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  • 1.
    Viegas, Edna Omar
    et al.
    Instituto Nacional de Saúde, Maputo, Mozambique; Division of Clinical Microbiology, Department of Laboratory Medicine, Huddinge, Karolinska Institutet, Sweden; Universidade Eduardo Mondlane, Maputo, Mozambique.
    Tembe, Nelson
    Instituto Nacional de Saúde, Maputo, Mozambique; Division of Clinical Microbiology, Department of Laboratory Medicine, Huddinge, Karolinska Institutet, Sweden; Universidade Eduardo Mondlane, Maputo, Mozambique.
    Nilsson, Charlotta
    Division of Clinical Microbiology, Department of Laboratory Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden; Public Health Agency of Sweden (Folkhälsomyndigheten), Stockholm, Sweden.
    Meggi, Bindiya
    Instituto Nacional de Saúde, Maputo, Mozambique.
    Maueia, Cremildo
    Instituto Nacional de Saúde, Maputo, Mozambique.
    Augusto, Orvalho
    Universidade Eduardo Mondlane, Maputo, Mozambique.
    Stout, Richard
    Bioject Medical Technologies Inc, Tualatin OR, United States.
    Scarlatti, Gabriella
    Institute for Research and Health Care (IRCCS), San Raffaele Scientific Institute, Milan, Italy.
    Ferrari, Guido
    Department of Surgery and Molecular Genetics and Microbiology, Duke University Medical Center, Durham NC, United States.
    Earl, Patricia
    Division of Intramural Research, National Institute of Allergy and Infectious Diseases (NIAD)/National Institutes of Health (NIH), Bethesda MD, United States.
    Wahren, Britta
    Department of Microbiology, Tumor and Cell biology, Karolinska Institutet, Stockholm, Sweden.
    Andersson, Sören
    Örebro University, School of Medical Sciences. Department of Laboratory Medicine, Faculty of Health and Medical Sciences, Örebro University, Örebro, Sweden.
    Robb, Merlin
    The Henry M. Jackson Foundation for the Advancement of Military Medicine, The Military HIV Research Program, Walter Reed Army Institute of Research, Bethesda MD, United States.
    Osman, Nafissa
    Universidade Eduardo Mondlane, Maputo, Mozambique.
    Biberfeld, Gunnel
    Microbiology,Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.
    Jani, Ilesh
    Instituto Nacional de Saúde, Maputo, Mozambique.
    Sandström, Eric
    Microbiology,Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.
    Intradermal HIV-1 DNA immunization using needle-free ZetajetTM injection followed by HIV-modified vaccinia virus Ankara vaccination is safe and immunogenic in Mozambican young adults: a phase I randomized controlled trial2018In: AIDS Research and Human Retroviruses, ISSN 0889-2229, E-ISSN 1931-8405, Vol. 34, no 2, p. 193-205Article in journal (Refereed)
    Abstract [en]

    We assessed safety and immunogenicity of HIV-DNA priming using Zetajet<sup>TM</sup>, a needle-free device intradermally followed by intramuscular HIV-MVA boosts, in 24 healthy Mozambicans. Volunteers were randomized to receive three immunizations of 600 µg (n = 10; 2 x 0.1mL) or 1200 µg (n = 10; 2 x 0.2mL) of HIV-DNA (3 mg/mL), followed by two boosts of 10<sup>8</sup>pfu HIV-MVA. Four subjects received placebo saline injections. Vaccines and injections were safe and well tolerated with no difference between the two priming groups. After three HIV-DNA immunizations, IFN-γ ELISpot responses to Gag were detected in 9/17 (53%) vaccinees, while none responded to Env. After the first HIV-MVA, the overall response rate to Gag and/or Env increased to 14/15 (93%); 14/15 (93%) to Gag and 13/15 (87%) to Env. There were no significant differences between the immunization groups in frequency of response to Gag and Env or magnitude of Gag responses. Env responses were significantly higher in the higher-dose group (median 420 vs 157.5 SFC/million PBMC, p=0.014). HIV-specific antibodies to subtype C gp140 and subtype B gp160 were elicited in all vaccinees after the second HIV-MVA, without differences in titers between the groups. Neutralizing antibody responses were not detected. Two (13%) of 16 vaccinees, one in each of the priming groups, exhibited antibodies mediating antibody-dependent cellular cytotoxicity to CRF01_AE. In conclusion, HIV-DNA vaccine delivered intradermally in volumes of 0.1-0.2 mL using Zetajet<sup>TM</sup> was safe and well tolerated. Priming with the 1200 µg dose of HIV-DNA generated higher magnitudes of ELISpot responses to Env.

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