새로운 뎅기 백신 후보, Novel dengue vaccine candidate(TAK-003)

지금까지 혈청 음성인 사람에서 안전하게 투약될 수 있는 뎅기 바이러스 백신은 없었습니다. Tetravalent DENV vaccine candidate인 TAK-003를 아시아와 라틴 아메리카의 풍토 지역에서 20,000명 이상을 대상으로 위약군과 백신 2회 투약군으로 무작위 할당하여 투약하였습니다. 12개월 추적 관찰 동안 백신을 투약한 군에서 뎅기열이 덜 발생하였습니다(0.5 versus 2.5 per 100-person years). 전체 백신 효능은 81%이었고 혈청 음성인 5200명 가운데 백신 효능은 75 %이었습니다.

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N Engl J Med 2019; 381:2009-2019 DOI: 10.1056/NEJMoa1903869

Figure 2. Cumulative Incidence of Virologically Confirmed Dengue According to Baseline Serostatus.

Insets show the same data on an expanded y axis. The tables below the graphs show numbers of participants under follow-up at various time points to the end of the part 1 trial period.

Thus far there is no dengue virus (DENV) vaccine that may be safely administered to seronegative individuals; the efficacy and safety of TAK-003, a tetravalent DENV vaccine candidate, are under investigation. In a trial in DENV-endemic regions of Asia and Latin America, more than 20,000 children age 4 to 16 years were randomly assigned to receive two doses of vaccine or placebo [47]. At 12 months of follow-up, fewer cases of confirmed DENV infection were observed among vaccinated individuals (0.5 versus 2.5 per 100-person years); the overall vaccine efficacy was 81 percent. Among approximately 5200 seronegative individuals, vaccine efficacy was 75 percent. The incidence of serious adverse events was similar in the vaccine and placebo groups. Longer-term data will be important to further define the efficacy and safety of this vaccine.

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REF. UpToDate 2020.02.02