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
Sponsor: Gylden Pharma Ltd
Listed as NCT07394426, this observational or N/A phase trial focuses on Chikungunya and Chikungunya Fever and remains actively recruiting participants. Sponsored by Gylden Pharma Ltd, it has been updated 2 times since 2026, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.
Status Flow
Change History
2 versions recorded-
May 4, 2026 — Present [daily]
Not Yet Recruiting
Phase: EARLY_PHASE1 → None
-
Feb 2026 — May 2026 [monthly]
Not Yet Recruiting EARLY_PHASE1
First recorded
Eligibility 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).
Contact Information
- Gylden Pharma Ltd
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
No location information available.