Clinical trials

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Condition / disease
Location
Status: Recruiting

Safety and Immunogenicity of a Self-Amplifying RNA Vaccine Against Crimean-Congo Hemorrhagic Fever

The goal of this clinical trial is to assess the safety, tolerability and immunogenicity of three dosage levels, and a single or two-dose administration regimen, of the investigational HDT-321 product administered intra-muscularly. The main questions it aims to answer are: * Is HDT-321 safe to use * Does HDT-321 provide protection against Crimean-Congo hemorrhagic fever virus (CCHFV) Researchers will record any adverse events and test blood samples to see if HDT-321 is safe and works to protect participants against Crimean-Congo hemorrhagic fever virus (CCHFV) Participants will: * Receive 1 or 2 doses of HDT-321 * Complete a memory aid and measurements for 7 days after receiving each dose of HDT-321 * Be followed throughout the study using phone calls and clinic visits to check for and record adverse events * Provide blood samples at specific study visits

Participants needed: 48
Trial details
Phase: Phase 1Age: 18-64Biological sex: AllType: InterventionalSponsor: HDT BioUpdated: Jul 28, 2025Locations: 1
Eligibility criteria

Males and non-pregnant females 18 to 64 years of age at the time of signing the... [+9]

Any medical disease or condition that, in the opinion of the participating site... [+15]