Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults (NCT07183709) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults
United States60 participantsStarted 2026-02-02
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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).
✓. 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.
✓
What they're measuring
1
Proportion of participants experiencing Abnormal Clinical Safety Laboratory Adverse Events
Timeframe: Day 1 through Day 15
2
Proportion of participants experiencing Adverse Events of Special Interest (AESI)
Timeframe: Day 1 through Day 181
3
Proportion of participants experiencing Medically Attended Adverse Events (MAAEs)
Timeframe: Day 1 through Day 181
4
Proportion of participants experiencing New Onset Chronic Medical Conditions (NOCMCs)
Timeframe: Day 1 through Day 181
5
Proportion of participants experiencing potentially immune-mediated diseases (pIMDs)
Timeframe: Day 1 through Day 181
6
Proportion of participants experiencing Serious Adverse Events (SAEs)
Timeframe: Day 1 through Day 181
7
Proportion of participants experiencing Solicited Local Adverse Events (AEs)
Timeframe: Day 1 through Day 8
8
Trial details
NCT IDNCT07183709
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per investigator discretion.
Exclusion criteria
✕. Positive SARS-CoV-2 Polymerase Chain Reaction \[PCR\] at screening.
✕. Abnormal vital signs at screening (Grade 1 or higher) \*:
✕. 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.
✕. History of any significant neurological or neurodevelopmental conditions.\*\*\*
Proportion of participants experiencing Solicited Systemic Adverse Events (AEs)
Timeframe: Day 1 through Day 8
9
Proportion of participants experiencing Unsolicited Adverse Events (AEs)
Timeframe: Day 1 through Day 29
10
Proportion of participants responding to each category on the vaccine tolerability assessment