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.

National Institute of Allergy and Infectious Diseases (NIAID) logo

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase

Completed
Phase 1

Conditions

HIV Infections

Treatments

Biological: HIV-1 Peptide Vaccine, Microparticulate Monovalent
Biological: HIV-1 Peptide Immunogen, Multivalent

Study type

Interventional

Funder types

NIH

Identifiers

NCT00000846
AVEG 023

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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