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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)

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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.

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.

Condition or disease Intervention/treatment Phase
Prevention of Ebola Infection Biological: V920 Consistency Lot A Biological: V920 Consistency Lot B Biological: V920 Consistency Lot C Biological: V920 High-dose Lot Biological: Placebo to V920 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : August 17, 2015
Actual Primary Completion Date : May 2, 2016
Actual Study Completion Date : September 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: V920 Consistency Lot A
Participants received a 1.0 mL intramuscular injection of V920 on Day 1
Biological: V920 Consistency Lot A
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
Biological: V920 Consistency Lot B
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
Biological: V920 Consistency Lot C
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
Biological: V920 High-dose Lot
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
Biological: Placebo to V920
Sodium chloride 0.9%, sterile solution for intramuscular injection




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503202


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02503202     History of Changes
Other Study ID Numbers: V920-012
2015-001658-14 ( EudraCT Number )
V920-012 ( Other Identifier: Merck Protocol Number )
First Posted: July 20, 2015    Key Record Dates
Results First Posted: October 12, 2018
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

Additional relevant MeSH terms:
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Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Virus Diseases
Filoviridae Infections
Mononegavirales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs