy
Retroviridae Infections
Immunologic Deficiency Syndromes
Aluminum Hydroxide

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009