NCT00528489

Brief Summary

The purpose of this study is to determine the safety, tolerability, and immune response to the DNA HIV vaccine, PENNVAX-B alone, in combination with IL-12, or with 2 different doses of IL-15.

Trial Health

87
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

Timeline
Completed

Started Oct 2007

Typical duration for phase_1 hiv-infections

Geographic Reach
1 country

8 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 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

2.3 years

First QC Date

September 10, 2007

Last Update Submit

October 13, 2021

Conditions

HIV Infections

Keywords

HIV SeronegativityDNA Plasmid VaccineHIV Preventive Vaccine

Outcome Measures

Primary Outcomes (2)

  • Safety data including local and systemic reactogenicity sign and symptoms, laboratory measures of safety, and adverse and serious adverse events

    Throughout study

  • Safety data from Groups 1 and 4

    Throughout study

Secondary Outcomes (2)

  • HIV-1 specific interferon gamma ELISpot and/or intracellular cytokine staining T cell response

    2 weeks after 3rd and 4th vaccinations

  • HIV-1 specific neutralizing and binding antibody assays

    2 weeks after 3rd and 4th vaccinations

Study Arms (4)

1

EXPERIMENTAL

PENNVAX-B with 0.8 mg IL-15 administered in both deltoids at Months 0, 1, 3, and 6

Biological: PennVax BBiological: IL-15

2

EXPERIMENTAL

PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6

Biological: PennVax B

3

EXPERIMENTAL

PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6

Biological: PennVax BBiological: IL-12

4

EXPERIMENTAL

PENNVAX-B with 2 mg IL-15 injected into both deltoids at Months 0, 1, 3, and 6

Biological: PennVax BBiological: IL-15

Interventions

PennVax BBIOLOGICAL

DNA vaccine containing the HIV genes Gag, Pol, and Env

1234
IL-12BIOLOGICAL

Cytokine injection

3
IL-15BIOLOGICAL

Cytokine injection

14

Eligibility Criteria

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

You may qualify if:

  • HIV-1 and -2 uninfected
  • Willing to receive HIV test results
  • Good general health
  • Certain laboratory values within normal range or with site physician approval
  • Negative for Hepatitis B surface antigen
  • Negative Hepatitis C test
  • Willing to use acceptable methods of contraception

You may not qualify if:

  • HIV vaccines or placebos in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
  • Immunosuppressive medications within 168 days prior to first study vaccination. Participants using corticosteroid nasal spray for allergies or topical corticosteroids for mild, uncomplicated dermatitis are not excluded.
  • Blood products within 120 days prior to first study vaccination
  • Receipt of immunoglobulin within 60 days prior to first vaccination
  • Live attenuated vaccines within 30 days prior to first study vaccination
  • Any vaccine that is not a live attenuated vaccine within 14 days prior to first study vaccination
  • Investigational research agents within 60 days prior to first study vaccination
  • Current anti-tuberculosis (TB) preventive therapy or treatment clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health. More information about this criterion can be found in the protocol.
  • Any medical, psychiatric, social, occupational, or other condition or responsibility that in the opinion of the investigator would interfere with the study. More information about this criterion can be found in the protocol.
  • Allergy to amide-type local anesthetics
  • Serious adverse reactions to vaccines
  • Autoimmune disease or immunodeficiency
  • Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded.
  • Asthma other than mild, well-controlled asthma. More information on this criterion can be found in the protocol.
  • Type 1 or type 2 diabetes mellitus. Participants with histories of isolated gestational diabetes are not excluded.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Alabama Vaccine CRS

Birmingham, Alabama, 35294, United States

Location

San Francisco Vaccine and Prevention CRS

San Francisco, California, United States

Location

Brigham and Women's Hosp. CRS

Boston, Massachusetts, 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

3535 Market Street CRS

Philadelphia, Pennsylvania, United States

Location

Vanderbilt Vaccine CRS

Nashville, Tennessee, United States

Location

Related Publications (4)

  • Johnston MI, Fauci AS. An HIV vaccine--evolving concepts. N Engl J Med. 2007 May 17;356(20):2073-81. doi: 10.1056/NEJMra066267. No abstract available.

    PMID: 17507706BACKGROUND

  • Ogawa H, Ueno M, Uchibori H, Matsumoto I, Seno N. Direct carbohydrate analysis of glycoproteins electroblotted onto polyvinylidene difluoride membrane from sodium dodecyl sulfate-polyacrylamide gel. Anal Biochem. 1990 Nov 1;190(2):165-9. doi: 10.1016/0003-2697(90)90175-9.

    PMID: 1705391BACKGROUND

  • McBurney SP, Ross TM. Developing broadly reactive HIV-1/AIDS vaccines: a review of polyvalent and centralized HIV-1 vaccines. Curr Pharm Des. 2007;13(19):1957-64. doi: 10.2174/138161207781039841.

    PMID: 17627529BACKGROUND

  • 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

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

Interleukin-12Interleukin-15

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Scott Parker, MD

    HVTN, FHCRC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2007

First Posted

September 12, 2007

Study Start

October 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

US(8)