A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 Mcg of Env 2-3 in MF59 - Tabular View

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A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 Mcg of Env 2-3 in MF59

This study has been completed.

Study NCT00000632. Last updated on June 23, 2005. Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 Mcg of Env 2-3 in MF59

Official Title ^†

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 Mcg of Env 2-3 in MF59

Brief Summary

To evaluate the safety and immune response of 100 mcg Env 2-3 antigen administered on days 0, 30, 180, and 365.

Preliminary immunologic data from protocol VEU 005B show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. Evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest.

Detailed Description

Twelve healthy volunteers receive injections of 100 mcg Env 2-3 in MF59 emulsion and two volunteers receive MF59 only on days 0, 30, 180, and 365. Follow-up continues for 6 months after the last injection.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Safety Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

HIV Infections
HIV Seronegativity

Intervention ^†

Biological: Env 2-3

MEDLINE PMIDs

9486388, 8744579

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

Completion Date

Eligibility Criteria ^†

Inclusion Criteria

Subjects are:

Normal, healthy adults (by history and physical examination) who fully comprehend the purpose and details of the study.

Exclusion Criteria

Co-existing Condition:

Subjects with the following conditions or symptoms are excluded:

Positive syphilis serology (such as VDRL) unless positive test is due to a documented clinical event that occurred and was treated 5 or more years prior to enrollment.
Circulating hepatitis B antigenemia.

Subjects with the following prior conditions are excluded:

History of immunodeficiency, chronic illness, or autoimmune disease.
Evidence of depression or under treatment for psychiatric problems during the past year.

Prior Medication:

Excluded:

Immunosuppressive medications.

Prior Treatment:

Excluded:

Blood transfusions or cryoprecipitates within the past 6 months.

Identifiable high-risk behavior for HIV infection, including:

history of intravenous drug use; syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the last 6 months; more than two sexual partners, or sexual contact with a high-risk partner, in the preceding 6 months.

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00000632

Organization ID

AVEG 005C

Secondary IDs ^††

Study Sponsor ^†

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^††

Biocine

Investigators ^†

Study Chair:

Dolin R

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

October 2002

First Received Date ^†

November 2, 1999

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.