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SARS-CoVPhase 1NCT05870839

Study of VXCO-100, a SARS-CoV Candidate Vaccine in Healthy Adults in the United States

A Phase 1 study testing VXCO-100 in people with SARS-CoV and SARS-CoV-2, run by Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and immunogenicity of ascending dose levels of VXCO-100 in healthy adults. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
SARS-CoV, SARS-CoV-2
What is being tested?
VXCO-100
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
3 sitesUnited States
Study dates
11 May 2023to 10 Apr 2024
Phase
Phase 1
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A participant must meet all the following criteria to be eligible for the study:
  • Adults ages 18 years and older.
  • Judged by the investigator to be healthy based on participant-reported medical history, physical examination, vital signs, and laboratory assessment.
  • Able to provide written informed consent.
  • Willing to disclose prior COVID-19 vaccination status.
  • Willing to disclose prior participant-reported SARS-CoV-2 infection status.
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  • Prior receipt of at least 3 injections with a COVID-19 mRNA vaccine with the most recent dose at least 6 months prior to enrollment.
  • Willing to comply with all study procedures during the follow-up period of approximately 12 or 24 months, depending on number of doses received.
  • Body mass index of ≤ 40 kg/m2 within 30 days prior to enrollment
  • Electrocardiogram (ECG) without clinically significant abnormalities. Laboratory Criteria within 30 days before enrollment
  • White blood cells (WBC) and differential within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval.
  • Total lymphocyte count ≥ 800 cells/µL.
  • Platelets between 125,000 and 500,000 cells/µL.
  • Hemoglobin within institutional normal range or accompanied by the PI or designee approval.
  • Alanine aminotransferase (ALT) ≤ 1.25 x institutional upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) ≤ 1.25 x institutional ULN.
  • Serum creatinine ≤ 1.1 x institutional ULN.
  • Ferritin, iron and TIBC within institutional normal range or accompanied by the PI or designee approval.
  • For participants of childbearing potential:
  • Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test (urine or serum) on the day of enrollment.
  • Must agree to avoid pregnancy from 21 days prior to study Day 1 until at least 90 days after last study vaccination.

Who cannot join

  • A participant will be excluded if one or more of the following conditions apply:
  • Known SARS-CoV-2 infection or positive test result within 6 months prior to Day 1.
  • Ongoing prophylactic COVID-19 treatment, or monoclonal antibody infusion within 6 months prior to Day 1.
  • Any COVID-19 vaccination within 6 months prior to Day 1.
  • Exhibits symptoms consistent with COVID-19 as assessed by study clinician such as: fever, dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhea, shortness of breath or dyspnea within 14 days prior to in Day 1.
  • Known close contact (as defined by CDC, 2021a) with someone who has COVID-19 within 14 days prior to Day 1.
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  • History or presence of self-reported or medically documented significant medical or psychiatric condition(s) as assessed by study clinician, including:
  • At high risk of severe COVID-19 disease, such as significant history of COPD or chronic lung disease, chronic kidney disease, serious heart conditions (such as heart failure, coronary artery disease or cardiomyopathies), sickle cell disease, diabetes.
  • Clinically significant central nervous system disease such as epilepsy, encephalopathy, or a history of severe mental illness.
  • Severe liver and/or kidney diseases, uncontrolled hypertension, or ongoing or highly likely to recur malignancies.
  • Ongoing or recent clinically significant history of alcohol or drug abuse.
  • Current participation in an interventional clinical study with an investigational drug/biologic/device agent or receipt of any investigational agent within 30 days prior to Day 1.
  • Evidence of infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
  • History of myocarditis or pericarditis.
  • Diagnosed with congenital or acquired immune deficiency, ongoing lymphoma, leukemia, or other clinically significant immune compromising or autoimmune conditions.
  • History of known coagulation dysfunction (e.g., coagulation factor deficiency, known thrombocytopenia, platelet dysfunction, coagulation disease, etc.).
  • Receipt of any live attenuated vaccine within 30 days, or with any other (non-live) vaccine within 14 days prior to Day 1.
  • Received more than 10 days of any systemic immunosuppressants or cytotoxic medications within 30 days prior to Day 1, any within 14 days prior to Day 1 or is anticipating the need for immunosuppressants at any time during participation in the study.
  • Received any blood products within 3 months prior to Day 1.
  • Donated > 450 mL of whole blood within 30 days prior to Day 1.
  • History of unexplained or recurrent anaphylaxis or angioedema, or a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any vaccine, or to any component of the study vaccine.
  • For participants of childbearing potential: breastfeeding or planning to become pregnant during trial duration.
  • Any condition that, in the opinion of the investigator, would (a) pose a health risk to the participant if enrolled or (b) could interfere with evaluation of the study vaccine or interpretation of study results.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Maryland, Baltimore, Center for Vaccine Development and Global Health

    Baltimore, Maryland, 21201

  • The Hope Clinic of Emory University

    Decatur, Georgia, 30030

  • University of Rochester Medical Center - Vaccine Research Unit

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of VXCO-100 in Healthy Adults in the United States

The purpose of this study is to evaluate the safety and immunogenicity of ascending dose levels of VXCO-100 in healthy adults.

Read the detailed description

This is a phase 1, multisite clinical trial to evaluate the safety and immunogenicity of 3 dose levels of VXCO-100 in healthy adult volunteers.

Participants will be vaccinated with 1 dose of VXCO-100 on Day 1. A subset of participants will be offered an optional interim boost at month 3.

Safety will be evaluated 1) before proceeding to a higher dose level and 2) prior to enrollment of participants aged 56 years and older at a particular dose level.

Conditions
SARS-CoV, SARS-CoV-2
Being tested
VXCO-100
Keywords
Covid-19, SARS-CoV-2, Coronavirus, Vaccine, Sarbecoviruses, Covid
Medical subject headings
Severe Acute Respiratory Syndrome, COVID-19, Coronavirus Infections

What participants receive

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

  • VXCO-100Biological

    Sterile liquid for injection

Study groups in NCT05870839
Study groupRoleWhat they receive
VXCO-100 Group 1ExperimentalParticipants 18-55 years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection
Receives: Biological: VXCO-100
VXCO-100 Group 2ExperimentalParticipants 18-55 years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection
Receives: Biological: VXCO-100
VXCO-100 Group 3ExperimentalParticipants 18-55 years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection
Receives: Biological: VXCO-100
VXCO-100 Group 4ExperimentalParticipants 56+ years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection
Receives: Biological: VXCO-100
VXCO-100 Group 5ExperimentalParticipants 56+ years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection
Receives: Biological: VXCO-100
VXCO-100 Group 6ExperimentalParticipants 56+ years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection
Receives: Biological: VXCO-100

What is being measured

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

  1. Number and percentage of participants with solicited local adverse events

    Measured: For 7 days after each product administration

  2. Number and percentage of participants with solicited systemic adverse events

    Measured: For 7 days after each product administration

  3. Number and percentage of participants with unsolicited and safety laboratory-based adverse events

    Measured: For 28 days after each product administration

  4. Numbers and percentages of participants with serious adverse events (SAEs) including suspected unexpected serious adverse reactions (SUSARs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs)

    Measured: For up to 304 days after each product administration

Secondary outcomes (3)

  1. Response rate measured by geometric mean titer of the serum neutralizing antibody (Nab) against the ancestral (Wuhan) strain

    Measured: At baseline and 21 days after each product administration

  2. Response rate measured by GMT of Nab against selected variants of concern

    Measured: At baseline and 21 days after each product administration

  3. Numbers and percentages of participants with positive Th1 or Th2 cytokine responses for CD4 and CD8 as measured by multi-parameter intracellular cytokine staining

    Measured: At baseline and 7 days after each product administration

Timeline

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

  1. First posted23 May 2023
  2. Study start11 May 2023
  3. Primary completion10 Apr 2024
  4. Study completion10 Apr 2024

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
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05870839
Sponsor's protocol ID
VC 101
Status last verified
Dec 2024
First submitted
12 May 2023
Last updated
10 Dec 2024
Results posted
No
Data monitoring committee
Yes
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 VXCO-100 in people with SARS-CoV and SARS-CoV-2, run by Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company at 3 sites in United States.

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 21 inclusion and 23 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: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 and percentage of participants with solicited local adverse events (time frame: For 7 days after each product administration). 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 NCT05870839.

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 10 Dec 2024.

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