{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T13:47:16Z","timestamp":1785937636255,"version":"3.56.0"},"reference-count":24,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,8,5]]},"abstract":"<jats:title>ABSTRACT.<\/jats:title>\n                  <jats:p>Since its introduction in 1999, West Nile virus (WNV) has become endemic to the United States and many other countries around the world and is a leading cause of viral encephalitis each year. Despite the need, there are no licensed vaccines or therapies to address West Nile virus disease. The HBV-002 vaccine, which consists of the recombinant WNV envelope subunit protein (WN-80E) and Alhydrogel \u201885\u2019 (Croda Pharma, Princeton, NJ), was tested in an open-label, dose-escalation Phase 1 clinical trial (NCT00707642) alongside a WN-80E cohort without adjuvant. HBV-002 was found to be generally safe and well-tolerated, with mild, short-lived adverse events (AEs; 23 of 25 participants experienced Grade 1 AEs, and one participant experienced a Grade 2 AE that was determined not to be related to the vaccine). HBV-002 was immunogenic in all participants who received the adjuvanted HBV-002, as evidenced by virus-neutralizing antibody titers post-dose 3. The magnitude of the immune responses was dose-dependent and declined over time. Overall, these results reveal the potential of the vaccine candidate but indicate the need to further optimize the vaccine formulation or schedule to ensure long-lasting protection.<\/jats:p>","DOI":"10.4269\/ajtmh.26-0124","type":"journal-article","created":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T16:27:13Z","timestamp":1779380833000},"page":"366-371","source":"Crossref","is-referenced-by-count":0,"title":["A Phase 1, Open Label, Safety Study of HBV-002 (West Nile Recombinant Subunit Vaccine) in Healthy Adults"],"prefix":"10.4269","volume":"115","author":[{"given":"Beth-Ann G.","family":"Coller","sequence":"first","affiliation":[{"name":"Hawaii Biotech, Inc., Honolulu, Hawaii, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David E.","family":"Clements","sequence":"additional","affiliation":[{"name":"Hawaii Biotech, Inc., Honolulu, Hawaii, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Yelmene","sequence":"additional","affiliation":[{"name":"Hawaii Biotech, Inc., Honolulu, Hawaii, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy","family":"Martyak","sequence":"additional","affiliation":[{"name":"Hawaii Biotech, Inc., Honolulu, Hawaii, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mike","family":"Thorne","sequence":"additional","affiliation":[{"name":"Hawaii Biotech, Inc., Honolulu, Hawaii, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vidya","family":"Pai","sequence":"additional","affiliation":[{"name":"Hawaii Biotech, Inc., Honolulu, Hawaii, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robbin","family":"Henley","sequence":"additional","affiliation":[{"name":"Hawaii Biotech, Inc., Honolulu, Hawaii, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maile","family":"O\u2019Connell","sequence":"additional","affiliation":[{"name":"Hawaii Biotech, Inc., Honolulu, Hawaii, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolyn","family":"Weeks-Levy","sequence":"additional","affiliation":[{"name":"Hawaii Biotech, Inc., Honolulu, Hawaii, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D. Elliot","family":"Parks","sequence":"additional","affiliation":[{"name":"Hawaii Biotech, Inc., Honolulu, Hawaii, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2795","reference":[{"issue":"4","key":"b1","series-title":"Pathogens","first-page":"193","article-title":"Current understanding of West Nile virus clinical manifestations, immune responses, neuroinvasion, and immunotherapeutic implications","volume":"8","author":"Bai","year":"2019"},{"issue":"2","key":"b2","series-title":"Viruses","first-page":"606","article-title":"Clinical manifestations and outcomes of West Nile virus infection","volume":"6","author":"Sejvar","year":"2014"},{"key":"b3","article-title":"West Nile Virus: Historic Data (1999\u20132024).","year":"2026"},{"issue":"1","key":"b4","series-title":"MMWR Surveill Summ","first-page":"1","article-title":"Surviellance for West Nile virus disease \u2013 United States, 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vaccine","volume":"25","author":"Lieberman","year":"2007"},{"issue":"15","key":"b9","series-title":"Vaccine","first-page":"2913","article-title":"Efficacy and durability of a recombinant subunit West Nile vaccine candidate in protecting hamsters from West Nile encephalitis","volume":"25","author":"Watts","year":"2007"},{"issue":"6","key":"b10","series-title":"Am J Trop Med Hyg","first-page":"955","article-title":"Evaluation of the efficacy of a recombinant subunit West Nile vaccine in Syrian golden hamsters","volume":"79","author":"Siirin","year":"2008"},{"issue":"9","key":"b11","series-title":"Clin Vaccine Immunol","first-page":"1332","article-title":"Immunogenicity and protective efficacy of a recombinant subunit West Nile virus vaccine in Rhesus monkeys","volume":"16","author":"Lieberman","year":"2009"},{"issue":"12","key":"b12","series-title":"IDrugs","first-page":"880","article-title":"Advances in flavivirus vaccine 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