Phase 1 Dose Ranging Study to Assess the Safety, Reactogenicity, and Immunogenicity of PepGNP-COVID19, a Synthetic Nanoparticle-based, T Cell Priming Peptide Vaccine Against SARS-CoV-2 As a Booster Dose

Publication date: Sep 18, 2025

This Phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of PepGNP-COVID19, a synthetic nanoparticle-based, T cell-priming peptide vaccine against SARS-CoV-2, when administered as a booster dose in healthy adults. PepGNP-COVID19 is designed to induce broad and durable T cell-mediated immune responses by delivering conserved SARS-CoV-2 peptides covalently bound to carbohydrate-coated gold nanoparticles, with the goal of enhancing tissue-resident cytotoxic T lymphocytes in the respiratory tract and reducing the need for frequent antigen updates. This randomized, participant-blinded, dose-ranging, multi-site trial will enroll 60 healthy adults aged 18-64 years, with a target of 8 of 20 participants in each cohort being > / = 50 years of age. Participants will receive a single intradermal injection of PepGNP-COVID19 at one of three dosage levels (0. 83 nmol, 2. 5 nmol, or 7. 5 nmol in a volume of 0. 05 mL). The primary objective is to evaluate the safety, reactogenicity, and tolerability of a single intradermal dose of PepGNP-COVID19 at three dosage levels in previously vaccinated healthy adults.

Concepts	Keywords
Marijuana	booster dose
Menopausal	Covid-19
Monogamous	Dose Ranging
Nanoparticle	Immunogenicity
Vaccine	PepGNP-COVID19
	Phase 1
	Reactogenicity
	Safety
	SARS-CoV-2
	Vaccine

Semantics

Type	Source	Name
disease	MESH	COVID19
disease	IDO	cell
drug	DRUGBANK	Gold
disease	IDO	site
disease	IDO	history
disease	MESH	amenorrhea
disease	MESH	clinical significance
disease	IDO	blood
pathway	REACTOME	SARS-CoV-2 Infection
disease	MESH	psychiatric
disease	MESH	disease liver
disease	MESH	hematologic malignancy
disease	MESH	malignancy
disease	MESH	carcinoma in situ
disease	MESH	Bell’s palsy
disease	MESH	migraine headaches
disease	MESH	emergency
disease	MESH	epilepsy
disease	MESH	seizures
disease	MESH	encephalopathy
disease	MESH	focal neurologic deficits
disease	MESH	syndrome
disease	MESH	encephalomyelitis
disease	MESH	transverse myelitis
disease	MESH	stroke
disease	MESH	transient ischemic attack
disease	MESH	multiple sclerosis
disease	MESH	Parkinson’s disease
disease	MESH	amyotrophic lateral sclerosis
pathway	KEGG	Amyotrophic lateral sclerosis
disease	MESH	Creutzfeldt-Jakob disease
disease	MESH	Alzheimer’s disease
disease	MESH	asthma
pathway	KEGG	Asthma
disease	MESH	cardiovascular disease
disease	MESH	congestive heart failure
disease	MESH	cardiomyopathy
disease	MESH	ischemic heart disease
disease	MESH	myocarditis
disease	MESH	pericarditis
disease	MESH	cardiac arrhythmia
disease	MESH	autoimmune disease
disease	MESH	hypothyroidism
drug	DRUGBANK	Hepatitis B Vaccine (Recombinant)
disease	IDO	immunodeficiency
disease	MESH	infections
drug	DRUGBANK	Prednisone
disease	MESH	hypersensitivity
disease	MESH	anaphylaxis
disease	MESH	urticaria
disease	MESH	angioedema
drug	DRUGBANK	Medical Cannabis
disease	MESH	scars
drug	DRUGBANK	Ethanol
disease	MESH	Infectious Diseases