NCT00115960

Brief Summary

The purpose of this study is to determine the safety of and immune response to an experimental HIV vaccine, HIV-1 gag DNA, with and without an IL-15 DNA adjuvant (at escalating doses of 100, 500, and 1500 mcg). This study will also test the safety of and immune response to the HIV-1 gag DNA vaccine plus IL-15 DNA adjuvant given with or without 2 other adjuvant-containing booster vaccines.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
2 countries

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

June 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2005

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

First QC Date

June 26, 2005

Last Update Submit

October 13, 2021

Conditions

HIV Infections

Keywords

IL-12IL-15HIV SeronegativityHIV Preventive Vaccine

Outcome Measures

Primary Outcomes (3)

  • Local and systemic reactogenicity signs and symptoms, as assessed after each injection

    12 months postinjection for Part A, and 15 months after the first injection in Part B

  • Laboratory measures of safety, as assessed after each injection

    12 months postinjection for Part A, and 15 months after the first injection in Part B

  • Adverse and serious adverse experiences, as assessed after each injection

    12 months postinjection for Part A, and 15 months after the first injection in Part B

Secondary Outcomes (3)

  • HIV-specific cellular responses by IFN-gamma ELISpot

    12 months postinjection for Part A, and 15 months after the first injection in Part B

  • HIV binding antibody by ELISA

    12 months postinjection for Part A, and 15 months after the first injection in Part B

  • Social impact variables

    At the end of the study

Study Arms (6)

1

EXPERIMENTAL

Group 1 will receive 3 vaccinations of the HIV-1 gag DNA vaccine, or placebo. Vaccinations will be given at Months 0, 1, and 3.

Biological: HIV-1 gag DNA

2

EXPERIMENTAL

Group 2 will receive 3 vaccinations of either the HIV-1 gag DNA vaccine with a low dose of IL-15 adjuvant, or a placebo. Vaccinations will be given at Months 0, 1, and 3.

Biological: HIV-1 gag DNABiological: IL-15 DNA adjuvant

3

EXPERIMENTAL

Group 3 will receive 3 vaccinations of either the HIV-1 gag vaccine with a medium dose of IL-15 adjuvant, or a placebo. Vaccinations will be given at Months 0, 1, and 3.

Biological: HIV-1 gag DNABiological: IL-15 DNA adjuvant

4

EXPERIMENTAL

Group 4 will receive 3 vaccinations of either the HIV-1 gag vaccine with a high dose of IL-15 adjuvant, or a placebo. Vaccinations will be given at Months 0, 1, and 3.

Biological: HIV-1 gag DNABiological: IL-15 DNA adjuvant

5

EXPERIMENTAL

In Part B, Group 5 will receive 5 vaccinations of either the HIV-1 gag vaccine plus IL-15 DNA, or placebo. Vaccinations will occur at Months 0, 1, 3, 6, and 9.

Biological: HIV-1 gag DNABiological: IL-15 DNA adjuvant

7

EXPERIMENTAL

In Part B, Group 7 will receive 3 vaccinations of the HIV-1 gag vaccine with a high dose of IL-15 adjuvant (maximum tolerated dose from Part A) followed by 2 vaccinations of the gag DNA vaccine with IL-12 DNA adjuvant. Some participants will receive placebo instead of this vaccine regimen. For Group 7, the HIV-1 gag vaccine with IL-15 adjuvant vaccinations will be given at Months 0, 1, and 3, and booster vaccinations will be given at Months 6 and 9.

