A Phase 1, Open Label, Dose-Escalation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of a Nanoparticle Carrier-Formulated Self-Amplifying RNA Vaccine Against Crimean-Congo Hemorrhagic Fever (HDT-321) in Healthy Adults
HDT Bio
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
Description
This is an open-label, dose-escalation, first-in-human study to evaluate the safety, reactogenicity and immunogenicity of the investigational product HDT-321 in approximately 48 healthy adults aged 18-64 years. Four groups of 12 participants at three dosage levels will be sequentially recruited in the study, starting with the lowest dose. Groups 1, 2 and 4 will receive 2 doses and group 3 will receive 1 dose of HDT-321. Study progression and dose escalation will occur according to the following: Group 1 (10 μg): Three sentinel participants will be initially enrolled and followed for 7 days…
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- Biological10 ug HDT 321
HDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV)
- Biological25ug HDT-321
HDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV)
- Biological50ug HDT-321
HDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV)
Location
- Flourish Research San Antonio (Clinical Trials of Texas)San Antonio, Texas