Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults

NCT07183709 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 25-1105
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

COVID-19

Keywords

booster dose; Covid-19; Dose Ranging; Immunogenicity; PepGNP-COVID19; Phase 1; Reactogenicity; Safety; SARS-CoV-2; Vaccine

Outcome Measures

Primary Outcomes (10)

• Proportion of participants experiencing Abnormal Clinical Safety Laboratory Adverse Events

  Day 1 through Day 15

• Proportion of participants experiencing Adverse Events of Special Interest (AESI)

  Day 1 through Day 181

• Proportion of participants experiencing Medically Attended Adverse Events (MAAEs)

  Day 1 through Day 181

• Proportion of participants experiencing New Onset Chronic Medical Conditions (NOCMCs)

  Day 1 through Day 181

• Proportion of participants experiencing potentially immune-mediated diseases (pIMDs)

  Day 1 through Day 181

• Proportion of participants experiencing Serious Adverse Events (SAEs)

  Day 1 through Day 181

• Proportion of participants experiencing Solicited Local Adverse Events (AEs)

  Day 1 through Day 8

• Proportion of participants experiencing Solicited Systemic Adverse Events (AEs)

  Day 1 through Day 8

• Proportion of participants experiencing Unsolicited Adverse Events (AEs)

  Day 1 through Day 29

• Proportion of participants responding to each category on the vaccine tolerability assessment

  Based on responses to Global Tolerability Assessment questionnaire

  Day 29

Secondary Outcomes (2)

• Geometric mean titer of SARS-CoV-2 anti-spike serum binding IgA and IgG antibodies

  Day 1 through Day 181

• Median, Q1, and, Q3 of the percentage of CD8+ T cells specific to vaccine dextramers

  Day 1 through Day 181

Study Arms (3)

Cohort 1

EXPERIMENTAL

0.05ml of 0.83nmol PepGNP-COVID19 administered intradermally on Day 1 in Healthy Adult participants, 18 to 64 years of age; (8 of 20 participants aged \> / = 50 years) N= 20

Biological: PepGNP-COVID19; Other: Sterile Water for Injection

Cohort 2

EXPERIMENTAL

0.05ml of 2.5nmol PepGNP-COVID19 administered intradermally on Day 1 in Healthy Adult participants, 18 to 64 years of age; (8 of 20 participants aged \> / = 50 years) N= 20

Biological: PepGNP-COVID19; Other: Sterile Water for Injection

Cohort 3

EXPERIMENTAL

0.05ml of 7.5 nmol PepGNP-COVID19 administered intradermally on Day 1 in Healthy Adult participants, 18 to 64 years of age; (8 of 20 participants aged \> / = 50 years) N= 20

Biological: PepGNP-COVID19; Other: Sterile Water for Injection

Interventions

Sterile Water for Injection OTHER

A sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection

Cohort 1; Cohort 2; Cohort 3

PepGNP-COVID19 BIOLOGICAL

A synthetic T cell priming setpoint-modifying SARS-CoV-2 vaccine composed of ultrasmall carbohydrate-coated gold nanoparticles carrying covalently bound MHC class I-binding SARS-CoV-2 peptides.

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provides written informed consent prior to initiation of any study procedures.
• Able to understand and agrees to comply with planned study procedures and be available for all study visits.
• Non-pregnant adults, 18 through 64 years of age, inclusive at time of study product administration.
• Participants of childbearing potential\* must agree to use or have practiced true abstinence\*\* or use at least one acceptable primary form of contraception\*\*\* \*These criteria apply to females who are in a heterosexual relationship who are of childbearing potential. Not of childbearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation/salpingectomy).
• \*\*True abstinence is 100% of the time, no sexual intercourse (penis enters the vagina). Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods.
• \*\*\*Acceptable forms of primary contraception include a monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more before the participant's study product administration, intrauterine devices, birth control pills, and injectable/implantable/insertable/transdermal hormonal birth control products. Must have used at least one acceptable primary form of contraception for at least 30 days before study product administration and agree to continue at least one acceptable primary form of contraception through 60 days after study product administration.
• Participants of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours prior to study product administration.
• In general self-reported, good health.\*\*\*\*
• Receipt of a complete primary authorized or approved COVID-19 vaccine series and at least one booster\*\*\*\*\* with last vaccination at least 16 weeks prior to study product administration.
• \*\*\*\*\*Primary series and/or booster may have been received as part of participation in a clinical trial (see MOP for further details).
• Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per investigator discretion.
• Must agree to have samples stored for secondary research.

You may not qualify if:

• Positive SARS-CoV-2 Polymerase Chain Reaction \[PCR\] at screening.
• Abnormal vital signs at screening (Grade 1 or higher) \*:
• \*Grade 1 or higher is equivalent to: Systolic blood pressure (SBP) \> / =141 mmHg or \< / = 89 mmHg Diastolic blood pressure (DBP) \> / =91 mmHg Heart rate (HR) is \> / =101 beats per minute or \< / = 54 beats per minute Oral temperature \> / =38.0°C (100.4°F)
• History of SARS-CoV-2 infection or receipt of any COVID-19 vaccine \< 16 weeks prior to study product administration.
• Pregnant or breastfeeding.
• Blood or plasma donation within 4 weeks prior to planned study product administration.
• Receipt of antibody or blood-derived products within 90 days prior to planned study product administration.
• Any self-reported or documented significant medical or psychiatric diseases\*\* or any other condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.
• \*\*Significant medical or psychiatric conditions include but are not limited to significant kidney disease, liver disease, history of hematologic malignancy, ongoing other malignancy or recent diagnosis of malignancy in the last five years excluding treated basal cell and squamous cell carcinoma of the skin, and cervical carcinoma in situ, which are allowed.
• History of any significant neurological or neurodevelopmental conditions.\*\*\*
• \*\*\*Including history of Bell's palsy, history of four or more migraine headaches in the past 12 months that interfered with normal daily activity or any migraine headache in the past 5 years that required emergency or inpatient medical care, epilepsy, seizures in the last 5 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease.
• History of significant respiratory disease requiring daily medications currently, history of asthma in the past 5 years, or any treatment of respiratory disease exacerbations in the last 5 years.
• History of cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), including any history of myocarditis or pericarditis, or uncontrolled cardiac arrhythmia.
• Any autoimmune disease, including hypothyroidism, without a defined non-autoimmune cause.
• Has an acute illness, as determined by the site PI or appropriate sub-investigator within 72 hours prior to study product administration.\*\*\*\*

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

University of Alabama at Birmingham School of Medicine - Infectious Disease

Birmingham, Alabama, 35222, United States

Location

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037-3201, United States

Location

Cincinnati Children's Hospital Medical Center Vaccine Research Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Injections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study will be single blinded. Participants will be blinded to the dose of the study product that they receive, to reduce potential bias in reporting reactogenicity and adverse events (AEs). Since the three doses of the PepGNPCovid19 vaccine are of the same volume and appearance, no masking of the Nanopass MicronJet (TM) 600 delivery device is needed. Participants will be unblinded and informed of the dose of the study product they received at the final study visit, following institutional policies. Study personnel performing immunogenicity assays will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 19, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): October 18, 2026
• Study Completion (Estimated): October 18, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-02-09

Locations

US (3)