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AIDS Res Hum Retroviruses. 2018 Feb;34(2):193-205. doi: 10.1089/AID.2017.0121. Epub 2017 Nov 27.

Intradermal HIV-1 DNA Immunization Using Needle-Free Zetajet Injection Followed by HIV-Modified Vaccinia Virus Ankara Vaccination Is Safe and Immunogenic in Mozambican Young Adults: A Phase I Randomized Controlled Trial.

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1 Instituto Nacional de Saúde , Maputo, Mozambique .
2 Division of Clinical Microbiology, Department of Laboratory Medicine, Karolinska Institutet , Huddinge, Sweden .
3 Eduardo Mondlane University , Maputo, Mozambique .
4 Public Health Agency of Sweden , Stockholm, Sweden .
5 Bioject, Inc. , Tualatin, Oregon.
6 IRCCS San Raffaele Scientific Institute , Milan, Italy .
7 Department of Surgery and Molecular Genetics and Microbiology, Duke University Medical Center , Durham, North Carolina.
8 Division of Intramural Research, National Institute of Allergy and Infectious Diseases (NIAD)/National Institutes of Health (NIH) , Bethesda, Maryland.
9 Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet , Stockholm, Sweden .
10 Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro University , Örebro, Sweden .
11 The Military HIV Research Program, Walter Reed Army Institute of Research and The Henry M. Jackson Foundation for the Advancement of Military Medicine , Bethesda, Maryland.
12 Department of Education and Clinical Research, Karolinska Institutet , Stockholm, Sweden .


We assessed the safety and immunogenicity of HIV-DNA priming using Zetajet™, 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 × 0.1 ml) or 1,200 μg (n = 10; 2 × 0.2 ml) of HIV-DNA (3 mg/ml), followed by two boosts of 108 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 Envelope (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 peripheral blood mononuclear cell, p = .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 was safe and well tolerated. Priming with the 1,200 μg dose of HIV-DNA generated higher magnitudes of ELISpot responses to Env.



HIV; HIV-DNA; HIV-MVA; Mozambique; vaccine


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