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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02503202
Recruitment Status : Completed
First Posted : July 20, 2015
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE July 17, 2015
First Posted Date  ICMJE July 20, 2015
Results First Submitted Date  ICMJE September 7, 2018
Results First Posted Date  ICMJE October 12, 2018
Last Update Posted Date October 12, 2018
Actual Study Start Date  ICMJE August 17, 2015
Actual Primary Completion Date May 2, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2015)
Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody [ Time Frame: Day 28 postvaccination ]
Change History Complete list of historical versions of study NCT02503202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2015)
  • Percentage of Participants Reporting Serious Adverse Experiences [ Time Frame: Up to Day 42 postvaccination ]
  • Percentage of Participants with Vaccine Report Card (VRC)-prompted Injection-site Adverse Events [ Time Frame: Up to Day 5 postvaccination ]
  • Percentage of Participants with VRC-prompted Elevated Temperature [ Time Frame: Up to Day 42 postvaccination ]
  • Percentage of Participants with Arthralgia/Arthritis [ Time Frame: Day 5 through Day 42 postvaccination ]
  • Percentage of Participants with Petechial/purpuric Rash [ Time Frame: Day 5 through Day 42 postvaccination ]
  • Percentage of Participants with Vesicular Lesions [ Time Frame: Day 5 through Day 42 postvaccination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Prevention of Ebola Infection
Intervention  ICMJE
  • Biological: V920 Consistency Lot A
    V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection
  • Biological: V920 Consistency Lot B
    V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection
  • Biological: V920 Consistency Lot C
    V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection
  • Biological: V920 High-dose Lot
    V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine high-dose lot, live, attenuated, sterile solution for intramuscular injection
  • Biological: Placebo to V920
    Sodium chloride 0.9%, sterile solution for intramuscular injection
Study Arms  ICMJE
  • Experimental: V920 Consistency Lot A
    Participants received a 1.0 mL intramuscular injection of V920 on Day 1
    Intervention: Biological: V920 Consistency Lot A
  • Experimental: V920 Consistency Lot B
    Participants received a 1.0 mL intramuscular injection of V920 on Day 1
    Intervention: Biological: V920 Consistency Lot B
  • Experimental: V920 Consistency Lot C
    Participants received a 1.0 mL intramuscular injection of V920 on Day 1
    Intervention: Biological: V920 Consistency Lot C
  • Experimental: V920 High-dose Lot
    Participants received a 1.0 mL intramuscular injection of V920 on Day 1
    Intervention: Biological: V920 High-dose Lot
  • Placebo Comparator: Placebo to V920
    Participants received a 1.0 mL intramuscular injection of placebo on Day 1
    Intervention: Biological: Placebo to V920
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2018)
1197
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2015)
1125
Actual Study Completion Date  ICMJE September 29, 2017
Actual Primary Completion Date May 2, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   Spain,   United States
 
Administrative Information
NCT Number  ICMJE NCT02503202
Other Study ID Numbers  ICMJE V920-012
2015-001658-14 ( EudraCT Number )
V920-012 ( Other Identifier: Merck Protocol Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP