Prevention of Ebola Infection Clinical Trial
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
| Verified date | October 2018 |
| Source | Merck Sharp & Dohme Corp. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1197 |
| Est. completion date | September 29, 2017 |
| Est. primary completion date | May 2, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme Corp. |
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Day 28 postvaccination | |
| Primary | 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. | Up to Month 6 postvaccination | |
| Primary | 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. | Up to Day 5 postvaccination | |
| Primary | 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). | Up to Day 42 postvaccination | |
| Primary | 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. | From Day 5 to Day 42 postvaccination | |
| Primary | 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. | Up to Day 42 postvaccination | |
| Primary | 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. | Up to Day 42 postvaccination |