NCT00301184

Brief Summary

The purpose of this study is to determine the safety of and immune response to a DNA HIV vaccine, pGA2/JS7, followed by a modified vaccinia (smallpox) HIV vaccine, MVA/HIV62, in HIV uninfected adults.

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 Apr 2006

Typical duration for phase_1 hiv-infections

Geographic Reach
1 country

6 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

March 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2006

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

First QC Date

March 8, 2006

Last Update Submit

August 4, 2022

Conditions

HIV Infections

Keywords

HIV SeronegativityHIV Preventive VaccineHIV DNA VaccineModified Vaccinia Ankara Vaccine

Outcome Measures

Primary Outcomes (3)

  • Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse and serious experiences)

    Throughout study

  • Immunogenicity, as defined by the protocol

    Throughout study

  • Social impacts (negative experiences or problems reported by the participants)

    Throughout study

Study Arms (4)

1A

EXPERIMENTAL

One 0.3 mg dose of DNA HIV vaccine or placebo administered at study entry and Month 2, followed by one dose of 1x10\^7 TCID50 MVA or placebo at Months 4 and 6

Biological: pGA2/JS7 DNABiological: Modified vaccinia Ankara/HIV62

1B

EXPERIMENTAL

One 3.0 mg dose of DNA HIV vaccine or placebo administered at study entry and Month 2, followed by one dose of 1x10\^8 TCID50MVA or placebo administered at Months 4 and 6

Biological: pGA2/JS7 DNABiological: Modified vaccinia Ankara/HIV62

2A

EXPERIMENTAL

One MTD (determined in Part 1) of DNA HIV vaccine or placebo administered at study entry. One dose of placebo or MTD of MVA at Months 2 and 6

Biological: pGA2/JS7 DNABiological: Modified vaccinia Ankara/HIV62

2B

EXPERIMENTAL

One dose of placebo or MTD of MVA administered at study entry and Months 2 and 6

Biological: Modified vaccinia Ankara/HIV62

Interventions

pGA2/JS7 DNABIOLOGICAL

DNA Vaccine

1A1B2A
Modified vaccinia Ankara/HIV62BIOLOGICAL

Recombinant Modified Ankara Vaccine

Also known as: MVA
1A1B2A2B

Eligibility Criteria

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

You may qualify if:

  • HIV uninfected
  • Has access to a participating HIV Vaccine Trials Unit (HVTU) and is willing to be followed for the duration of the study
  • Understands vaccination procedure
  • Willing to receive HIV test results
  • Good general health
  • Willing to use acceptable forms of contraception

You may not qualify if:

  • Received HIV vaccines in prior HIV vaccine trial
  • Received vaccinia vaccine. More information on this criterion can be found in the protocol.
  • Recreational cocaine or methamphetamine use within 12 months prior to study entry
  • Immunosuppressive medications within 168 days prior to first study vaccine administration. Participants who use corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for mild, uncomplicated dermatitis are not excluded.
  • 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 (for influenza or pneumococcal vaccines) or 30 days (for allergy treatment with antigen injections) prior to first study vaccine administration
  • Current tuberculosis prophylaxis or therapy
  • Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
  • Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol.
  • Any job-related responsibility that would interfere with the study
  • Allergy to egg products
  • Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Alabama Vaccine CRS

Birmingham, Alabama, 35294-2041, United States

Location

Project Brave HIV Vaccine CRS

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hosp. CRS

Boston, Massachusetts, 02115, United States

Location

Saint Louis Univ. School of Medicine, HVTU

St Louis, Missouri, 63110-2500, United States

Location

Univ. of Rochester HVTN CRS

Rochester, New York, 14642-0001, United States

Location

Vanderbilt Vaccine CRS

Nashville, Tennessee, 37232, United States

Location

Related Publications (7)

  • Cebere I, Dorrell L, McShane H, Simmons A, McCormack S, Schmidt C, Smith C, Brooks M, Roberts JE, Darwin SC, Fast PE, Conlon C, Rowland-Jones S, McMichael AJ, Hanke T. Phase I clinical trial safety of DNA- and modified virus Ankara-vectored human immunodeficiency virus type 1 (HIV-1) vaccines administered alone and in a prime-boost regime to healthy HIV-1-uninfected volunteers. Vaccine. 2006 Jan 23;24(4):417-25. doi: 10.1016/j.vaccine.2005.08.041. Epub 2005 Aug 24.

    PMID: 16176847BACKGROUND

  • Goonetilleke N, Moore S, Dally L, Winstone N, Cebere I, Mahmoud A, Pinheiro S, Gillespie G, Brown D, Loach V, Roberts J, Guimaraes-Walker A, Hayes P, Loughran K, Smith C, De Bont J, Verlinde C, Vooijs D, Schmidt C, Boaz M, Gilmour J, Fast P, Dorrell L, Hanke T, McMichael AJ. Induction of multifunctional human immunodeficiency virus type 1 (HIV-1)-specific T cells capable of proliferation in healthy subjects by using a prime-boost regimen of DNA- and modified vaccinia virus Ankara-vectored vaccines expressing HIV-1 Gag coupled to CD8+ T-cell epitopes. J Virol. 2006 May;80(10):4717-28. doi: 10.1128/JVI.80.10.4717-4728.2006.

    PMID: 16641265BACKGROUND

  • Mwau M, Cebere I, Sutton J, Chikoti P, Winstone N, Wee EG, Beattie T, Chen YH, Dorrell L, McShane H, Schmidt C, Brooks M, Patel S, Roberts J, Conlon C, Rowland-Jones SL, Bwayo JJ, McMichael AJ, Hanke T. A human immunodeficiency virus 1 (HIV-1) clade A vaccine in clinical trials: stimulation of HIV-specific T-cell responses by DNA and recombinant modified vaccinia virus Ankara (MVA) vaccines in humans. J Gen Virol. 2004 Apr;85(Pt 4):911-919. doi: 10.1099/vir.0.19701-0.

    PMID: 15039533BACKGROUND

  • Smith JM, Amara RR, Campbell D, Xu Y, Patel M, Sharma S, Butera ST, Ellenberger DL, Yi H, Chennareddi L, Herndon JG, Wyatt LS, Montefiori D, Moss B, McClure HM, Robinson HL. DNA/MVA vaccine for HIV type 1: effects of codon-optimization and the expression of aggregates or virus-like particles on the immunogenicity of the DNA prime. AIDS Res Hum Retroviruses. 2004 Dec;20(12):1335-47. doi: 10.1089/aid.2004.20.1335.

    PMID: 15650426BACKGROUND

  • Sutter G, Staib C. Vaccinia vectors as candidate vaccines: the development of modified vaccinia virus Ankara for antigen delivery. Curr Drug Targets Infect Disord. 2003 Sep;3(3):263-71. doi: 10.2174/1568005033481123.

    PMID: 14529359BACKGROUND

  • Goepfert PA, Elizaga ML, Sato A, Qin L, Cardinali M, Hay CM, Hural J, DeRosa SC, DeFawe OD, Tomaras GD, Montefiori DC, Xu Y, Lai L, Kalams SA, Baden LR, Frey SE, Blattner WA, Wyatt LS, Moss B, Robinson HL; National Institute of Allergy and Infectious Diseases HIV Vaccine Trials Network. Phase 1 safety and immunogenicity testing of DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles. J Infect Dis. 2011 Mar 1;203(5):610-9. doi: 10.1093/infdis/jiq105. Epub 2011 Jan 31.

    PMID: 21282192BACKGROUND

  • Elizaga ML, Vasan S, Marovich MA, Sato AH, Lawrence DN, Chaitman BR, Frey SE, Keefer MC; MVA Cardiac Safety Working Group. Prospective surveillance for cardiac adverse events in healthy adults receiving modified vaccinia Ankara vaccines: a systematic review. PLoS One. 2013;8(1):e54407. doi: 10.1371/journal.pone.0054407. Epub 2013 Jan 17.

    PMID: 23349878DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

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

  • Paul Goepfert, MD

    University of Alabama at Birmingham

    STUDY CHAIR

  • Christine Mhorag Hay, MD

    University of Rochester

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 8, 2006

First Posted

March 10, 2006

Study Start

April 1, 2006

Study Completion

December 1, 2008

Last Updated

August 8, 2022

Record last verified: 2022-08

Locations

US(6)