ClinicalTrials.gg
Not yet recruitingNCT07902583Updated Oct 29, 2026

Pancoronavirus Vaccine Study in Healthy Adults Ages 18-55

A Phase 1 interventional study of Cov-RBD-scNP-001 and ACU-026-001-1 in Coronavirus Infection, sponsored by Duke University. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Duke University · Phase 1, Interventional, and Prevention

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coronavirus Infection

Keywords

  • Pancoronavirus Vaccine
  • Betacoronavirus
  • Immunogenicity
03

In context

Coronavirus Infections

1,112 studies on the registry are indexed under Coronavirus Infections; 52 are open to participants now.

This study's planned enrollment of 36 is below the median of 120 across 655 interventional studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Provide written 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 must agree to use or have practiced true abstinence or use at least one acceptable primary form of .
  • 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.
  • 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.

Exclusion criteria

Exclusion:

  • Positive SARS-CoV-2 PCR at screening.
  • Abnormal vital signs (Grade 1 or higher) at screening.
  • (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.
  • Has an acute illness, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination.
  • Has known , or 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 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) 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 study involving any IP within 60 days, or 5 half-lives, whichever is longer, before the first vaccine administration.
  • Has a history of 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 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.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Active comparator
    Cohort 1A

    Cov-RBD-scNP-001 20 mcg

    Biological: Cov-RBD-scNP-001

  • Active comparator
    Cohort 1B

    Cov-RBD-scNP-001 20 mcg + ACU-026-001-1 1 mg

    Biological: Cov-RBD-scNP-001 · Biological: ACU-026-001-1

  • Active comparator
    Cohort 2A

    Cov-RBD-scNP-001 50 mcg

    Biological: Cov-RBD-scNP-001

  • Active comparator
    Cohort 2B

    Cov-RBD-scNP-001 50 mcg + ACU-026-001-1 1 mg

    Biological: Cov-RBD-scNP-001 · Biological: ACU-026-001-1

  • Active comparator
    Cohort 3A

    Cov-RBD-scNP-001 10 mcg

    Biological: Cov-RBD-scNP-001

  • Active comparator
    Cohort 3B

    Cov-RBD-scNP-001 10 mcg + ACU-026-001-1 1 mg

    Biological: Cov-RBD-scNP-001 · Biological: ACU-026-001-1

Interventions

  • BiologicalCov-RBD-scNP-001

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

  • BiologicalACU-026-001-1

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

06

What researchers measure

Primary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: Up to Day 394

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline, Day 57

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Oct 2027, 10 months later.

Of 26 non-industry phase 1 interventional studies under Coronavirus Infections, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 19. This study's planned 10 months is below that.

Counting every sponsor, half of 61 studies reached it within 10 months; a quarter within 3 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2026
First posted
Oct 29, 2026
StartEst.
Nov 16, 2026
Primary completionEst.
Oct 7, 2027
CompletionEst.
Oct 7, 2027
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07902583
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Oct 29, 2026
Start date
Nov 16, 2026 (estimated)
Primary completion
Oct 7, 2027 (estimated)
Completion
Oct 7, 2027 (estimated)
Last update
Oct 29, 2026

Study contacts

Emmanuel Walter
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: ACU-026-001

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