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

NCT ID: NCT02548078

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-09
• Study Completion Date: 2017-05-15

Brief Summary

The purpose of this study is to assess the safety and reactogenicity of a single IM dose of the GSK3390107A (ChAd3 EBO-Z) vaccine, overall and in children aged 1 to 5, 6 to 12, and 13 to 17 years, separately.

Considering the risk of exposure to Ebola and the potential (based on animal data) for the investigational GSK3390107A (ChAd3-EBO-Z) vaccine to afford at least partial protection, all children in the study will receive the investigational GSK3390107A (ChAd3 EBO-Z) vaccine. The children in the Group GSK3390107A+Nimenrix will receive the investigational GSK3390107A (ChAd3-EBO-Z) vaccine at Day 0 of the study, whereas the children in the Group Nimenrix+GSK3390107A will receive Nimenrix at Day 0 (as a control). At Month 6, the children in the Group Nimenrix+GSK3390107A will receive the investigational GSK3390107A (ChAd3-EBO-Z) vaccine (provided that no safety concerns are raised), whereas the children in the Group GSK3390107A+Nimenrix will receive Nimenrix.

Conditions

Virus Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

GSK3390107A+Nimenrix Group

Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

A single dose administered intramuscular

Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine

Intervention Type: BIOLOGICAL

A single dose administered intramuscular

Nimenrix+GSK3390107A Group

Subjects in the Nimenrix +GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

A single dose administered intramuscular

Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine

Intervention Type: BIOLOGICAL

A single dose administered intramuscular

Interventions

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

A single dose administered intramuscular

Intervention Type: BIOLOGICAL

Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine

A single dose administered intramuscular

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subject's parent(s)/ legally acceptable representative(s) (LAR[s]) who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g. 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' parent(s)/ LAR[s] prior to performing any study specific procedure. In addition, written/ thumb printed in-formed assent should be obtained if appropriate (from all subjects aged 13 to 17 years and from younger subjects as per local requirements).
• A male or female child aged 1 to 17 years inclusive at the time of Screening.
• Subjects with a negative RDT test for Malaria within 30 days prior to randomisation into the study.

OR Subjects with a positive RDT test for Malaria who completed antimalarial treatment at least 5 days prior to randomisation into the study.

• Healthy subjects as per Investigator judgement, as estab-lished by medical history, clinical examination and haema-tology/ biochemistry laboratory parameters screening be-fore entering into the study.
• Female subjects of non-childbearing potential may be enrolled in the study.

• Non-childbearing potential is defined as pre-menarche or ovariectomy.
• 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

• Child in care.
• 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 chim-panzee adenoviral vectored investigational vaccine.
• Known prior EBOV or SUDV disease.
• Travel to country affected by the EBOV epidemic or direct contact with person with EVD within 21 days prior to the Day 0 visit.
• History of any reaction or hypersensitivity (such as ana-phylaxis, urticaria (hives), respiratory difficulty, angioe-dema, 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.
• Acute or chronic illness determined by medical history, clinical examination and laboratory screening tests in-cluding, but not limited to:
• Clinically significant immunosuppressive or immunodeficient condition (e.g. clinical acquired immune deficiency syndrome [AIDS]).
• Major congenital defects.
• Malnutrition (defined as weight for age Z-score less than -3, or other clinical signs of malnutrition).
• Any clinically significant haematological or biochemical laboratory abnormality.
• Pregnant female.
• Any condition that in the Investigator's opinion may po-tentially compromise subject safety or interfere with sub-ject assessment or compliance.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Bamako, , Mali

GSK Investigational Site

Dakar, , Senegal

Countries

Mali; Senegal

References

Tapia MD, Sow SO, Mbaye KD, Thiongane A, Ndiaye BP, Ndour CT, Mboup S, Keshinro B, Kinge TN, Vernet G, Bigna JJ, Oguche S, Koram KA, Asante KP, Gobert P, Hogrefe WR, 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 children in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2020 Jun;20(6):719-730. doi: 10.1016/S1473-3099(20)30019-0. Epub 2020 Mar 19.

Reference Type: DERIVED

PMID: 32199492 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014-004714-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

202090

Identifier Type: -

Identifier Source: org_study_id