Safety and Immunogenicity of a Plasmid HIV Vaccine in HIV Uninfected Adults (C001)

This study has been completed.
Sponsor:
Collaborators:
Aaron Diamond AIDS Research Center
University of Rochester
Information provided by (Responsible Party):
International AIDS Vaccine Initiative
ClinicalTrials.gov Identifier:
NCT00249106
First received: November 3, 2005
Last updated: February 8, 2013
Last verified: September 2011
  Purpose

The purpose of this study is to determine the safety and immune response to a investigational DNA Plasmid HIV vaccine, ADVAX e/g + ADVAX p/n-t (ADVAX), at three different dosage levels, in adults who are not infected with HIV.


Condition Intervention Phase
HIV Infection
Biological: ADVAX
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Placebo-Controlled, Dose-Escalating, Double-Blinded Phase 1 Safety and Immunogenicity Study of Clade C DNA Vaccine ADVAX e/g + ADVAX p/N-t (ADVAX) Administered Intramuscularly to HIV-Uninfected, Healthy Volunteers.

Resource links provided by NLM:


Further study details as provided by International AIDS Vaccine Initiative:

Primary Outcome Measures:
  • Safety of ADVAX [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    dose escalation study


Secondary Outcome Measures:
  • Immunogenicity of ADVAX [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: December 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIV vaccine
dosage escalation of ADVAX
Biological: ADVAX
Other Name: DNA HIV vaccine
Placebo Comparator: Placebo
Sodium phosphate
Biological: ADVAX
Other Name: DNA HIV vaccine

Detailed Description:

This is a dose escalation trial. Study site staff and volunteers will be blinded, blinding will not apply to the assignment of dose levels (low, middle or high).

Volunteers will be screened up to 42 days before vaccination and will be followed for 18 months after the first vaccination.

15 volunteers will be randomized in a 4:1 ratio of active vaccine to placebo. Safety and tolerability of the ADVAX e/g + ADVAX p/n-t investigational product will be evaluated at least 14 days after the tenth volunteer in the lower dosage group receives the second injection before proceeding to the nextdosage group.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, adult males and females;
  • Age at least 18 years on the day of screening and no greater than 60 years on the day of the first vaccination;
  • Available for follow up for the planned duration of the study (screening plus 18 months);
  • In the opinion of the principal investigator or designee, has understood the information provided. Written informed consent needs to be given before any study-related procedures are performed;
  • Willing to undergo HIV testing and counseling, and receive HIV test results;
  • If sexually active female, using an effective method of contraception from screening until at least 4 months after last vaccination, and willing to undergo urine pregnancy test.
  • If sexually active male, willing to use an effective method of contraception from screening until 4 months after the last vaccination.

Exclusion Criteria:

  • Clinically relevant abnormality on history or examination including history of immunodeficiency or use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the designated trial physician in last 6 months;
  • Any acute or chronic medical condition requiring care of a physician (e.g.,, diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the investigator, would preclude participation;
  • Any of the following abnormal laboratory parameters that are moderate, severe, or very severe: haematology (hemoglobin, absolute neutrophil count, absolute lymphocyte count, absolute CD4/CD8 count, platelets); urinalysis, biochemistries (total bilirubin, creatinine, AST, ALT). Volunteers with mild laboratory abnormalities that are judged by the principal investigator or designee to be not clinically significant may be enrolled.
  • Reported high- risk behaviour for HIV infection, defined as:
  • Had unprotected vaginal or anal sex with a known HIV infected person or a casual partner (i.e., no continuing established relationship) within 6 months before vaccination
  • Engaged in sex work for money or drugs within 6 months before vaccination
  • Used injection drugs (illicit), or Acquired an STD within 6 months before vaccination ;
  • If female, pregnant or planning a pregnancy within 4 months after last vaccination or lactating;
  • Receipt of blood transfusion or blood products 6 months prior to vaccination;
  • Receipt of a live attenuated vaccine (other than influenza) within 30 days or other vaccine within 14 days of vaccination;
  • Participation in another clinical trial of an investigational product currently or within past 12 weeks or expected participation during this study;
  • Receipt of another experimental HIV vaccine at any time;
  • Infected with HIV-1 or HIV-2 as indicated by ELISA and/or RT-PCR;
  • History of severe local or systemic reaction to vaccination or history of severe allergic reactions;
  • Confirmed diagnosis of hepatitis B (surface antigen, HbsAg); hepatitis C (HCV antibodies) or active syphillis;
  • History of grand-mal epilepsy, or currently taking anti-epileptics;
  • In the opinion of the investigator, unlikely to comply with protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249106

Locations
United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
International AIDS Vaccine Initiative
Aaron Diamond AIDS Research Center
University of Rochester
Investigators
Principal Investigator: David Ho, MD ADARC
Principal Investigator: Michael Keefer, MD University of Rochester
Study Director: Soe Than, MD International AIDS Vaccine Initiative
  More Information

Publications:
Responsible Party: International AIDS Vaccine Initiative
ClinicalTrials.gov Identifier: NCT00249106     History of Changes
Other Study ID Numbers: IAVI C001
Study First Received: November 3, 2005
Last Updated: February 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 21, 2014