Expired Study
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Baltimore, Maryland 21205


Purpose:

To evaluate, in healthy adult volunteers, the safety and immunogenicity of multivalent HIV-1 peptide immunogen, a formulation of HIV-1 gp120 principal neutralizing domain (PND) branched synthetic peptides from 15 viral strains representative of diverse worldwide isolates. Because there is considerable variation among HIV-1 virus strains from differing geographical locations worldwide, a multivalent peptide vaccine has been constructed to include prevalent and divergent isolates, potentially providing for wide coverage of geographically isolated epidemics.


Study summary:

Because there is considerable variation among HIV-1 virus strains from differing geographical locations worldwide, a multivalent peptide vaccine has been constructed to include prevalent and divergent isolates, potentially providing for wide coverage of geographically isolated epidemics. Fourteen volunteers are entered at one of two dose levels of multivalent candidate vaccine. At each dose level, 12 volunteers receive vaccine and two receive placebo. At least eight volunteers at the low dose level must be monitored for 2 weeks before subsequent volunteers are entered at the high dose. Intramuscular injections are given on days 0, 28, and 168, and patients are followed for a minimum of 48 weeks after the initial immunization. Approximately 13 clinical visits are required.


Criteria:

Inclusion Criteria Subjects must have: - Normal history and physical exam. - HIV negativity by ELISA within 8 weeks of immunization. - CD4 count >= 400 cells/mm3. - Normal urinalysis. Exclusion Criteria Co-existing Condition: Subjects with the following symptoms or conditions are excluded: - Positive hepatitis B surface antigen. - Medical or psychiatric condition or occupational responsibilities that preclude study compliance. - Active syphilis. NOTE: Subjects whose serology is documented to be a false positive or due to a remote (> 6 months) treated infection are eligible. - Active tuberculosis. NOTE: Subjects with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible. Subjects with the following prior conditions are excluded: - History of immunodeficiency, chronic illness, or autoimmune disease. - History of anaphylaxis or other serious reactions to vaccines. Prior Medication: Excluded: - History of immunosuppressive medications. - Live attenuated vaccines within 60 days prior to study entry (NOTE: Medically indicated subunit or killed vaccines, e.g., influenza or pneumococcal, are not exclusionary, but should not be given within 2 weeks of HIV immunization). - Experimental agents within 30 days prior to study entry. - Prior HIV vaccines. Prior Treatment: Excluded: - Blood products or immunoglobulin within the past 6 months. Identifiable higher risk behavior for HIV infection, including the following: - History of injection drug use within the past 12 months. - Higher risk sexual behavior as defined by the AVEG.


Study is Available At:


Original ID:

AVEG 017


NCT ID:

NCT00000795


Secondary ID:


Study Acronym:


Brief Title:

A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects


Official Title:

A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Masking:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

28


Enrollment Type:


Overall Contact Information

Official Name:Keefer M
Study Chair

Study Dates

Verification Date:October 2002
Last Changed Date:September 8, 2008
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:HIV-1 Peptide Immunogen, Multivalent

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Kelleher AD, Emery S, Cunningham P, Duncombe C, Carr A, Golding H, Forde S, Hudson J, Roggensack M, Forrest BD, Cooper DA. Safety and immunogenicity of UBI HIV-1MN octameric V3 peptide vaccine administered by subcutaneous injection. AIDS Res Hum Retroviruses. 1997 Jan 1;13(1):29-32.
PMID:8989424
Reference Type:Reference
Citation:Evans TG, Fitzgerald T, Gibbons DC, Keefer MC, Soucier H. Th1/Th2 cytokine responses following HIV-1 immunization in seronegative volunteers. The AIDS Vaccine Evaluation Group. Clin Exp Immunol. 1998 Feb;111(2):243-50.
PMID:9486388
Reference Type:Reference
Citation:Kahn J, Murcar N, Elbeik T, Staprans S, Hanson C, Mayer Y, Doyle R, Gonzalez L, Koff W. UBI HIV-1MN octameric V3 peptide vaccine in HIV-1 negative humans. Conf Adv AIDS Vaccine Dev. 1996 Feb 11-15:167 [Poster 47]

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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