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    Safety and Immunogenicity of an AS03B-Adjuvanted Inactivated Tetravalent Dengue Virus Vaccine Administered on Varying Schedules to Healthy U.S. Adults: A Phase 1/2 Randomized Study

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    Author
    Lin, L.
    Lyke, K.E.
    Koren, M.
    Jarman, R.G.
    Eckels, K.H.
    Lepine, E.
    McArthur, M.A.
    Currier, J.R.
    Friberg, H.
    Moris, P.
    Keiser, P.B.
    De La Barrera, R.
    Vaughn, D.W.
    Paris, R.M.
    Thomas, S.J.
    Schmidt, A.C.
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    Date
    2020
    Journal
    The American journal of tropical medicine and hygiene
    Publisher
    American Society of Tropical Medicine and Hygiene
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.4269/ajtmh.19-0738
    Abstract
    Dengue disease and its causative agents, the dengue viruses (DENV-1–4), cause high morbidity in tropical and subtropical regions. We evaluated three dosing regimens of the investigational tetravalent AS03B-adjuvanted dengue-purified inactivated vaccine (DPIV+AS03B). In this phase 1/2, observer-blind, placebo-controlled study (NCT02421367), 140 healthy adults were randomized 1:1:2 to receive DPIV+AS03B according to the following regimens: 0–1 month (M), 0–1–6 M, or 0–3 M. Participants received DPIV+AS03B or placebo at M0, M1, M3, and M6 according to their dosing schedule. Primary objectives were 1) to evaluate the safety of DPIV+AS03B for 28 days (D) after each dose; 2) to demonstrate the added value of a booster dose (0–1–6 M versus 0–1 M) based on neutralizing antibody titers to each DENV type (DENV-1–4) at 28 D after the last dose; and, if this objective was met, 3) to demonstrate the benefit of a longer interval between the first and second doses (0–1 M versus 0–3 M). Adverse events (AEs) within 7 D after vaccination tended to be more frequent after DPIV+AS03B doses than placebo; the number of grade 3 AEs was low (£ 4.5% after DPIV+AS03B; £ 2.9% after placebo), with no obvious differences across groups. Within 28 D following each dose, the frequency of unsolicited AEs after DPIV+AS03B appeared higher for three-dose (0–1–6 M) than two-dose (0–1 M and 0–3 M) regimens. No serious AEs were considered related to vaccination, and no potential immune-mediated diseases were reported during the study. All three schedules were well tolerated. Both primary immunogenicity objectives were demonstrated. The 0–3 M and 0–1–6 M regimens were more immunogenic than the 0–1 M regimen.
    Keyword
    Dengue--prevention & control
    Dengue Vaccines--administration & dosage
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85087858285&doi=10.4269%2fajtmh.19-0738&partnerID=40&md5=6b836582892e89455b6e8daeffb305f0; http://hdl.handle.net/10713/13372
    ae974a485f413a2113503eed53cd6c53
    10.4269/ajtmh.19-0738
    Scopus Count
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