Biological: HIV-1 gag DNABiological: IL-15 DNA adjuvantBiological: IL-12 DNA adjuvant

Interventions

HIV-1 gag DNABIOLOGICAL

DNA vaccine containing the HIV gene gag

123457
IL-15 DNA adjuvantBIOLOGICAL

Cytokine injection

23457
IL-12 DNA adjuvantBIOLOGICAL

Cytokine injection

7

Eligibility Criteria

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

You may qualify if:

  • HIV uninfected
  • Access to a participating HIV Vaccine Trials Unit (HVTU)
  • Willing to receive HIV test results
  • Willing and able to comply with all study requirements
  • In good general health
  • Willing to use acceptable methods of contraception for at least 21 days prior to study entry and until the last study visit. More information about this criterion can be found in the protocol.
  • Hepatitis B surface antigen negative
  • Anti-hepatitis C virus (anti-HCV) antibody negative or negative HCV PCR if anti-HCV antibody is positive

You may not qualify if:

  • HIV vaccines in prior HIV vaccine trial
  • Immunosuppressive medications within 168 days prior to first vaccination
  • Blood products within 120 days prior to first vaccination
  • Immunoglobulin within 60 days prior to first vaccination
  • Live attenuated vaccines within 30 days prior to first vaccination
  • Investigational research agents within 30 days prior to first vaccination
  • Medically indicated subunit or killed vaccines within 14 days prior to first study vaccine administration, or allergy treatment with antigen injections within 30 days prior to first vaccination
  • Current tuberculosis (TB) prophylaxis or therapy
  • Clinically significant medical condition, physical exam findings, abnormal laboratory results, or past medical history with clinically significant implications for current health
  • Any medical, psychiatric, or social condition that, in the opinion of the investigator, may interfere with the study
  • Any occupational or other responsibility that, in the opinion of the investigator, may interfere with the study
  • Diagnosis of allergy to amide-type local anesthetics
  • Serious adverse reaction to vaccines, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, or abdominal pain. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
  • Autoimmune disease or immunodeficiency
  • Unstable asthma
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Brigham and Women's Hosp. CRS

Boston, Massachusetts, 02115, 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

Univ. of Rochester HVTN CRS

Rochester, New York, 14642-0001, United States

Location

NY Blood Ctr./Bronx CRS

The Bronx, New York, 10456, United States

Location

Miriam Hospital's HVTU

Providence, Rhode Island, United States

Location

Sao Paulo HVTU - CRT DST/AIDS CRS

São Paulo, Brazil

Location

Related Publications (5)

  • Boyer JD, Chattergoon M, Muthumani K, Kudchodkar S, Kim J, Bagarazzi M, Pavlakis G, Sekaly R, Weiner DB. Next generation DNA vaccines for HIV-1. J Liposome Res. 2002 Feb-May;12(1-2):137-42. doi: 10.1081/lpr-120004786.

    PMID: 12604047BACKGROUND

  • Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. doi: 10.2174/1389450043490686.

    PMID: 14738219BACKGROUND

  • Xin KQ, Hamajima K, Sasaki S, Tsuji T, Watabe S, Okada E, Okuda K. IL-15 expression plasmid enhances cell-mediated immunity induced by an HIV-1 DNA vaccine. Vaccine. 1999 Feb 26;17(7-8):858-66. doi: 10.1016/s0264-410x(98)00271-0.

    PMID: 10067692BACKGROUND

  • 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

  • Kalams SA, Parker S, Jin X, Elizaga M, Metch B, Wang M, Hural J, Lubeck M, Eldridge J, Cardinali M, Blattner WA, Sobieszczyk M, Suriyanon V, Kalichman A, Weiner DB, Baden LR; NIAID HIV Vaccine Trials Network. Safety and immunogenicity of an HIV-1 gag DNA vaccine with or without IL-12 and/or IL-15 plasmid cytokine adjuvant in healthy, HIV-1 uninfected adults. PLoS One. 2012;7(1):e29231. doi: 10.1371/journal.pone.0029231. Epub 2012 Jan 5.

    PMID: 22242162DERIVED

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

  • Lindsey Baden, MD

    Harvard University

    STUDY CHAIR

  • Xia Jin, MD, PhD

    University of Rochester

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2005

First Posted

June 27, 2005

Study Completion

July 1, 2008

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

US(6)BR(1)