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

NCT05870839 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: VC 101
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of ascending dose levels of VXCO-100 in healthy 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 up to 304 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 (6)

VXCO-100 Group 1

EXPERIMENTAL

Participants 18-55 years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection

Biological: VXCO-100

VXCO-100 Group 2

EXPERIMENTAL

Participants 18-55 years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection

Biological: VXCO-100

VXCO-100 Group 3

EXPERIMENTAL

Participants 18-55 years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection

Biological: VXCO-100

VXCO-100 Group 4

EXPERIMENTAL

Participants 56+ years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection

Biological: VXCO-100

VXCO-100 Group 5

EXPERIMENTAL

Participants 56+ years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection

Biological: VXCO-100

VXCO-100 Group 6

EXPERIMENTAL

Participants 56+ years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection

Biological: VXCO-100

Interventions

VXCO-100 BIOLOGICAL

Sterile liquid for injection

VXCO-100 Group 1; VXCO-100 Group 2; VXCO-100 Group 3; VXCO-100 Group 4; VXCO-100 Group 5; VXCO-100 Group 6

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.
• 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).

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.
• 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.

Sponsors & Collaborators

• Vaccine Company, Inc.: lead

Study Sites (3)

The Hope Clinic of Emory University

Decatur, Georgia, 30030, United States

Location

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

Baltimore, Maryland, 21201, United States

Location

University of Rochester Medical Center - Vaccine Research Unit

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19; Coronavirus Infections

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

• Justin Ortiz, MD, MS

  University of Maryland

  PRINCIPAL INVESTIGATOR

• Nadine Rouphael, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Angela Branche, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: May 11, 2023
• Primary Completion: April 10, 2024
• Study Completion: April 10, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)