Last updated: 04/13/2020 09:50:11
A study to evaluate the safety and immunogenicity of a candidate Ebola Vaccine in adults
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2016-23-12
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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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).
Exclusion criteria:
- 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.
- Pregnant female.
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.
Any unstable chronic medical condition (e.g. uncontrolled asthma).
Trial location(s)
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
Completed
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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