Last updated: 04/13/2020 09:50:11

A study to evaluate the safety and immunogenicity of a candidate Ebola Vaccine in adults

GSK study ID
202091
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Safety and immunogenicity study of GSK Biologicals’ investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (GSK3390107A) in adults in Africa
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of subjects with solicited local adverse events

Timeframe: During the 7-Day (Days 0-6) post-vaccination period

Number of subjects with solicited general adverse events

Timeframe: During the 7-Day (Days 0-6) post-vaccination period

Number of subjects with unsolicited adverse events (AEs)

Timeframe: During the 30-Day (Days 0-29) post-vaccination period

Percentage of subjects with haematological laboratory abnormalities

Timeframe: At Screening

Percentage of subjects with haematological laboratory abnormalities

Timeframe: At Day 3

Percentage of subjects with haematological laboratory abnormalities

Timeframe: At Day 6

Percentage of subjects with haematological laboratory abnormalities

Timeframe: At Day 30

Percentage of subjects with haematological laboratory abnormalities

Timeframe: At Month 6

Percentage of subjects with haematological laboratory abnormalities

Timeframe: At Month 6 + 6 Days

Percentage of subjects with haematological laboratory abnormalities

Timeframe: At Month 6 + 30 Days

Percentage of subjects with haematological laboratory abnormalities

Timeframe: At Month 12

Percentage of subjects with biochemical laboratory abnormalities

Timeframe: At Screening

Percentage of subjects with biochemical laboratory abnormalities

Timeframe: At Day 3

Percentage of subjects with biochemical laboratory abnormalities

Timeframe: At Day 6

Percentage of subjects with biochemical laboratory abnormalities

Timeframe: At Day 30

Percentage of subjects with biochemical laboratory abnormalities

Timeframe: At Month 6

Percentage of subjects with biochemical laboratory abnormalities

Timeframe: At Month 6 + 6 Days

Percentage of subjects with biochemical laboratory abnormalities

Timeframe: At Month 6 + 30 Days

Percentage of subjects with biochemical laboratory abnormalities

Timeframe: At Month 12

Number of subjects with adverse events of specific interest (AESI)

Timeframe: During the 7-Day (Days 0-6) post-vaccination period

Number of subjects with Serious Adverse Events (SAEs)

Timeframe: During the entire study period (up to Month 12)

Secondary outcomes:

Concentrations of anti-glycoprotein Ebola Zaire Virus (anti-GP EBOV)

Timeframe: At Day 0, Day 30, Month 6 and Month 12

Percentage of seronegative/seropositive subjects for anti-GP EBOV antibodies

Timeframe: At Day 0, Day 30, Month 6 and Month 12

Interventions:
  • Biological/vaccine: GlaxoSmithKline (GSK) Biologicals’ investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)
  • Drug: Placebo
  • Enrollment:
    3024
    Primary completion date:
    2016-23-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Milagritos D Tapia, Samba O Sow, Birahim P Ndiaye, Khardiata D Mbaye, Aliou Thiongane, Cheikh T Ndour, Souleymane Mboup, Julie Ake, Babajide Keshinro, Gideon A Akintunde, Thompson Kinge, Guy Vernet, Jean J Bigna, Stephen Oguche, Kwadwo A Koram, Kwaku P Asante, Wayne R Hogrefe, Stephan Günther, Abdi Naficy, Iris De Ryck, Muriel Debois, Patricia Bourguignon, Erik Jongert, William R Ballou, Marguerite Koutsoukos and François Roman on behalf of the Zaire EBola Research Alliance group. Safety, reactogenicity and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in adults in Africa: A randomized, observer-blind, placebo-controlled, phase 2 trial. The Lancet Infectious Diseases. 2020.
    Medical condition
    Virus Diseases
    Product
    GSK3390107A
    Collaborators
    Not applicable
    Study date(s)
    July 2015 to December 2016
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • 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.
    • 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Abuja, Nigeria
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bamako, Mali
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bamenda, Cameroon
    Status
    Study Complete
    Location
    GSK Investigational Site
    Dakar, Senegal
    Status
    Study Complete
    Location
    GSK Investigational Site
    Yaounde, Cameroon
    Status
    Study Complete

    Study documents

    Scientific result summary
    Available language(s): English
    Protocol
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2016-23-12
    Actual study completion date
    2016-23-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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    Access to clinical trial data by researchers
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