NCT00061243

Brief Summary

This study will evaluate the safety of and immune response to a new HIV vaccine. The vaccine in this trial uses pieces of HIV DNA and HIV proteins. The vaccine itself cannot cause HIV infection or AIDS.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2003

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

September 26, 2008

Status Verified

December 1, 2005

Enrollment Period

1 year

First QC Date

May 22, 2003

Last Update Submit

September 25, 2008

Conditions

HIV Infections

Keywords

HIVVaccineDNA primeProtein boostHIV SeronegativityHIV preventive vaccine

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    Throughout study

Secondary Outcomes (2)

  • Cross-clade neutralizing antibody

    Throughout study

  • Cellular immunity

    Throughout study

Study Arms (5)

1

EXPERIMENTAL

Participants will receive different doses of the vaccine to determine the optimal dose

Biological: HIV-1 DNA vaccine with protein vaccine boost

2

EXPERIMENTAL

Participants will receive different doses of the vaccine to determine the optimal dose

Biological: HIV-1 DNA vaccine with protein vaccine boost

3

EXPERIMENTAL

Participants will receive different doses of the vaccine to determine the optimal dose

Biological: HIV-1 DNA vaccine with protein vaccine boost

4

EXPERIMENTAL

Participants will receive the vaccine through either intradermal or intramuscular administration

Biological: HIV-1 DNA vaccine with protein vaccine boost

5

EXPERIMENTAL

Participants will receive the vaccine through either intradermal or intramuscular administration

Biological: HIV-1 DNA vaccine with protein vaccine boost

Interventions

HIV-1 DNA vaccine with protein vaccine boostBIOLOGICAL

Three doses of DNA vaccination will be administered at weeks 0, 4, and 12, and 2 doses of protein vaccination at weeks 20 and 28

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Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • HIV uninfected
  • Good general health as determined by medical history, physical examination, vital signs, and clinical laboratory measurements
  • Body Mass Index (BMI) =\< 32
  • Hepatitis B surface antigen negative
  • Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive
  • Low risk for HIV exposure
  • No co-existent endocrine conditions
  • No evidence of hepatic insufficiency, significant renal insufficiency, or proteinuria
  • Acceptable methods of contraception
  • Anticipated availability for the planned follow-up period of one year

You may not qualify if:

  • Certain medications during the 2 weeks prior to study entry
  • Donation of a unit of blood within 2 months prior to study entry
  • Participation in a study of investigational or marketed drugs within 1 month prior to study entry
  • Blood transfusion within 6 months prior to study entry
  • Pregnant, breastfeeding, or planning pregnancy during the study period
  • History of significant adverse reaction to any vaccine
  • Prior receipt of any experimental HIV vaccine
  • Morbid obesity (\> 195% of ideal body weight)
  • Hypertension (patients may be taking concomitant antihypertensive medication during the study if approved by study officials)
  • History of chronic medical illness, malignancy, or autoimmune disorder
  • History of immunodeficiency or treatment with immunosuppressive medications
  • History of organ transplant
  • Medical or psychiatric obstacle to compliance with protocol
  • Significant urine concentration of any drug that could interfere with the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts School of Medicine

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jeff Kennedy, MD

    University of Massachusetts, Worcester

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 22, 2003

First Posted

May 23, 2003

Study Start

April 1, 2004

Primary Completion

April 1, 2005

Study Completion

April 1, 2010

Last Updated

September 26, 2008

Record last verified: 2005-12

Locations

US(1)