Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of VXCO-100 in Adults in the Republic of South Africa
Overview
- Phase
- Phase 1
- Intervention
- VXCO-100
- Conditions
- SARS-CoV
- Sponsor
- Vaccine Company, Inc.
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Number and percentage of participants with solicited local adverse events
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of ascending dose levels of VXCO-100 in adults.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •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.
Exclusion Criteria
- •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
- •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
Arms & Interventions
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.
Intervention: VXCO-100
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.
Intervention: VXCO-100
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.
Intervention: VXCO-100
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.
Intervention: COVID-19 mRNA vaccine
Outcomes
Primary Outcomes
Number and percentage of participants with solicited local adverse events
Time Frame: For 7 days after each product administration
Number and percentage of participants with unsolicited and safety laboratory-based adverse events
Time Frame: For 28 days after each product administration
Number and percentage of participants with solicited systemic adverse events
Time Frame: For 7 days after each product administration
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)
Time Frame: For 364 days after each product administration
Secondary Outcomes
- Response rate measured by GMT of Nab against selected variants of concern(At baseline and 21 days after each product administration)
- Response rate measured by geometric mean titer of the serum neutralizing antibody (Nab) against the ancestral (Wuhan) strain(At baseline and 21 days after each product administration)
- Numbers and percentages of participants with positive Th1 or Th2 cytokine responses for CD4 and CD8 as measured by multi-parameter intracellular cytokine staining(At baseline and 7 days after each product administration)