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)
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevention of Ebola Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2015-07-20
Enrollment: 1197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody
timeFrame: Day 28 postvaccination
measure: Percentage of Participants Reporting Serious Adverse Events
timeFrame: Up to Month 6 postvaccination
measure: Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card
timeFrame: Up to Day 5 postvaccination
measure: Percentage of Participants With Elevated Maximum Temperature
timeFrame: Up to Day 42 postvaccination
measure: Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card
timeFrame: From Day 5 to Day 42 postvaccination
measure: Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card
timeFrame: Up to Day 42 postvaccination
measure: Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card
timeFrame: Up to Day 42 postvaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.