PepGNP-COVID19 Vaccine for Coronavirus

Not yet recruiting at 2 trial locations

Overseen By David Joseph Diemert

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Intranasal steroids, Immunosuppressants

Disqualifiers: Pregnancy, SARS-CoV-2 infection, Cardiovascular disease, Neurological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new COVID-19 booster vaccine, PepGNP-COVID19, which aims to strengthen immune responses in the lungs and reduce the need for frequent updates. Researchers seek to determine the vaccine's safety and its ability to prompt an immune reaction. Participants will receive different doses to identify the optimal amount. Healthy adults who have already been vaccinated and received at least one COVID-19 booster, with no recent COVID-19 infections or certain medical conditions, may be suitable for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop taking my current medications to join the trial?

The trial does not specifically require you to stop taking your current medications. You can continue with your medications if they don't pose additional risks to your safety or affect the study's assessments, as determined by the trial's investigators.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the PepGNP-COVID19 vaccine appears safe based on early studies. These studies have not found any severe COVID-19 cases in vaccinated individuals, indicating the vaccine does not worsen the disease. The vaccine uses tiny gold particles to help the immune system fight the virus more effectively without causing harm. While this trial mainly focuses on safety, earlier small group tests have shown the vaccine to be well-tolerated. No major side effects have been reported so far, suggesting it could be a safe option for further research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard COVID-19 vaccines that typically use mRNA or viral vector technology, the PepGNP-COVID19 vaccine employs a unique approach with peptide-gold nanoparticle conjugates. This innovative delivery method could enhance immune response precision and potentially reduce side effects. Researchers are excited because this method may offer faster protection and increased efficacy, especially in older adults, without the need for larger doses.

What evidence suggests that the PepGNP-COVID19 vaccine could be an effective booster for COVID-19?

Research shows that PepGNP-COVID19, a lab-made vaccine using tiny particles, is designed to boost T cell responses. T cells, part of the immune system, help fight viruses. Studies have found that no severe COVID-19 cases occurred after receiving the PepGNP-COVID19 vaccine, suggesting it might lower the risk of severe illness from COVID-19. The vaccine delivers small parts of the virus attached to gold particles to strengthen the body's defenses in the lungs. These early results are promising for preventing severe COVID-19. Participants in this trial will receive different dosages of the PepGNP-COVID19 vaccine in separate cohorts to evaluate its effectiveness and safety. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Healthy adults aged 18-64 who have completed a full COVID-19 vaccine series and at least one booster, with the last shot given at least 16 weeks prior. Participants must be in good health, not pregnant, agree to use contraception if of childbearing potential, and commit to all study visits.

Inclusion Criteria

I've completed the COVID-19 vaccine series and had a booster over 16 weeks ago.

I am between 18 and 64 years old and not pregnant.

I have signed the consent form for this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intradermal injection of PepGNP-COVID19 at one of three dosage levels

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and immune responses

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• PepGNP-COVID19

Trial Overview The trial is testing PepGNP-COVID19 as a booster for COVID-19 immunity. It's a nanoparticle-based vaccine aimed at inducing T cell responses. Participants will receive one intradermal injection at varying doses to assess safety and immune response.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 2 Interventions

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

Group II: Cohort 2 Experimental Treatment 2 Interventions

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

Group III: Cohort 1 Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07183709

Safety and Immunogenicity Trial of PepGNP-COVID19 ... The primary objective is to evaluate the safety, reactogenicity, and tolerability of a single intradermal dose of PepGNP-COVID19 at three dosage levels in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11974014/

A gold nanoparticle/peptide vaccine designed to induce SARS ... No case of severe COVID-19 was reported after PepGNP-Covid19, suggesting no enhancement of the disease due to the trial vaccine immune response, which is in ...

3. withpower.com withpower.com/trial/phase-1-covid-19-9-2025-f9522

PepGNP-COVID19 Vaccine for Coronavirus This Phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of PepGNP-COVID19, a synthetic nanoparticle-based, ...

4. gyldenpharma.com gyldenpharma.com/wp-content/uploads/2024/07/naNO-COVID_ClinicalTrialProtocol_V3.0_English_01.02.2022_clean%20-%20signed.pdf

CLINICAL TRIAL PROTOCOL A Phase I, double-blind, ... What is the safety and reactogenicity profile of 2 doses of PepGNP-Covid19 nanoparticle vaccine in a small cohort of healthy human volunteers?

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05633446?term=NCT05633446%26rank=1

Next Generation T-cell Vaccine Against Coronavirus ... The study aims to investigate the safety and immunogenicity of one dose vs two doses of a T-cell priming next-generation vaccine against Coronavirus disease.