study of vxco-100, a sars-cov candidate vaccine in healthy adults in the united states

Conditions: SARS-CoV; SARS-CoV-2

Summary: the purpose of this study is to evaluate the safety and immunogenicity of ascending dose levels of vxco-100 in healthy adults.

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.

Keywords: covid-19 sars-cov-2 coronavirus vaccine sarbecoviruses covid