Coronavirus Disease (COVID-19)Phase 1NCT04569786
Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001)
A Phase 1 study testing V590 in people with Coronavirus Disease (COVID-19), run by Merck Sharp & Dohme LLC at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease (COVID-19)
- What is being tested?
- V590
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 7 sitesUnited States
- Study dates
- 29 Oct 2020to 18 Feb 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Alliance for Multispecialty Reseach, LLC ( Site 0004)
Knoxville, Tennessee, 37920
Celerion ( Site 0001)
Lincoln, Nebraska, 68502
Clinical Pharmacology of Miami ( Site 0003)
Miami, Florida, 33014
Worldwide Clinical Trials ( Site 0007)
San Antonio, Texas, 78217
QPS Miami Research Associates ( Site 0005)
South Miami, Florida, 33143
Bio-Kinetic Clinical Applications (QPS) ( Site 0006)
Springfield, Missouri, 65802
Celerion ( Site 0002)
Tempe, Arizona, 85283
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Safety and Immunogenicity of V590 in Healthy Adults
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
- Coronavirus Disease (COVID-19)
- Being tested
- V590, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V590Biological
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).
PlaceboOther
Placebo administered via IM injection.
| Study group | Role | What they receive |
|---|---|---|
| V590 5.00x10^5 pfu (Panel A) | Experimental | 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. Receives: Biological: V590; Other: Placebo |
| V590 2.40x10^6 pfu (Panel B) | Experimental | 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. Receives: Biological: V590; Other: Placebo |
| V590 1.15x10^7 pfu (Panel C) | Experimental | 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. Receives: Biological: V590; Other: Placebo |
| V590 5.55x10^7 pfu (Panel D) | Experimental | 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. Receives: Biological: V590; Other: Placebo |
| Part 2: 5.00x10^5 pfu (Panel E) | Experimental | 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. Receives: Biological: V590; Other: Placebo |
| Part 2: 2.40x10^6 pfu (Panel F) | Experimental | 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. Receives: Biological: V590; Other: Placebo |
| Part 2: 1.15x10^7 pfu (Panel G) | Experimental | 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 Receives: Biological: V590; Other: Placebo |
| Part 2: 5.55x10^7 pfu (Panel H) | Experimental | 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. Receives: Biological: V590; Other: Placebo |
| Part 3: 5.55x10^7 pfu (Panel I) | Experimental | 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. Receives: Biological: V590; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 days post-vaccination
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2-4, 5-7 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start29 Oct 2020
- Primary completion18 Feb 2021
- Study completion18 Feb 2021
Why it stopped: The study was terminated based on an interim assessment of immunogenicity.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease (COVID-19)Studies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569786
- Sponsor's protocol ID
- V590-001
- Other IDs
- V590-001
- Status last verified
- Dec 2021
- First submitted
- 24 Sep 2020
- Last updated
- 29 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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 35809371Kreuzberger 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 at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Safety and Immunogenicity of V590 in Healthy Adults
- ClinicalTrials.gov ID
- NCT04569786
- Acronym / sponsor ID
- V590-001
- Conditions
- Coronavirus Disease (COVID-19)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated based on an interim assessment of immunogenicity.
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Posted 29 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| V590 5.00x10^5 pfu (Panel A) | Experimental | Biological: V590, Other: PlaceboParticipants 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. |
| V590 2.40x10^6 pfu (Panel B) | Experimental | Biological: V590, Other: PlaceboParticipants 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. |
| V590 1.15x10^7 pfu (Panel C) | Experimental | Biological: V590, Other: PlaceboParticipants 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. |
| V590 5.55x10^7 pfu (Panel D) | Experimental | Biological: V590, Other: PlaceboParticipants 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. |
| Part 2: 5.00x10^5 pfu (Panel E) | Experimental | Biological: V590, Other: PlaceboParticipants 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. |
| Part 2: 2.40x10^6 pfu (Panel F) | Experimental | Biological: V590, Other: PlaceboParticipants 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. |
| Part 2: 1.15x10^7 pfu (Panel G) | Experimental | Biological: V590, Other: PlaceboParticipants 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 |
| Part 2: 5.55x10^7 pfu (Panel H) | Experimental | Biological: V590, Other: PlaceboParticipants 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. |
| Part 3: 5.55x10^7 pfu (Panel I) | Experimental | Biological: V590, Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (36 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V590Single 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). | Biological | Part 2: 1.15x10^7 pfu (Panel G), Part 2: 2.40x10^6 pfu (Panel F), Part 2: 5.00x10^5 pfu (Panel E), Part 2: 5.55x10^7 pfu (Panel H), Part 3: 5.55x10^7 pfu (Panel I), V590 1.15x10^7 pfu (Panel C), V590 2.40x10^6 pfu (Panel B), V590 5.00x10^5 pfu (Panel A), V590 5.55x10^7 pfu (Panel D) |
| PlaceboPlacebo administered via IM injection. | Other | Part 2: 1.15x10^7 pfu (Panel G), Part 2: 2.40x10^6 pfu (Panel F), Part 2: 5.00x10^5 pfu (Panel E), Part 2: 5.55x10^7 pfu (Panel H), Part 3: 5.55x10^7 pfu (Panel I), V590 1.15x10^7 pfu (Panel C), V590 2.40x10^6 pfu (Panel B), V590 5.00x10^5 pfu (Panel A), V590 5.55x10^7 pfu (Panel D) |
Primary outcome
Percentage of Participants With at Least 1 Solicited Injection Site Adverse Event
Time frame: Up to 5 days post-vaccination
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.
Percentage of Participants With at Least 1 Solicited Systemic Adverse Event
Time frame: Up to 28 days post-vaccination
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.
Percentage of Participants With at Least 1 Unsolicited Adverse Event
Time frame: Up to ~28 days post-vaccination
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.
Percentage of Participants With at Least 1 Medically Attended Adverse Event
Time frame: Up to 28 days post-vaccination
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.
Percentage of Participants With at Least 1 Serious Adverse Event
Time frame: Active monitoring through Day 28 post-vaccination (Up to a maximum of ~90 days post-vaccination)
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.
Geometric Mean Titers for Serum Neutralizing Antibodies as Measured by Plaque Reduction Neutralization Test
Time frame: 28 days post-vaccination
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.
7 secondary outcomes
Geometric Mean Titers for SNAs as Measured by PRNT- 7 Days
Time frame: 7 days post-vaccination
Geometric Mean Titers for SNAs as Measured by PRNT- 14 Days
Time frame: 14 days post vaccination
Geometric Mean Titers for Total Anti-Spike Immunoglobulin G Antibodies as Measured by Enzyme-Linked Immunosorbent Assay
Time frame: 7, 14, and 28 days post vaccination
Number of Participants With Vaccine Viremia as Measured by Reverse Transcription-Polymerase Chain Reaction
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
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
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
Time frame: 2-4, 5-7 days post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35809371Robbins 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.
- Derived from this study: PubMed 34473343Kreuzberger 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.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V590 in people with Coronavirus Disease (COVID-19), run by Merck Sharp & Dohme LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With at Least 1 Solicited Injection Site Adverse Event (time frame: Up to 5 days post-vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04569786, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.