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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorHDT Bio

About this trial

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

Qualifiers

Males and non-pregnant females 18 to 64 years of age at the time of signing the ICF.

Body mass index (BMI) 17 to 35 inclusive at screening.

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.

Screening laboratory values within the laboratory reference ranges or considered non-clinically significant (NCS) if within Grade 1 severity on the toxicity grading scale.

Disqualifiers

Any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes study participation. Including Acute, subacute, intermittent, or chronic medical diseases or conditions that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of the trial. Significant respiratory disease (COPD) requiring daily medications, asthma that is not well controlled, significant cardiovascular disease, history of myocarditis or pericarditis, myocardial infarction, coronary artery bypass surgery or stent placement, or uncontrolled cardiac arrhythmia, Neurological or neurodevelopmental conditions, ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, blood dyscrasias or significant disorder of coagulation, chronic liver disease, including fatty liver, autoimmune disease, including localized or history of psoriasis or hypothyroidism without a defined non-autoimmune cause and Immunodeficiency of any cause.

Abnormal screening electrocardiogram (ECG)

History of hypersensitivity or severe reactions to previous vaccinations

History of hypersensitivity or severe reactions to products known to contain polyethylene glycol (PEG).

Trial design

Treatments tested in this trial

  • 10 ug HDT 321
  • 25ug HDT-321
  • 50ug HDT-321

Treatment groups

48 Participants
are divided into 4 treatment groups

Sponsors and collaborators

HDT Bio

Lead sponsor

DFNet Research Inc.

Collaborator

Technical Resources International, Inc.

Collaborator

BioAgilytix Labs, LLC

Collaborator

The University of Texas Medical Branch, Galveston

Collaborator

Clinical Trials of Texas, Inc.

Collaborator

Quest Laboratories

Collaborator