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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
10 ug HDT 321
Biological/VaccineHDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV)
25ug HDT-321
Biological/VaccineHDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV)
50ug HDT-321
Biological/VaccineHDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV)
Treatment groups
48 Participants
are divided into 4 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Group D: Group 4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Solicited local and systemic adverse events (AEs)
Frequency and grade of solicited local and systemic AEs during the 7-day follow-up period after each study injection (i.e. the day of administration and 6 subsequent days).
Time frame
Day 1-7 post administration2
Unsolicited study product related adverse events
Frequency and grade of unsolicited study product related AEs reported during the 28-day follow-up period after each study injection.
Time frame
Day 1-28 post administration3
Laboratory abnormalities
Occurrence of laboratory abnormalities at 7 days post injection visit (increased or decreased outside normal ranges, as determined by the FDA Guidance for Industry Toxicity Grading Scale for Healthy Adults Enrolled in Preventive Vaccine Clinical Trials, 2007)
Time frame
Day 1-7 post administration4
Serious AEs, AEs of Special Interest, Medically Attended AEs, and New-Onset of Chronic Diseases
Frequency and grade of Serious AEs (SAEs), AEs of Special Interest (AESIs), Medically-Attended AEs (MAAEs), and New-Onset of Chronic Diseases (NOCDs) during the duration of participation in the study.
Time frame
Day 1 to end of study participation (Day 394)Secondary outcomes
1
Immunogenicity of HDT-321
Evaluate the immunogenicity of HDT-321 as measured by IgG ELISA to the CCHFV NP measured 28 and 56 days after each injection. Using geometric mean titers (GMTs) of circulating antibodies against CCHFV NP through Day 57 along with seroconversion rate for anti-NP antibody through Day 57.
Time frame
Day 1 to Day 57Other outcomes
1
Exploratory immunogenicity of HDT-321
Evaluate antibody subclass response as measured by IgG1, IgG2, IgG3, and IgG4 ELISA to the CCHFV NP. Using geometric mean titers (GMT) of antigen-specific IgG1, IgG2, IgG3, and IgG4.
Time frame
Day 1 to end of study participation (Day 394)2
Exploratory immunogenicity of HDT-321
Evaluate the immunogenicity of HDT-321 as measured by IgG ELISA to the CCHFV NP measured after Day 57. Using geometric mean titers (GMTs) of circulating antibodies against CCHFV NP and seroconversion rate for anti-NP antibody.
Time frame
Day 57 to the end of study participation (Day 394)3
Exploratory Immunogenicity of HDT-321
Evaluate the immunogenicity of HDT-321 vaccine as measured by IgG ELISA to the CCHFV NP from other strains. Using geometric mean titers (GMT) of strain-specific, antigen-specific IgG.
Time frame
Day 1 to end of study participation (Day 394)4
Exploratory immunogenicity of HDT-321
evaluate the immunogenicity as measured by IgM and IgA ELISA to the CCHFV NP. Using geometric mean titers (GMT) of antigen-specific IgM and IgA
Time frame
Day 1 to end of study participation (Day 394)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov