TerminatedNCT04569786Updated Dec 29, 2021Results posted

Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001)

A Phase 1 interventional study of V590 and Placebo in Coronavirus Disease (COVID-19), sponsored by Merck Sharp & Dohme LLC. Terminated at 7 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-29.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Prevention

Why this study was terminated

The study was terminated based on an interim assessment of immunogenicity.

Phase: Phase 1
Study type: Interventional
Enrollment: 232
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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.

Read the detailed description

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.

Conditions studied

Coronavirus Disease (COVID-19)

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In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 232 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.

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Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Is in overall good health based on medical history, physical examination, and vital sign (VS) measurements performed prior to randomization, as assessed by the investigator.
Is in overall good health based on laboratory safety tests obtained at the screening visit.
Has a body mass index (BMI) ≤30 kg/m2 inclusive (after rounding to the nearest whole number).
Parts 1 and 2 (Panels A-H) only: Has negative testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) based on both antibody and reverse transcription polymerase chain reaction (RT-PCR), at screening and upon start of domiciling.
Part 3 (Panel I) only: Has positive serology (antibody) testing for SARS-CoV-2, also with negative SARS CoV-2 RT-PCR testing at screening and upon start of domiciling, and without symptoms of respiratory infection for at minimum 3 weeks preceding screening.
Has been practicing social distancing for at least two weeks prior to planned start of domiciling and has had no close contacts with known active SARS-CoV-2 infection in that time period.
Is male or female, from 18 years to 54 years of age inclusive (Parts 1 and 3 [Panels A-D, I]) or ≥ 55 years of age (Part 2 [Panels E-H]) at the time of signing the informed consent.
Male participants are eligible to participate if they agree to the following during the intervention period and for at least 2 months after administration 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 (vasectomized or secondary to medical cause).
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP), or is a WOCBP and using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle. A WOCBP must have a negative highly sensitive pregnancy test before the first dose of study intervention. If a urine test cannot be confirmed as negative, a serum pregnancy test is required.

Exclusion criteria

Exclusion Criteria:

Has a known hypersensitivity to any component of V590 or placebo.
Has any known or suspected active clinically significant autoimmune disease or immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination.
Has 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 of ongoing liver disease or, at the time of screening, has any one of the following: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × Upper Limit of Normal (ULN), alkaline phosphatase and direct bilirubin > ULN (total bilirubin may be up to 2 × ULN as long as direct bilirubin is equal to or below the ULN), or prothrombin time (PT) international normalized ratio (INR) > 1.25.
Has a history of asthma or allergic asthma that required systemic corticosteroids in the previous year.
Has a history of Guillain-Barré syndrome.
Has a history of diabetes mellitus, requiring medication at the time of assessment, OR has a hemoglobin A1c ≥ 6.5.
Has a history of any medical condition that would put the participant at risk for severe SARS-CoV-2 disease as judged by the investigator.
Has any ongoing, symptomatic, acute or chronic illness requiring medical or surgical care or any condition that is immunosuppressive.
Is mentally or legally incapacitated, has significant emotional problems at the time of screening visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years.
Has a history of cancer (malignancy).
Participant has an estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73 m\^2.
Has a history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to a vaccine or prescription or non-prescription drugs or food as judged by the investigator.
Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)-1 or 2 antibodies. Individuals with antibodies to hepatitis C may be enrolled if hepatitis C viral load is negative and there is no evidence of or history of liver disease.
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pre-study (screening) visit.
A WOCBP who has a positive urine or serum pregnancy test before vaccination.
A WOCBP who is breastfeeding.
Has any unstable chronic medical condition, including one that has resulted in change in therapy (medication or other) in the 30 days prior to randomization or hospitalization in the previous year or might be predicted to result in hospitalization in the year after enrollment.
Has received or is expected to receive any SARS-CoV-2 vaccine or other coronavirus vaccine during the study (except V590), is using investigational agents for prophylaxis of SARS-CoV-2 or is taking any systemic antiviral medications.
Has received any intra-articular steroid injections within the 3 months prior to study vaccination or is expected to require intra-articular steroid injection during the study.
Is receiving immunosuppressive therapy or has received immunosuppressive therapy within 6 months of enrollment.
Has received a blood transfusion or blood products, including immunoglobulin, in the 3 months before anticipated study vaccination.
Is expected to be receiving or is currently receiving antipyretic or analgesic medication on a daily or every other day basis from randomization through Day 7
Has ever participated in an investigational study of a SARS-CoV-2 vaccine, a coronavirus vaccine, or an antiviral or other biologic product intended for the treatment of COVID-19.
Has participated in another vaccine study within 3 months prior to screening or has participated in an investigational study within 4 weeks prior to the screening visit.
Has ever received a vaccine based on vesicular stomatitis virus (VSV).
Has a Fridericia's corrected time from Q wave to T wave (QTcF) interval >470 msec (male) or >480 msec (female), has a history of risk factors for Torsades de Pointes, or has uncorrected hypokalemia or hypomagnesemia.
Is under the age of legal consent.
Is smoking or vaping and/or has a history of chronic smoking or vaping within approximately six months prior to planned vaccination.
Does not agree to follow the alcohol restrictions
Has a tattoo, scar, or other physical finding at the area of the vaccination site that would interfere with intramuscular injection or a local tolerability assessment.
Is a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 1 year.
Presents any concern by the investigator regarding safe participation in the study or for any other reason the investigator considers the participant inappropriate for participation in the study.
Lives in a nursing home or long-term care facility.
Is currently working in an occupation with high risk of exposure to SARS-CoV-2 (e.g., health care worker with direct patient contact, emergency response personnel).

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Double (Participant, Investigator)
Enrollment: 232 participants (actual)

Study arms

Experimental
V590 5.00x10^5 pfu (Panel A)
Participants in this 18 to 54-year-old SARS-CoV-2 seronegative cohort (Panel A) will receive a single dose of V590 5.00x10\^5 pfu or placebo on Day 1.
Biological: V590 · Other: Placebo
Experimental
V590 2.40x10^6 pfu (Panel B)
Participants in this 18 to 54-year-old SARS-CoV-2 seronegative cohort (Panel B) will receive a single dose of 2.40x10\^6 pfu or placebo on Day 1.
Biological: V590 · Other: Placebo
Experimental
V590 1.15x10^7 pfu (Panel C)
Participants in this 18 to 54-year-old SARS-CoV-2 seronegative cohort (Panel C) will receive a single dose of 1.15x10\^7 pfu or placebo on Day 1.
Biological: V590 · Other: Placebo
Experimental
V590 5.55x10^7 pfu (Panel D)
Participants in this 18 to 54-year-old SARS-CoV-2 seronegative cohort (Panel D) will receive a single dose of V590 5.55x10\^7 pfu or placebo on Day 1.
Biological: V590 · Other: Placebo
Experimental
Part 2: 5.00x10^5 pfu (Panel E)
Participants in this ≥ 55 years old SARS CoV-2 seronegative cohort (Panel E) will receive a single dose of V590 5.00x10\^5 pfu or placebo on Day 1.
Biological: V590 · Other: Placebo
Experimental
Part 2: 2.40x10^6 pfu (Panel F)
Participants in this ≥ 55 years old SARS-CoV-2 seronegative cohort (Panel F) will receive a single dose of 2.40x10\^6 pfu or placebo on Day 1.
Biological: V590 · Other: Placebo
Experimental
Part 2: 1.15x10^7 pfu (Panel G)
Participants in this ≥ 55 years old SARS-CoV-2 seronegative cohort (Panel G) will receive a single dose of V590 1.15x10\^7 pfu or placebo on Day 1
Biological: V590 · Other: Placebo
Experimental
Part 2: 5.55x10^7 pfu (Panel H)
Participants in this ≥ 55 years old SARS-CoV-2 seronegative cohort (Panel H) will receive a single dose of V590 5.55x10\^7 pfu or placebo on Day 1.
Biological: V590 · Other: Placebo
Experimental
Part 3: 5.55x10^7 pfu (Panel I)
Participants in this 18 to 54-year-old SARS-CoV-2 seropositive cohort (Panel I) will receive a single dose of V590 5.55x10\^7 pfu or placebo on Day 1.
Biological: V590 · Other: Placebo

Interventions

BiologicalV590
Single dose of V590 administered via intramuscular (IM) injection with dosage levels of 5.00x10\^5 pfu/mL (Panels A, E), 2.40x10\^6 pfu/mL (Panels B,F), 1.15x10\^7 pfu/mL (Panels C, G), 5.55x10\^7 pfu/mL (Panels D, H, I).
OtherPlacebo
Placebo administered via IM injection.

What researchers measure

Primary outcomes

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.
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

Secondary outcomes

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

Results

Posted Dec 29, 2021

Limitations and caveats

The study was terminated based on an interim assessment of immunogenicity.

Participant flow

The planned enrollment total was approximately 252 participants.

Participant flow — Overall Study
Milestone	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo
Started	39	39	42	56	56
Completed	38	39	38	49	55
Not completed	1	0	4	7	1
Withdrew: Lost to follow-up	1	0	4	1	0
Withdrew: Withdrawal by subject	0	0	0	5	1
Withdrew: Physician decision	0	0	0	1	0

Outcome measures

PrimaryPercentage 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
Reported as:: Number · Percentage of Participants

Percentage of Participants With at Least 1 Solicited Injection Site Adverse Event
Percentage of Participants	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo
Injection site redness/erythema	0.0	0.0	0.0	1.8	0.0
Injection site pain	28.2	35.9	31.0	42.9	46.4
Injection site swelling	0.0	2.6	2.4	3.6	0.0

PrimaryPercentage 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
Reported as:: Number · Percentage of Participants

Percentage of Participants With at Least 1 Solicited Systemic Adverse Event
Percentage of Participants	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo
Joint stiffness/arthralgia	5.1	7.7	0.0	12.5	8.9
Tiredness/fatigue	10.3	15.4	11.9	12.5	16.1
Headache	15.4	12.8	9.5	16.1	19.6
Joint swelling	0.0	0.0	0.0	1.8	3.6
Muscle pain/myalgia	10.3	7.7	0.0	10.7	7.1
Nausea	5.1	5.1	0.0	3.6	8.9
Oral disorder	0.0	0.0	0.0	1.8	1.8
Rash	10.3	0.0	2.4	3.6	0.0

PrimaryPercentage 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
Reported as:: Number · Percentage of Participants

Percentage of Participants With at Least 1 Unsolicited Adverse Event
Percentage of Participants	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo
Percentage of Participants With at Least 1 Unsolicited Adverse Event	6	10	13	21	16

PrimaryPercentage 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.

Time frame:: Up to 28 days post-vaccination
Reported as:: Number · Percentage of Participants

Percentage of Participants With at Least 1 Medically Attended Adverse Event
Percentage of Participants	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo
Percentage of Participants With at Least 1 Medically Attended Adverse Event	0.0	0.0	0.0	5.4	0.0

PrimaryPercentage 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)
Reported as:: Number · Percentage of Participants

Percentage of Participants With at Least 1 Serious Adverse Event
Percentage of Participants	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo
Percentage of Participants With at Least 1 Serious Adverse Event	0.0	0.0	0.0	1.8	0.0

PrimaryGeometric 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
Reported as:: Geometric mean · Titer

Geometric Mean Titers for Serum Neutralizing Antibodies as Measured by Plaque Reduction Neutralization Test
Titer	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo
Geometric Mean Titers for Serum Neutralizing Antibodies as Measured by Plaque Reduction Neutralization Test	6.39 (4.54 to 8.99)	7.00 (4.93 to 9.92)	7.67 (5.50 to 10.70)	15.78 (11.37 to 21.91)	6.98 (5.17 to 9.42)

Statistical analysis

V590 5.00x10^5 Plaque Forming Units (Pfu) vs Placebo · Longitudinal data analysis (LDA) method · p = 0.649 (1-sided) · Gmt ratio: 0.92 · 90% CI 0.63 to 1.34GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.
V590 2.40x10^6 Pfu vs Placebo · LDA model · p = 0.495 (1-sided) · Gmt ratio: 1.00 · 90% CI 0.68 to 1.48GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.
V590 1.15x10^7 Pfu vs Placebo · LDA Model · p = 0.339 (1-sided) · Gmt ratio: 1.10 · 90% CI 0.75 to 1.60GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.
V590 5.55x10^7 Pfu vs Placebo · LDA Model · p = <0.001 (1-sided) · Gmt ratio: 2.26 · 90% CI 1.56 to 3.28GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.

SecondaryGeometric 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
Reported as:: Geometric mean · Titers

Geometric Mean Titers for SNAs as Measured by PRNT- 7 Days
Titers	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo
Geometric Mean Titers for SNAs as Measured by PRNT- 7 Days	5.32 (4.68 to 6.04)	17.07 (1.96 to 148.60)	5.0 (5.0 to 5.0)	—	9.78 (1.89 to 50.47)

SecondaryGeometric 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
Reported as:: Geometric mean · Titers

Geometric Mean Titers for SNAs as Measured by PRNT- 14 Days
Titers	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo
Geometric Mean Titers for SNAs as Measured by PRNT- 14 Days	5.94 (4.66 to 7.56)	6.64 (4.58 to 9.62)	7.32 (5.84 to 9.18)	15.26 (9.73 to 23.95)	6.45 (4.67 to 8.91)

SecondaryGeometric 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
Reported as:: Geometric mean · Titers

Geometric Mean Titers for Total Anti-Spike Immunoglobulin G Antibodies as Measured by Enzyme-Linked Immunosorbent Assay
Titers	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo
Day 7	56.60 (44.04 to 72.75)	65.78 (43.63 to 99.15)	51.90 (48.13 to 55.97)	58.06 (45.70 to 73.77)	68.36 (47.01 to 99.39)
Day 14	56.01 (44.51 to 70.47)	65.10 (43.75 to 96.86)	63.63 (52.31 to 77.39)	104.12 (72.27 to 150.01)	67.13 (47.26 to 95.36)
Day 28	62.82 (45.48 to 86.77)	69.78 (47.31 to 102.93)	69.14 (53.00 to 90.20)	107.58 (75.93 to 152.41)	71.13 (49.82 to 101.57)

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Vaccine Viremia as Measured by Reverse Transcription-Polymerase Chain Reaction
Participants	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu
Day 1	4	5	9	8
Day 2	6	8	24	54
Day 3	4	5	22	48
Day 4	1	6	9	30
Day 5	1	0	0	0
Day 6	0	0	0	0
Day 7	0	0	0	0
Day 14	0	0	0	0
Day 28	0	0	0	0

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Viral Shedding in Saliva as Measured by RT-PCR
Participants	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo
Day 7	0	0	0	1	1
Day 14	—	—	—	0	0
Day 28	—	—	—	0	0

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Viral Shedding in Urine as Measured by RT-PCR
Participants	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo
Day 7	0	0	0	0	0

SecondaryNumber 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

No measurements were reported for this outcome.

Adverse events

Collected over Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination]). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
V590 5.00x10^5 Plaque Forming Units (Pfu)	0/39 (0%)	0/39 (0%)	19/39 (48.7%)
V590 2.40x10^6 Pfu	0/39 (0%)	0/39 (0%)	23/39 (59%)
V590 1.15x10^7 Pfu	0/42 (0%)	0/42 (0%)	23/42 (54.8%)
V590 5.55x10^7 Pfu	0/56 (0%)	1/56 (1.8%)	39/56 (69.6%)
Placebo	0/56 (0%)	0/56 (0%)	36/56 (64.3%)

Most frequent serious events

Most frequent serious events
Event	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo
Amaurosis fugaxEye disorders	0/39	0/39	0/42	1/56	0/56

Most frequent other events

Showing 10 of 89

Most frequent other events
Event	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo
Injection site painGeneral disorders	11/39	14/39	13/42	24/56	27/56
HeadacheNervous system disorders	6/39	5/39	4/42	9/56	11/56
FatigueGeneral disorders	4/39	6/39	5/42	7/56	9/56
ArthralgiaMusculoskeletal and connective tissue disorders	2/39	3/39	0/42	7/56	5/56
MyalgiaMusculoskeletal and connective tissue disorders	4/39	3/39	0/42	6/56	4/56
RashSkin and subcutaneous tissue disorders	4/39	0/39	1/42	2/56	0/56
NauseaGastrointestinal disorders	2/39	2/39	0/42	2/56	5/56
Back painMusculoskeletal and connective tissue disorders	2/39	0/39	0/42	4/56	1/56
Chest discomfortGeneral disorders	0/39	0/39	0/42	3/56	0/56
CoughRespiratory, thoracic and mediastinal disorders	0/39	0/39	0/42	1/56	3/56

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo	Total
Mean	48.9 ± 18.8	50.9 ± 16.0	51.0 ± 13.7	48.0 ± 16.1	47.3 ± 16.9	49.0 ± 16.3

Sex: Female, Male
Sex: Female, Male(Participants)	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo	Total
Female	12	22	23	32	29	118
Male	27	17	19	24	27	114

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo	Total
Hispanic or Latino	13	20	13	31	19	96
Not Hispanic or Latino	26	19	29	25	37	136
Unknown or Not Reported	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	V590 5.00x10^5 Plaque Forming Units (Pfu)	V590 2.40x10^6 Pfu	V590 1.15x10^7 Pfu	V590 5.55x10^7 Pfu	Placebo	Total
American Indian or Alaska Native	1	0	0	1	0	2
Asian	0	1	1	0	2	4
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0
Black or African American	3	5	4	7	8	27
White	35	33	35	48	46	197
More than one race	0	0	2	0	0	2
Unknown or Not Reported	0	0	0	0	0	0

Study locations

7 sites

Celerion ( Site 0002)
Tempe, Arizona 85283, United States
Clinical Pharmacology of Miami ( Site 0003)
Miami, Florida 33014, United States
QPS Miami Research Associates ( Site 0005)
South Miami, Florida 33143, United States
Bio-Kinetic Clinical Applications (QPS) ( Site 0006)
Springfield, Missouri 65802, United States
Celerion ( Site 0001)
Lincoln, Nebraska 68502, United States
Alliance for Multispecialty Reseach, LLC ( Site 0004)
Knoxville, Tennessee 37920, United States
Worldwide Clinical Trials ( Site 0007)
San Antonio, Texas 78217, United States

References and documents

Publications

Robbins JA, Tait D, Huang Q, Dubey S, Crumley T, Cote J, Luk J, Sachs JR, Rutkowski K, Park H, Schwab R, Howitt WJ, Rondon JC, Hernandez-Illas M, O'Reilly T, Smith W, Simon J, Hardalo C, Zhao X, Wnek R, Cope A, Lai E, Annunziato P, Guris D, Stoch SA. Safety and immunogenicity of intramuscular, single-dose V590 (rVSV-SARS-CoV-2 Vaccine) in healthy adults: Results from a phase 1 randomised, double-blind, placebo-controlled, dose-ranging trial. EBioMedicine. 2022 Aug;82:104138. doi: 10.1016/j.ebiom.2022.104138. Epub 2022 Jul 6. PubMed 35809371 ↗
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. PubMed 34473343 ↗

Study documents

Protocol and statistical analysis plan · Feb 17, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04569786
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Sep 30, 2020
Start date: Oct 29, 2020
Primary completion: Feb 18, 2021
Completion: Feb 18, 2021
Results posted: Dec 29, 2021
Last update: Dec 29, 2021

Study contacts

Medical Director

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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