Clinical trial NCT02485301: A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults
Official title: Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Adults in Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Virus Diseases
Keywords: Protection against Ebola Zaire virus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-06-30
Enrollment: 3024
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Number of Subjects With Solicited Local Adverse Events
timeFrame: During the 7-Day (Days 0-6) post-vaccination period
measure: Number of Subjects With Solicited General Adverse Events
timeFrame: During the 7-Day (Days 0-6) post-vaccination period
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 30-Day (Days 0-29) post-vaccination period
measure: Percentage of Subjects With Haematological Laboratory Abnormalities
timeFrame: At Screening
measure: Percentage of Subjects With Haematological Laboratory Abnormalities
timeFrame: At Day 3
measure: Percentage of Subjects With Haematological Laboratory Abnormalities
timeFrame: At Day 6
measure: Percentage of Subjects With Haematological Laboratory Abnormalities
timeFrame: At Day 30
measure: Percentage of Subjects With Haematological Laboratory Abnormalities
timeFrame: At Month 6
measure: Percentage of Subjects With Haematological Laboratory Abnormalities
timeFrame: At Month 6 + 6 Days
measure: Percentage of Subjects With Haematological Laboratory Abnormalities
timeFrame: At Month 6 + 30 Days
measure: Percentage of Subjects With Haematological Laboratory Abnormalities
timeFrame: At Month 12
measure: Percentage of Subjects With Biochemical Laboratory Abnormalities
timeFrame: At Screening
measure: Percentage of Subjects With Biochemical Laboratory Abnormalities
timeFrame: At Day 3
measure: Percentage of Subjects With Biochemical Laboratory Abnormalities
timeFrame: At Day 6
measure: Percentage of Subjects With Biochemical Laboratory Abnormalities
timeFrame: At Day 30
measure: Percentage of Subjects With Biochemical Laboratory Abnormalities
timeFrame: At Month 6
measure: Percentage of Subjects With Biochemical Laboratory Abnormalities
timeFrame: At Month 6 + 6 Days
measure: Percentage of Subjects With Biochemical Laboratory Abnormalities
timeFrame: At Month 6 + 30 Days
measure: Percentage of Subjects With Biochemical Laboratory Abnormalities
timeFrame: At Month 12
measure: Number of Subjects With Adverse Events of Specific Interest (AESI)
timeFrame: During the 7-Day (Days 0-6) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (up to Month 12)
Secondary outcomes:
measure: Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV)
timeFrame: At Day 0, Day 30, Month 6 and Month 12
measure: Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies
timeFrame: At Day 0, Day 30, Month 6 and Month 12
Other outcomes:
Locations:
city: Bamenda
country: Cameroon
facility: GSK Investigational Site
city: Yaounde
country: Cameroon
facility: GSK Investigational Site
city: Bamako
country: Mali
facility: GSK Investigational Site
city: Abuja
country: Nigeria
facility: GSK Investigational Site
city: Dakar
country: Senegal
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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, Gunther 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.