GTU-MultiHIV BOther Names: DNA-GTU vaccine, FIT-06 vaccine, GTU MultiHIV multi-gene, GTU-MultiHIV, GTU-MultiHIV B Clade, GTU-MultiHIV B DNA, GTU-multi-HIVB, Gene Transport Unit (GTU)-MultiHIV DNA Vaccine Drug Class: Therapeutic Vaccines Organization: FIT Biotech Phase of Development: GTU-MultiHIV B is in Phase II development as a therapeutic HIV vaccine. (GTU-MultiHIV B has also been studied as a preventive HIV vaccine.)
(Compound details obtained from Treatment Action Group website,1 FIT Biotech website,2 and Treatment Action Group HIV TB HCV Pipeline Report 2018)3
What is GTU-MultiHIV B?
GTU-MultiHIV B is an investigationalbeing studied as a possible strategy to treat people living with HIV.1 GTU-MultiHIV B belongs to a group of HIV vaccines called therapeutic HIV vaccines.
How do therapeutic HIV vaccines work?
A What is a Therapeutic HIV Vaccine? fact sheet.is a type of vaccine that’s designed to improve the body’s to HIV in a person living with HIV.4 Therapeutic vaccines work by strengthening the to recognize and eliminate HIV from the body. To learn more, read the AIDSinfo
There are several types of therapeutic vaccines currently being studied to treat HIV. GTU-MultiHIV B is a DNA vaccine and is made up of parts of HIV’s genetic information. The HIV genetic information is meant to produce an immune response against HIV in the body. Besides being studied as a therapeutic HIV vaccine, GTU-MultiHIV B is also being investigated to see if it can prevent HIVin people who do not have the .3,5 This vaccine record focuses on the study of GTU-MultiHIV B as a therapeutic vaccine.
Which clinical trials are studying GTU-MultiHIV B?
Study Names: CUT*HIVTHER 001; NCT02457689
Status: This study has been completed.
Location: United Kingdom
Purpose: The purpose of this study was to look at GTU-MultiHIV B vaccine’s safety and ability to produce an immune response in the body when GTU-MultiHIV B was given by two different methods.6
Study Names: VRI02/ANRS 149 LIGHT; NCT01492985
Status: This study is ongoing, but not recruiting participants.
Purpose: The purpose of this study is to find out whether a combination of GTU-MultiHIV B and another investigational therapeutic vaccine called LIPO-5 can produce an immune response in the body that controls levels after treatment interruption.7
Study Names: FIT-06; EudraCT 2005-003071-20
Status: This study has been completed.
Location: South Africa
Purpose: The purpose of this study was to look at GTU-MultiHIV B vaccine’s safety and ability to produce an immune response in the body when GTU-MultiHIV B was given by two different injection methods. Investigators also evaluated if the vaccine had any beneficial effects on participants’ viral load levels and CD4 counts.8–10
Study Names: EHVA T01/ANRS VRI05; NCT02972450
Status: This study is not yet open for participant recruitment.
Purpose: The purpose of this trial is to evaluate the effectiveness of three different strategies in controlling viral load after treatment interruption of ART. The three strategies are GTU-MultiHIV B combined with MVA HIV-B, vedolizumab only, and GTU-MultiHIV B combined with MVA HIV-B plus vedolizumab.11
A Phase I study (NCT01130376) involving GTU-MultiHIV B given in combination with in participants on a suppressive ART regimen has also been completed.12,13
For more details on the studies listed above, see the Health Professional version of this drug summary.
What side effects might GTU-MultiHIV B cause?
One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of GTU-MultiHIV B listed above.VRI02/ANRS 149 LIGHT (NCT01492985):
In this study, participants were enrolled to receive GTU-MultiHIV B and LIPO-5 vaccines or vaccines. A preliminary safety analysis of participants who had received at least one vaccine injection found that a majority of participants experienced at least one side effect, most of which were mild. One participant experienced a serious side effect – arthritis – which was possibly related to (study vaccine or placebo). Among those participants who underwent a treatment interruption of ART, all had . Twenty-three percent of participants had symptoms similar to after treatment interruption of ART, although symptoms were mostly mild. One participant transmitted HIV during the period of treatment interruption.7,14FIT-06; EudraCT 2005-003071-20:
Results of this study showed no serious side effects related to GTU-MultiHIV B. Local vaccine reactions that occurred immediately or 30 minutes after injections were mild to moderate in severity and were seen more often in participants receiving theinjection than in participants receiving the injection. Examples of local vaccine reactions that occurred include bleeding at the injection site and swelling and hardening of tissue. Other side effects that occurred in participants receiving GTU-MultiHIV B and participants receiving placebo included swelling of , upper respiratory tract infections, and increased blood levels of creatine phosphokinase (an that’s normally found in the heart, brain, and skeletal muscles).8,9,15
Because GTU-MultiHIV B is still being studied, information on possible side effects of the vaccine is not complete. As testing of GTU-MultiHIV B continues, additional information on possible side effects will be gathered.
Where can I get more information about clinical trials studying GTU-MultiHIV B?
More information about GTU-MultiHIV B-related research studies is available from the AIDSinfo database of study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.
Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a NIH Clinical Research Trials and You.is right for you. For information, visit
- Treatment Action Group website. Research toward a cure trials. http://www.treatmentactiongroup.org/cure/trials. Accessed January 25, 2019.
- FIT Biotech website. Our technology. https://www.fitbiotech.com/our-tech. Accessed January 25, 2019.
- Jefferys R. The HIV vaccines, passive immunization, and antibody gene transfer pipeline. Treatment Action Group HIV TB HCV Pipeline Report 2018. http://www.pipelinereport.org/2018/hiv-vaccines-pipeline. Accessed January 25, 2019.
- The History of Vaccines website. The development of HIV vaccines. https://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Accessed January 25, 2019.
- Smith PL, Tanner H, Dalgleish A. Developments in HIV-1 immunotherapy and therapeutic vaccination. F1000Prime Rep. 2014;6(43). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4047951/. Accessed January 25, 2019.
- Imperial College London. A randomized Phase I/II 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. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 27, 2015. NLM Identifier: NCT02457689. https://clinicaltrials.gov/ct2/show/NCT02457689. Accessed January 25, 2019.
- French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS). Evaluation of a therapeutic immunization strategy associating a DNA vaccine (GTU-MultiHIV B) followed by a lipopeptide vaccine (LIPO-5) in the control of viral replication following antiretroviral treatment interruption in HIV-1 infected patients with a CD4 cell count ≥ 600/mm3. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on November 24, 2011. NLM Identifier: NCT01492985. https://clinicaltrials.gov/ct2/show/NCT01492985. Accessed January 25, 2019.
- Vardas E, Stanescu I, Leinonen M, et al. Indicators of therapeutic effect in FIT-06, a Phase II trial of a DNA vaccine, GTU(®)-Multi-HIVB, in untreated HIV-1 infected subjects. Vaccine. 2012;30(27):4046-4054.
- Vardas E, Stanescu I, Leinonen M, et al. Indicators of therapeutic effect in FIT-06: A Phase II Trial of a DNA vaccine GTU®-MultiHIV, in untreated HIV-1 infected participants. Slides presented at: AIDS Vaccine 2010; September 28 – October 1, 2010; Atlanta, GA. http://www.webcitation.org/6vB5fvLol. Accessed January 25, 2019.
- FIT Biotech Oyj Plc. Immunogenicity and therapeutic effects of GTU-MultiHIV B clade DNA vaccine. A randomized, controlled, phase II clinical trial in treatment-naive HIV-positive subjects. In: EU Clinical Trials Register. Registered on July 08, 2005. EudraCT Number: 2005-003071-20. https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003071-20/FI. Accessed January 25, 2019.
- French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS). A Phase I/II randomised therapeutic HIV vaccine trial in individuals who started antiretrovirals during primary or chronic infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on November 10, 2016. NLM Identifier: NCT02972450. https://clinicaltrials.gov/ct2/show/NCT02972450. Accessed January 25, 2019.
- Imperial College London. A randomised, open labelled, Phase I, safety, toxicity, and exploratory immunogenicity evaluation of therapeutic immunisation +/- IL-2, GM-CSF and growth hormone in HIV-1 infected subjects receiving highly active anti-retroviral therapy. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 25, 2010. NLM Identifier: NCT01130376. https://clinicaltrials.gov/ct2/show/NCT01130376. Accessed January 25, 2019.
- Herasimtschuk A, Downey J, Nelson M, et al. Therapeutic immunisation plus cytokine and hormone therapy improves CD4 T-cell counts, restores anti-HIV-1 responses and reduces immune activation in treated chronic HIV-1 infection. Vaccine. 2014;32(51):7005-7013.
- Levy Y, Lelievre J-D, Perrier A, et al. Preliminary safety results from VRI02 ANRS 149 Light (lipopeptide and DNA GTU HIV therapeutic trial). Poster presented at: HIV Research for Prevention (HIVR4P); October 17-21, 2016; Chicago, IL. Poster P27.09. https://www.abstractstosubmit.com/hivr4p2016/eposter/main.php?do=YToyOntzOjU6Im1vZHVsIjtzOjY6ImRldGFpbCI7czo4OiJkb2N1bWVudCI7aTo3NTt9&. Accessed January 25, 2019.
- Vardas E, Stanescu I, Valtavaara M, et al. Indicators of therapeutic vaccine effect using GTU-MultiHIV B clade DNA in treatment-naive subtype C HIV-1 infected subjects. Abstract presented at: International AIDS Conference (IAC); July 18-23, 2010; Vienna, Austria. Abstract MOPDB102. http://www.abstract-archive.org/Abstract/Share/1945. Accessed January 25, 2019.
Last Reviewed: January 28, 2019
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