ACTIVE_NOT_RECRUITING

Pancoronavirus Vaccine Study in Healthy Adults

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-08

Study Completion:2026-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06950177

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Provide written informed consent prior to the initiation of any trial procedures. 2. Able to understand and agrees to comply with all planned trial procedures and be available for all study visits. 3. Male, or non-pregnant, non-breastfeeding female, age 18-55 years, inclusive, at time first study vaccination. 4. Women of childbearing potential must agree to use or have practiced true abstinence or use at least one acceptable primary form of contraception. 5. 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. 6. 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. 7. In good general health 8. 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 9. Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per investigator discretion. 10. Must agree to have samples stored for secondary research.	1. Positive SARS-CoV-2 PCR at screening. 2. Abnormal vital signs (Grade 1 or higher) at screening. 3. Body mass index (BMI) of \< 18 kilograms/square meter (kg/m\^2) or \> 35 kg/m\^2 (inclusive) at screening 4. History of SARS-CoV-2 infection or receipt of any COVID-19 vaccine \< 16 weeks prior to study vaccination. 5. Woman who is pregnant or breastfeeding. 6. Blood or plasma donation within 4 weeks prior to study vaccination. 7. Receipt of antibody or blood-derived products (except Rho D immunoglobulin) within 90 days prior to study vaccination. 8. 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. 9. Has an acute illness, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination. 10. Has known human immunodeficiency virus, hepatitis B or hepatitis C infection at screening. 11. Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antigen or antibody at screening. 12. Has an ongoing symptomatic condition for which there are ongoing medical investigations, but no diagnosis or treatment plan. 13. Has any confirmed or suspected immunosuppressive or immunodeficient state such as asplenia, recurrent severe infections and chronic immunosuppressant medication within the past 6 months 14. 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. 15. Has any significant disorder of coagulation requiring ongoing or intermittent treatment. 16. Has participated in another investigational study involving any IP within 60 days, or 5 half-lives, whichever is longer, before the first vaccine administration. 17. 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. 18. Receipt of inactivated/subunit vaccine within 14 days prior to vaccine administration or live vaccine within 28 days prior to vaccine administration. 19. Plan to receive a COVID-19 booster vaccine within the 209 days following the first study vaccination. 20. Planned international travel in the period between vaccination through Study Day 57 visit. 21. Has a history of alcohol or drug abuse within 3 years prior to study vaccination. 22. Has any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere with participant compliance or safety evaluations. 23. 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. 24. Has a history of receipt of an investigational ferritin-based vaccine. 25. 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

Inclusion Criteria

Exclusion Criteria

1. Provide written informed consent prior to the initiation of any trial procedures.
2. Able to understand and agrees to comply with all planned trial procedures and be available for all study visits.
3. Male, or non-pregnant, non-breastfeeding female, age 18-55 years, inclusive, at time first study vaccination.
4. Women of childbearing potential must agree to use or have practiced true abstinence or use at least one acceptable primary form of contraception.
5. 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.
6. 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.
7. In good general health
8. 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
9. Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per investigator discretion.
10. Must agree to have samples stored for secondary research.

1. Positive SARS-CoV-2 PCR at screening.
2. Abnormal vital signs (Grade 1 or higher) at screening.
3. Body mass index (BMI) of \< 18 kilograms/square meter (kg/m\^2) or \> 35 kg/m\^2 (inclusive) at screening
4. History of SARS-CoV-2 infection or receipt of any COVID-19 vaccine \< 16 weeks prior to study vaccination.
5. Woman who is pregnant or breastfeeding.
6. Blood or plasma donation within 4 weeks prior to study vaccination.
7. Receipt of antibody or blood-derived products (except Rho D immunoglobulin) within 90 days prior to study vaccination.
8. 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.
9. Has an acute illness, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination.
10. Has known human immunodeficiency virus, hepatitis B or hepatitis C infection at screening.
11. Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antigen or antibody at screening.
12. Has an ongoing symptomatic condition for which there are ongoing medical investigations, but no diagnosis or treatment plan.
13. Has any confirmed or suspected immunosuppressive or immunodeficient state such as asplenia, recurrent severe infections and chronic immunosuppressant medication within the past 6 months
14. 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.
15. Has any significant disorder of coagulation requiring ongoing or intermittent treatment.
16. Has participated in another investigational study involving any IP within 60 days, or 5 half-lives, whichever is longer, before the first vaccine administration.
17. 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.
18. Receipt of inactivated/subunit vaccine within 14 days prior to vaccine administration or live vaccine within 28 days prior to vaccine administration.
19. Plan to receive a COVID-19 booster vaccine within the 209 days following the first study vaccination.
20. Planned international travel in the period between vaccination through Study Day 57 visit.
21. Has a history of alcohol or drug abuse within 3 years prior to study vaccination.
22. Has any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere with participant compliance or safety evaluations.
23. 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.
24. Has a history of receipt of an investigational ferritin-based vaccine.
25. 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

Contacts and Locations

Study Locations (Sites)

Duke University Health System

Durham, North Carolina, 27709

United States

Collaborators and Investigators

Sponsor: Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-08

Study Completion Date2026-08-30

Study Record Updates

Study Start Date2025-07-08

Study Completion Date2026-08-30

Terms related to this study

Additional Relevant MeSH Terms

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