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

NCT00623753 | Terminated Phase 1 DMC

• 1 other identifier: DVP-I
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Vaccine; Prevention; HIV; AIDS; Human Immunodeficiency Virus; HIV Seronegativity, HIV Preventive Vaccine

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (1)

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

  1 year

Study Arms (1)

A

EXPERIMENTAL

Biological: EnvDNA, PolyEnv1, EnvPro

Interventions

EnvDNA, PolyEnv1, EnvPro BIOLOGICAL

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.

A

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Pat Flynn, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2008
• First Posted: February 26, 2008
• Study Start: May 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: April 26, 2017

Record last verified: 2011-09

Locations

US (1)