Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06126822
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-10-05
Brief Title:
Safety and Immunogenicity of Ervebo and Zabdeno Booster Vaccines Against Ebola Virus Following Previous Vaccination With the ZabdenoMvabea or Ervebo Vaccine Schedules in DRC
Sponsor:
Institute of Tropical Medicine Belgium
Organization:
Institute of Tropical Medicine Belgium
Study Overview
Official Title:
Safety and Immunogenicity of Ervebo and Zabdeno Booster Vaccines Against Ebola Virus Following Previous Vaccination With the ZabdenoMvabea or Ervebo Vaccine Schedules in DRC a Mix-and-match Phase II RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EBO-BOOST
Brief Summary:
The goal of this randomized controlled trial is to investigate whether individuals in DRC previously vaccinated with ZabdenoMvabea or Ervebo vaccine schedules against Ebola virus can be safely and adequately boosted with homologous or heterologous vaccine schedules
Participants will be randomized to receive either a homologous or heterologous vaccine schedule and will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of immunological responses against Ebola virus between both schedules Safety and tolerability of the vaccines will be evaluated by recording Adverse Events AEs and grading physical and vital signs evaluations
Participants will be randomized to receive either a homologous or heterologous vaccine schedule and will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of immunological responses against Ebola virus between both schedules Safety and tolerability of the vaccines will be evaluated by recording Adverse Events AEs and grading physical and vital signs evaluations
Detailed Description:
The aim of this randomized controlled with four arms is to investigate whether individuals previously vaccinated with ZabdenoMvabea or Ervebo vaccine schedules against Ebola virus can be safely and adequately boosted with homologous and heterologous vaccine schedules We hypothesize that heterologous booster vaccine schedules generate a non-inferior boosting in antibodies and cellular responses against Ebola virus as compared to homologous schedules and incite a similar safety profile
Based on the predefined variables living place and time since vaccination the research team will pre-select and re-contact individuals previously included in the Phase III EBOVAC vaccine database EBOSURV participant database and the Programme Élargi de Vaccination PEV database Participants will be contacted by phone and if they agree to participate they are scheduled on predefined screeningrecruitment days taken place at the 2 recruitment sites INRB Goma and INRB Kinshasa
A total of 624 participants will be included 312 will be previously vaccinated with ZabdenoMvabea and 312 participants with Ervebo Within those two groups half of the participants n156 will be randomized to a single Ervebo booster vaccine and the other half n156 to a single Zabdeno booster vaccine Participants will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of antibody- and cellular response against EBOV between homologous and heterologous schedules Safety and tolerability of the vaccines will be evaluated by recording Adverse Events AEs and grading physical and vital signs evaluations An additional 50 non-vaccinated participants will be recruited in Kinshasa for assay optimization
In case of insufficient participants living close to the recruitment centers a community outreach will be undertaken with a lower amount of visits for logistical reasons
Based on the predefined variables living place and time since vaccination the research team will pre-select and re-contact individuals previously included in the Phase III EBOVAC vaccine database EBOSURV participant database and the Programme Élargi de Vaccination PEV database Participants will be contacted by phone and if they agree to participate they are scheduled on predefined screeningrecruitment days taken place at the 2 recruitment sites INRB Goma and INRB Kinshasa
A total of 624 participants will be included 312 will be previously vaccinated with ZabdenoMvabea and 312 participants with Ervebo Within those two groups half of the participants n156 will be randomized to a single Ervebo booster vaccine and the other half n156 to a single Zabdeno booster vaccine Participants will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of antibody- and cellular response against EBOV between homologous and heterologous schedules Safety and tolerability of the vaccines will be evaluated by recording Adverse Events AEs and grading physical and vital signs evaluations An additional 50 non-vaccinated participants will be recruited in Kinshasa for assay optimization
In case of insufficient participants living close to the recruitment centers a community outreach will be undertaken with a lower amount of visits for logistical reasons
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None