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

NCT05938075 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: VC 102
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

SARS-CoV; SARS-CoV-2

Keywords

Covid-19; SARS-CoV-2; Coronavirus; Vaccine; Sarbecoviruses; Covid

Outcome Measures

Primary Outcomes (4)

• Number and percentage of participants with solicited local adverse events

  For 7 days after each product administration

• Number and percentage of participants with solicited systemic adverse events

  For 7 days after each product administration

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

  For 28 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)

  For 364 days after each product administration

Secondary Outcomes (3)

• 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

• Response rate measured by GMT of Nab against selected variants of concern

  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

Study Arms (4)

VXC0-100 at Dose level 1

EXPERIMENTAL

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.

Biological: VXCO-100

VXC0-100 at Dose level 2

EXPERIMENTAL

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.

Biological: VXCO-100

VXC0-100 at Dose level 3

EXPERIMENTAL

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.

Biological: VXCO-100

COVID-19 mRNA vaccine

EXPERIMENTAL

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.

Biological: COVID-19 mRNA vaccine

Interventions

VXCO-100 BIOLOGICAL

Sterile suspension for injection

VXC0-100 at Dose level 1; VXC0-100 at Dose level 2; VXC0-100 at Dose level 3

COVID-19 mRNA vaccine BIOLOGICAL

Sterile suspension for injection

COVID-19 mRNA vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vaccine Company, Inc.: lead
• Medical Research Council, South Africa: collaborator

Study Sites (2)

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

Johannesburg, Gauteng, South Africa

Location

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

Botha’s Hill, KwaZulu-Natal, South Africa

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19; Coronavirus Infections

Interventions

CVnCoV COVID-19 vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Officials

• Glenda Gray, MBChB, FC

  Medical Research Council, South Africa

  PRINCIPAL INVESTIGATOR

• Ravindre Panchia, MBChB

  Perinatal HIV Research Unit (PHRU)

  PRINCIPAL INVESTIGATOR

• Anusha Nana, BPharm

  Perinatal HIV Research Unit (PHRU)

  PRINCIPAL INVESTIGATOR

• Mbalizethu Mntambo, MBChB

  HIV and other Infectious Diseases Research Unit (HIDRU)

  PRINCIPAL INVESTIGATOR

• Samantha Siva, MMEDSc

  HIV and other Infectious Diseases Research Unit (HIDRU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 10, 2023
• Study Start: August 4, 2023
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2)