- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02503202
Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012)
October 9, 2018 updated by: Merck Sharp & Dohme LLC
A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Immunogenicity of Three Consistency Lots and a High Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults
The study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults.
The primary purpose of this study was to demonstrate consistency in the immune responses of participants receiving 3 separate lots of V920 through 28 days postvaccination.
In addition to the 3 lot groups, a high-dose group and a placebo group were studied.
A subset of participants representative of all treatment groups continued through 24 months postvaccination in the extension study for the evaluation of long-term safety.
The primary hypothesis states that the geometric mean titer of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibody at 28 days postvaccination is equivalent across the three consistency lots.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
1197
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Not of reproductive potential, or of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner for 2 months following study vaccination.
Exclusion Criteria:
- Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 90 days of participation in this trial.
- Has previously been randomized in another clinical trial and received V920 or any other Ebola vaccine.
- Has been exposed to Ebola virus at any time prior to study entry.
- Is pregnant or breastfeeding or plans to conceive within 2 months following study vaccination.
- Has direct household exposure to a pregnant or lactating woman at the time of participation in this trial.
- Has had a fever (≥100.5ºF/38.0ºC) within 48 hours prior to study entry.
- Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/day for persons weighing >10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to study entry.
- Has received systemic corticosteroids exceeding physiologic replacement doses (~5 mg/day prednisone equivalent) within 14 days prior to study entry.
- Has received any live virus vaccine within 30 days prior to study entry or any other (nonlive virus) vaccine within 14 days prior to study entry.
- Has known or suspected impairment of immunological function (e.g., HIV positive).
- Has direct household exposure to a person with known or suspected impairment of immunological function (e.g., HIV positive).
- Has a clinically significant history of intravenous (IV) drug abuse within 12 months prior to study entry.
- Has a known allergy/sensitivity or contraindication to investigational product(s) or its/their excipients (e.g., albumin).
- Has a history of malignancy <=5 years prior to study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: V920 Consistency Lot A
Participants received a 1.0 mL intramuscular injection of V920 on Day 1
|
V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection
|
Experimental: V920 Consistency Lot B
Participants received a 1.0 mL intramuscular injection of V920 on Day 1
|
V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection
|
Experimental: V920 Consistency Lot C
Participants received a 1.0 mL intramuscular injection of V920 on Day 1
|
V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection
|
Experimental: V920 High-dose Lot
Participants received a 1.0 mL intramuscular injection of V920 on Day 1
|
V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine high-dose lot, live, attenuated, sterile solution for intramuscular injection
|
Placebo Comparator: Placebo to V920
Participants received a 1.0 mL intramuscular injection of placebo on Day 1
|
Sodium chloride 0.9%, sterile solution for intramuscular injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody
Time Frame: Day 28 postvaccination
|
Serum was collected for determination of geometric mean titer (GMT) of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibodies using an enzyme-linked immunosorbent assay (GP-ELISA).
The unit of measure is ELISA units/mL (EU/mL).
The lower limit of quantification for the assay was 36.11
EU/mL.
|
Day 28 postvaccination
|
Percentage of Participants Reporting Serious Adverse Events
Time Frame: Up to Month 6 postvaccination
|
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore 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.
A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is any other important medical event, is a cancer, or is associated with an overdose.
|
Up to Month 6 postvaccination
|
Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card
Time Frame: Up to Day 5 postvaccination
|
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore 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, and swelling.
|
Up to Day 5 postvaccination
|
Percentage of Participants With Elevated Maximum Temperature
Time Frame: Up to Day 42 postvaccination
|
Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination through Day 42.
Elevated temperature was defined as ≥38.0°
C (≥100.4°
F).
|
Up to Day 42 postvaccination
|
Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card
Time Frame: From Day 5 to Day 42 postvaccination
|
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore 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.
Adverse events of arthralgia and arthritis were prompted on the VRC.
|
From Day 5 to Day 42 postvaccination
|
Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card
Time Frame: Up to Day 42 postvaccination
|
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore 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.
Rash AEs prompted on the VRC were petechial rash, purpuric rash, and vesicular-type rash.
|
Up to Day 42 postvaccination
|
Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card
Time Frame: Up to Day 42 postvaccination
|
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore 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.
Vesicular lesion AEs prompted on the VRC included blister and rash vesicular.
|
Up to Day 42 postvaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Halperin SA, Arribas JR, Rupp R, Andrews CP, Chu L, Das R, Simon JK, Onorato MT, Liu K, Martin J, Helmond FA; V920-012 Study Team. Six-Month Safety Data of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein Vaccine in a Phase 3 Double-Blind, Placebo-Controlled Randomized Study in Healthy Adults. J Infect Dis. 2017 Jun 15;215(12):1789-1798. doi: 10.1093/infdis/jix189.
- Grant-Klein RJ, Antonello J, Nichols R, Dubey S, Simon JK. Effects of Gamma Irradiation of Human Serum Samples from rVSVDeltaG-ZEBOV-GP (V920) Ebola Virus Vaccine Recipients on Plaque-Reduction Neutralization Assays. Am J Trop Med Hyg. 2021 Mar 29;104(5):1751-1754. doi: 10.4269/ajtmh.20-1055.
- Halperin SA, Das R, Onorato MT, Liu K, Martin J, Grant-Klein RJ, Nichols R, Coller BA, Helmond FA, Simon JK; V920-012 Study Team. Immunogenicity, Lot Consistency, and Extended Safety of rVSVDeltaG-ZEBOV-GP Vaccine: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adults. J Infect Dis. 2019 Aug 30;220(7):1127-1135. doi: 10.1093/infdis/jiz241.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 17, 2015
Primary Completion (Actual)
May 2, 2016
Study Completion (Actual)
September 29, 2017
Study Registration Dates
First Submitted
July 17, 2015
First Submitted That Met QC Criteria
July 17, 2015
First Posted (Estimate)
July 20, 2015
Study Record Updates
Last Update Posted (Actual)
October 12, 2018
Last Update Submitted That Met QC Criteria
October 9, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V920-012 (Other Identifier: Merck Protocol Number)
- 2015-001658-14 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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