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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
263
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
Percentage of Participants With at Least One Solicited Injection Site Adverse Event (AE) After Any Study Intervention
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Injection site AEs of pain/tenderness, swelling, and redness/erythema were assessed.
Time frame: Up to 5 days after any study intervention
Percentage of Participants With at Least One Solicited Systemic AE After Any Study Intervention
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Systemic AEs of fever, muscle pain, joint pain, headache, fatigue, rash, or nausea were assessed.
Time frame: Up to 14 days after any study intervention
Percentage of Participants With at Least One Unsolicited Adverse Event After Any Study Intervention
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. All unsolicited AEs were assessed.
Time frame: Up to 28 days after any study intervention
Percentage of Participants With at Least 1 Serious Adverse Event
An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Time frame: Up to 56 days after vaccination 1 and up to 122 days after vaccination 2 (up to 178 days)
Percentage of Participants Who Discontinued Study Treatment Due to an Adverse Event
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
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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
Time frame: Up to 57 days
Percentage of Participants With at Least 1 Medically Attended Adverse Event (MAAE)
A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason.
Time frame: Up to 56 days after vaccination 1 and up to 122 days after vaccination 2 (up to 178 days)
Geometric Mean Titers for Serum Neutralizing Antibodies (nAb) as Measured by Pseudo-virus Neutralization Assay (PNA)
Serum samples were collected and the titers of serum neutralization antibodies were assessed using PNA. Geometric mean titers were calculated using a constrained longitudinal data analysis (cLDA) method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. The point estimates were calculated by exponentiating the estimates of the mean of the natural log values; and the within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: Days 1, 15, 29, 57, 71, and 85
Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Serum samples were collected and the concentrations of total anti-spike IgG antibodies were assessed using ELISA. Geometric mean concentrations were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. The point estimates were calculated by exponentiating the estimates of the mean of the natural log values; and the within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: Days 1, 15, 29, 57, 71, and 85
Geometric Mean Fold Rise (GMFR) for Serum nAb as Measured by PNA
Serum samples were collected and the titers of serum neutralization antibodies were assessed using PNA. Geometric mean titers were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 1).
Time frame: Days 1, 15, 29, 57, 71, and 85
Geometric Mean Fold Rise (GMFR) of Total Anti-Spike IgG Antibodies as Measured by ELISA
Serum samples were collected and the total anti-spike IgG antibodies assessed using ELISA. Geometric mean concentrations were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 1).
Time frame: Days 1, 15, 29, 57, 71, and 85