RecruitingPhase 1Biological intervention
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