Ignite Creation Date:
2024-05-06 @ 1:01 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01712425
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2012-10-04
Brief Title:
Safety and Immunogenicity of ChAdV63HIVconsv and MVAHIVconsv Candidate HIV-1 Vaccines in Recently HIV-1 Infected Individuals
Sponsor:
IrsiCaixa
Organization:
IrsiCaixa
Study Overview
Official Title:
Safety and Immunogenicity of ChAdV63HIVconsv and MVAHIVconsv Candidate HIV-1 Vaccines in Recently HIV-1 Infected Individuals With Early Viral Suppression After Initiation of Antiretroviral Therapy HAART
Status:
COMPLETED
Status Verified Date:
2024-05
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:
The HIVconsv gene was constructed by assembling the 14 most conserved regions of the HIV-1 proteome into one chimaeric protein This gene has been inserted into 2 leading non-replicating vaccine vectors an attenuated chimpanzee adenovirus serotype 63 ChAdV63 and a modified vaccinia virus Ankara MVA to construct the ChAdV63HIVconsv and MVAHIVconsv HIV-1 candidate vaccines The present study is named ChAd-MVAHIVconsv-BCN01 and it is a phase I multicenter primarybooster therapeutic vaccination study to evaluate the safety and immunogenicity of ChAdV63HIVcons and MVAHIVconsv HIV-1 vaccines delivered intramuscularly according to a 0-8 weeks or a 0-24 weeks schedule to recently HIV-1 infected individuals with early viral suppression 6 months after initiation of TenofovirEmtricitabine plus Raltegravir
Detailed Description:
It is a Phase I multicenter primarybooster therapeutic vaccination study to evaluate the safety and immunogenicity of ChAdV63HIVcons and MVAHIVconsv HIV-1 vaccines delivered intramuscularly according to a 0-8 weeks or a 0-24 weeks schedule to recently HIV-1 infected individuals with early viral suppression 6 months after initiation of TenofovirEmtricitabine plus Raltegravir
24 patients who meet all eligibility criteria will be enrolled first 10 individuals will be assigned in the 0-24 week primeboost regimen ARM A The next 10 volunteers will be assigned in the 0-8 week primeboost regimen ARM BFour additional volunteers will be included as back-up and assigned 2 in ARM A and 2 in ARM B to cover a possible 10 of patients who drop-off during the follow-up Purpose of staging of 2 study arms is just to shorten overall study duration from screening of first volunteer to 6 months after last immunisation of last volunteer
Lastly 24 patients who also meet all eligibility criteria will be enrolled as controls will also initiate promptly antiretroviral treatment with TenofovirEmtricitabine plus Raltegravir but will not receive the investigational vaccines Control patients will consecutively be assigned to the 0-24w control arm ARM C long control or 0-8w control arm ARM D short control until 12 patients per arm are reached The purpose of the control arms is to have a study population to compare the viral reservoir decay kinetics in the absence of vaccination
24 patients who meet all eligibility criteria will be enrolled first 10 individuals will be assigned in the 0-24 week primeboost regimen ARM A The next 10 volunteers will be assigned in the 0-8 week primeboost regimen ARM BFour additional volunteers will be included as back-up and assigned 2 in ARM A and 2 in ARM B to cover a possible 10 of patients who drop-off during the follow-up Purpose of staging of 2 study arms is just to shorten overall study duration from screening of first volunteer to 6 months after last immunisation of last volunteer
Lastly 24 patients who also meet all eligibility criteria will be enrolled as controls will also initiate promptly antiretroviral treatment with TenofovirEmtricitabine plus Raltegravir but will not receive the investigational vaccines Control patients will consecutively be assigned to the 0-24w control arm ARM C long control or 0-8w control arm ARM D short control until 12 patients per arm are reached The purpose of the control arms is to have a study population to compare the viral reservoir decay kinetics in the absence of vaccination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-000846-39 | EUDRACT_NUMBER | None | None |