Ignite Creation Date:
2024-05-06 @ 4:07 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02457689
Status:
COMPLETED
Last Update Posted:
2016-11-10
First Post:
2015-05-27
Brief Title:
The Safety and Immunogenicity of the DNA-GTU Vaccine Administered to HIV-infected Patients on ART vs Placebo
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
A Randomized Phase III Study to Assess the Safety and Immunogenicity of the DNA-GTU Vaccine Administered by Two Novel Routes Compared to Placebo in HIV-infected Patients on Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2016-10
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:
CUTHIVTHER001
Brief Summary:
CUTHIVTHER 001 is a randomised placebo-controlled Phase III study aimed at exploring the safety and immunogenicity of two different modes of delivery of a GTU DNA plasmid vaccine GTU-multiHIV B clade in HIV infected volunteers on antiretroviral therapy ART
Transcutaneous TC delivery to enhance intramuscular delivery and
Electroporation EP enhanced intramuscular delivery Participants will be randomised 111 to TCEPsaline for the purposes of analysis Half the saline group will receive TC saline and half will receive EP saline
30 HIV infected male and female volunteers aged 18-45 years who have been on ART for at least 6 months with 2 or more HIV plasma viral load measurements 50 copies HIV RNAml prior to enrolment
The investigational HIV-1 vaccine GTU-MultiHIV B clade encodes for a MultiHIV antigen which is a synthetic fusion protein consisting of full-length polypeptides of Rev Nef Tat p17 and p24 and containing more than 20 Th and CTL epitopes of protease reverse transcriptase RT and gp160 regions of the HAN2 HIV-1 B clade
Vaccine is provided in sealed vials at 2mgml and a single 1ml IM injection of 2mg GTU-MultiHIV DNA IM into the thigh is required to deliver a 2mg dose Individuals in Group 2 will receive a further 04mg GTU-MultiHIV DNA in 02ml administered by TC a novel needle-free method of vaccine delivery
Transcutaneous TC delivery to enhance intramuscular delivery and
Electroporation EP enhanced intramuscular delivery Participants will be randomised 111 to TCEPsaline for the purposes of analysis Half the saline group will receive TC saline and half will receive EP saline
30 HIV infected male and female volunteers aged 18-45 years who have been on ART for at least 6 months with 2 or more HIV plasma viral load measurements 50 copies HIV RNAml prior to enrolment
The investigational HIV-1 vaccine GTU-MultiHIV B clade encodes for a MultiHIV antigen which is a synthetic fusion protein consisting of full-length polypeptides of Rev Nef Tat p17 and p24 and containing more than 20 Th and CTL epitopes of protease reverse transcriptase RT and gp160 regions of the HAN2 HIV-1 B clade
Vaccine is provided in sealed vials at 2mgml and a single 1ml IM injection of 2mg GTU-MultiHIV DNA IM into the thigh is required to deliver a 2mg dose Individuals in Group 2 will receive a further 04mg GTU-MultiHIV DNA in 02ml administered by TC a novel needle-free method of vaccine delivery
Detailed Description:
The investigators are exploring combination regimens with the overall aims of i optimising immune responses and ii developing safe and well tolerated strategies which will favour the development of T-cell responses that may enhance anti-HIV HIV therapy with the forward looking goal of working towards functional eradication of infection The investigator proposes to combine the previously used IM and TC methods because preclinical data suggest that the combination of methods will favour the development of CD8 T cell responses All groups will receive 60mg of the vaccine IM given in 3 doses over 12 weeks Group 1 will receive the 60mg IM with electroporation EP and Group 2 will receive the 60mg IM without EP but together with an additional 12mg vaccine TC The primary immunogenicity endpoint will be to determine whether either intervention group augments the cellular responses to vaccine specific peptides in relation to baseline It is anticipated that none of subjects receiving saline placebo would have an increase in vaccine specific responses relative to those at baseline Therefore if the differences between the active groups and saline placebo are sufficiently large for example 80 responders in a GTU-MultiHIV DNA active group 10 in the control group this would be significant
Should the regimes prove safe acceptable and induce significant immunogenicity then the intention is to move one or both regimes into a larger study powered to determine their potential long-term impact on therapy when used in combination with conventional ARV regimens Proof of concept that DNA vaccination can induce de novo HIV specific responses that are associated with control of viral replication would justify further investigation of their use in immunotherapies combined with ART intensification andor anti-latency drugs
Should the regimes prove safe acceptable and induce significant immunogenicity then the intention is to move one or both regimes into a larger study powered to determine their potential long-term impact on therapy when used in combination with conventional ARV regimens Proof of concept that DNA vaccination can induce de novo HIV specific responses that are associated with control of viral replication would justify further investigation of their use in immunotherapies combined with ART intensification andor anti-latency drugs
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