Loading clinical trials...

A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001) | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001)

A Phase 1/Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Safety, Tolerability and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Younger and Older Participants

NCT04498247•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The primary objective of this early Phase 1/2 study is to identify the V591 dose that achieves the target immune response in humans based on preclinical or early clinical data.

Detailed Description

This study was terminated and modifications to the dosing regimens and clinical/laboratory procedures were implemented for trial discontinuation according to Protocol Amendment 04. Per protocol, certain panels were never enrolled and/or the second dose of study intervention was not administered.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Is in overall good health based on medical history, physical examination, electrocardiogram (ECG) and vital sign (VS) measurements performed prior to randomization.
•Is in overall good health based on laboratory safety tests obtained at the screening visit.
•Has been practicing social distancing for at least two weeks prior to planned Day 1 vaccination and has no close contacts with known active severe acute respiratory syndrome coronavirus (SARS-CoV)-2 infection in that time period.
•Sentinel trial participants ONLY (Panel A, Panel B, and the first 5 participants of Panel E): Seronegative for SARS-COV-2.
•Is male or female, from 18 years to 55 years of age (inclusive) (Parts 1 and 2A) or \>55 years of age (Part 2B), at the time of providing documented informed consent.
•Male participants are eligible to participate if they agree to refrain from donating sperm during the intervention period and for at least 6 months after the last dose of study intervention, be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent OR agree to use contraception unless confirmed to be azoospermic .
•Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
•A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or Is a WOCBP and using an acceptable contraceptive method or be abstinent from heterosexual intercourse as their preferred and usual lifestyle.
•A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
•Refrain from donating oocyte during the intervention period and for at least 6 months after the last dose of study intervention.
+6 more criteria

Exclusion Criteria

•Is currently actively infected with SARS-CoV-2 (confirmed by polymerase chain reaction;\[PCR\]).
•Has prior medical history of confirmed SARS-CoV-2 infection or known exposure to an individual with confirmed coronavirus disease 2019 (COVID-19) disease or SARS CoV-2 infection within the past 2 weeks. With the exception of the sentinel participants (Panel A, Panel B, and the first 5 participants of Panel E), study participants will not be screened for enrollment by SARS-CoV-2 serology, allowing those who may have had a prior asymptomatic SARS-CoV-2 infection to be enrolled.
•Has a history of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of known or suspected allergic reaction likely to be exacerbated by any component of the COVID-19 vaccine.
•Is currently (or highly suspected to be) immunocompromised, including anticipating the need for systemic immunosuppressive treatment within the next 6 months or 12 months for 2-dose Day 1, Day 169 panels or has been diagnosed or highly suspected as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition that could impact the immune response or the safety of the study vaccine.
•Has clinically significant thrombocytopenia or other coagulation disorder contraindicating intramuscular vaccination or repeated venipuncture.
•Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study or interfere with the participant's participation for the full duration of the study.
•Has a history or presence of clinically significant pulmonary disorders (e.g. chronic obstructive pulmonary disease \[COPD\], etc.), or asthma.
•Has a history of confirmed SARS-CoV-1 or Middle Eastern respiratory syndrome (MERS)
•Has a history of or current clinically significant medical condition that puts or may put a participant at increased risk for severe SARS-CoV-2 disease, such as conditions associated with increased risk of severe illness from COVID-19, cancer, chronic kidney disease, COPD, immunocompromised state (weakened immune system) from solid organ transplant, obesity (BMI of 30 or higher), serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies, sickle cell disease, Type 2 diabetes mellitus, asthma, cerebrovascular disease, cystic fibrosis, hypertension or high blood pressure, an immunocompromised state (weakened immune system), neurologic conditions, such as dementia, liver disease, pregnancy, pulmonary fibrosis (having damaged or scarred lung tissues), smoking, thalassemia (a type of blood disorder), or Type 1 diabetes mellitus.
•Part 2B ONLY: Older adult participants having mild, well controlled hypertension as is widely characteristic of aging are allowed if their medication regimens have not substantively changed for the past 6 months, hypertension has not led to hospitalization or currently increased rate of clinic visits over the past year, and hypertension has not been confirmed as putting subjects at increased risk of severe illness from COVID-19 by the CDC (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/groups-at-higher-risk.html).
+24 more criteria

Locations (9)

Research Centers of America, LLC ( Site 0014)

Hollywood, Florida, United States

Alliance for Multispecialty Research, LLC ( Site 0013)

Wichita, Kansas, United States

Central Kentucky Research Associates, Inc. ( Site 0011)

Lexington, Kentucky, United States

The Center for Pharmaceutical Research PC ( Site 0012)

Kansas City, Missouri, United States

SCRI-CCCIT GesmbH ( Site 0006)

Salzburg, Austria

Medizinische Universitaet Wien ( Site 0007)

Vienna, Austria

Universitair Ziekenhuis Gent ( Site 0003)

Ghent, Oost-Vlaanderen, Belgium

SGS Life Science Services ( Site 0001)

Antwerp, Belgium

ATC - Clinical Pharmacology Unit ( Site 0002)

Liège, Belgium

Key Dates

Start Date

August 27, 2020

Primary Completion Date

March 5, 2021

Completion Date

March 5, 2021

Last Updated

December 23, 2021

Enrollment

263

ACTUAL participants

Conditions

Coronavirus Disease (COVID-19)

Interventions

V591

BIOLOGICAL

Placebo

OTHER

Survey of the Moderna COVID-19 Vaccine in People at High-Risk of Developing Severe COVID-19 Symptoms

NCT04892888

Coronavirus Disease (COVID-19)

View study

UNKNOWNNA

Cardiorespiratory Exercise & Chinese Medicine for Rehabilitation of Discharged Coronavirus Disease (COVID-19) Patients

NCT04572360

Coronavirus Disease (COVID-19)

View study

UNKNOWNPHASE3

Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions