Last reviewed · How we verify

NCT02485301

A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults

Completed Phase 2 Results posted Last updated 4 January 2018
What this trial tests

Phase 2 trial testing GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) in Virus Diseases in 3,024 participants. Completed in 23 December 2016.

Timeline
15 July 2015
Primary endpoint
23 December 2016
23 December 2016

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment3,024
Start date15 July 2015
Primary completion23 December 2016
Estimated completion23 December 2016
Sites5 locations across Senegal, Mali, Cameroon, Nigeria

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Virus Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Solicited Local Adverse Events Primary · 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.

Any Pain
GroupValue95% CI
GSK3390107A Group356
Placebo+GSK3390107A Group57
Grade 3 Pain
GroupValue95% CI
GSK3390107A Group3
Placebo+GSK3390107A Group0
Any Redness
GroupValue95% CI
GSK3390107A Group2
Placebo+GSK3390107A Group0
Grade 3 Redness
GroupValue95% CI
GSK3390107A Group0
Placebo+GSK3390107A Group0
Any Swelling
GroupValue95% CI
GSK3390107A Group9
Placebo+GSK3390107A Group5
Grade 3 Swelling
GroupValue95% CI
GSK3390107A Group0
Placebo+GSK3390107A Group0
Number of Subjects With Solicited General Adverse Events Primary · 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.

Any Fatigue
GroupValue95% CI
GSK3390107A Group284
Placebo+GSK3390107A Group94
Grade 3 Fatigue
GroupValue95% CI
GSK3390107A Group11
Placebo+GSK3390107A Group3
Related Fatigue
GroupValue95% CI
GSK3390107A Group243
Placebo+GSK3390107A Group72
Any Fever
GroupValue95% CI
GSK3390107A Group106
Placebo+GSK3390107A Group24
Grade 3 Fever
GroupValue95% CI
GSK3390107A Group3
Placebo+GSK3390107A Group0
Related Fever
GroupValue95% CI
GSK3390107A Group88
Placebo+GSK3390107A Group17
Any Gastro
GroupValue95% CI
GSK3390107A Group73
Placebo+GSK3390107A Group49
Grade 3 Gastro
GroupValue95% CI
GSK3390107A Group2
Placebo+GSK3390107A Group0
Number of Subjects With Unsolicited Adverse Events (AEs) Primary · 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.

GroupValue95% CI
GSK3390107A Group123
Placebo+GSK3390107A Group119
Percentage of Subjects With Haematological Laboratory Abnormalities Primary · 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.

RBC, Low
GroupValue95% CI
GSK3390107A Group14.6
Placebo+GSK3390107A Group14.2
RBC, Normal
GroupValue95% CI
GSK3390107A Group70.8
Placebo+GSK3390107A Group69.1
RBC, High
GroupValue95% CI
GSK3390107A Group14.6
Placebo+GSK3390107A Group16.6
Neutrophils, Low
GroupValue95% CI
GSK3390107A Group50.2
Placebo+GSK3390107A Group48.3
Neutrophils, Normal
GroupValue95% CI
GSK3390107A Group49.5
Placebo+GSK3390107A Group51.5
Neutrophils, High
GroupValue95% CI
GSK3390107A Group0.3
Placebo+GSK3390107A Group0.2
Lymphocytes, Low
GroupValue95% CI
GSK3390107A Group0.9
Placebo+GSK3390107A Group1.0
Lymphocytes, Normal
GroupValue95% CI
GSK3390107A Group97.8
Placebo+GSK3390107A Group98.0
Percentage of Subjects With Haematological Laboratory Abnormalities Primary · 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.

RBC, Low
GroupValue95% CI
GSK3390107A Group19.0
Placebo+GSK3390107A Group20.4
RBC, Normal
GroupValue95% CI
GSK3390107A Group70.9
Placebo+GSK3390107A Group66.5
RBC, High
GroupValue95% CI
GSK3390107A Group10.2
Placebo+GSK3390107A Group13.1
Neutrophils, Low
GroupValue95% CI
GSK3390107A Group77.9
Placebo+GSK3390107A Group56.8
Neutrophils, Normal
GroupValue95% CI
GSK3390107A Group21.8
Placebo+GSK3390107A Group42.7
Neutrophils, High
GroupValue95% CI
GSK3390107A Group0.3
Placebo+GSK3390107A Group0.5
Lymphocytes, Low
GroupValue95% CI
GSK3390107A Group2.9
Placebo+GSK3390107A Group1.4
Lymphocytes, Normal
GroupValue95% CI
GSK3390107A Group96.4
Placebo+GSK3390107A Group97.8
Percentage of Subjects With Haematological Laboratory Abnormalities Primary · 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.

RBC, Low
GroupValue95% CI
GSK3390107A Group20.6
Placebo+GSK3390107A Group21.5
RBC, Normal
GroupValue95% CI
GSK3390107A Group68.6
Placebo+GSK3390107A Group67.2
RBC, High
GroupValue95% CI
GSK3390107A Group10.8
Placebo+GSK3390107A Group11.3
Neutrophils, Low
GroupValue95% CI
GSK3390107A Group65.2
Placebo+GSK3390107A Group53.5
Neutrophils, Normal
GroupValue95% CI
GSK3390107A Group34.2
Placebo+GSK3390107A Group46.2
Neutrophils, High
GroupValue95% CI
GSK3390107A Group0.5
Placebo+GSK3390107A Group0.3
Lymphocytes, Low
GroupValue95% CI
GSK3390107A Group0.9
Placebo+GSK3390107A Group2.4
Lymphocytes, Normal
GroupValue95% CI
GSK3390107A Group97.8
Placebo+GSK3390107A Group96.2
Percentage of Subjects With Haematological Laboratory Abnormalities Primary · 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.

RBC, Low
GroupValue95% CI
GSK3390107A Group15.8
Placebo+GSK3390107A Group17.4
RBC, Normal
GroupValue95% CI
GSK3390107A Group67.0
Placebo+GSK3390107A Group67.6
RBC, High
GroupValue95% CI
GSK3390107A Group17.2
Placebo+GSK3390107A Group15.0
Neutrophils, Low
GroupValue95% CI
GSK3390107A Group56.4
Placebo+GSK3390107A Group55.6
Neutrophils, Normal
GroupValue95% CI
GSK3390107A Group43.6
Placebo+GSK3390107A Group43.7
Neutrophils, High
GroupValue95% CI
GSK3390107A Group0
Placebo+GSK3390107A Group0.7
Lymphocytes, Low
GroupValue95% CI
GSK3390107A Group2.4
Placebo+GSK3390107A Group2.2
Lymphocytes, Normal
GroupValue95% CI
GSK3390107A Group96.2
Placebo+GSK3390107A Group97.3
Percentage of Subjects With Haematological Laboratory Abnormalities Primary · 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.

RBC, Low
GroupValue95% CI
GSK3390107A Group16.2
Placebo+GSK3390107A Group17.2
RBC, Normal
GroupValue95% CI
GSK3390107A Group69.5
Placebo+GSK3390107A Group67.9
RBC, High
GroupValue95% CI
GSK3390107A Group14.3
Placebo+GSK3390107A Group14.9
Neutrophils, Low
GroupValue95% CI
GSK3390107A Group50.9
Placebo+GSK3390107A Group50.2
Neutrophils, Normal
GroupValue95% CI
GSK3390107A Group48.6
Placebo+GSK3390107A Group49.5
Neutrophils, High
GroupValue95% CI
GSK3390107A Group0.5
Placebo+GSK3390107A Group0.3
Lymphocytes, Low
GroupValue95% CI
GSK3390107A Group1.7
Placebo+GSK3390107A Group1.6
Lymphocytes, Normal
GroupValue95% CI
GSK3390107A Group96.9
Placebo+GSK3390107A Group97.4
Percentage of Subjects With Haematological Laboratory Abnormalities Primary · 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.

RBC, Low
GroupValue95% CI
Placebo+GSK3390107A Group18.6
RBC, Normal
GroupValue95% CI
Placebo+GSK3390107A Group70.1
RBC, High
GroupValue95% CI
Placebo+GSK3390107A Group11.3
Neutrophils, Low
GroupValue95% CI
Placebo+GSK3390107A Group57.4
Neutrophils, Normal
GroupValue95% CI
Placebo+GSK3390107A Group42.4
Neutrophils, High
GroupValue95% CI
Placebo+GSK3390107A Group0.2
Lymphocytes, Low
GroupValue95% CI
Placebo+GSK3390107A Group0.7
Lymphocytes, Normal
GroupValue95% CI
Placebo+GSK3390107A Group97.8
Percentage of Subjects With Haematological Laboratory Abnormalities Primary · 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.

RBC, Low
GroupValue95% CI
Placebo+GSK3390107A Group21.6
RBC, Normal
GroupValue95% CI
Placebo+GSK3390107A Group66.1
RBC, High
GroupValue95% CI
Placebo+GSK3390107A Group12.3
Neutrophils, Low
GroupValue95% CI
Placebo+GSK3390107A Group55.9
Neutrophils, Normal
GroupValue95% CI
Placebo+GSK3390107A Group43.7
Neutrophils, High
GroupValue95% CI
Placebo+GSK3390107A Group0.4
Lymphocytes, Low
GroupValue95% CI
Placebo+GSK3390107A Group2.0
Lymphocytes, Normal
GroupValue95% CI
Placebo+GSK3390107A Group96.3
Percentage of Subjects With Haematological Laboratory Abnormalities Primary · 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.

RBC, Low
GroupValue95% CI
GSK3390107A Group15.3
Placebo+GSK3390107A Group17.9
RBC, Normal
GroupValue95% CI
GSK3390107A Group67.0
Placebo+GSK3390107A Group65.8
RBC, High
GroupValue95% CI
GSK3390107A Group17.7
Placebo+GSK3390107A Group16.3
Neutrophils, Low
GroupValue95% CI
GSK3390107A Group55.0
Placebo+GSK3390107A Group54.0
Neutrophils, Normal
GroupValue95% CI
GSK3390107A Group44.6
Placebo+GSK3390107A Group45.6
Neutrophils, High
GroupValue95% CI
GSK3390107A Group0.4
Placebo+GSK3390107A Group0.4
Lymphocytes, Low
GroupValue95% CI
GSK3390107A Group1.8
Placebo+GSK3390107A Group3.7
Lymphocytes, Normal
GroupValue95% CI
GSK3390107A Group96.9
Placebo+GSK3390107A Group95.0
Percentage of Subjects With Biochemical Laboratory Abnormalities Primary · At Screening

Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.

Aminotransferase, Low
GroupValue95% CI
GSK3390107A Group4.7
Placebo+GSK3390107A Group5.1
Aminotransferase, Normal
GroupValue95% CI
GSK3390107A Group92.9
Placebo+GSK3390107A Group93.3
Aminotransferase, High
GroupValue95% CI
GSK3390107A Group2.4
Placebo+GSK3390107A Group1.6
Creatinine, Low
GroupValue95% CI
GSK3390107A Group0
Placebo+GSK3390107A Group0.4
Creatinine, Normal
GroupValue95% CI
GSK3390107A Group95.2
Placebo+GSK3390107A Group93.6
Creatinine, High
GroupValue95% CI
GSK3390107A Group4.8
Placebo+GSK3390107A Group6.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end (Month 12).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK3390107A Group
Serious: 11/1509 (1%)
Deaths: 1/1509
Placebo+GSK3390107A Group
Serious: 18/1504 (1%)
Deaths: 2/1504

Serious adverse events (27 terms)

ReactionSystemGSK3390107A GroupPlacebo+GSK3390107A Group
Abortion spontaneousPregnancy, puerperium and perinatal conditions——
MalariaInfections and infestations——
Type 2 diabetes mellitusMetabolism and nutrition disorders——
Foetal distress syndromePregnancy, puerperium and perinatal conditions——
GastroenteritisInfections and infestations——
AppendicitisInfections and infestations——
NasopharyngitisInfections and infestations——
PneumoniaInfections and infestations——
Pneumonia bacterialInfections and infestations——
Pulmonary tuberculosisInfections and infestations——
Craniocerebral injuryInjury, poisoning and procedural complications——
Snake biteInjury, poisoning and procedural complications——
Subdural haematomaInjury, poisoning and procedural complications——
Inguinal herniaGastrointestinal disorders——
Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
PneumothoraxRespiratory, thoracic and mediastinal disorders——
Gastroenteritis bacterialInfections and infestations——
InfectionInfections and infestations——
Multiple injuriesInjury, poisoning and procedural complications——
Ovarian cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
Face presentationPregnancy, puerperium and perinatal conditions——
Postpartum haemorrhagePregnancy, puerperium and perinatal conditions——
MacrosomiaGeneral disorders——
Sudden deathGeneral disorders——
Drug-induced liver injuryHepatobiliary disorders——
Other adverse events (5 terms — click to expand)

ReactionSystemGSK3390107A GroupPlacebo+GSK3390107A Group
PainGeneral disorders——
HeadacheNervous system disorders——
FatigueGeneral disorders——
PyrexiaGeneral disorders——
Gastrointestinal disorderGastrointestinal disorders——

Most-reported serious reactions: Abortion spontaneous, Malaria, Type 2 diabetes mellitus, Foetal distress syndrome, Gastroenteritis, Appendicitis, Nasopharyngitis, Pneumonia.

Data from ClinicalTrials.gov NCT02485301 adverse events section.

Sponsor's own 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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. New Vaccine Technologies to Combat Outbreak Situations.
    Rauch S, Jasny E, Schmidt KE, Petsch B. · · 2018 · cited 380× · PMID 30283434 · DOI 10.3389/fimmu.2018.01963
  2. Ebola: Lessons on Vaccine Development.
    Feldmann H, Feldmann F, Marzi A. · · 2018 · cited 40× · PMID 30200851 · DOI 10.1146/annurev-micro-090817-062414
  3. Ebola vaccines in clinical trial: The promising candidates.
    Wang Y, Li J, Hu Y, Liang Q, et al · · 2017 · cited 40× · PMID 27764560 · DOI 10.1080/21645515.2016.1225637
  4. Vaccines against Ebola virus and Marburg virus: recent advances and promising candidates.
    Suschak JJ, Schmaljohn CS. · · 2019 · cited 37× · PMID 31589088 · DOI 10.1080/21645515.2019.1651140
  5. Ebola virus disease candidate vaccines under evaluation in clinical trials.
    Martins KA, Jahrling PB, Bavari S, Kuhn JH. · · 2016 · cited 37× · PMID 27160784 · DOI 10.1080/14760584.2016.1187566
  6. Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in adults in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial.
    Tapia MD, Sow SO, Ndiaye BP, Mbaye KD, et al · · 2020 · cited 33× · PMID 32199491 · DOI 10.1016/s1473-3099(20)30016-5
  7. Ebola response in Sierra Leone: The impact on children.
    Fitzgerald F, Awonuga W, Shah T, Youkee D. · · 2016 · cited 12× · PMID 27177732 · DOI 10.1016/j.jinf.2016.04.016

Verify or expand the search:

Other trials of GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)

Trials testing the same drug.

Other recruiting trials for Virus Diseases

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02485301.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing