Virus DiseasesPhase 2NCT02485301
A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults
A Phase 2 study testing GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) in people with Virus Diseases, run by GlaxoSmithKline at 5 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virus Diseases
- What is being tested?
- GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,024 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 15 Jul 2015to 23 Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Cameroon2 sites
GSK Investigational Site
Bamenda
GSK Investigational Site
Yaoundé
About this study
Official title: Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Adults in Africa
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.
- Conditions
- Virus Diseases
- Being tested
- GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A), Placebo
- Keywords
- Protection against Ebola Zaire virus
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)Biological
A single dose administrated intramuscular
PlaceboDrug
A single dose administrated intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group EBO-Z | Experimental | The subjects in the Group EBO-Z will receive the vaccine at Day 0 of the study Receives: Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) |
| Group Placebo/ EBO-Z | 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 Receives: Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Solicited Local Adverse Events
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.
Measured: During the 7-Day (Days 0-6) post-vaccination period
Number of Subjects With Solicited General Adverse Events
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.
Measured: During the 7-Day (Days 0-6) post-vaccination period
Number of Subjects With Unsolicited Adverse Events (AEs)
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.
Measured: During the 30-Day (Days 0-29) post-vaccination period
Percentage of Subjects With Haematological Laboratory Abnormalities
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.
Measured: At Screening
Percentage of Subjects With Haematological Laboratory Abnormalities
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.
Measured: At Day 3
Percentage of Subjects With Haematological Laboratory Abnormalities
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.
Measured: At Day 6
Percentage of Subjects With Haematological Laboratory Abnormalities
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.
Measured: At Day 30
Percentage of Subjects With Haematological Laboratory Abnormalities
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.
Measured: At Month 6
Percentage of Subjects With Haematological Laboratory Abnormalities
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.
Measured: At Month 6 + 6 Days
Percentage of Subjects With Haematological Laboratory Abnormalities
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.
Measured: At Month 6 + 30 Days
Percentage of Subjects With Haematological Laboratory Abnormalities
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.
Measured: At Month 12
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Measured: At Screening
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Measured: At Day 3
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Measured: At Day 6
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Measured: At Day 30
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Measured: At Month 6
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Measured: At Month 6 + 6 Days
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Measured: At Month 6 + 30 Days
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Measured: At Month 12
Number of Subjects With Adverse Events of Specific Interest (AESI)
AESI included clinical symptoms of thrombocytopenia.
Measured: During the 7-Day (Days 0-6) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
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.
Measured: During the entire study period (up to Month 12)
Secondary outcomes (2)
Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV)
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).
Measured: At Day 0, Day 30, Month 6 and Month 12
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies
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.
Measured: At Day 0, Day 30, Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study start15 Jul 2015
- Primary completion23 Dec 2016
- Study completion23 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virus DiseasesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 3,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485301
- Sponsor's protocol ID
- 202091
- Status last verified
- Nov 2017
- First submitted
- 18 Jun 2015
- Last updated
- 4 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 32199491
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Adults in Africa
- ClinicalTrials.gov ID
- NCT02485301
- Acronym / sponsor ID
- 202091
- Conditions
- Virus Diseases
- Keywords
- Protection against Ebola Zaire virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,024 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2015 (actual)
- Primary completion
- 23 Dec 2016 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Posted 4 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group EBO-Z | Experimental | Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)The subjects in the Group EBO-Z will receive the vaccine at Day 0 of the study |
| Group Placebo/ EBO-Z | Placebo comparator | Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A), Drug: PlaceboThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)A single dose administrated intramuscular | Biological | Group EBO-Z, Group Placebo/ EBO-Z |
| PlaceboA single dose administrated intramuscular | Drug | Group Placebo/ EBO-Z |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV)
Time frame: At Day 0, Day 30, Month 6 and Month 12
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies
Time frame: At Day 0, Day 30, Month 6 and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32199491Tapia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) in people with Virus Diseases, run by GlaxoSmithKline at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Cameroon, Mali, Nigeria, Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Solicited Local Adverse Events (time frame: During the 7-Day (Days 0-6) post-vaccination period). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02485301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2018.