NCT00187148

Brief Summary

This protocol will evaluate the safety and tolerability of the vaccine EnvDNA in healthy adults. DNA-based vaccines are being studied for the prevention of human immunodeficiency virus (HIV), malaria and hepatitis. DNA vaccines have been well tolerated in human studies to date. The vaccine that will be tested in this study was made from the information that the virus uses to make a small part of the HIV. This small part is called the envelope or coating around the virus. We hope the body will make an immune response against the HIV envelope coat. Our potential HIV DNA envelope vaccine is called EnvDNA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

April 26, 2017

Status Verified

June 1, 2011

Enrollment Period

4.8 years

First QC Date

September 12, 2005

Last Update Submit

April 24, 2017

Conditions

Human Immunodeficiency VirusHIV Infections

Keywords

VaccinePreventionHIVAIDS

Outcome Measures

Primary Outcomes (1)

  • To evaluate the tolerability and safety of the EnvDNA vaccine

    1 year

Secondary Outcomes (1)

  • To characterize the kinetics, duration and magnitude of any HIV-envelope specific immune response elicited by EnvDNA

    1 year

Study Arms (1)

1

OTHER
Biological: EnvDNA

Interventions

EnvDNABIOLOGICAL

administered as 100 mcg of DNA in 1.5mL PBS every 28 days for 3 injections

1

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults; age greater than 18 years, less than or equal to 40 years
  • HIV-1 negative as documented by negative ELISA and negative Western blot analysis within 30 days prior to immunization
  • Normal history and physical exam
  • Normal complete blood count and differential obtained within 60 days prior to immunization, and defined as:
  • hemoglobin greater than or equal to 12.0 gm/dl for females and greater than or equal to 14.0 gm/dl for males
  • white blood cell count greater than or equal to 3500 cells/mm3
  • platelet count between 150,000 and 550,000 cells/mm3
  • CD4+ T cell count greater than or equal to 400 cells/mm3 (if a single CD4+ T cell count \<400 cells/mm3 is obtained, a repeat count will be performed and immunization will proceed if the repeat count is greater than or equal to 400 cells/mm3)
  • Anti-nuclear antibody titer \<1:80 (by IFA) and negative anti-DNA antibody within 60 days prior to immunization
  • Negative for Hepatitis B surface antigen and Hepatitis C
  • AST and ALT within normal institutional limits obtained within 60 days prior to immunization
  • Serum creatinine, Na+, K+ and Cl- within normal institutional limits, obtained within 60 days prior to immunization
  • Serum creatine phosphokinase (CPK) within normal institutional limits obtained within 60 days prior to immunization
  • Not planning to become pregnant during study vaccinations and for three months after last vaccination
  • Availability for at least one year of follow-up

You may not qualify if:

  • History of immunosuppressive illness, chronic illness (e.g. asthma, diabetes, hypertension, bleeding diathesis, etc), or
  • Receiving therapy or prophylaxis for tuberculosis
  • Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol. Specifically excluded are persons with a history of suicide attempts, recent suicidal ideation or who have past or present psychosis
  • Use of experimental agents within 30 days prior to study enrollment
  • Receipt of blood products or immunoglobulin in the past 6 months
  • Subjects with known allergy to the antibiotic kanamycin
  • Pregnancy at the time of vaccination (urine pregnancy test)
  • Nursing mother at the time of vaccination
  • Any member of the Investigator's laboratory program
  • Participation in previous HIV vaccine trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pat Flynn, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

February 1, 2005

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

April 26, 2017

Record last verified: 2011-06

Locations

US(1)