NCT07394426

A Phase I Study of PepGNP-ChikV in Healthy Volunteers

A Phase I, Dose-escalation, Randomized, Single-blind, Placebo-controlled Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of PepGNP-ChikV, a Synthetic Nanoparticle-based T Cell Next-generational Vaccine Against Chikungunya in Healthy Adults

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Gylden Pharma Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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 30 minutes 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).

Conditions

• Chikungunya
• Chikungunya Fever
• Chikungunya Virus Infection
• Chikungunya Virus Infections
• Chikungunya Virus

Interventions

Type	Name	Description
BIOLOGICAL	PepGNP-ChikV	PepGNP-ChikV vaccine will be administered by an intradermal microneedle device
BIOLOGICAL	Placebo	Placebo (sterile WFI) will be administered by an intradermal microneedle device

Timeline

• Start date: 2026-08-03
• Primary completion: 2027-12-01
• Completion: 2028-05-01
• First posted: 2026-02-06
• Last updated: 2026-02-06