Ignite Creation Date:
2024-05-06 @ 1:37 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01859325
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2013-05-16
Brief Title:
Therapeutic Vaccine for HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Randomized Double-Blind Placebo-Controlled Study of a Multi-Antigen DNA Vaccine Prime Delivered by In Vivo Electroporation rVSV Booster Vaccine in HIV-Infected Patients Who Began Antiretroviral Therapy During AcuteEarly Infection
Status:
COMPLETED
Status Verified Date:
2018-05
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:
Background
- In most people who have human immunodeficiency virus HIV the immune system cannot control or cure the infection Antiretroviral therapy drugs can keep the amount of HIV virus low for a long time However this treatment does not remove the virus from the body In the vast majority of patients antiretroviral therapy also will not protect the body from the virus once treatment stops Researchers want to see if therapeutic vaccination can help people with HIV Therapeutic vaccination means giving vaccines to treat an infection that someone already has HIV in this case It may help the bodys immune system attack the infection This study will look at different measures of HIV infection after receiving either therapeutic vaccination or a placebo
Objectives
- To see whether therapeutic vaccination is safe and can affect how the body responds to HIV infection
Eligibility
- Individuals between 18 and 65 years of age who have HIV and are taking antiretroviral therapy drugs
Design
Participants will be screened with a physical exam and medical history Blood and urine samples will be collected
During the screening visit and throughout the study until week 56 participants will continue to take their HIV medications
Participants will be divided into two groups One group will have the study vaccines The other will have a placebo
The first study vaccine or placebo will be given in weeks 4 12 and 36 The second study vaccine or the placebo will be given in weeks 24 and 48 Blood samples and other tests will be given at each visit
After the study visit at week 56 participants will stop their HIV medications until week 72 From weeks 58 through 72 they will come in every 2 weeks for study visits each visit will take about 1 hour to complete These visits will look at the body s response to the vaccines and their HIV viral load After week 72 participants will re-start their HIV medications
There will be follow-up study visits from weeks 76 to 96 with blood tests and other studies
- In most people who have human immunodeficiency virus HIV the immune system cannot control or cure the infection Antiretroviral therapy drugs can keep the amount of HIV virus low for a long time However this treatment does not remove the virus from the body In the vast majority of patients antiretroviral therapy also will not protect the body from the virus once treatment stops Researchers want to see if therapeutic vaccination can help people with HIV Therapeutic vaccination means giving vaccines to treat an infection that someone already has HIV in this case It may help the bodys immune system attack the infection This study will look at different measures of HIV infection after receiving either therapeutic vaccination or a placebo
Objectives
- To see whether therapeutic vaccination is safe and can affect how the body responds to HIV infection
Eligibility
- Individuals between 18 and 65 years of age who have HIV and are taking antiretroviral therapy drugs
Design
Participants will be screened with a physical exam and medical history Blood and urine samples will be collected
During the screening visit and throughout the study until week 56 participants will continue to take their HIV medications
Participants will be divided into two groups One group will have the study vaccines The other will have a placebo
The first study vaccine or placebo will be given in weeks 4 12 and 36 The second study vaccine or the placebo will be given in weeks 24 and 48 Blood samples and other tests will be given at each visit
After the study visit at week 56 participants will stop their HIV medications until week 72 From weeks 58 through 72 they will come in every 2 weeks for study visits each visit will take about 1 hour to complete These visits will look at the body s response to the vaccines and their HIV viral load After week 72 participants will re-start their HIV medications
There will be follow-up study visits from weeks 76 to 96 with blood tests and other studies
Detailed Description:
The advent of combination antiretroviral therapy cART has dramatically improved the clinical outcome in human immunodeficiency virus HIV-infected individuals through sustained reduction in viral replication However it has become clear that cART alone cannot eradicate HIV in infected individuals likely in part due to the persistence of viral reservoirs in peripheral blood and various tissue compartments Consequently a major thrust of HIV research over the past several years has been to develop therapeutic strategies that can eliminate persistent viral reservoirs and boost host immunity to control viral replication upon discontinuation of cART Therapeutic HIV vaccination is one approach that could potentially achieve these goals through vaccine-induced improvement in HIV-specific immune responses andor by direct reactivation of HIV-specific CD4 memory T cells that harbor latent HIV An effective therapeutic vaccine could augment immunologic control of HIV infection and potentially obviate the need for chronic cART
The current study is an exploratory randomized 2-arm 11 double-blind placebo-controlled trial evaluating the safety and efficacy of an HIV-1 multiantigen plasmid DNA HIV-MAG pDNA vaccine prime in combination with an interleukin-12 plasmid DNA IL-12 pDNA adjuvant delivered by in vivo electroporation followed by a recombinant vesicular stomatitis virus vector containing the HIV-1 gag gene rVSV HIV gag booster vaccine in subjects on cART who started therapy during acute or early HIV infection
Subjects will be randomized to receive placebo or the HIV-MAG pDNA 3000 g vaccine prime and IL-12 pDNA adjuvant 1000 g at week 0 4 12 and 36 and the rVSV HIV gag booster vaccine 1x107 plaque-forming units at week 24 and 48 The HIV-MAG pDNA vaccine prime and IL-12 pDNA adjuvant will be administered as 2 IM injections 1 into each deltoid with electroporation using the Ichor TDS device while the rVSV HIV gag booster vaccine will be administered as 2 conventional IM injections 1 into each deltoid After the week 56 visit all subjects will undergo an analytical treatment interruption to determine if the vaccination strategy results in an improved immune control of viral replication as evidenced by a blunted or absent rebound in HIV plasma viremia All subjects will be followed through week 96 for safety and efficacy parameters
The study population includes HIV-infected adults who began cART during acute or early infection Subjects must be receiving an effective cART regimen with a CD4 cell count of 450 cellsmm3 at screening and they must have documented viral suppression below the limit of detection for greater than1 year The rationale for testing the study vaccine regimen in this subject population is because these individuals may have a relatively preserved immune function which could be augmented by therapeutic vaccination
The current study is an exploratory randomized 2-arm 11 double-blind placebo-controlled trial evaluating the safety and efficacy of an HIV-1 multiantigen plasmid DNA HIV-MAG pDNA vaccine prime in combination with an interleukin-12 plasmid DNA IL-12 pDNA adjuvant delivered by in vivo electroporation followed by a recombinant vesicular stomatitis virus vector containing the HIV-1 gag gene rVSV HIV gag booster vaccine in subjects on cART who started therapy during acute or early HIV infection
Subjects will be randomized to receive placebo or the HIV-MAG pDNA 3000 g vaccine prime and IL-12 pDNA adjuvant 1000 g at week 0 4 12 and 36 and the rVSV HIV gag booster vaccine 1x107 plaque-forming units at week 24 and 48 The HIV-MAG pDNA vaccine prime and IL-12 pDNA adjuvant will be administered as 2 IM injections 1 into each deltoid with electroporation using the Ichor TDS device while the rVSV HIV gag booster vaccine will be administered as 2 conventional IM injections 1 into each deltoid After the week 56 visit all subjects will undergo an analytical treatment interruption to determine if the vaccination strategy results in an improved immune control of viral replication as evidenced by a blunted or absent rebound in HIV plasma viremia All subjects will be followed through week 96 for safety and efficacy parameters
The study population includes HIV-infected adults who began cART during acute or early infection Subjects must be receiving an effective cART regimen with a CD4 cell count of 450 cellsmm3 at screening and they must have documented viral suppression below the limit of detection for greater than1 year The rationale for testing the study vaccine regimen in this subject population is because these individuals may have a relatively preserved immune function which could be augmented by therapeutic vaccination
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 13-I-0141 | None | None | None |