期刊
HUMAN VACCINES & IMMUNOTHERAPEUTICS
卷 15, 期 9, 页码 2195-2204出版社
TAYLOR & FRANCIS INC
DOI: 10.1080/21645515.2018.1546523
关键词
dengue vaccine; recombinant; subunit; immunogenicity; safety
资金
- Merck & Co., Inc., Kenilworth, NJ, USA
There is an unmet medical need for vaccines to prevent dengue. V180 is an investigational recombinant subunit vaccine that consists of truncated dengue envelope proteins (DEN-80E) for all 4 serotypes. Three dosage levels of the tetravalent DEN-80E antigens were assessed in a randomized, placebo-controlled, Phase I dose-escalation, first-in-human proof-of-principle trial in healthy, flavivirus-naive adults in Australia (NCT01477580). The 9 V180 formulations that were assessed included either ISCOMATRIX (TM) adjuvant (2 dosage levels), aluminum-hydroxide adjuvant, or were unadjuvanted, and were compared to phosphate-buffered saline placebo. Volunteers received 3 injections of assigned product on a 0, 1, 2 month schedule, and were followed for safety through 1 year after the last injection. Antibody levels were assessed at 6 time-points: enrollment, 28 days after each injection, and 6 and 12 months Postdose 3 (PD3). Of the 98 randomized participants, 90 (92%) received all 3 injections; 83 (85%) completed 1-year follow-up. Immunogenicity was measured by a qualified Focus Reduction Neutralization Test with a 50% neutralization cutoff (FRNT50). All 6 V180 formulations with ISCOMATRIX (TM) adjuvant showed robust immunogenicity, while the 1 aluminum-adjuvanted and 2 unadjuvanted formulations were poorly immunogenic. Geometric mean antibody titers generally declined at 6 months and 1 year PD3. All 9 V180 formulations were generally well tolerated. Formulations with ISCOMATRIX (TM) adjuvant were associated with more adverse events than aluminum-adjuvanted or unadjuvanted formulations.
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