Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-02 @ 6:00 AM
Study NCT ID:
NCT05909358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-18
First Post:
2023-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Solidarity/Tokomeza Ebola Trial
Sponsor:
Makerere University
Organization:
Study Overview
Official Title:
A Phase I/II Randomized Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Sudan Ebolavirus Vaccines in Uganda
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
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:
TOKOMEZA
Brief Summary:
The TokomezaPlus Ebola trial is a phase I/II double blind randomised clinical trial designed to assess the safety and immunogenicity of candidate SUDV vaccines in Uganda during the inter outbreak period. Uganda is prone to Ebola virus disease outbreaks especially those caused by the Ebola Sudan (SUDV) species. TokomezaPlus Ebola Vaccine trial protocol has two main components: a) Safety b) Immunogenicity and is designed to create a living protocol that will be used to study the safety and immunogenicity of SUDV-candidate vaccines in the East African EVD-prone countries.
Detailed Description:
The Sudan ebolavirus and the Zaire ebolavirus are classified as different species, and vaccines and monoclonal antibodies that are effective against Zaire ebolavirus disease are unlikely to be of any use against SUVD. But, the epidemiology of SUVD is thought to be similar to that of Zaire ebolavirus disease.
There is an urgent need to test the safety and immunogenicity of the candidate vaccine(s) developed against Sudan ebolavirus. Once safety and immunogenicity (including extended immunogenicity) have been proven, these vaccines could be deployed for future outbreaks as part of the response.
OBJECTIVES Phase 1 Objectives
1. To determine the safety of rVSV-SUDV candidate SUDV vaccine among healthy volunteers
2. To determine the immunogenicity of rVSV-SUDV candidate SUDV vaccine
Phase 2 Primary objectives
1. To determine the safety of ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccine(s) among healthy volunteers and persons with stable comorbidities.
2. To determine the immunogenicity of the three candidate SUDV vaccines.
Secondary objectives
1. To determine the durability of SUDV-specific induced immune responses following vaccination with ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccine(s).
2. To determine the factors associated with vaccine-induced immune responses.
3. To determine the putative cross reactivity \& protection exerted by the SUDV vaccine candidates against other ebolaviruses (e. g. Bundibugyo ebolavirus (BUDV) and EBOV).
Exploratory objectives
1. To determine the effect of SUDV vaccines on host gene expression
2. To determine the T and B cell specific responses and immune profiling in response to vaccination
3. To determine the effect of SUDV vaccines on the host metabolome
4. To determine the effect of SUDV vaccines on host immune responses
END POINTS
Primary Endpoints
1. Number of solicited, unsolicited adverse and serious adverse events that are determined as possibly, probably and definitely related to the investigational products.
2. Binding antibody titres, neutralization activity and cell mediated immune responses.
Secondary Endpoints
1. Durability of SUDV-specific induced immune responses following vaccination.
2. Factors associated with vaccine-induced immune responses.
3. To determine the putative cross reactivity \& protection exerted by the SUDV vaccine candidates against other ebolaviruses (e. g. Bundibugyo ebolavirus (BUDV) and EBOV).
TRIAL PARTICIPANTS This trial will enroll a total 250 healthy, adult volunteers (18-50 years) (150 intervention arm and 100 placebo arm) for the phase I rVSV-SUDV vaccine. The DSMB will review day 28 post vaccination safety data for all the phase I participants and day 56 post vaccination binding antibody IgG and IgM data for 50 participants randomly selected who receive the rVSV SUDV and 10 participants who receive the placebo to make a recommendation regarding proceeding to phase II. Participants enrolled in phase I of the rVSV-SUDV candidate vaccine will contribute data to phase II for this vaccine. For the Phase II trial (ChAdox1, CAd3 and rVSV-SUDV vaccines), 2121 volunteers aged 6 - 65 years will be included (606 for each of the vaccine arms and 303 to placebo). A randomly selected subset of120 participants per vaccine and 50 placebo recipients will participate in extended immunogenicity studies (long term immunogenicity and exploratory studies). 100 participants from each intervention arm participating in extended immunogenicity will randomly be selected to receive a homologous booster 12months post vaccination.
STATISTICAL ANALYSIS The primary analysis is the comparison of occurrence of solicited (within 7 days) and unsolicited adverse events (occurring within 56 days) considered possibly, probably or definitely related to vaccines as well as adverse and SAEs occurring within 24 months' post-vaccination between each candidate vaccine and placebo. AEs will be summarized with counts, percentages, and, when provided, exact 95% CIs will be provided. SAEs will be graded according to DAIDS. The primary analysis for the immunogenicity is the change in serum IgG and IgM titres from baseline to 56days post vaccination.
There is an urgent need to test the safety and immunogenicity of the candidate vaccine(s) developed against Sudan ebolavirus. Once safety and immunogenicity (including extended immunogenicity) have been proven, these vaccines could be deployed for future outbreaks as part of the response.
OBJECTIVES Phase 1 Objectives
1. To determine the safety of rVSV-SUDV candidate SUDV vaccine among healthy volunteers
2. To determine the immunogenicity of rVSV-SUDV candidate SUDV vaccine
Phase 2 Primary objectives
1. To determine the safety of ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccine(s) among healthy volunteers and persons with stable comorbidities.
2. To determine the immunogenicity of the three candidate SUDV vaccines.
Secondary objectives
1. To determine the durability of SUDV-specific induced immune responses following vaccination with ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccine(s).
2. To determine the factors associated with vaccine-induced immune responses.
3. To determine the putative cross reactivity \& protection exerted by the SUDV vaccine candidates against other ebolaviruses (e. g. Bundibugyo ebolavirus (BUDV) and EBOV).
Exploratory objectives
1. To determine the effect of SUDV vaccines on host gene expression
2. To determine the T and B cell specific responses and immune profiling in response to vaccination
3. To determine the effect of SUDV vaccines on the host metabolome
4. To determine the effect of SUDV vaccines on host immune responses
END POINTS
Primary Endpoints
1. Number of solicited, unsolicited adverse and serious adverse events that are determined as possibly, probably and definitely related to the investigational products.
2. Binding antibody titres, neutralization activity and cell mediated immune responses.
Secondary Endpoints
1. Durability of SUDV-specific induced immune responses following vaccination.
2. Factors associated with vaccine-induced immune responses.
3. To determine the putative cross reactivity \& protection exerted by the SUDV vaccine candidates against other ebolaviruses (e. g. Bundibugyo ebolavirus (BUDV) and EBOV).
TRIAL PARTICIPANTS This trial will enroll a total 250 healthy, adult volunteers (18-50 years) (150 intervention arm and 100 placebo arm) for the phase I rVSV-SUDV vaccine. The DSMB will review day 28 post vaccination safety data for all the phase I participants and day 56 post vaccination binding antibody IgG and IgM data for 50 participants randomly selected who receive the rVSV SUDV and 10 participants who receive the placebo to make a recommendation regarding proceeding to phase II. Participants enrolled in phase I of the rVSV-SUDV candidate vaccine will contribute data to phase II for this vaccine. For the Phase II trial (ChAdox1, CAd3 and rVSV-SUDV vaccines), 2121 volunteers aged 6 - 65 years will be included (606 for each of the vaccine arms and 303 to placebo). A randomly selected subset of120 participants per vaccine and 50 placebo recipients will participate in extended immunogenicity studies (long term immunogenicity and exploratory studies). 100 participants from each intervention arm participating in extended immunogenicity will randomly be selected to receive a homologous booster 12months post vaccination.
STATISTICAL ANALYSIS The primary analysis is the comparison of occurrence of solicited (within 7 days) and unsolicited adverse events (occurring within 56 days) considered possibly, probably or definitely related to vaccines as well as adverse and SAEs occurring within 24 months' post-vaccination between each candidate vaccine and placebo. AEs will be summarized with counts, percentages, and, when provided, exact 95% CIs will be provided. SAEs will be graded according to DAIDS. The primary analysis for the immunogenicity is the change in serum IgG and IgM titres from baseline to 56days post vaccination.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: