NCT00069030

Brief Summary

This study will test the safety of and immune system response to a new HIV vaccine. The vaccine in this study is made from HIV DNA produced in a laboratory. Only part of the virus's DNA is used in the vaccine and the vaccine itself cannot cause HIV infection or AIDS. In addition to HIV DNA, the vaccine contains interleukin-2 (IL-2) DNA fused to a portion of immunoglobulin (Ig) DNA. IL-2 is a chemical that stimulates the immune system and may improve response to the vaccine. Study hypothesis: The IL-2/Ig plasmid will be very well tolerated in humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Dec 2003

Typical duration for phase_1 hiv-infections

Geographic Reach
1 country

7 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2003

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2003

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

First QC Date

September 12, 2003

Last Update Submit

October 13, 2021

Conditions

HIV Infections

Keywords

HIV SeronegativityHIV Preventive VaccineHIV-1AIDS VaccinesVaccines, DNADose-Response Relationship, ImmunologicCytokinesPlasmidsAdjuvants, ImmunologicDrug Administration ScheduleInterleukinIL2IgIL@/Ig

Outcome Measures

Primary Outcomes (2)

  • Clinical observation and monitoring of hematological, chemical, and immunologic parameters

  • local and systemic adverse reactions after each injection and for 12 months after last injection

Interventions

VRC-HIVDNA009-00-VP (Gag-Pol-Nef-multiclade-Env) with adjuvant VRC-ADJDNA004-IL2-VPBIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • HIV negative
  • Willing to receive HIV test results
  • Good general health
  • Acceptable methods of contraception for females of reproductive potential
  • Hepatitis B surface antigen negative
  • Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive
  • Normal thyroid stimulating hormone (TSH) level

You may not qualify if:

  • HIV vaccines or placebos in prior HIV vaccine trial
  • Immunosuppressive medications within 168 days prior to first study vaccine administration
  • Blood products within 120 days prior to first study vaccine administration
  • Immunoglobulin within 60 days prior to first study vaccine administration
  • Live attenuated vaccines within 30 days prior to first study vaccine administration
  • Investigational research agents within 30 days prior to first study vaccine administration
  • Subunit or killed vaccines within 14 days prior to first study vaccine administration
  • Current tuberculosis prophylaxis or therapy
  • Clinical depression with pharmacological treatment within the past 2 years
  • Active syphilis
  • Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
  • Autoimmune disease or immunodeficiency
  • Unstable asthma
  • Type 1 or Type 2 Diabetes Mellitus
  • Thyroid disease requiring treatment
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Project Brave HIV Vaccine CRS

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hosp. CRS

Boston, Massachusetts, 02115, United States

Location

Fenway Community Health Clinical Research Site (FCHCRS)

Boston, Massachusetts, 02215, United States

Location

NY Blood Ctr./Union Square CRS

New York, New York, 10003, United States

Location

HIV Prevention & Treatment CRS

New York, New York, 10032, United States

Location

NY Blood Ctr./Bronx CRS

The Bronx, New York, 10456, United States

Location

Miriam Hospital's HVTU

Providence, Rhode Island, 02906, United States

Location

Related Publications (7)

  • Barouch DH, Santra S, Schmitz JE, Kuroda MJ, Fu TM, Wagner W, Bilska M, Craiu A, Zheng XX, Krivulka GR, Beaudry K, Lifton MA, Nickerson CE, Trigona WL, Punt K, Freed DC, Guan L, Dubey S, Casimiro D, Simon A, Davies ME, Chastain M, Strom TB, Gelman RS, Montefiori DC, Lewis MG, Emini EA, Shiver JW, Letvin NL. Control of viremia and prevention of clinical AIDS in rhesus monkeys by cytokine-augmented DNA vaccination. Science. 2000 Oct 20;290(5491):486-92. doi: 10.1126/science.290.5491.486.

    PMID: 11039923BACKGROUND

  • Barouch DH, Santra S, Steenbeke TD, Zheng XX, Perry HC, Davies ME, Freed DC, Craiu A, Strom TB, Shiver JW, Letvin NL. Augmentation and suppression of immune responses to an HIV-1 DNA vaccine by plasmid cytokine/Ig administration. J Immunol. 1998 Aug 15;161(4):1875-82.

    PMID: 9712056BACKGROUND

  • Moore JP, Parren PW, Burton DR. Genetic subtypes, humoral immunity, and human immunodeficiency virus type 1 vaccine development. J Virol. 2001 Jul;75(13):5721-9. doi: 10.1128/JVI.75.13.5721-5729.2001. No abstract available.

    PMID: 11390574BACKGROUND

  • Approaches to the development of broadly protective HIV vaccines: challenges posed by the genetic, biological and antigenic variability of HIV-1: Report from a meeting of the WHO-UNAIDS Vaccine Advisory Committee Geneva, 21-23 February 2000. AIDS. 2001 Apr 13;15(6):W1-W25. No abstract available.

    PMID: 11371709BACKGROUND

  • Walker LG, Walker MB, Heys SD, Lolley J, Wesnes K, Eremin O. The psychological and psychiatric effects of rIL-2 therapy: a controlled clinical trial. Psychooncology. 1997 Dec;6(4):290-301. doi: 10.1002/(SICI)1099-1611(199712)6:43.0.CO;2-G.

    PMID: 9451748BACKGROUND

  • Jin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.

    PMID: 25820067DERIVED

  • Baden LR, Blattner WA, Morgan C, Huang Y, Defawe OD, Sobieszczyk ME, Kochar N, Tomaras GD, McElrath MJ, Russell N, Brandariz K, Cardinali M, Graham BS, Barouch DH, Dolin R; NIAID HIV Vaccine Trials Network 044 Study Team. Timing of plasmid cytokine (IL-2/Ig) administration affects HIV-1 vaccine immunogenicity in HIV-seronegative subjects. J Infect Dis. 2011 Nov 15;204(10):1541-9. doi: 10.1093/infdis/jir615. Epub 2011 Sep 21.

    PMID: 21940420DERIVED

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

  • Raphael Dolin, MD

    Harvard Medical School (HMS and HSDM)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2003

First Posted

September 16, 2003

Study Start

December 1, 2003

Study Completion

December 1, 2006

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

US(7)