ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000795
  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.


Condition Intervention Phase
HIV Infections
Biological: HIV-1 Peptide Immunogen, Multivalent
Phase I

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Double-Blind, Safety Study
Official Title:   A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects

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

Estimated Enrollment:   28

Detailed Description:

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.

  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.
  • 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000795

Locations
United States, Maryland
Johns Hopkins Univ / Ctr for Immunological Research    
      Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

Investigators
Study Chair:     Keefer M    
  More Information


Publications:

Study ID Numbers:   AVEG 017
First Received:   November 2, 1999
Last Updated:   September 8, 2008
ClinicalTrials.gov Identifier:   NCT00000795
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic  
HIV-1  
AIDS Vaccines  
HIV Seronegativity  
HIV Preventive Vaccine  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers