Safety and Immunogenicity of a Self-Amplifying RNA Vaccine Against Crimean-Congo Hemorrhagic Fever
This study tests a new vaccine called HDT-321 designed to protect against Crimean-Congo Hemorrhagic Fever, a serious viral disease. Researchers will give different doses of the vaccine to healthy volunteers and monitor them closely to ensure it is safe and that it helps the body build immunity against the virus.
Key Objective: This trial tests whether HDT-321 can safely trigger an immune response that could protect people against Crimean-Congo Hemorrhagic Fever.
Who to Consider: Healthy adults who are interested in helping develop a new vaccine and are willing to receive injections and participate in safety monitoring should consider enrolling.
Trial Parameters
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: 1. Males and non-pregnant females 18 to 64 years of age at the time of signing the ICF. 2. Body mass index (BMI) 17 to 35 inclusive at screening. 3. Considered by the PI or designee to be in good general health as determined by medical history, physical examination, vital sign measurements\*, and clinical laboratory assessments conducted no more than 30 days prior to the first study injection administration. 4. Screening laboratory values within the laboratory reference ranges or considered non-clinically significant (NCS) if within Grade 1 severity on the toxicity grading scale. 5. Negative human immunodeficiency virus (HIV) 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. 6. Women of childbearing potential must agree to use or have practiced true abstinence or use at least one acceptable primary form of contraception3 for at least 30 days prior to the first injection and for 60 days after the last injection. Female participa