Safety and Immunogenicity of a Randomized Phase 1 Prime-Boost Trial With ALVAC-HIV (vCP205) and Oligomeric Glycoprotein 160 From HIV-1 Strains MN and LAI-2 Adjuvanted in Alum or Polyphosphazene.

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  • Additional Information
    • Affiliation:
      Department of Retrovirology, US Army Medical Directorate, Armed Forces Institute of Medical Sciences, Bangkok, Thailand
      Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, Maryland
      US Military HIV Research Program, Maryland
      International AIDS Vaccine Initiative, New York, New York
      Consultant, Savannah, Georgia
      Sanofi Pasteur, Marcy l'Etoile, France
      Institute of Human Virology, University of Maryland School of Medicine, Baltimore, Maryland
      US Military Malaria Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland
      Advanced Biosciences Laboratories, Rockville, Maryland
      Duke University School of Medicine, Durham, North Carolina
      Office of the Global AIDS Coordinator, Washington D.C.
      International Vaccine Institute, Seoul, Republic of Korea
    • Subject Terms:
    • Subject Terms:
    • Abstract:
      Background: Prime-boost regimens comprising ALVAC-HIV (prime) and human immunodeficiency virus type 1 (HIV) Env (boost) induce HIV-specific neutralizing antibody and cell-mediated immune responses, but the impact of boost schedule and adjuvant requires further definition.Methods: A phase 1 trial was conducted. In part A (open label), 19 volunteers received oligomeric glycoprotein 160 from HIV strains MN and LAI-2 (ogp160 MN/LAI-2) with dose escalation (25, 50, 100 μg) and either polyphosphazene (pP) or alum adjuvant. In part B, 72 volunteers received either placebo (n=12) or recombinant canarypox virus expressing HIV antigens (ALVAC-HIV [vCP205]) with different doses and schedules of ogp160 MN/LAI-2 in pP or alum (n = 60).Results: The vaccines were safe and well tolerated, with no vaccine-related serious adverse events. Anti-gp70 V1V2 antibody responses were detected in 17 of 19 part A volunteers (89%) and 10%-100% of part B volunteers. Use of a peripheral blood mononuclear cell-based assay revealed that US-1 primary isolate neutralization was induced in 2 of 19 recipients of ogp160 protein alone (10.5%) and 5 of 49 prime-boost volunteers (10.2%). Among ogp160 recipients, those who received pP were more likely than those who received alum to have serum that neutralized tier 2 viruses (12% vs 0%; P = .015).Conclusions: Administration of ogp160 with pP induces primary isolate tier 2 neutralizing antibody responses in a small percentage of volunteers, demonstrating proof of concept and underscoring the importance of further optimization of prime-boost strategies for HIV infection prevention.Clinical Trials Registration: NCT00004579.
    • Journal Subset:
      Biomedical; Editorial Board Reviewed; Peer Reviewed; USA
    • Special Interest:
      Evidence-Based Practice
    • ISSN:
      0022-1899
    • MEDLINE Info:
      PMID: NLM26908741 NLM UID: 0413675
    • Grant Information:
      P30 AI064518/AI/NIAID NIH HHS/United States
    • Publication Date:
      20170910
    • Publication Date:
      20180528
    • PubMed Central ID:
      PMC4878724 [Available on 06/15/17]
    • DOI:
      http://dx.doi.org/10.1093/infdis/jiw059
    • Accession Number:
      115684304
  • Citations
    • ABNT:
      O’CONNELL, R. J. et al. Safety and Immunogenicity of a Randomized Phase 1 Prime-Boost Trial With ALVAC-HIV (vCP205) and Oligomeric Glycoprotein 160 From HIV-1 Strains MN and LAI-2 Adjuvanted in Alum or Polyphosphazene. Journal of Infectious Diseases, [s. l.], v. 213, n. 12, p. 1946–1954, 2016. DOI 10.1093/infdis/jiw059. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=115684304. Acesso em: 12 ago. 2020.
