Overview

This trial is active, not recruiting.

Condition virus diseases
Treatments glaxosmithkline (gsk) biologicals' investigational recombinant chimpanzee adenovirus type 3-vectored ebola zaire vaccine (chad3-ebo-z) (gsk3390107a), placebo
Phase phase 2
Sponsor GlaxoSmithKline
Start date July 2015
End date December 2016
Trial size 2796 participants
Trial identifier NCT02485301, 202091

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
The subjects in the Group EBO-Z will receive the vaccine at Day 0 of the study
glaxosmithkline (gsk) biologicals' investigational recombinant chimpanzee adenovirus type 3-vectored ebola zaire vaccine (chad3-ebo-z) (gsk3390107a)
A single dose administrated intramuscular
(Placebo Comparator)
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
glaxosmithkline (gsk) biologicals' investigational recombinant chimpanzee adenovirus type 3-vectored ebola zaire vaccine (chad3-ebo-z) (gsk3390107a)
A single dose administrated intramuscular
placebo
A single dose administrated intramuscular

Primary Outcomes

Measure
Occurrence of each solicited local and general AE
time frame: Up to Day 7 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: Up to Day 30 after each vaccination (i.e. the day of vaccination and 29 subsequent days), in a sub-cohort of 750 subjects per group.
Occurrence of any SAE, in all subjects, in both groups
time frame: From Day 0 to study end at Month 24
Occurrence of clinical symptoms of thrombocytopenia (AE of specific interest)
time frame: Up to Day 7 after vaccination at Day 0 (i.e. Day 0 up to Day 6).
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count)
time frame: At Screening (Day 0)
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count)
time frame: At Day 3
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count)
time frame: At Day 6
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count)
time frame: At Day 30
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count)
time frame: At Month 6
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count)
time frame: At Month 12
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count)
time frame: At Month 6 + 6 days in a sub cohort of 750 subjects in the Group Placebo/ EBO-Z.
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count)
time frame: At Month 6 + 30 days in a sub cohort of 750 subjects in the Group Placebo/ EBO-Z.
Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
time frame: At Screening (Day 0)
Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
time frame: At Day 3
Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
time frame: At Day 6
Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
time frame: At Month 30
Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
time frame: At Month 6
Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
time frame: At Month 12
Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
time frame: At Month 6 + 6 days in a sub cohort of 750 subjects in the Group Placebo/ EBO-Z.
Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
time frame: At Month 6 + 30 days in a sub cohort of 750 subjects in the Group Placebo/ EBO-Z.

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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 information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.