Clinical trial NCT05870839: Study of VXCO-100, a SARS-CoV Candidate Vaccine in Healthy Adults in the United States
Official title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of VXCO-100 in Healthy Adults in the United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: SARS-CoV
SARS-CoV-2
Keywords: Covid-19
SARS-CoV-2
Coronavirus
Vaccine
Sarbecoviruses
Covid
Lead sponsor: Vaccine Company, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-23
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and immunogenicity of ascending dose levels of VXCO-100 in healthy 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 healthy adult volunteers.

Participants will be vaccinated with 1 dose of VXCO-100 on Day 1. A subset of participants will be offered an optional interim boost at month 3.

Safety will be evaluated 1) before proceeding to a higher dose level and 2) prior to enrollment of participants aged 56 years and older at a particular dose level.

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.
* 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).
* Aspartate aminotransferase (AST) ≤ 1.25 x institutional ULN.
* Serum creatinine ≤ 1.1 x institutional ULN.
* Ferritin, iron and TIBC within institutional normal range or accompanied by the PI or designee approval.

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.

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.
* 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.
* 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 the study vaccine.
* For participants 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.

Primary outcomes:
measure: Number and percentage of participants with solicited local adverse events
timeFrame: For 7 days after each product administration
measure: Number and percentage of participants with solicited systemic adverse events
timeFrame: For 7 days after each product administration
measure: Number and percentage of participants with unsolicited and safety laboratory-based adverse events
timeFrame: For 28 days after each product administration
measure: 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)
timeFrame: For up to 304 days after each product administration
Secondary outcomes:
measure: Response rate measured by geometric mean titer of the serum neutralizing antibody (Nab) against the ancestral (Wuhan) strain
timeFrame: At baseline and 21 days after each product administration
measure: Response rate measured by GMT of Nab against selected variants of concern
timeFrame: At baseline and 21 days after each product administration
measure: Numbers and percentages of participants with positive Th1 or Th2 cytokine responses for CD4 and CD8 as measured by multi-parameter intracellular cytokine staining
timeFrame: At baseline and 7 days after each product administration
Other outcomes:
Locations:
city: Decatur
country: United States
facility: The Hope Clinic of Emory University
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland, Baltimore, Center for Vaccine Development and Global Health
state: Maryland
city: Rochester
country: United States
facility: University of Rochester Medical Center - Vaccine Research Unit
state: New York
Study officials:
affiliation: University of Maryland
name: Justin Ortiz, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Nadine Rouphael, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Angela Branche, MD
role: PRINCIPAL_INVESTIGATOR
References: