Partnership for Research on Ebola VACcinations

Phase 1

• Conditions: Ebola virus disease (EVD); MedDRA version: 21.1Level: LLTClassification code 10014074Term: Ebola virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-001798-18-Outside-EU/EEA
• Lead Sponsor: Inserm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-10
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Informed consent/assent
- Age greater than or equal to 1 year
- Planned residency in the area of the study site for the next 12 months
- Willingness to comply with the protocol requirements
Are the trial subjects under 18? yes
Number of subjects for this age range: 1400
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Fever greater than 38º Celsius
- History of EVD (self-report)
- Pregnancy (a negative urine pregnancy test is required for females of child-bearing potential, i.e., females who have experienced menarche or who are aged 14 years and older)
- Positive HIV test for participants less than 18 years of age
- Reported current breast-feeding
- Prior vaccination against Ebola (self-report)
- Any vaccination in the past 28 days or planned within the 28 days after randomization (initial vaccination)
- In the judgement of the clinician, any clinically significant acute/chronic condition that would limit the ability of the participant to meet the requirements of the study protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Antibody response 12 months after randomization;Secondary Objective: - antibody response at 7, 14, 28, 56, 63 days and at 3, 6, 24, 36, 48, 60 months after randomization<br>- serious adverse events up to 60 months after randomization<br>- injection site reactions and adverse events at the prime- and booster-vaccination visits, during the first week following randomization and through 7, 14, and 28 days and through 3 months<br>- changes in biochemical markers and complete blood count measurements at 7 and 63 days after randomization (children only)<br>- operational research including ethnographic, participatory and/or qualitative<br>- analyze the early vaccine signature, identify early correlates of durable antibody responses and propose in silico methods to optimally allocate vaccine strategies at the individual level;Primary end point(s): GP-EBOV antibody response;Timepoint(s) of evaluation of this end point: 12 months after randomization

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): There are a number of secondary endpoints. Antibody levels will be determined at multiple time points to assess the immediacy and long-term durability of the response. SAEs through 60 months will be collected. AEs of lesser severity, including injection site reactions and targeted symptoms, will be collected following the initial vaccination and following the booster. In addition, substudies will examine a) T cell and memory B cell changes, b) viral shedding and c) the relationship between the levels of exposure to malaria and helminth infections and the rate of decline in antibody titre to Ebola.;Timepoint(s) of evaluation of this end point: Up to 60 months after randomization