Pancoronavirus Vaccine Study in Healthy Adults

NCT06950177 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: Pro00117785
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Number of participants with solicited local and systemic reactogenicity events from the time of each study vaccination through 7 days after each study vaccination by dosage amount

  Day 7, Day 36

• Number of participants with study vaccine-related and unrelated unsolicited non-serious adverse events from the time of the first study vaccination through approximately 28 days after the last study vaccination (Day 57) by dosage amount

  Day 57

• Number of participants with clinical safety laboratory adverse events from the time of each study vaccination through approximately 28 days after each study vaccination by dosage amount

  Day 29, Day 57

• Number of participants with AESIs, SAEs, MAAEs, NOCMCs, and PIMMCs at any time following the first vaccination through 12 months following the last dose received by dosage amount

  Adverse events of special interest (AESIs); serious adverse events (SAEs); medically-attended adverse events (MAAEs); new-onset chronic medical conditions (NOCMCs); potentially immune-mediated medical conditions (PIMMCs).

  Day 394

Secondary Outcomes (3)

• Geometric mean ID50 titers (IU50/mL) of neutralizing antibody levels against multiple betacoronaviruses before vaccination and 28 days (Day 57) following second vaccination

  Day 57

• Geometric mean fold rise (ID50) titers of neutralizing antibody levels against multiple betacoronaviruses from before vaccination to 28 days (Day 57) following second vaccination

  Day 57

• Binding titers (BAU/mL) of antibodies to SARS-CoV-2 Spike (WA-1 isolate) protein from plasma specimens before vaccination to 28 days (Day 57) following second vaccination

  Day 57

Study Arms (3)

Low Dose

EXPERIMENTAL

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.

Biological: CoV-RBD-scNP-001 and 3M-052-AF

Medium Dose

EXPERIMENTAL

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.

Biological: CoV-RBD-scNP-001 and 3M-052-AF

High Dose

EXPERIMENTAL

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.

Biological: CoV-RBD-scNP-001 and 3M-052-AF

Interventions

CoV-RBD-scNP-001 and 3M-052-AF BIOLOGICAL

All subjects will receive the investigational vaccine CoV-RBD-scNP-001 adjuvanted with 3M-052-AF.

High Dose; Low Dose; Medium Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provide written informed consent prior to the initiation of any trial procedures.
• Able to understand and agrees to comply with all planned trial procedures and be available for all study visits.
• Male, or non-pregnant, non-breastfeeding female, age 18-55 years, inclusive, at time first study vaccination.
• Women of childbearing potential must agree to use or have practiced true abstinence or use at least one acceptable primary form of contraception.
• Note: These criteria are applicable to females in a relationship with a male, and who are of child-bearing potential).
• Not of childbearing potential - 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 Essure® placement).
• True abstinence is 100% of time no sexual intercourse (male's penis enters the female's vagina). (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception).
• Acceptable forms of primary contraception include monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the participant's first vaccination, tubal ligation, 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 prior to the first vaccination and continue at least one acceptable primary form of contraception through 60 days after the last vaccination.
• Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each study vaccination.
• Male participants are eligible to participate if they agree to refrain from donating sperm and to be abstinent from heterosexual intercourse with a female of childbearing potential as their preferred and usual lifestyle or must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person during the intervention period and for at least 90 days after the last dose of study product.
• In good general health
• Reported receipt of a complete primary COVID-19 vaccine series and at least one booster with last vaccination at least 16 weeks prior to study vaccine dose 1
• A complete primary COVID-19 vaccine series is defined as two Pfizer or Moderna COVID-19 vaccines.
• Booster may be either homologous or heterologous to the primary vaccine series and must be an FDA authorized/approved vaccine though authorized/approved doses may have been received as part of a clinical trial.

You may not qualify if:

• Positive SARS-CoV-2 PCR at screening.
• Abnormal vital signs (Grade 1 or higher) at screening.
• 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 ≤ 50 beats per minute
• Oral temperature ≥ 38.0°C (100.4°F)
• Body mass index (BMI) of \< 18 kilograms/square meter (kg/m\^2) or \> 35 kg/m\^2 (inclusive) at screening
• History of SARS-CoV-2 infection or receipt of any COVID-19 vaccine \< 16 weeks prior to study vaccination.
• Woman who is pregnant or breastfeeding.
• Blood or plasma donation within 4 weeks prior to study vaccination.
• Receipt of antibody or blood-derived products (except Rho D immunoglobulin) within 90 days prior to study vaccination.
• Any self-reported or medically documented significant medical or psychiatric disease or condition(s) that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
• Significant medical or psychiatric conditions include but are not limited to respiratory disease (e.g., chronic obstructive pulmonary disease \[COPD\]) requiring daily medications currently, history of asthma in the past 5 years, or any treatment of exacerbation of an underlying respiratory disease in the last 5 years. Significant kidney disease, liver disease, or cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), including any history of myocarditis or pericarditis, or uncontrolled cardiac arrhythmia. Neurological or neurodevelopmental conditions (e.g., 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). Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding treated basal cell and squamous cell carcinoma of the skin, which are allowed. 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 vaccination.

Sponsors & Collaborators

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

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27709, United States

Location

MeSH Terms

Conditions

COVID-19

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 30, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)