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SARS-CoVPhase 1NCT05938075

Study of VXCO-100, a SARS-CoV Candidate Vaccine, in Adults in the Republic of South Africa

A Phase 1 study testing VXCO-100 and COVID-19 mRNA vaccine in people with SARS-CoV and SARS-CoV-2, run by Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company at 2 sites in South Africa.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate the safety and immunogenicity of ascending dose levels of VXCO-100 in 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 and COVID-19 mRNA vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
2 sitesSouth Africa
Study dates
4 Aug 2023to 25 Jul 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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  • Willing to comply with all study procedures during the follow-up period of approximately 12 months.
  • Body mass index of ≤ 40 kg/m2 within 30 days prior to enrollment
  • Electrocardiogram (ECG) without clinically significant abnormalities.
  • Clinical screening laboratory evaluations (i.e., CBC, iron, ferritin, TIBC, platelets, ALT, AST, creatinine) are within acceptable normal reference ranges at the clinical laboratory being used or are not deemed clinically significant by study clinician.
  • 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
  • Active participation in an interventional clinical study with an investigational drug/biologic/device agent receipt of any specimen collection within 30 days prior to Day 1
  • Evidence of infection with hepatitis B virus or hepatitis C virus
  • Positive test result for human immunodeficiency virus (HIV) with the exception that 30% of participants may be HIV-infected, if stable on antiretrovirals with stable CD4 >350 cells/mm3 and virally suppressed
  • 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 VXCO-100.
  • For persons 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

2 sites in 1 country.

South Africa2 sites

  • HIV and other Infectious Diseases Research Unit (HIDRU), South African Medical Research Council

    Botha’s Hill, KwaZulu-Natal

  • Perinatal HIV Research Unit (PHRU), Chris Hani Baragwanath Academic Hospital

    Johannesburg, Gauteng

Other trials in South Africa

About this study

Official title: Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of VXCO-100 in Adults in the Republic of South Africa

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

Participants will be vaccinated with a selected dose of VXCO-100 or a COVID-19 mRNA vaccine. Participants will receive a dose of VXCO-100 on Day 1. A matched optional boost on month 6 will be offered to a subset of participants in Groups 1-3. Participants receiving a COVID-19 mRNA vaccine will be vaccinated on Day 1 and Day 21.

Safety will be evaluated before proceeding to a higher dose level.

Conditions
SARS-CoV, SARS-CoV-2
Being tested
VXCO-100, COVID-19 mRNA vaccine
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 suspension for injection

  • COVID-19 mRNA vaccineBiological

    Sterile suspension for injection

Study groups in NCT05938075
Study groupRoleWhat they receive
VXC0-100 at Dose level 1ExperimentalParticipants will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection on Day 1 and then an optional boost of VXCO-100 at Dose Level 1 on Month 6.
Receives: Biological: VXCO-100
VXC0-100 at Dose level 2ExperimentalParticipants will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection on Day 1 and then an optional boost of VXCO-100 at Dose Level 2 on Month 6.
Receives: Biological: VXCO-100
VXC0-100 at Dose level 3ExperimentalParticipants will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection on Day 1 and then an optional boost of VXCO-100 at Dose Level 3 on Month 6.
Receives: Biological: VXCO-100
COVID-19 mRNA vaccineExperimentalParticipants will receive a COVID-19 mRNA vaccine on Day 1 and then a boost with the same COVID-19 mRNA vaccine at Day 21.
Receives: Biological: COVID-19 mRNA vaccine

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 364 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 posted10 Jul 2023
  2. Study start4 Aug 2023
  3. Primary completion25 Jul 2024
  4. Study completion25 Jul 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
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05938075
Sponsor's protocol ID
VC 102
Status last verified
Dec 2024
First submitted
5 Jul 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 and COVID-19 mRNA vaccine in people with SARS-CoV and SARS-CoV-2, run by Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company at 2 sites in South Africa.

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 13 inclusion and 24 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 2 sites in South Africa. 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 NCT05938075.

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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