This is a Phase I, randomized, single-blind, placebo-controlled, study of four separate dose cohorts, with a 42-day interval between each vaccine dose, of a novel Chikungunya Peptide Immunotherapy Vaccine in Healthy Adults (18-60 years of age).
All participants will undergo a screening visit scheduled for a maximum of 28 days before the enrolment in the clinical study and will provide a blood sample for clinical laboratory tests (complete blood count (CBC)\*, platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, serum creatinine and activated partial thromboplastin time (aPTT), human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV)), and a urine sample for tests for Urinary protein, Urinary blood, Urinary glucose and human chorionic gonadotropin β-subunit (βhCG) urine test (only the female participants)) in order to confirm their eligibility for participation in the study.
A total of 40 participants are planned to be enrolled. A randomization system will be used to assign treatment group and participant number at the clinical site.
Participants will receive 2 injections, 42 days apart. A final visit will take place at Day 407 (i.e. 365 days after last vaccination).
Participants will be kept under observation for a minimum of one hour after each vaccination to ensure their safety. Reactogenicity data will be collected in all participants after each vaccine injection: solicited injection site reactions will be collected for Days 0-10 and Days 42-52 and solicited systemic reactions will be collected for Days 0-21 and Days 42-63. Unsolicited events will be collected for Days 0-52. Serious adverse events (SAEs) will be reported throughout the study (from inclusion until 12 months after last vaccination). Serious and non-serious medically attended adverse events (MAAEs) and adverse events of special interest (AESIs) will be collected throughout the study (from inclusion until 12 months after last vaccination).
Healthy individuals aged ≥18 years to ≤60 years of age, inclusive at time of consent, who are not receiving any excluded concomitant medications as detailed in protocol
Informed consent form signed.
Determined to be eligible by the Investigator based on medical history, physical examination, and screening laboratory testing.
Women of childbearing potential* are willing to use effective birth control method(s)** for a minimum of 14 days prior to dosing through 90 days after last study vaccination.
Self-reported or documented history of laboratory-confirmed chikungunya or other mosquito-borne (arthropod) disease, such as Zika or dengue within 90 days prior to consent.
Travel in the previous 90 days to areas where exposure to flaviviruses such as Zika, dengue, West Nile Fever are common, as well as areas increasing in cases of chikungunya (refer to the following website: Chikungunya virus disease worldwide overview).
Self-reported or documented receipt of any chikungunya (alphavirus) or flavivirus vaccine (investigational or licensed) within 90 days prior to consent.
Receipt of any licensed vaccine, including COVID-19 vaccine, within the 28 days prior to consent or planned receipt within 90 days following last study vaccination (if unplanned circumstances subsequent to enrolment necessitate the receipt of a licensed vaccine e.g. tetanus and rabies, in unavoidable clinical settings, these should be documented in the source documents by the Investigator and not considered a protocol deviation. However, if the licensed vaccine is not urgently required, it should be delayed until at least 90 days following last study vaccination).
Sequential
PepGNP-ChikV
Biological/VaccinePepGNP-ChikV vaccine will be administered by an intradermal microneedle device
Placebo
Biological/VaccinePlacebo (sterile WFI) will be administered by an intradermal microneedle device
To assess the safety of PepGNP-ChikV candidate vaccine
Incidence of serious adverse events (SAEs), medically attended adverse events (MAAEs) and adverse events of special interest (AESIs)
To assess the reactogenicity of PepGNP-ChikV candidate vaccine
Incidence of solicited local and systemic reactogenicity adverse events (AEs)
To assess the tolerability of PepGNP-ChikV candidate vaccine
Incidence of unsolicited AEs
To determine the CHIKV-specific cellular immune response induced by PepGNP-ChikV
CHIKV-specific immune responses assessed by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) assays
To determine the PepGNP-ChikV -specific T cell characterization immune responses
Magnitude, phenotype, and percentage of PepGNP-ChikV peptide (antigen)-specific memory T cells as measured by flow cytometry (including multimers).
To determine the PepGNP-ChikV -specific T cell memory profile immune response
Magnitude, phenotype, and percentage of PepGNP-ChikV peptide (antigen)-specific functional, activation induced T cells as measured by flow cytometry
To check the presence of neutralizing or enhancing antibody responses
Surrogate Virus Neutralization Tests (sVNTs) to determine neutralizing antibody titres against CHIKV
To check the absence of an antibody mediated response
Magnitude and profiling of expressed, circulating acute cytokine (e.g. IL-1α, Il-1β, IL-1RA, IFN-γ, IFN-α, TNF-α, IL-15 and MCP-1) responses after administration of PepGNP-ChikV vaccine as measured by multiplex platforms (MSD, Luminex)
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