Actively Recruiting
Safety and Immunogenicity of a Self-Amplifying RNA Vaccine Against Crimean-Congo Hemorrhagic Fever
Led by HDT Bio · Updated on 2025-07-28
48
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
H
HDT Bio
Lead Sponsor
D
DFNet Research Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety and Immunogenicity of a Self-Amplifying RNA Vaccine Against Crimean-Congo Hemorrhagic Fever
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and non-pregnant females aged 18 to 64 years
- Body mass index (BMI) between 17 and 35 at screening
- In good general health as determined by medical history, physical exam, vital signs, and lab tests within 30 days before first vaccine dose
- Screening lab values normal or not clinically significant if mild
- Negative tests for HIV 1/2, hepatitis B surface antigen, and hepatitis C antibodies
- Women of childbearing potential must use effective contraception or abstain before and after vaccination and have negative pregnancy tests at screening and before each injection
- Able to understand and follow study procedures and available for all visits and calls
- Provide written informed consent
- Agree to avoid donating blood or blood products 30 days before screening and during the study
- Agree not to receive any licensed vaccine 28 days before and after study injections
You will not qualify if you...
- Any medical condition considered by the investigator to prevent safe study participation, including serious respiratory, cardiovascular, neurological, immunological, or chronic diseases
- Abnormal electrocardiogram at screening
- History of severe allergic reactions to vaccines or PEG-containing products
- Allergy to antibiotics similar to kanamycin
- Use of immunosuppressive or immune-modifying drugs for more than 14 days within 6 months prior to first injection (except certain steroids)
- Received immunoglobulins or blood products within 60 days before enrollment
- Donated blood products within 30 days before enrollment
- Participated in another clinical trial with investigational treatments during this study
- Received or plans to receive any non-study vaccine within 28 days before or after each study injection
- Febrile illness within 24 hours before each injection
- Current heavy smoking or vaping defined as 1 pack or more per day
- Known or suspected alcohol or drug abuse in past 12 months
- Breastfeeding or planning to breastfeed during vaccination period
- Unlikely to comply with study requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Flourish Research San Antonio (Clinical Trials of Texas)
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
J
James Keary
CONTACT
A
Aude Frevol
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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