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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

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.

Condition or disease Intervention/treatment Phase
Virus Diseases Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3024 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Adults in Africa
Actual Study Start Date : July 15, 2015
Actual Primary Completion Date : December 23, 2016
Actual Study Completion Date : December 23, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: Group EBO-Z
The subjects in the Group EBO-Z will receive the vaccine at Day 0 of the study
Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)
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
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485301


Locations
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Cameroon
GSK Investigational Site
Bamenda, Cameroon
GSK Investigational Site
Yaounde, Cameroon
Mali
GSK Investigational Site
Bamako, Mali
Nigeria
GSK Investigational Site
Abuja, Nigeria
Senegal
GSK Investigational Site
Dakar, Senegal
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02485301    
Other Study ID Numbers: 202091
First Posted: June 30, 2015    Key Record Dates
Results First Posted: January 4, 2018
Last Update Posted: January 4, 2018
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Protection against Ebola Zaire virus
Additional relevant MeSH terms:
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Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs