IDEAS home Printed from https://ideas.repec.org/a/plo/pone00/0008816.html
   My bibliography  Save this article

Phase 1 Safety and Immunogenicity Evaluation of ADMVA, a Multigenic, Modified Vaccinia Ankara-HIV-1 B'/C Candidate Vaccine

Author

Listed:
  • Sandhya Vasan
  • Sarah J Schlesinger
  • Zhiwei Chen
  • Arlene Hurley
  • Angela Lombardo
  • Soe Than
  • Phumla Adesanya
  • Catherine Bunce
  • Mark Boaz
  • Rosanne Boyle
  • Eddy Sayeed
  • Lorna Clark
  • Daniel Dugin
  • Mar Boente-Carrera
  • Claudia Schmidt
  • Qing Fang
  • Ba Lei
  • Yaoxing Huang
  • Gerasimos J Zaharatos
  • David F Gardiner
  • Marina Caskey
  • Laura Seamons
  • Martin Ho
  • Len Dally
  • Carol Smith
  • Josephine Cox
  • Dilbinder Gill
  • Jill Gilmour
  • Michael C Keefer
  • Patricia Fast
  • David D Ho

Abstract

Background: We conducted a Phase I dose-escalation trial of ADMVA, a Clade-B'/C-based HIV-1 candidate vaccine expressing env, gag, pol, nef, and tat in a modified vaccinia Ankara viral vector. Sequences were derived from a prevalent circulating HIV-1 recombinant form in Yunnan, China, an area of high HIV incidence. The objective was to evaluate the safety and immunogenicity of ADMVA in human volunteers. Methodology/Principal Findings: ADMVA or placebo was administered intramuscularly at months 0, 1 and 6 to 50 healthy adult volunteers not at high risk for HIV-1. In each dosage group [1×107 (low), 5×107 (mid), or 2.5×108 pfu (high)] volunteers were randomized in a 3∶1 ratio to receive ADMVA or placebo in a double-blinded design. Subjects were followed for local and systemic reactogenicity, adverse events including cardiac adverse events, and clinical laboratory parameters. Study follow up was 18 months. Humoral immunogenicity was evaluated by anti-gp120 binding ELISA, immunoflourescent staining, and HIV-1 neutralization. Cellular immunogenicity was assessed by a validated IFNγ ELISpot assay and intracellular cytokine staining. Anti-vaccinia binding titers were measured by ELISA. Conclusions/Significance: ADMVA was well-tolerated and elicited durable humoral and cellular immune responses. Trial Registration: Clinicaltrials.gov NCT00252148

Suggested Citation

  • Sandhya Vasan & Sarah J Schlesinger & Zhiwei Chen & Arlene Hurley & Angela Lombardo & Soe Than & Phumla Adesanya & Catherine Bunce & Mark Boaz & Rosanne Boyle & Eddy Sayeed & Lorna Clark & Daniel Dugi, 2010. "Phase 1 Safety and Immunogenicity Evaluation of ADMVA, a Multigenic, Modified Vaccinia Ankara-HIV-1 B'/C Candidate Vaccine," PLOS ONE, Public Library of Science, vol. 5(1), pages 1-7, January.
  • Handle: RePEc:plo:pone00:0008816
    DOI: 10.1371/journal.pone.0008816
    as

    Download full text from publisher

    File URL: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0008816
    Download Restriction: no

    File URL: https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0008816&type=printable
    Download Restriction: no

    File URL: https://libkey.io/10.1371/journal.pone.0008816?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:plo:pone00:0008816. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    We have no bibliographic references for this item. You can help adding them by using this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: plosone (email available below). General contact details of provider: https://journals.plos.org/plosone/ .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.