- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02485301
A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults
December 4, 2017 updated by: GlaxoSmithKline
Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Adults in Africa
The purpose of this study is to assess the safety and immunogenicity of the investigational ChAd3-EBO-Z vaccine administered to approximately 3 000 adults in Africa as a single IM dose Considering the risk of exposure to Ebola and the potential (based on animal data) for the investigational ChAd3-EBO-Z vaccine to afford at least partial protection, all subjects in the study will receive the investigational ChAd3-EBO-Z vaccine.
The subjects in the Group EBO-Z will receive the vaccine at Day 0 of the study, whereas the subjects in the Group Placebo/ EBO-Z will receive a placebo at Day 0 (as a control) and will receive the investigational ChAd3-EBO-Z vaccine at Month 6, provided that no safety concerns are raised.
In addition, vaccinating all subjects in the study with the investigational ChAd3 EBO Z vaccine will allow an increase of the safety database of the investigational vaccine.
In case the geographic range of Ebola virus Zaire (EBOV) transmission expands to encompass any of the regions where this trial is conducted, earlier administration of the investigational ChAd3-EBO-Z vaccine to the subjects in the Group Placebo/ EBO-Z will be considered in that region.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
3024
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g. capability of or availability for Diary Card completion, return for follow-up visits, availability for clinical follow-up throughout the study period).
- Written/ thumb printed informed consent obtained from the subject prior to performing any study specific procedure or written/ thumb printed informed consent obtained from the subject's parent(s)/ legally acceptable representative(s) (LAR[s]) and written/ thumb printed informed assent obtained from the subject, for minor subjects. This will only be applicable for countries where the legal age of majority is ≥ 21 years.
- A male or female aged 18 years of age or older at the time of Screening.
- Healthy subjects as per Investigator judgement, as established by medical history, clinical examination and haematology/ biochemistry laboratory parameters screening before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to the Day 0 visit, and
- has a negative pregnancy test at the Day 0 visit, and
- has agreed to continue adequate contraception until 30 days after the Month 6 visit.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the Day 0 visit, or planned use during the study period.
- Previous vaccination with an investigational EBOV or Marburg vaccine, or previous vaccination with a chimpanzee adenoviral vectored investigational vaccine.
- Known prior EBOV or SUDV disease.
- Travel to a country affected by the EBOV epidemic or direct contact with a person with EVD within 21 days prior to the Day 0 visit.
- History of any reaction or hypersensitivity (such as anaphylaxis, urticaria [hives], respiratory difficulty, angioedema, or abdominal pain) likely to be exacerbated by any component of the study vaccine.
- Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each vaccination visit.
Serious acute or chronic illness determined by medical history and clinical examination including, but not limited to:
- Clinically significant immunosuppressive or immunodeficient condition (e.g. clinical acquired immune deficiency syndrome [AIDS]).
- Any clinically significant haematological (CBC, including differential count and platelet count) or biochemical (ALT, creatinine) laboratory abnormality.
- Any chronic illness with recent signs of exacerbation, or imposing a change in the chronic treatment regimen, within 3 months prior to the Day 0 visit.
- Any unstable chronic medical condition (e.g. uncontrolled asthma).
- Pregnant female.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group EBO-Z
The subjects in the Group EBO-Z will receive the vaccine at Day 0 of the study
|
A single dose administrated intramuscular
|
PLACEBO_COMPARATOR: Group Placebo/ EBO-Z
The subjects in the Group Placebo/ EBO-Z will receive a placebo at Day 0 (as a control) and will receive the investigational ChAd3-EBO-Z vaccine at Month 6
|
A single dose administrated intramuscular
A single dose administrated intramuscular
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Solicited Local Adverse Events
Time Frame: During the 7-Day (Days 0-6) post-vaccination period
|
Assessed solicited local adverse events were pain, redness and swelling.
Any = occurrence of any solicited local adverse event regardless of their intensity grade.
Grade 3 Pain = significant pain at rest.
Prevented normal every day activities.
Grade 3 Redness/Swelling = redness/swelling spreading beyond 100 millimeters (mm) from injection site.
|
During the 7-Day (Days 0-6) post-vaccination period
|
Number of Subjects With Solicited General Adverse Events
Time Frame: During the 7-Day (Days 0-6) post-vaccination period
|
Assessed solicited general adverse events were fatigue, fever [defined as axillary temperature higher than or equal to (≥) 37.5 degrees Celsius (°C)], gastrointestinal (gastro) adverse events [nausea, vomiting, diarrhoea and/or abdominal pain] and headache.
Any = occurrence of any general adverse events regardless of intensity grade or relationship to vaccination.
Grade 3 fatigue, gastrointestinal symptoms and headache = adverse event that prevented normal activities.
Grade 3 fever = fever ≥ 39.5 °C.
Related = adverse event assessed by the investigator as related to the vaccination.
|
During the 7-Day (Days 0-6) post-vaccination period
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Time Frame: During the 30-Day (Days 0-29) post-vaccination period
|
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
|
During the 30-Day (Days 0-29) post-vaccination period
|
Percentage of Subjects With Haematological Laboratory Abnormalities
Time Frame: At Screening
|
Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count.
Reference range indicators used were: high, low, normal.
|
At Screening
|
Percentage of Subjects With Haematological Laboratory Abnormalities
Time Frame: At Day 3
|
Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count.
Reference range indicators used were: high, low, normal.
|
At Day 3
|
Percentage of Subjects With Haematological Laboratory Abnormalities
Time Frame: At Day 6
|
Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count.
Reference range indicators used were: high, low, normal.
|
At Day 6
|
Percentage of Subjects With Haematological Laboratory Abnormalities
Time Frame: At Day 30
|
Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count.
Reference range indicators used were: high, low, normal.
|
At Day 30
|
Percentage of Subjects With Haematological Laboratory Abnormalities
Time Frame: At Month 6
|
Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count.
Reference range indicators used were: high, low, normal.
|
At Month 6
|
Percentage of Subjects With Haematological Laboratory Abnormalities
Time Frame: At Month 6 + 6 Days
|
Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count.
Reference range indicators used were: high, low, normal.
|
At Month 6 + 6 Days
|
Percentage of Subjects With Haematological Laboratory Abnormalities
Time Frame: At Month 6 + 30 Days
|
Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count.
Reference range indicators used were: high, low, normal.
|
At Month 6 + 30 Days
|
Percentage of Subjects With Haematological Laboratory Abnormalities
Time Frame: At Month 12
|
Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count.
Reference range indicators used were: high, low, normal.
|
At Month 12
|
Percentage of Subjects With Biochemical Laboratory Abnormalities
Time Frame: At Screening
|
Biochemical parameters assessed included: aminotransferase and creatinine.
Reference range indicators used were: high, low, normal.
|
At Screening
|
Percentage of Subjects With Biochemical Laboratory Abnormalities
Time Frame: At Day 3
|
Biochemical parameters assessed included: aminotransferase and creatinine.
Reference range indicators used were: high, low, normal.
|
At Day 3
|
Percentage of Subjects With Biochemical Laboratory Abnormalities
Time Frame: At Day 6
|
Biochemical parameters assessed included: aminotransferase and creatinine.
Reference range indicators used were: high, low, normal.
|
At Day 6
|
Percentage of Subjects With Biochemical Laboratory Abnormalities
Time Frame: At Day 30
|
Biochemical parameters assessed included: aminotransferase and creatinine.
Reference range indicators used were: high, low, normal.
|
At Day 30
|
Percentage of Subjects With Biochemical Laboratory Abnormalities
Time Frame: At Month 6
|
Biochemical parameters assessed included: aminotransferase and creatinine.
Reference range indicators used were: high, low, normal.
|
At Month 6
|
Percentage of Subjects With Biochemical Laboratory Abnormalities
Time Frame: At Month 6 + 6 Days
|
Biochemical parameters assessed included: aminotransferase and creatinine.
Reference range indicators used were: high, low, normal.
|
At Month 6 + 6 Days
|
Percentage of Subjects With Biochemical Laboratory Abnormalities
Time Frame: At Month 6 + 30 Days
|
Biochemical parameters assessed included: aminotransferase and creatinine.
Reference range indicators used were: high, low, normal.
|
At Month 6 + 30 Days
|
Percentage of Subjects With Biochemical Laboratory Abnormalities
Time Frame: At Month 12
|
Biochemical parameters assessed included: aminotransferase and creatinine.
Reference range indicators used were: high, low, normal.
|
At Month 12
|
Number of Subjects With Adverse Events of Specific Interest (AESI)
Time Frame: During the 7-Day (Days 0-6) post-vaccination period
|
AESI included clinical symptoms of thrombocytopenia.
|
During the 7-Day (Days 0-6) post-vaccination period
|
Number of Subjects With Serious Adverse Events (SAEs)
Time Frame: During the entire study period (up to Month 12)
|
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
During the entire study period (up to Month 12)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV)
Time Frame: At Day 0, Day 30, Month 6 and Month 12
|
Anti-GP EBOV antibody concentrations were measured by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMC), and expressed in ELISA units per milliliter (EU/mL).
|
At Day 0, Day 30, Month 6 and Month 12
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies
Time Frame: At Day 0, Day 30, Month 6 and Month 12
|
A seronegative subject (S-) is a subject whose titer is below (<) 36.11
EU/mL.
A seropositive subject (S+) is a subject whose titer is greater than or equal to (≥) 36.11
EU/mL.
|
At Day 0, Day 30, Month 6 and Month 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 15, 2015
Primary Completion (ACTUAL)
December 23, 2016
Study Completion (ACTUAL)
December 23, 2016
Study Registration Dates
First Submitted
June 18, 2015
First Submitted That Met QC Criteria
June 25, 2015
First Posted (ESTIMATE)
June 30, 2015
Study Record Updates
Last Update Posted (ACTUAL)
January 4, 2018
Last Update Submitted That Met QC Criteria
December 4, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202091
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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