A Phase 1, Open Label, Safety Study of HBV-002 (West Nile Recombinant Subunit Vaccine) in Healthy Adults
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: 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 '85' (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.
Institution: Hawaii Biotech (United States)
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7161973871
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