A Phase I Study of PepGNP-ChikV in Healthy Volunteers (NCT07394426) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
A Phase I Study of PepGNP-ChikV in Healthy Volunteers
40 participantsStarted 2026-08-03
Plain-language summary
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).
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Male participants with a partner of childbearing potential must agree to use a highly effective method of contraception (e.g. sterilization or male condom) and refrain from sperm donation during the study and for at least 6 months after the last dose of study drug.
Exclusion criteria
✕. 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).
What they're measuring
1
To assess the safety of PepGNP-ChikV candidate vaccine
Timeframe: Onset within 365 days following last vaccination or EOS, whichever is later
2
To assess the reactogenicity of PepGNP-ChikV candidate vaccine
Timeframe: Onset within 10 days following each vaccination
3
To assess the tolerability of PepGNP-ChikV candidate vaccine
Timeframe: Onset within 52 days following each vaccination or End of Study visit (EOS), whichever is later
✕. 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).
✕. Known systemic hypersensitivity to any of the vaccine components (e.g. gold), or history of a life-threatening reaction to vaccines, or to a vaccine containing any of the same substances.
✕. Acute illness according to Investigator judgment especially if febrile (≥38.0°C).
✕. Screening laboratory testing, including vital signs, ECG, urinalysis and blood laboratory tests, must be within the normal reference ranges; if an isolated abnormality is reported, but is assessed by the Investigator as not clinically relevant the participant may be enrolled and the Investigator's judgement documented in the participant's source data. However, the following laboratory values must be within normal ranges: AST, ALT, bilirubin, all measures of renal function, neutrophil count and platelet count. If the Investigator suspects it to be an erroneous result, it can be repeated; the new result should be used for eligibility determination by the Investigator after documenting any clinical significance to any persistently abnormal result.
✕. A positive SARS-CoV-2 polymerase chain reaction (PCR) or a positive rapid SARS-CoV-2 antigen test at Screening.