    • AMA:
      O’Connell RJ, Excler J-L, Polonis VR, et al. Safety and Immunogenicity of a Randomized Phase 1 Prime-Boost Trial With ALVAC-HIV (vCP205) and Oligomeric Glycoprotein 160 From HIV-1 Strains MN and LAI-2 Adjuvanted in Alum or Polyphosphazene. Journal of Infectious Diseases. 2016;213(12):1946-1954. doi:10.1093/infdis/jiw059
    • APA:
      O’Connell, R. J., Excler, J.-L., Polonis, V. R., Ratto-Kim, S., Cox, J., Jagodzinski, L. L., Liu, M., Wieczorek, L., McNeil, J. G., El-Habib, R., Michael, N. L., Gilliam, B. L., Paris, R., VanCott, T. C., Tomaras, G. D., Birx, D. L., Robb, M. L., & Kim, J. H. (2016). Safety and Immunogenicity of a Randomized Phase 1 Prime-Boost Trial With ALVAC-HIV (vCP205) and Oligomeric Glycoprotein 160 From HIV-1 Strains MN and LAI-2 Adjuvanted in Alum or Polyphosphazene. Journal of Infectious Diseases, 213(12), 1946–1954. https://doi.org/10.1093/infdis/jiw059
    • Chicago/Turabian: Author-Date:
      O’Connell, Robert J., Jean-Louis Excler, Victoria R. Polonis, Silvia Ratto-Kim, Josephine Cox, Linda L. Jagodzinski, Michelle Liu, et al. 2016. “Safety and Immunogenicity of a Randomized Phase 1 Prime-Boost Trial With ALVAC-HIV (VCP205) and Oligomeric Glycoprotein 160 From HIV-1 Strains MN and LAI-2 Adjuvanted in Alum or Polyphosphazene.” Journal of Infectious Diseases 213 (12): 1946–54. doi:10.1093/infdis/jiw059.
    • Harvard:
      O’Connell, R. J. et al. (2016) ‘Safety and Immunogenicity of a Randomized Phase 1 Prime-Boost Trial With ALVAC-HIV (vCP205) and Oligomeric Glycoprotein 160 From HIV-1 Strains MN and LAI-2 Adjuvanted in Alum or Polyphosphazene’, Journal of Infectious Diseases, 213(12), pp. 1946–1954. doi: 10.1093/infdis/jiw059.
    • Harvard: Australian:
      O’Connell, RJ, Excler, J-L, Polonis, VR, Ratto-Kim, S, Cox, J, Jagodzinski, LL, Liu, M, Wieczorek, L, McNeil, JG, El-Habib, R, Michael, NL, Gilliam, BL, Paris, R, VanCott, TC, Tomaras, GD, Birx, DL, Robb, ML & Kim, JH 2016, ‘Safety and Immunogenicity of a Randomized Phase 1 Prime-Boost Trial With ALVAC-HIV (vCP205) and Oligomeric Glycoprotein 160 From HIV-1 Strains MN and LAI-2 Adjuvanted in Alum or Polyphosphazene’, Journal of Infectious Diseases, vol. 213, no. 12, pp. 1946–1954, viewed 12 August 2020, .
    • MLA:
      O’Connell, Robert J., et al. “Safety and Immunogenicity of a Randomized Phase 1 Prime-Boost Trial With ALVAC-HIV (VCP205) and Oligomeric Glycoprotein 160 From HIV-1 Strains MN and LAI-2 Adjuvanted in Alum or Polyphosphazene.” Journal of Infectious Diseases, vol. 213, no. 12, June 2016, pp. 1946–1954. EBSCOhost, doi:10.1093/infdis/jiw059.
    • Chicago/Turabian: Humanities:
      O’Connell, Robert J., Jean-Louis Excler, Victoria R. Polonis, Silvia Ratto-Kim, Josephine Cox, Linda L. Jagodzinski, Michelle Liu, et al. “Safety and Immunogenicity of a Randomized Phase 1 Prime-Boost Trial With ALVAC-HIV (VCP205) and Oligomeric Glycoprotein 160 From HIV-1 Strains MN and LAI-2 Adjuvanted in Alum or Polyphosphazene.” Journal of Infectious Diseases 213, no. 12 (June 15, 2016): 1946–54. doi:10.1093/infdis/jiw059.
    • Vancouver/ICMJE:
      O’Connell RJ, Excler J-L, Polonis VR, Ratto-Kim S, Cox J, Jagodzinski LL, et al. Safety and Immunogenicity of a Randomized Phase 1 Prime-Boost Trial With ALVAC-HIV (vCP205) and Oligomeric Glycoprotein 160 From HIV-1 Strains MN and LAI-2 Adjuvanted in Alum or Polyphosphazene. Journal of Infectious Diseases [Internet]. 2016 Jun 15 [cited 2020 Aug 12];213(12):1946–54. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=115684304