A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 Mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	Biocine
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000749

Purpose

To evaluate in healthy volunteers the safety and immune response to 200 mcg gp120 candidate vaccine in MF59 emulsion without MTP-PE at 0, 1 and 6 months.

Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest.

Condition	Intervention	Phase
HIV Infections	Biological: rgp120/HIV-1 SF-2	Phase I

Study Type:	Interventional
Study Design:	Prevention, Parallel Assignment, Safety Study
Official Title:	A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 Mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: MF 59

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

Detailed Description:

Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest.

Ten healthy volunteers receive 200 mcg gp120 in MF59 emulsion, and four volunteers receive placebo consisting of MF59 emulsion in PBS vehicle. Injections are given at months 0, 1, and 6. Patients are followed for 12 months following the third injection.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria

Subjects must have:

Normal history and physical exam.
Negative ELISA for HIV.
Normal cell-mediated immune responses using Merieux skin test.
Normal urinalysis.

Exclusion Criteria

Co-existing Condition:

Subjects with the following conditions are excluded:

Evidence of psychological or psychiatric problems that may lead to noncompliance with study requirements.
Positive syphilis serology. If serology is documented as a false positive or is due to a remote (> 6 months) treated infection, subject is eligible.
Circulating hepatitis B surface antigen.

Subjects with the following prior conditions are excluded:

History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
History of anaphylaxis or other adverse reactions to vaccines.

Prior Medication:

Excluded:

Prior HIV vaccines.
Immunoglobulins or vaccines within the past 3 months.
Experimental agents within the past 30 days.

Prior Treatment:

Excluded:

Blood transfusions or cryoprecipitates within the past 3 months.

Identifiable high-risk behavior for HIV infection, including:

Any history of intravenous (IV) drug use within the past year.
Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000749

Locations

United States, Tennessee
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States, 381052794
Vanderbilt Univ Hosp
Nashville, Tennessee, United States, 37232
United States, Washington
Univ of Washington / Pacific Med Ctr
Seattle, Washington, United States, 98144

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Biocine

Investigators

Study Chair:

Graham B

More Information

No publications provided

Study ID Numbers:	AVEG 007C
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000749 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Vaccines, Synthetic
HIV Envelope Protein gp120
AIDS Vaccines
HIV Seronegativity
HIV Preventive Vaccine

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 09, 2009