NCT06950177

Pancoronavirus Vaccine Study in Healthy Adults

A Phase I, Dose-escalation Study to Assess the Safety, Reactogenicity, and Immunogenicity of Two Doses of an Adjuvanted Novel Pancoronavirus Vaccine (Cov- RBD-scNP-001) in 18 Through 55-year-old Healthy Participants

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Coronaviruses (CoVs) have caused the severe acute respiratory syndrome (SARS) outbreak, the Middle East Respiratory Syndrome (MERS) outbreak, and now the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Although there are several approved or authorized vaccines for SARS-CoV-2, there are currently no vaccines approved to prevent diseases caused by multiple different coronaviruses. Two countermeasures with promise for controlling coronavirus outbreaks are recombinant neutralizing antibodies and vaccines directed against the virus. Between these two countermeasures, the ultimate solution to control the current COVID-19 pandemic and future CoV outbreaks is a pancoronavirus vaccine. In particular, a vaccine that can induce broader protection and can prevent severe disease caused by current SARS-CoV-2 variants of concern would help mitigate significant morbidity and mortality following SARS-CoV-2 infection. Additionally, an optimal pancoronavirus vaccine would prevent severe disease from other SARS-related viruses in the genus of coronaviruses-betacoronavirus-that are responsible for past outbreaks or could cause the next major outbreak in humans. Such a broadly active coronavirus vaccine would be an impactful first step towards preventing all life-threatening coronavirus human disease. The proposed vaccine immunogen (Cov-RBD-scNP-001) is composed of an engineered receptor binding domain (RBD) of SARS-CoV-2 WA-1 covalently linked in vitro to the surface of a Helicobacter pylori ferritin protein nanoparticle (RBD-scNP). The RBD has been engineered at two sites to improve its expression. The protein nanoparticle is composed of 24 individual ferritin subunits each of which can have a SARS-CoV-2 WA-1 RBD attached to it via a nine amino acid linker. The protein nanoparticle will be delivered with 3M-052-AF adjuvant - a TLR 7/8 agonist.

Detailed description

This is a single-site Phase I clinical trial in up to 51 males and non-pregnant, non-lactating women, 18 to 55 years old, inclusive, who are in good health and meet all eligibility criteria. 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-001 vaccine administered at three dosage levels - a 50 mcg (Low Dose Cohort) followed by a 100 mcg (Medium Dose Cohort) and lastly a 150 mcg (High Dose Cohort). Participants will be sequentially enrolled in the Low Dose, Medium Dose, and High Dose Cohorts. Within each dose cohort will be sentinel and expanded subgroups. Four participants will be enrolled into the sentinel subgroup and 13 will be enrolled in the expanded subgroup. The estimated time to complete enrollment is 6 months. The total duration of participant participation is up to 14 months. Follow-up study visits will occur at 3 days and at 1, 2 and 4 weeks after each vaccination, as well as 6 and 12 months after the last vaccination. Solicited adverse events will be assessed for 7 days following each vaccination. Unsolicited events will be assessed for 28 days following each vaccination. Blood and mucosal samples will be obtained for safety and immunogenicity assays at select study visits. Adverse events of special interest (AESIs), Serious adverse events (SAEs), Medically attended adverse events (MAAEs), New onset chronic medical conditions (NOCMCs), and potential immune-mediated medical conditions will be collected from the first vaccination through 12 months after the last vaccination. Clinical safety laboratory evaluations will be performed prior to, and 7 days post each vaccination and 28 days following the second vaccination. Nasal swabs will be self-collected or collected by staff at unscheduled illness visits to evaluate breakthrough SARS-CoV-2 infection (symptomatic infection or asymptomatic infection with a positive SARS-CoV-2 test outside the study).

Conditions

• COVID-19 Respiratory Infection
• SARS CoV 2 Infection
• COVID-19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	CoV-RBD-scNP-001 and 3M-052-AF	All subjects will receive the investigational vaccine CoV-RBD-scNP-001 adjuvanted with 3M-052-AF.

Timeline

• Start date: 2025-07-08
• Primary completion: 2026-08-30
• Completion: 2026-08-30
• First posted: 2025-04-30
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study