Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT03031912
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-27
First Post:
2016-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola
Sponsor:
Cecile Tremblay
Organization:
Study Overview
Official Title:
A Phase 2 Randomized, Multi-Center Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine Candidate in HIV-Infected Adults and Adolescents
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This is a randomized, placebo-controlled, multi-site, double-blind trial of V920 (rVSVΔG-ZEBOV-GP) Ebola Virus vaccine candidate in subjects with HIV infection to be conducted in conformance with Good Clinical Practices. The study will take place at 2 Canadian sites (Centre Hospitalier de l'Université de Montréal and Ottawa General Hospital) and 2 African sites (Centre MURAZ, Burkina Faso and Centre Hospitalier National Aristide Le Dantec, Dakar, Senegal). The Duration of Study: 365 days for each participant not including screening.
Detailed Description:
The study will enroll approximately 250 participants, \~100 at 2 sites in Canada and \~100 at 2 sites in Africa. Overall \~200 participants will receive the study vaccine and 50 will receive a placebo . Sequential enrollment of five study cohorts will occur over time at each study site according to CD4 T-cell counts: Group 1 will include adult subjects with CD4 ≥ 500 cells/mm3, Group 2 CD4 \> 350 and \< 500 cells/mm3, Group 3 CD4 ≥ 200 and ≤ 350 cells/mm3, Group 4 adolescents CD4 ≥ 200 cells/mm3, and Group 5 adults and adolescents CD4 ≥ 200 cells/mm3. Enrolment and vaccine administration will begin with the group with the highest CD4 count. When the D42 post-vaccination period is completed for all subjects in Group 1, and the Data Safety Monitoring Board (DSMB) has reviewed the safety data and determined that there are no concerns, enrolment and vaccination of the next CD4 cohort may begin. Similarly, when the D42 safety data for Group 2 has been reviewed/approved by the DSMB, enrolment and vaccination of participants in Group 3 may begin. Adolescents 13-17 years of age (inclusive) with CD4 ≥ 200 will be enrolled after D42 safety is reviewed in adults with CD4 ≥ 200. Adolescents 13-17 years of age (inclusive) and adults with CD4 ≥ 200 will be enrolled after D42 safety is reviewed in adolescents with CD4 ≥ 200.Within each group, participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of the study vaccine or the placebo in a ratio of 4 to 1 (160:40). Participants will complete memory aids for 42 days following vaccination.
Specific procedures to be performed during the trial, as well as their prescribed times and associated visit windows, are outlined in the Trial Flow Chart - Section 6.0. Details of each procedure are provided in Section 7.0 - Trial Procedures.
This trial will use an adaptive design based on pre-specified criteria, using an independent, external DSMB to monitor safety and immunogenicity. There will be 3 formal safety analyses performed by the DSMB. Data for at least 75% of participants must be available for each analysis. The first safety analysis will be conducted when the first group (CD4 ≥ 500 cells/mm3) will have completed 42 days of follow-up post vaccination. The second safety analysis will be conducted when the second group (CD4 \> 350 and \< 500 cells/mm3) will have completed 42 days of follow-up post vaccination. The third safety analysis will be conducted when the third group (Adults CD4 ≥ 200 and ≤ 350 cells/mm3) will have completed 42 days of follow-up post vaccination. The fourth safety analysis will be conducted when the fourth group (Adolescents CD4 ≥ 200) will have completed 42 days of follow-up post vaccination.
Results of the safety analysis will be reviewed by the DSMB, which will make recommendations to the Sponsor to continue, modify or end the trial according to the plan described briefly in Section 2.2 - Trial Diagram and in detail in Section 8.0 - Statistical Analysis Plan. In case of an outbreak of Ebola Zaire the DSMB may recommend to vaccinate subjects randomized to receive placebo with V920 provided at least 84 days of SAE follow-up is conducted.
Specific procedures to be performed during the trial, as well as their prescribed times and associated visit windows, are outlined in the Trial Flow Chart - Section 6.0. Details of each procedure are provided in Section 7.0 - Trial Procedures.
This trial will use an adaptive design based on pre-specified criteria, using an independent, external DSMB to monitor safety and immunogenicity. There will be 3 formal safety analyses performed by the DSMB. Data for at least 75% of participants must be available for each analysis. The first safety analysis will be conducted when the first group (CD4 ≥ 500 cells/mm3) will have completed 42 days of follow-up post vaccination. The second safety analysis will be conducted when the second group (CD4 \> 350 and \< 500 cells/mm3) will have completed 42 days of follow-up post vaccination. The third safety analysis will be conducted when the third group (Adults CD4 ≥ 200 and ≤ 350 cells/mm3) will have completed 42 days of follow-up post vaccination. The fourth safety analysis will be conducted when the fourth group (Adolescents CD4 ≥ 200) will have completed 42 days of follow-up post vaccination.
Results of the safety analysis will be reviewed by the DSMB, which will make recommendations to the Sponsor to continue, modify or end the trial according to the plan described briefly in Section 2.2 - Trial Diagram and in detail in Section 8.0 - Statistical Analysis Plan. In case of an outbreak of Ebola Zaire the DSMB may recommend to vaccinate subjects randomized to receive placebo with V920 provided at least 84 days of SAE follow-up is conducted.
Study Oversight
Has Oversight DMC:
True
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?: