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A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000846
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
November 2, 1999
August 31, 2001
December 9, 2005
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A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.
A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.
To evaluate safety and immunogenicity of 2 different HIV-1 peptide candidate vaccines, the UBI HIV-1 MN PND peptide immunogen and the UBI microparticulate monovalent HIV-1 MN branched peptide when administered sequentially by 2 different routes of immunization, parental priming followed by oral boosting.
After the prescreening, volunteers will be randomized into Group I or Group II. Each group will contain 16 volunteers. At least 5 volunteers in each group must be women. At month 0 all volunteers will receive multivalent HIV-1 peptide immunogen or the placebo. Group I will receive the injection in the deltoid and Group II will receive it in the anterior thigh. At months 1, 2 and 8 all patients will receive microparticulate monovalent HIV-1 peptide or the placebo. Follow up will be conducted.
Interventional
Phase 1
Masking: Double
Primary Purpose: Prevention
HIV Infections
  • Biological: HIV-1 Peptide Vaccine, Microparticulate Monovalent
  • Biological: HIV-1 Peptide Immunogen, Multivalent
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
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Inclusion Criteria

Patients must have or be:

  • Healthy.
  • Negative ELISA for HIV.
  • Negative for Hepatitis B surface antigen.
  • Normal urine dipstick.
  • Normal history and physical exam.
  • Availability for follow-up for planned duration of the study (60 weeks).

Risk Behavior: Required:

  • Lower or intermediate risk sexual behavior as defined by AVEG.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

  • Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol.
  • Active syphilis. NOTE: If the serology is documented to be a false positive or due to a remote (> 6 months) treated infection, the volunteer is eligible.
  • Active tuberculosis. NOTE: Volunteers with a positive PPD and a normal chest X-ray showing no evidence of TB and not requiring INH therapy are eligible.

Patients with any of the following prior conditions are excluded:

  • History of immunodeficiency, chronic illness, malignancy or autoimmune disease.
  • History of anaphylaxis or other serious adverse reactions to vaccines.
  • History of inflammatory gastrointestinal disease, celiac disease or intestinal malignancy.
  • History of acute gastroenteritis within the past month or gastrointestinal surgery within the past 12 months.

Prior Medication:

Excluded:

  • History of use of immunosuppressive medication.
  • Live attenuated vaccines within 60 days of study. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary but should be given at least 2 weeks away from HIV immunizations.
  • Use of experimental agents within 30 days prior to study.
  • Receipt of blood products or immunoglobulin in the past 6 months.
  • Prior receipt of HIV vaccines or a placebo recipient in an HIV vaccine trial.

Risk Behavior:

Excluded:

  • Subjects with identifiable higher risk behavior for HIV infection as determined by screening questionnaire designed to identify risk factors for HIV infection.
  • History of injection drug use within the last 12 months to enrollment.
  • Higher risk sexual behavior as defined by AVEG.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00000846
AVEG 023
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National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Mulligan M
National Institute of Allergy and Infectious Diseases (NIAID)
October 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP