Ebola VirusPhase 1NCT02314923

Placebo Controlled, Dose Response, Safety and Immunogenicity Study of Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-004)

A Phase 1 study testing V920 Vaccine in people with Ebola Virus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has affected several thousand people. There is no approved effective way to treat or prevent Ebola. Researchers are trying to develop a vaccine for it. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Ebola Virus
What is being tested?: V920 Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 513 participants
Where: No sites listed yet
Study dates: 5 Dec 2014to 23 Jun 2016
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 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult male or non-pregnant, non-lactating adult female, ages 18 to 60 (inclusive) at the time of screening
Have provided written informed consent prior to screening procedures
Free of clinically significant health problems, as determined by pertinent medical history, physical examination and clinical judgment of the investigator.
Available, able, and willing to participate for all study visits and procedures.
Males and females who are willing to practice abstinence from sexual intercourse with the opposite sex, or willing to use effective methods of contraception, from at least 30 days prior to vaccination until study end.
Be willing to minimize blood and body fluid exposure of others for 7 days after vaccination by:

Show all 10Show fewer

Using effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse
Avoiding the sharing of needles, razors, or toothbrushes
Avoiding open-mouth kissing
Resides in the geographic area of a clinical study site for 1 year after vaccination without risk of deployment outside the U.S.

Who cannot join

History of prior infection with a filovirus or prior participation in a filovirus vaccine trial
History of prior infection with VSV or receipt of a VSV vectored vaccine
Has been involved in the care in any capacity of a patient with Ebola virus infection within the previous 21 days
Is a healthcare worker who has direct contact with patients (nurse, physician, dentist, emergency medical technician, dental hygienist)
Has a house-hold contact (HHC) who is immunodeficient, on immunosuppressive medications, human immunodeficiency virus (HIV)-positive, pregnant, has an unstable medical condition
Has an HHC, or is a childcare worker who has direct contact with children, 5 years of age or younger

Show all 32Show fewer

Direct hands-on job preparing food in the food industry
History of employment in an industry involved in contact with ruminant animals, veterinary sciences, or other potential exposure to VSV
History of employment or activity which involves potential contact with filoviruses
History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
Known allergy to the components of the BPSC1001 vaccine product
Receipt of investigational product up to 30 days prior to randomization or ongoing participation in another clinical trial
Receipt of licensed non-live vaccines within 14 days of planned study immunization (30 days for live vaccines)
Ability to observe possible local reactions at the eligible injections sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical examination, and/or laboratory screening test. This would include a known hemoglobinopathy or coagulation abnormality.
Any baseline laboratory screening test which in the opinion of the investigator, is considered clinically significant
Any serologic evidence of hepatitis B or C infection
Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV-1, HIV-2 infection, cytotoxic therapy in the previous 5 years, and/or diabetes
Any chronic or active neurologic disorder, including migraines, seizures, and epilepsy, excluding a single febrile seizure as a child
Have a known history of Guillain-Barré Syndrome
Have an active malignancy or history of metastatic or hematologic malignancy
Suspected or known alcohol and/or illicit drug abuse within the past 5 years
Moderate or severe illness and/or fever >100.4°F within 1 week prior to vaccination (can be rescheduled)
Pregnant or lactating female, or female who intends to become pregnant during the study period
Administration of IgGs and/or any blood products within the 120 days preceding study entry or planned administration during the study period
History of blood donation within 60 days of enrollment or plans to donate within the study period
Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within 6 months of study entry
For corticosteroids, this includes prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day
Intranasal, topical, and intra-articular steroids are allowed
Unwilling to allow storage and use of blood for future vaccine research
28. Research staff or the immediate family of research staff directly involved with the clinical study.
29. Unwilling to undergo diagnostic evaluation of joint signs and symptoms, which may include arthrocentesis if clinically indicated based on presence of effusion and if the procedure is acceptable to the subject at the time (Cohort 2 only) 30. Unwilling to undergo diagnostic evaluation of skin rash, to include punch biopsy if clinically indicated and if the procedure is acceptable to the subject at the time (Cohort 2 only) 31. Research staff or the immediate family of research staff directly involved in the clinical study 32. Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study 33. Elective surgery or hospitalization planned during the period of study participation 34. Has traveled to an area where the World Health Organization has declared as an Ebola outbreak zone 35. History of chronic inflammatory disease (e.g., rheumatoid arthritis, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, Crohn's disease, ulcerative colitis, and gout), symptomatic osteoarthritis, or any other autoimmune or autoinflammatory disorder

About this study

Official title: A Phase 1 Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Safety and Immunogenicity of the BPSC-1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Subjects

Read the detailed description

Between 1994 and the present, there have been many Ebola viruses (EBOV) outbreaks affecting mostly central Africa. However, the 2014 West African outbreak significantly exceeds all previous outbreaks in geographic range, number of individuals affected and in disruption of typical activities of civil society.

This is a Phase 1 safety and tolerability study to evaluate a novel vaccine to Ebola using a live replicating vesicular stomatitis virus (VSV) replacing the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Zaire strain of Ebola (VSVΔG-ZEBOV also known as V920 and BPSC-1001).

Conditions: Ebola Virus
Being tested: V920 Vaccine, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

V920 VaccineBiological
Also called BPSC-1001
Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^3, 3x10^4, 3x10^5, 3x10^6, 9x10^6, 2x10^7, or 1x10^8 pfu.
PlaceboOther
0.9% Saline

Study groups in NCT02314923
Study group	Role	What they receive
3x10^3 pfu Vaccine Cohort 1	Experimental	Participants will receive a 1-mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0. Receives: Biological: V920 Vaccine
3x10^4 pfu Vaccine Cohort 1	Experimental	Participants will receive a 1-mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0. Receives: Biological: V920 Vaccine
3x10^5 pfu Vaccine Cohort 1	Experimental	Participants will receive a 1-mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0. Receives: Biological: V920 Vaccine
3x10^6 pfu Vaccine Cohort 1	Experimental	Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0. Receives: Biological: V920 Vaccine
9x10^6 pfu Vaccine Cohort 2	Experimental	Participants will receive a 1-mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0. Receives: Biological: V920 Vaccine
2x10^7 pfu Vaccine Cohort 2	Experimental	Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0. Receives: Biological: V920 Vaccine
1x10^8 pfu Vaccine Cohort 2	Experimental	Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0. Receives: Biological: V920 Vaccine
Placebo Cohort 1	Placebo comparator	Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0. Receives: Other: Placebo
3x10^6 pfu Vaccine Cohort 2	Experimental	Participants will receive a 1-mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0. Receives: Biological: V920 Vaccine
Placebo Cohort 2	Placebo comparator	Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With One or More Solicited Injection-site Adverse Events by Severity
An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, tenderness and swelling. AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least 1 solicited injection-site AE was summarized by grade.
Measured: Up to 14 days postvaccination
Percentage of Participants With One or More Solicited Systemic Adverse Events by Severity
An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Systemic AEs included subjective and objective fever, shivering/chills, sweats, myalgia, arthralgia, joint swelling, joint tenderness, fatigue, headache, gastrointestinal symptoms (nausea, vomiting, abdominal pain, and diarrhea), mucosal lesion, and skin lesion (including any blisters). AEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least one systemic AE was summarized by grade.
Measured: Up to 14 days postvaccination
Percentage of Participants With One or More Unsolicited Vaccine-related Adverse Event by Severity
An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Unsolicited vaccine-related AEs were those events not specifically listed as either an injection-site (local) or systemic in the VRC and were reported as at least possibly related to the study vaccine or placebo. The AEs were further assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least one unsolicited vaccine-related AE was summarized by grade..
Measured: Up to 56 days postvaccination
Percentage of Participants With One or More Serious Adverse Event (SAE) by Severity
An adverse event is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An SAE is an AE that results in death, is life-threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. SAEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening; 5=Fatal. The percentage of participants that experienced at least 1 SAE was summarized by grade.
Measured: Up to 360 days postvaccination
Geometric Mean Titers (GMTs) of Zaire Ebola Virus- (ZEBOV)-Specific Immunoglobulin-G (IgG) Antibody
Blood was drawn on Day 28 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by Enzyme-linked immunosorbent assay (ELISA).
Measured: 28 days postvaccination
Optimum Dose for General Use Prophylaxis With V920
The optimum dose for general use prophylaxis with V920 was determined following the review of all immunogenicity and safety data.
Measured: Day 360

Secondary outcomes (3)

Mean Copies of Vector Ribonucleic Acid (RNA) for Participants With a V920 Polymerase Chain Reaction (PCR) Result ≥ Lower Limit of Quantification (LLOQ)
Participants had blood, assessed for evidence of V920 via polymerase chain reaction (PCR). Mean copies of RNA was reported for all participants who had reading ≥ the LLOQ (62.5 copies/mL)
Measured: Days 1, 2, 3, 4, 7, 14 and 28 post-vaccination
Percentage of Participants With Seroconversion for ZEBOV-specific IgG
Blood was drawn on Days 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days to assess the GMTs via ELISA. Seroconversion was defined as a post-vaccination titer ≥ 200 ELISA Units/mL that was also at least a 4-fold increase in titer compared to baseline.
Measured: 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days postvaccination
Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies
Blood was drawn on Days 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days to assess the GMTs of Zaire ebolavirus neutralizing antibodies as determined plaque reduction neutralization titer (reciprocal of the dilution that resulted in a 60% decrease in plaques) (PRNT60).
Measured: 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days postvaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 201423 Jun 2016

First posted11 Dec 2014 (estimated)
Study start5 Dec 2014
Primary completion23 Jun 2016
Study completion23 Jun 2016

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 Ebola VirusStudies 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: Parallel groups
Model description: The study comprised two separate cohorts. Cohort 1 consisted of the 4 lower V920 dose groups (3x10\^3 pfu, 3x10\^4 pfu, 3x10\^5 pfu, and 3x10\^6 pfu). Cohort 2 consisted of the 3 higher V920 dose groups (9x10\^6 pfu, 2x10\^7 pfu, 1x10\^8 pfu) plus a bridging group that received vaccine at the highest dose evaluated in Cohort 1 (i.e. 3x10\^6 pfu). Both Cohorts 1 and 2 had a placebo group.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 513 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02314923
Sponsor's protocol ID: V920-004
Other IDs: NLG0507, V920-004
Status last verified: Jan 2020
First submitted: 8 Dec 2014
Last updated: 5 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Heppner DG Jr, Kemp TL, Martin BK, Ramsey WJ, Nichols R, Dasen EJ, Link CJ, Das R, Xu ZJ, Sheldon EA, Nowak TA, Monath TP; V920-004 study team. Safety and immunogenicity of the rVSV∆G-ZEBOV-GP Ebola virus vaccine candidate in healthy adults: a phase 1b randomised, multicentre, double-blind, placebo-controlled, dose-response study. Lancet Infect Dis. 2017 Aug;17(8):854-866. doi: 10.1016/S1473-3099(17)30313-4. Epub 2017 Jun 9.
PubMed 28606591
Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21.
PubMed 28647166

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Ebola, Bundibugyo Virus Disease (BVD)
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Study of Vaccines Against Bundibugyo Virus Disease in Contacts of Cases in the Democratic Republic of the Congo
Ebola Hemorrhagic Fever, Bundibugyo Virus Disease
Active, not recruitingPhase 1
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants
Ebola-Bundibugyo Virus Disease (Ebola-BDBV)
RecruitingPhase 1
A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health
Sudan Virus Disease

All Ebola Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Safety and Immunogenicity of the BPSC-1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT02314923
Acronym / sponsor ID: V920-004
Conditions: Ebola Virus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 513 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: BioProtection Systems Corporation, Department of Health and Human Services
Study start: 5 Dec 2014 (actual)
Primary completion: 23 Jun 2016 (actual)
Study completion: 23 Jun 2016 (actual)
First posted: 11 Dec 2014 (estimated)
Results: Posted 2 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 10
Model description: The study comprised two separate cohorts. Cohort 1 consisted of the 4 lower V920 dose groups (3x10^3 pfu, 3x10^4 pfu, 3x10^5 pfu, and 3x10^6 pfu). Cohort 2 consisted of the 3 higher V920 dose groups (9x10^6 pfu, 2x10^7 pfu, 1x10^8 pfu) plus a bridging group that received vaccine at the highest dose evaluated in Cohort 1 (i.e. 3x10^6 pfu). Both Cohorts 1 and 2 had a placebo group.

Arm	Type	Receives
3x10^3 pfu Vaccine Cohort 1	Experimental	Biological: V920 VaccineParticipants will receive a 1-mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
3x10^4 pfu Vaccine Cohort 1	Experimental	Biological: V920 VaccineParticipants will receive a 1-mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
3x10^5 pfu Vaccine Cohort 1	Experimental	Biological: V920 VaccineParticipants will receive a 1-mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
3x10^6 pfu Vaccine Cohort 1	Experimental	Biological: V920 VaccineParticipants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
9x10^6 pfu Vaccine Cohort 2	Experimental	Biological: V920 VaccineParticipants will receive a 1-mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
2x10^7 pfu Vaccine Cohort 2	Experimental	Biological: V920 VaccineParticipants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
1x10^8 pfu Vaccine Cohort 2	Experimental	Biological: V920 VaccineParticipants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
Placebo Cohort 1	Placebo comparator	Other: PlaceboParticipants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0.
3x10^6 pfu Vaccine Cohort 2	Experimental	Biological: V920 VaccineParticipants will receive a 1-mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
Placebo Cohort 2	Placebo comparator	Other: PlaceboParticipants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Healthy adult male or non-pregnant, non-lactating adult female, ages 18 to 60 (inclusive) at the time of screening
Have provided written informed consent prior to screening procedures
Free of clinically significant health problems, as determined by pertinent medical history, physical examination and clinical judgment of the investigator.
Available, able, and willing to participate for all study visits and procedures.
Males and females who are willing to practice abstinence from sexual intercourse with the opposite sex, or willing to use effective methods of contraception, from at least 30 days prior to vaccination until study end.

Key exclusion criteria (32 listed)

History of prior infection with a filovirus or prior participation in a filovirus vaccine trial
History of prior infection with VSV or receipt of a VSV vectored vaccine
Has been involved in the care in any capacity of a patient with Ebola virus infection within the previous 21 days
Is a healthcare worker who has direct contact with patients (nurse, physician, dentist, emergency medical technician, dental hygienist)
Has a house-hold contact (HHC) who is immunodeficient, on immunosuppressive medications, human immunodeficiency virus (HIV)-positive, pregnant, has an unstable medical condition

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
V920 VaccineAlso: BPSC-1001Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^3, 3x10^4, 3x10^5, 3x10^6, 9x10^6, 2x10^7, or 1x10^8 pfu.	Biological	1x10^8 pfu Vaccine Cohort 2, 2x10^7 pfu Vaccine Cohort 2, 3x10^3 pfu Vaccine Cohort 1, 3x10^4 pfu Vaccine Cohort 1, 3x10^5 pfu Vaccine Cohort 1, 3x10^6 pfu Vaccine Cohort 1, 3x10^6 pfu Vaccine Cohort 2, 9x10^6 pfu Vaccine Cohort 2
Placebo0.9% Saline	Other	Placebo Cohort 1, Placebo Cohort 2

Primary outcome

Percentage of Participants With One or More Solicited Injection-site Adverse Events by Severity
Time frame: Up to 14 days postvaccination
An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, tenderness and swelling. AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least 1 solicited injection-site AE was summarized by grade.
Percentage of Participants With One or More Solicited Systemic Adverse Events by Severity
Time frame: Up to 14 days postvaccination
An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Systemic AEs included subjective and objective fever, shivering/chills, sweats, myalgia, arthralgia, joint swelling, joint tenderness, fatigue, headache, gastrointestinal symptoms (nausea, vomiting, abdominal pain, and diarrhea), mucosal lesion, and skin lesion (including any blisters). AEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least one systemic AE was summarized by grade.
Percentage of Participants With One or More Unsolicited Vaccine-related Adverse Event by Severity
Time frame: Up to 56 days postvaccination
An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Unsolicited vaccine-related AEs were those events not specifically listed as either an injection-site (local) or systemic in the VRC and were reported as at least possibly related to the study vaccine or placebo. The AEs were further assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least one unsolicited vaccine-related AE was summarized by grade..
Percentage of Participants With One or More Serious Adverse Event (SAE) by Severity
Time frame: Up to 360 days postvaccination
An adverse event is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An SAE is an AE that results in death, is life-threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. SAEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening; 5=Fatal. The percentage of participants that experienced at least 1 SAE was summarized by grade.
Geometric Mean Titers (GMTs) of Zaire Ebola Virus- (ZEBOV)-Specific Immunoglobulin-G (IgG) Antibody
Time frame: 28 days postvaccination
Blood was drawn on Day 28 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by Enzyme-linked immunosorbent assay (ELISA).
Optimum Dose for General Use Prophylaxis With V920
Time frame: Day 360
The optimum dose for general use prophylaxis with V920 was determined following the review of all immunogenicity and safety data.

3 secondary outcomes

Mean Copies of Vector Ribonucleic Acid (RNA) for Participants With a V920 Polymerase Chain Reaction (PCR) Result ≥ Lower Limit of Quantification (LLOQ)
Time frame: Days 1, 2, 3, 4, 7, 14 and 28 post-vaccination
Percentage of Participants With Seroconversion for ZEBOV-specific IgG
Time frame: 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days postvaccination
Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies
Time frame: 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days postvaccination

Results and safety

Results posted to the registry on 2 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3x10^3 Plaque-forming Units (Pfu) V920: Cohort 1	64	61
3x10^4 Pfu V920: Cohort 1	64	60
3x10^5 Pfu V920: Cohort 1	64	62
3x10^6 Pfu V920: Cohort 1	64	63
Placebo: Cohort 1	74	73
3x10^6 Pfu V920: Cohort 2	20	19
9x10^6 Pfu V920: Cohort 2	48	43
2x10^7 Pfu V920: Cohort 2	47	42
1x10^8 Pfu V920: Cohort 2	48	46
Placebo: Cohort 2	20	20

Primary outcome: Percentage of Participants With One or More Solicited Injection-site Adverse Events by Severity

Time frame: Up to 14 days postvaccination. Number. Unit: Percentage of Participants

Measure	3x10^3 Pfu V920: Cohort 1 n = 64	3x10^4 Pfu V920: Cohort 1 n = 64	3x10^5 Pfu V920: Cohort 1 n = 64	3x10^6 Pfu V920: Cohort 1 n = 64	Placebo: Cohort 1 n = 74	3x10^6 Pfu V920: Cohort 2 n = 20	9x10^6 Pfu V920: Cohort 2 n = 47	2x10^7 Pfu V920: Cohort 2 n = 47	1x10^8 Pfu V920: Cohort 2 n = 48	Placebo: Cohort 2 n = 20
Grade 1 (Mild)	17.2	21.9	29.7	45.3	10.8	30.0	61.7	63.8	47.9	5.0
Grade 2 (Moderate)	0	1.6	1.6	1.6	1.4	0	8.5	8.5	16.7	0
Grade 3 (Severe)	0	0	0	0	0	0	0	0	0	0
Grade 4 (Potentially life-threatening)	0	0	0	0	0	0	0	0	0	0

Population analysed: All randomized participants who received study vaccination and had data available for the endpoint.

Primary outcome: Percentage of Participants With One or More Solicited Systemic Adverse Events by Severity

Time frame: Up to 14 days postvaccination. Number. Unit: Percentage of Participants

Measure	3x10^3 Pfu V920: Cohort 1 n = 64	3x10^4 Pfu V920: Cohort 1 n = 64	3x10^5 Pfu V920: Cohort 1 n = 64	3x10^6 Pfu V920: Cohort 1 n = 64	Placebo: Cohort 1 n = 74	3x10^6 Pfu V920: Cohort 2 n = 20	9x10^6 Pfu V920: Cohort 2 n = 47	2x10^7 Pfu V920: Cohort 2 n = 47	1x10^8 Pfu V920: Cohort 2 n = 48	Placebo: Cohort 2 n = 20
Grade 1 (Mild)	29.7	39.1	45.3	53.1	41.9	25.0	46.8	46.8	43.8	20.0
Grade 2 (Moderate)	10.9	4.7	10.9	14.1	4.1	25.0	19.1	23.4	27.1	5.0
Grade 3 (Severe)	0	0	3.1	1.6	0	0	2.1	4.3	4.2	0
Grade 4 (Potentially life-threatening)	0	0	0	0	0	0	0	0	0	0

Population analysed: All randomized participants who received study vaccination and had data available for the endpoint.

Primary outcome: Percentage of Participants With One or More Unsolicited Vaccine-related Adverse Event by Severity

Time frame: Up to 56 days postvaccination. Number. Unit: Percentage of Participants

Measure	3x10^3 Pfu V920: Cohort 1 n = 64	3x10^4 Pfu V920: Cohort 1 n = 64	3x10^5 Pfu V920: Cohort 1 n = 64	3x10^6 Pfu V920: Cohort 1 n = 64	Placebo: Cohort 1 n = 74	3x10^6 Pfu V920: Cohort 2 n = 20	9x10^6 Pfu V920: Cohort 2 n = 47	2x10^7 Pfu V920: Cohort 2 n = 47	1x10^8 Pfu V920: Cohort 2 n = 48	Placebo: Cohort 2 n = 20
1 (Mild)	7.8	14.1	7.8	9.4	6.8	15.0	14.9	17.0	14.6	10.0
2 (Moderate)	4.7	3.1	0	3.1	0	0	6.4	2.1	2.1	0
3 (Severe)	0	0	0	1.6	0	0	0	0	0	5.0
4 (Potentially Life-threatening)	0	0	0	0	0	0	0	0	0	0

Population analysed: All randomized participants who received study vaccination and had data available for the endpoint.

Primary outcome: Percentage of Participants With One or More Serious Adverse Event (SAE) by Severity

Time frame: Up to 360 days postvaccination. Number. Unit: Percentage of Participants

Measure	3x10^5 Pfu V920: Cohort 1 n = 64	3x10^6 Pfu V920: Cohort 1 n = 64	Placebo: Cohort 1 n = 74
1 (Mild)	0	1.6	0
2 (Moderate)	0	0	0
3 (Severe)	0	0	1.4
4 (Potentially Life-threatening)	1.6	0	0
5 (Fatal)	0	1.6	0

Population analysed: All randomized participants who received study vaccination and had data available for the endpoint.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 360 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3x10^3 Pfu V920: Cohort 1	0 of 64 (0%)	30 of 64 (46.9%)	0 of 64
3x10^4 Pfu V920: Cohort 1	0 of 64 (0%)	38 of 64 (59.4%)	0 of 64
3x10^5 Pfu V920: Cohort 1	1 of 64 (1.6%)	44 of 64 (68.8%)	0 of 64
3x10^6 Pfu V920: Cohort 1	2 of 64 (3.1%)	52 of 64 (81.3%)	1 of 64
Placebo: Cohort 1	1 of 74 (1.4%)	43 of 74 (58.1%)	0 of 74
3x10^6 Pfu V920: Cohort 2	0 of 20 (0%)	14 of 20 (70%)	0 of 20
9x10^6 Pfu V920: Cohort 2	0 of 47 (0%)	43 of 47 (91.5%)	0 of 47
2x10^7 Pfu V920: Cohort 2	0 of 47 (0%)	41 of 47 (87.2%)	0 of 47
1x10^8 Pfu V920: Cohort 2	0 of 48 (0%)	41 of 48 (85.4%)	0 of 48
Placebo: Cohort 2	0 of 20 (0%)	9 of 20 (45%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28606591Heppner DG Jr, Kemp TL, Martin BK, Ramsey WJ, Nichols R, Dasen EJ, Link CJ, Das R, Xu ZJ, Sheldon EA, Nowak TA, Monath TP; V920-004 study team. Safety and immunogenicity of the rVSV∆G-ZEBOV-GP Ebola virus vaccine candidate in healthy adults: a phase 1b randomised, multicentre, double-blind, placebo-controlled, dose-response study. Lancet Infect Dis. 2017 Aug;17(8):854-866. doi: 10.1016/S1473-3099(17)30313-4. Epub 2017 Jun 9.
Derived from this study: PubMed 28647166Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing V920 Vaccine in people with Ebola Virus, run by Merck Sharp & Dohme LLC.

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 10 inclusion and 32 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: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 Jan 2020). 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 One or More Solicited Injection-site Adverse Events by Severity (time frame: Up to 14 days postvaccination). 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 NCT02314923, 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 5 Feb 2020.