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Coronavirus InfectionPhase 1NCT07902583

Pancoronavirus Vaccine Study in Healthy Adults Ages 18-55

A Phase 1 study testing Cov-RBD-scNP-001 and ACU-026-001-1 in people with Coronavirus Infection, run by Duke University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

The purpose of this Phase I trial is to determine the breadth of immune response elicited by vaccination against betacoronaviruses and assess the safety, reactogenicity, and immunogenicity of Cov-RBD-scNP-001 with or without ACU-026-001-1 adjuvant in healthy adults ages 18-55. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Coronavirus Infection
What is being tested?
Cov-RBD-scNP-001 and ACU-026-001-1
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
16 Nov 2026to 7 Oct 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
  • 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 must use acceptable contraception or be vasectomized and must refrain from donating sperm for 90 days following study vaccination.
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  • 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 product dose
  • Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per investigator discretion.
  • Must agree to have samples stored for secondary research.

Who cannot join

  • Positive SARS-CoV-2 PCR at screening.
  • Abnormal vital signs (Grade 1 or higher) at screening.
  • 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.
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  • 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.
  • Has an acute illness, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination.
  • Has known human immunodeficiency virus, hepatitis B or hepatitis C infection at screening.
  • Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antigen or antibody at screening.
  • Has an ongoing symptomatic condition for which there are ongoing medical investigations, but no diagnosis or treatment plan.
  • Has any confirmed or suspected immunosuppressive or immunodeficient state such as asplenia, recurrent severe infections and chronic immunosuppressant medication within the past 6 months
  • Has taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to the first study vaccination. Intranasal, ophthalmic, or topical (skin or eyes) corticosteroids are permitted.
  • Has any significant disorder of coagulation requiring ongoing or intermittent treatment.
  • Has participated in another investigational study involving any IP within 60 days, or 5 half-lives, whichever is longer, before the first vaccine administration.
  • Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccine or to the candidate vaccine components.
  • Receipt of inactivated/subunit vaccine within 14 days prior to vaccine administration or live vaccine within 28 days prior to vaccine administration.
  • Prior receipt of CovRBD-scNP-001
  • Plan to receive a COVID-19 booster vaccine within the 209 days following the first study vaccination.
  • Planned international travel in the period between vaccination through Study Day 57 visit.
  • Has a history of alcohol or drug abuse within 3 years prior to study vaccination.
  • Has any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere with participant compliance or safety evaluations.
  • Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination.
  • Has a history of receipt of an investigational ferritin-based vaccine.
  • Has any abnormality or permanent body art (e.g., tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site.

About this study

Official title: A Phase I, Dose-ranging Study to Assess the Safety, Reactogenicity, and Immunogenicity of Two Doses of a Novel Pancoronavirus Vaccine (Cov-RBD-scNP-001) With or Without Adjuvant (ACU-026-001-01)

The purpose of this Phase I trial is to determine the breadth of immune response elicited by vaccination against betacoronaviruses and assess the safety, reactogenicity, and immunogenicity of Cov-RBD-scNP-001 with or without ACU-026-001-1 adjuvant in healthy adults ages 18-55.

Being tested
Cov-RBD-scNP-001, ACU-026-001-1
Keywords
Pancoronavirus Vaccine, Betacoronavirus, Immunogenicity
Medical subject headings
Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cov-RBD-scNP-001Biological

    All subjects in this group will receive the investigational vaccine Cov-RBD-scNP-001

  • ACU-026-001-1Biological

    All subjects in this group will receive Cov-RBD-scNP-001 adjuvanted with ACU-026-001-1

Study groups in NCT07902583
Study groupRoleWhat they receive
Cohort 1AActive comparatorCov-RBD-scNP-001 20 mcg
Receives: Biological: Cov-RBD-scNP-001
Cohort 1BActive comparatorCov-RBD-scNP-001 20 mcg + ACU-026-001-1 1 mg
Receives: Biological: Cov-RBD-scNP-001; Biological: ACU-026-001-1
Cohort 2AActive comparatorCov-RBD-scNP-001 50 mcg
Receives: Biological: Cov-RBD-scNP-001
Cohort 2BActive comparatorCov-RBD-scNP-001 50 mcg + ACU-026-001-1 1 mg
Receives: Biological: Cov-RBD-scNP-001; Biological: ACU-026-001-1
Cohort 3AActive comparatorCov-RBD-scNP-001 10 mcg
Receives: Biological: Cov-RBD-scNP-001
Cohort 3BActive comparatorCov-RBD-scNP-001 10 mcg + ACU-026-001-1 1 mg
Receives: Biological: Cov-RBD-scNP-001; Biological: ACU-026-001-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with solicited local and systemic reactogenicity events from the time of each study vaccination through 14 days after each study vaccination by dosage amount

    Measured: Up to Day 15, up to Day 43

  2. Number of participants with study product-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

    Measured: Up to Day 57

  3. 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

    Measured: Up to Day 29, up to Day 57

  4. 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

    AESIs (Adverse Events of Special Interest), SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Events), NOCMCs (New-Onset Chronic Medical Conditions), PIMMCs (Potential Immune-Mediated Medical Conditions)

    Measured: Up to Day 394

Secondary outcomes (3)

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

    Measured: Baseline, Day 57

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

    Measured: Baseline, Day 57

  3. 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

    Measured: Baseline, Day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start16 Nov 2026 (estimated)
  3. Primary completion7 Oct 2027 (estimated)
  4. Study completion7 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07902583
Sponsor's protocol ID
Pro00120275
Other IDs
26-0007
Status last verified
Oct 2026
First submitted
22 Oct 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cov-RBD-scNP-001 and ACU-026-001-1 in people with Coronavirus Infection, run by Duke University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with solicited local and systemic reactogenicity events from the time of each study vaccination through 14 days after each study vaccination by dosage amount (time frame: Up to Day 15, up to Day 43). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07902583.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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