Pancoronavirus Vaccine for Coronavirus

Overseen By Kristen Gunnell, MS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Duke University

Must not be taking: Corticosteroids, Immunosuppressants, others

Disqualifiers: Respiratory disease, Neurological conditions, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pancoronavirus vaccine designed to protect against multiple coronavirus strains, including those responsible for past outbreaks like SARS and MERS, as well as current and future COVID-19 variants. The vaccine, CoV-RBD-scNP-001, uses a special protein linked to nanoparticles to enhance immunity and is being tested in various doses. The study seeks healthy adults who have completed a primary COVID-19 vaccine series and at least one booster, with the last shot taken at least 16 weeks prior. Participants will help researchers assess the vaccine's safety and its ability to trigger an immune response. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative vaccine.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you can continue taking medications if they are stable and do not pose additional risks, as determined by the trial's medical team.

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

Research has shown that the pancoronavirus vaccine, CoV-RBD-scNP-001, has promising safety results from earlier studies. These studies examined the vaccine's ability to combat different coronavirus strains. Although specific safety data from human trials is not yet available, the vaccine's components, such as the engineered receptor binding domain (RBD) and the 3M-052-AF adjuvant (a substance that enhances the immune response), have been studied separately.

In animal studies, the vaccine protected against various SARS-CoV-2 variants, suggesting potential safety and effectiveness for humans. However, as this trial is in an early phase, the primary focus is on assessing safety. Researchers are closely monitoring participants for any side effects. Participation in this trial contributes to important research that could lead to a vaccine protecting against multiple coronaviruses in the future. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about CoV-RBD-scNP-001 because it introduces a novel approach to preventing coronavirus infections. Unlike traditional vaccines that target a specific strain, this pancoronavirus vaccine aims to provide broad protection against multiple coronavirus types. This is achieved through a unique mechanism that uses a recombinant protein nanoparticle, potentially offering a more universal defense. Additionally, the vaccine is administered intravenously, which is different from the common intramuscular delivery, possibly enhancing its efficacy. If successful, this vaccine could represent a significant advancement over current options, which typically require updates to address new variants.

What evidence suggests that this trial's vaccine could be effective against coronaviruses?

Research has shown that the CoV-RBD-scNP-001 vaccine could offer protection against several coronaviruses. Studies have found that this vaccine can generate strong immune responses that combat different versions of the COVID-19 virus, including those with mutations like those seen in Danish minks. The vaccine employs a special protein particle that aids the immune system in recognizing and attacking the virus effectively. Early results also suggest it might protect against other SARS-related viruses, which could cause future outbreaks. Participants in this trial will receive different doses of the CoV-RBD-scNP-001 vaccine to evaluate its effectiveness and safety across various dosing levels. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Healthy adults who can follow the trial procedures and visit schedule. Women must use effective contraception or be non-childbearing (post-menopausal or surgically sterile). Participants need to provide informed consent.

Inclusion Criteria

I have signed the consent form for this trial.

I understand and agree to follow the study's procedures and attend all visits.

I cannot have children because I am post-menopausal or have had surgery to prevent pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two doses of the Cov-RBD-scNP-001 vaccine on Days 1 and 29 at three dosage levels: 50 mcg, 100 mcg, and 150 mcg

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 3 days, 1, 2, and 4 weeks after each vaccination, and at 6 and 12 months after the last vaccination

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• CoV-RBD-scNP-001

Trial Overview The study tests a pancoronavirus vaccine, CoV-RBD-scNP-001 with adjuvant 3M-052-AF, aiming for broad protection against various coronaviruses including SARS-CoV-2 variants.

How Is the Trial Designed?

Group I: Medium Dose Experimental Treatment 1 Intervention

Participants in the Medium Dose Group will receive CoV-RBD-scNP-001 100 mcg + 3M-052-AF 5 mcg intravenously at Days 1 and 29.

Group II: Low Dose Experimental Treatment 1 Intervention

Participants in the Low Dose Group will receive CoV-RBD-scNP-001 50 mcg + 3M-052-AF 5 mcg intravenously at Days 1 and 29.

Group III: High Dose Experimental Treatment 1 Intervention

Participants in the High Dose Group will receive CoV-RBD-scNP-001 150 mcg + 3M-052-AF 5 mcg intravenously at Days 1 and 29.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06950177

NCT06950177 | Pancoronavirus Vaccine Study in Healthy ... The clinical trial is designed to assess the safety, reactogenicity and immunogenicity of two doses, one each, administered on Days 1 and 29 of the Cov-RBD-scNP ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8528238/

Neutralizing antibody vaccine for pandemic and pre-emergent ... Additionally, we observed RBD-scNP and S-2P mRNA-LNP immune plasma IgG binding to SARS-CoV-2 S was unaffected by mutations observed in Danish minks, B.1.351, P.

3. nature.com nature.com/articles/s41467-022-33985-4

Breadth of SARS-CoV-2 neutralization and protection ... These results demonstrate the ability of RBD-scNPs to induce broad neutralization of SARS-CoV-2 variants and to protect animals from multiple different SARS- ...

4. mdpi.com mdpi.com/2076-393X/13/4/424

Recent Advances and Efficacy of SARS-CoV-2 Vaccines ... The RBD-scNP vaccine has shown efficacy against multiple coronaviruses ... Vaccine effectiveness and duration of protection against symptomatic infections and ...

5. absolutelymaybe.plos.org absolutelymaybe.plos.org/2025/05/31/intranasal-vaccine-trial-results-and-more-on-preventing-covid-infection-nextgen-vax-update-29/

Intranasal Vaccine Trial Results and More on Preventing ... This month, there are the first clinical trial results from an intranasal DNA vaccine, with some signs that it might protect against infection.

6. nature.com nature.com/articles/s41586-021-03594-0

Neutralizing antibody vaccine for pandemic and pre- ... RBD–scNP-immune plasma IgG did not bind the spike protein from the four endemic human coronaviruses or MERS-CoV (Extended Data Fig. 5a, c). The ...

7. pnas.org pnas.org/doi/10.1073/pnas.2106433118

Efficacy and breadth of adjuvanted SARS-CoV-2 receptor- ... These findings suggest potential for RBD-based vaccines being efficacious against SARS-CoV-2 variants and other related coronavirus species.