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A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02485301
Recruitment Status : Completed
First Posted : June 30, 2015
Results First Posted : January 4, 2018
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE June 18, 2015
First Posted Date  ICMJE June 30, 2015
Results First Submitted Date  ICMJE May 16, 2017
Results First Posted Date  ICMJE January 4, 2018
Last Update Posted Date January 4, 2018
Actual Study Start Date  ICMJE July 15, 2015
Actual Primary Completion Date December 23, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
  • Occurrence of each solicited local and general AE [ Time Frame: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days), in a sub cohort of 750 subjects per group. ]
  • Occurrence of any unsolicited AE [ Time Frame: During a 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days), in a sub-cohort of 750 subjects per group. ]
  • Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) [ Time Frame: At Screening, Day 3, Day 6, Day 30, Month 6 and Month 12 in a sub cohort of 750 subjects per group, and at Month 6 + 6 days and Month 6 + 30 days in a sub cohort of 750 subjects in the Group Placebo/ EBO-Z. ]
  • Occurrence of clinical symptoms of thrombocytopenia (AE of specific interest) [ Time Frame: During a 7-day follow-up period after vaccination at Day 0 (i.e. Day 0 up to Day 6). ]
  • Occurrence of any SAE, in all subjects, in both groups [ Time Frame: For the whole study duration (Day 0 to Month 24) ]
  • Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [ Time Frame: At Screening, Day 3, Day 6, Day 30, Month 6 and Month 12 in a sub cohort of 750 subjects per group, and at Month 6 + 6 days and Month 6 + 30 days in a sub cohort of 750 subjects in the Group Placebo/ EBO-Z. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
Anti-GP EBOV antibody titres, as measured by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: At Day 0 and Day 30, in a sub-cohort of 750 subjects per group. At Month 6 and Month 6 + 30 days, in a sub-cohort of 750 subjects in the Group Placebo/ EBO-Z. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults
Official Title  ICMJE Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Adults in Africa
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Virus Diseases
Intervention  ICMJE
  • Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)
    A single dose administrated intramuscular
  • Drug: Placebo
    A single dose administrated intramuscular
Study Arms  ICMJE
  • Experimental: Group EBO-Z
    The subjects in the Group EBO-Z will receive the vaccine at Day 0 of the study
    Intervention: Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)
  • 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
    Interventions:
    • Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)
    • Drug: Placebo
Publications * Tapia MD, Sow SO, Ndiaye BP, Mbaye KD, Thiongane A, Ndour CT, Mboup S, Ake JA, Keshinro B, Akintunde GA, Kinge TN, Vernet G, Bigna JJ, Oguche S, Koram KA, Asante KP, Hogrefe WR, Günther S, Naficy A, De Ryck I, Debois M, Bourguignon P, Jongert E, Ballou WR, Koutsoukos M, Roman F; Zaire EBola Research Alliance group. Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in adults in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2020 Jun;20(6):707-718. doi: 10.1016/S1473-3099(20)30016-5. Epub 2020 Mar 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2017)
3024
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2015)
2796
Actual Study Completion Date  ICMJE December 23, 2016
Actual Primary Completion Date December 23, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cameroon,   Mali,   Nigeria,   Senegal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02485301
Other Study ID Numbers  ICMJE 202091
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP