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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)

Primary Purpose

Prevention of Ebola Infection

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

V920 Consistency Lot A

V920 Consistency Lot B

V920 Consistency Lot C

V920 High-dose Lot

Placebo to V920

About this trial

This is an interventional prevention trial for Prevention of Ebola Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

V920 Consistency Lot A

V920 Consistency Lot B

V920 Consistency Lot C

V920 High-dose Lot

Placebo to V920

Arm Description

Participants received a 1.0 mL intramuscular injection of V920 on Day 1

Participants received a 1.0 mL intramuscular injection of placebo on Day 1

Outcomes

Primary Outcome Measures

Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody

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

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

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

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

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

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02503202

First Posted

July 17, 2015

Last Updated

October 9, 2018

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02503202

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

August 17, 2015 (Actual)

Primary Completion Date

May 2, 2016 (Actual)

Study Completion Date

September 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prevention of Ebola Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1197 (Actual)

8. Arms, Groups, and Interventions

Arm Title

V920 Consistency Lot A

Arm Type

Experimental

Arm Description

Participants received a 1.0 mL intramuscular injection of V920 on Day 1

Arm Title

V920 Consistency Lot B

Arm Type

Experimental

Arm Description

Participants received a 1.0 mL intramuscular injection of V920 on Day 1

Arm Title

V920 Consistency Lot C

Arm Type

Experimental

Arm Description

Participants received a 1.0 mL intramuscular injection of V920 on Day 1

Arm Title

V920 High-dose Lot

Arm Type

Experimental

Arm Description

Participants received a 1.0 mL intramuscular injection of V920 on Day 1

Arm Title

Placebo to V920

Arm Type

Placebo Comparator

Arm Description

Participants received a 1.0 mL intramuscular injection of placebo on Day 1

Intervention Type

Biological

Intervention Name(s)

V920 Consistency Lot A

Intervention Description

V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection

Intervention Type

Biological

Intervention Name(s)

V920 Consistency Lot B

Intervention Description

V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection

Intervention Type

Biological

Intervention Name(s)

V920 Consistency Lot C

Intervention Description

V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection

Intervention Type

Biological

Intervention Name(s)

V920 High-dose Lot

Intervention Description

V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine high-dose lot, live, attenuated, sterile solution for intramuscular injection

Intervention Type

Biological

Intervention Name(s)

Placebo to V920

Intervention Description

Sodium chloride 0.9%, sterile solution for intramuscular injection

Primary Outcome Measure Information:

Title

Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody

Description

Time Frame

Day 28 postvaccination

Title

Percentage of Participants Reporting Serious Adverse Events

Description

Time Frame

Up to Month 6 postvaccination

Title

Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card

Description

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.

Time Frame

Up to Day 5 postvaccination

Title

Percentage of Participants With Elevated Maximum Temperature

Description

Time Frame

Up to Day 42 postvaccination

Title

Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card

Description

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.

Time Frame

From Day 5 to Day 42 postvaccination

Title

Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card

Description

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.

Time Frame

Up to Day 42 postvaccination

Title

Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card

Description

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.

Time Frame

Up to Day 42 postvaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

28549145

Citation

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.

Results Reference

result

PubMed Identifier

33782211

Citation

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.

Results Reference

derived

PubMed Identifier

31505665

Citation

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.

Results Reference

derived

PubMed Identifier

28647166

Citation

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.

Results Reference

derived

Learn more about this trial

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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