The primary objective of this study is to evaluate the safety and tolerability of V590 versus placebo and to assess the immunogenicity of V590 on Day 28. The primary hypothesis is that at least one well-tolerated dose of V590 increases the geometric mean titers (GMTs) of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike serum neutralizing antibody, as measured by plaque reduction neutralization test (PRNT), compared to placebo.
This study was terminated and study objectives, endpoints, and procedures were modified accordingly via Protocol Amendment 03. Analysis included the intervention doses (V590 5.00 x 10\^5 plaque forming units \[pfu\], V590 2.4 x 10\^6 pfu, V590 1.15 x 10\^7 pfu, V590 5.55 x 10\^7 pfu or placebo) as specified in the protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
232
Celerion ( Site 0002)
Tempe, Arizona, United States
Clinical Pharmacology of Miami ( Site 0003)
Miami, Florida, United States
QPS Miami Research Associates ( Site 0005)
South Miami, Florida, United States
Bio-Kinetic Clinical Applications (QPS) ( Site 0006)
Springfield, Missouri, United States
Percentage of Participants With at Least 1 Solicited Injection Site Adverse Event
An adverse event (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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited injection site AEs (injection site redness/erythema, pain, swelling) were assessed.
Time frame: Up to 5 days post-vaccination
Percentage of Participants With at Least 1 Solicited Systemic 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited systemic AEs (joint stiffness/arthralgia, tiredness/fatigue, headache, joint swelling, muscle pain/myalgia, nausea, oral disorder, and rash) were assessed.
Time frame: Up to 28 days post-vaccination
Percentage of Participants With at Least 1 Unsolicited 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Participants with reported unsolicited AEs were assessed.
Time frame: Up to ~28 days post-vaccination
Percentage of Participants With at Least 1 Medically Attended Adverse Event
A medically attended adverse event (MAAE) is an AE 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. Any MAAE was assessed.
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Celerion ( Site 0001)
Lincoln, Nebraska, United States
Alliance for Multispecialty Reseach, LLC ( Site 0004)
Knoxville, Tennessee, United States
Worldwide Clinical Trials ( Site 0007)
San Antonio, Texas, United States
Time frame: Up to 28 days post-vaccination
Percentage of Participants With at Least 1 Serious Adverse Event
A serious adverse event (SAE) is "life threatening," requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other important medical event. Any SAE was assessed. Active monitoring of SAEs occurred through Day 28 but were collected per protocol till study completion/termination or \~90 days post-vaccination.
Time frame: Active monitoring through Day 28 post-vaccination (Up to a maximum of ~90 days post-vaccination)
Geometric Mean Titers for Serum Neutralizing Antibodies as Measured by Plaque Reduction Neutralization Test
Serum samples were collected and the presence of serum neutralization antibodies (SNAs) were assessed using plaque reduction neutralization test (PRNT). Geometric mean titers (GMTs) and 95% confidence intervals (CIs), GMT ratios and 90% CIs, and p-values are estimated from a longitudinal data analysis (LDA) model and are provided in accordance with the statistical analysis plan.
Time frame: 28 days post-vaccination
Geometric Mean Titers for SNAs as Measured by PRNT- 7 Days
Serum samples were collected and analyzed on a subset of participants but assays were not conducted on all samples that were collected. Due to the early termination of the study, testing was prioritized for the key samples and timepoints that would provide the required safety and immunogenicity data to support programmatic decision-making and subsequent clinical studies. Blank cells indicate that data were not generated and no data were available. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: 7 days post-vaccination
Geometric Mean Titers for SNAs as Measured by PRNT- 14 Days
Serum samples were collected for all participants and the presence of SNAs was assessed using PRNT. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: 14 days post vaccination
Geometric Mean Titers for Total Anti-Spike Immunoglobulin G Antibodies as Measured by Enzyme-Linked Immunosorbent Assay
Serum samples were collected and the total anti-spike immunoglobulin G (IgG) antibodies were assessed using enzyme-linked immunosorbent assay (ELISA). The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: 7, 14, and 28 days post vaccination
Number of Participants With Vaccine Viremia as Measured by Reverse Transcription-Polymerase Chain Reaction
Positive viremia was defined as detectable reverse transcription polymerase chain reaction (RT-PCR) results greater than or equal to the lower limit of detection (≥ LLOD); results were deemed quantifiable if the result was greater than or equal to the lower limit of quantification (≥ LLOQ). The number of participants who have a positive V590 RT-PCR result greater than or equal to the lowest limit of detection (≥LLOD) were assessed.
Time frame: 1, 2, 3, 4, 5, 6, 7, 14 and 28 days post-vaccination
Number of Participants With Viral Shedding in Saliva as Measured by RT-PCR
The number of participants with viral shedding detected by RT-PCR in saliva specimens was assessed. Only Day 7 samples were assayed for all participants. Day 14 and 28 samples for a participant were assayed if the Day 7 result was positive (≥LLOD). Due to the early termination of the study, testing was prioritized for the key samples and timepoints that would provide the required safety and immunogenicity data to support programmatic decision-making and subsequent clinical studies. Blank cells indicate data were not generated and no data were available. Additional sample testing is not possible because the viral shedding assay is not qualified for samples that have been stored for this length of time.
Time frame: 1, 2, 3, 4, 5, 6, 7, 14, and 28 days post-vaccination
Number of Participants With Viral Shedding in Urine as Measured by RT-PCR
The number of participants with viral shedding detected by RT-PCR in urine specimens was assessed. Due to the early termination of the study, testing was prioritized for the key samples and timepoints that would provide the required safety and immunogenicity data to support programmatic decision-making and subsequent clinical studies. Only Day 7 samples were assayed for all participants. Day 14 and 28 samples for a participant were assayed if the Day 7 result was positive (≥LLOD). Blank cells indicate data were not generated and no data were available.
Time frame: 1, 2, 3, 4, 5, 6, 7, 14, and 28 days post-vaccination
Number of Participants With Viral Shedding in Stool (If Assayed) as Measured by RT-PCR
The study was terminated and V590 stool samples for viral shedding (considered optional per protocol) were not assayed. Due to the early termination of the study, testing was prioritized for the key samples and timepoints that would provide the required safety and immunogenicity data to support programmatic decision-making and subsequent clinical studies. Blank cells indicate that data were not generated and no data were available.
Time frame: 2-4, 5-7 days post-vaccination