Study of VXCO-100, a SARS-CoV Candidate Vaccine, in Adults in the Republic of South Africa
NCT ID: NCT05938075
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
130 participants
INTERVENTIONAL
2023-08-04
2024-07-25
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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VXC0-100 at Dose level 1
Participants 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.
VXCO-100
Sterile suspension for injection
VXC0-100 at Dose level 2
Participants 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.
VXCO-100
Sterile suspension for injection
VXC0-100 at Dose level 3
Participants 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.
VXCO-100
Sterile suspension for injection
COVID-19 mRNA vaccine
Participants will receive a COVID-19 mRNA vaccine on Day 1 and then a boost with the same COVID-19 mRNA vaccine at Day 21.
COVID-19 mRNA vaccine
Sterile suspension for injection
Interventions
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VXCO-100
Sterile suspension for injection
COVID-19 mRNA vaccine
Sterile suspension for injection
Eligibility Criteria
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Inclusion Criteria
1. Adults ages 18 years and older
2. Judged by the investigator to be healthy based on participant-reported medical history, physical examination, vital signs, and laboratory assessment.
3. Able to provide written informed consent.
4. Willing to disclose prior COVID-19 vaccination status.
5. Willing to disclose prior participant-reported SARS-CoV-2 infection status.
6. Willing to comply with all study procedures during the follow-up period of approximately 12 months.
7. Body mass index of ≤ 40 kg/m2 within 30 days prior to enrollment
8. Electrocardiogram (ECG) without clinically significant abnormalities.
9. 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:
10. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test (urine or serum) on the day of enrollment
11. Must agree to avoid pregnancy from 21 days prior to study Day 1 until at least 90 days after last study vaccination.
Exclusion Criteria
1. Known SARS-CoV-2 infection or positive test result within 6 months prior to Day 1
2. Ongoing prophylactic COVID-19 treatment, or monoclonal antibody infusion within 6 months prior to Day 1
3. Any COVID-19 vaccination within 6 months prior to Day 1
4. 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
5. Known close contact (as defined by CDC, 2021a) with someone who has COVID-19 within 14 days prior to Day 1
6. History or presence of self-reported or medically documented significant medical or psychiatric condition(s) as assessed by study clinician, including:
1. 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
2. Clinically significant central nervous system disease such as epilepsy, encephalopathy, or a history of severe mental illness
3. Severe liver and/or kidney diseases, uncontrolled hypertension, or ongoing or highly likely to recur malignancies
4. Ongoing or recent clinically significant history of alcohol or drug abuse
7. 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
8. Evidence of infection with hepatitis B virus or hepatitis C virus
9. 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
10. History of myocarditis or pericarditis
11. Diagnosed with congenital or acquired immune deficiency, ongoing lymphoma, leukemia, or other clinically significant immune compromising or autoimmune conditions.
12. History of known coagulation dysfunction (e.g., coagulation factor deficiency, known thrombocytopenia, platelet dysfunction, coagulation disease, etc.)
13. Receipt of any live attenuated vaccine within 30 days, or with any other (non-live) vaccine within 14 days prior to Day 1
14. 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.
15. Received any blood products within 3 months prior to Day 1
16. Donated \> 450 mL of whole blood within 30 days prior to Day 1
17. 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.
18. For persons of childbearing potential: breastfeeding or planning to become pregnant during trial duration.
19. 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.
18 Years
ALL
Yes
Sponsors
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Medical Research Council, South Africa
OTHER
Vaccine Company, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Glenda Gray, MBChB, FC
Role: PRINCIPAL_INVESTIGATOR
Medical Research Council, South Africa
Ravindre Panchia, MBChB
Role: PRINCIPAL_INVESTIGATOR
Perinatal HIV Research Unit (PHRU)
Anusha Nana, BPharm
Role: PRINCIPAL_INVESTIGATOR
Perinatal HIV Research Unit (PHRU)
Mbalizethu Mntambo, MBChB
Role: PRINCIPAL_INVESTIGATOR
HIV and other Infectious Diseases Research Unit (HIDRU)
Samantha Siva, MMEDSc
Role: PRINCIPAL_INVESTIGATOR
HIV and other Infectious Diseases Research Unit (HIDRU)
Locations
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Perinatal HIV Research Unit (PHRU), Chris Hani Baragwanath Academic Hospital
Johannesburg, Gauteng, South Africa
HIV and other Infectious Diseases Research Unit (HIDRU), South African Medical Research Council
Botha’s Hill, KwaZulu-Natal, South Africa
Countries
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Other Identifiers
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VC 102
Identifier Type: -
Identifier Source: org_study_id