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THV01

THV01

Other Names: THV01-1, THV01-2 Drug Class: Therapeutic Vaccines Organization: Theravectys Phase of Development: I/IIa

(Compound details obtained from Treatment Action Group website,1 Theravectys website,2 and IAS Towards an HIV Cure Symposium 2015 Poster PE62 LB3)

What is THV01?

What is THV01?

THV01 is an investigational vaccine being studied as a possible strategy to treat people living with HIV. THV01 belongs to a group of HIV vaccines called therapeutic HIV vaccines.1,4

To learn how investigational vaccines and drugs are tested during clinical trials, read the AIDSinfo What is an Investigational HIV Drug? and HIV/AIDS Clinical Trials fact sheets.

How do therapeutic HIV vaccines work?

How do therapeutic HIV vaccines work?

A therapeutic HIV vaccine is a type of vaccine that’s designed to improve the body’s immune response to HIV in a person living with HIV.5 Therapeutic vaccines work by strengthening the immune system to recognize and eliminate HIV from the body.6,7 To learn more, read the AIDSinfo What is a Therapeutic HIV Vaccine? fact sheet.

There are several types of therapeutic vaccines currently being studied to treat HIV. THV01 belongs to a group of vaccines called viral vector vaccines.4 This type of vaccine delivers pieces of HIV’s DNA into the body’s cells. The body then uses this genetic information to produce an immune system response that can fight the virus.8

Which clinical trials are studying THV01?

Which clinical trials are studying THV01?

Study Names: THV01-11-01; NCT02054286
Phase: I/IIa
Status: This study is ongoing, but not recruiting participants.
Location: Belgium and France
Purpose: The purpose of this study is to examine the safety and effectiveness of three different dose levels of THV01 when compared to a placebo.9

For more details on the study listed above, see the Health Professional version of this drug summary.

What side effects might THV01 cause?

What side effects might THV01 cause?

One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in the study of THV01 listed above.

THV01-11-01; (NCT02054286):

In this Phase I/IIa study, no serious side effects have been reported. Side effects related to the treatment were similar across the three groups receiving THV01 and the placebo group. The only exception was pain at the injection site, which was more commonly reported in participants receiving the highest dose of THV01.3

Because THV01 is still being studied, information on possible side effects of the vaccine is not complete. As testing of THV01 continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying THV01?

Where can I get more information about clinical trials studying THV01?

More information about THV01-related research studies is available from ClinicalTrials.gov.

References

References

  1. Treatment Action Group website. Research toward a cure trials. http://www.treatmentactiongroup.org/cure/trials. Accessed March 28, 2019.
  2. Theravectys website. Clinical trials. http://www.theravectys.com/clinical-trials/. Accessed March 28, 2019.
  3. Toussaint H, Sarry E, Bejanariu A, et al. A first-in-human Phase I/II trial demonstrates the safety and the immunogenicity of a lentiviral-based therapeutic HIV vaccine eliciting potent polyfunctional multispecific CD8 and CD4 T-cell responses in HIV-infected individuals. Poster presented at: International AIDS Society (IAS) Towards an HIV Cure Symposium; July 18-19, 2015; Vancouver, Canada. Poster PE62 LB. https://www.iasociety.org/Web/WebContent/File/HIV_Cure_Symposium_2015/Posters2/PE62_Toussaint.pdf. Accessed March 28, 2019.
  4. Frick M, Gaudino A, Harrington M, et al. Treatment Action Group. 2017 pipeline report. http://www.pipelinereport.org/sites/default/files/2017%20Pipeline%20Report%20Final.pdf. Published July 2017. Accessed March 28, 2019.
  5. The History of Vaccines website. The development of HIV vaccines. https://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Accessed March 28, 2019.
  6. Smith PL, Tanner H, Dalgleish A. Developments in HIV-1 immunotherapy and therapeutic vaccination. F1000Prime Rep. 2014;6(43).
  7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4047951/. Accessed March 28, 2019.
  8. Graziani GM, Angel JB. Evaluating the efficacy of therapeutic HIV vaccines through analytical treatment interruptions. J Int AIDS Soc. 2015;18(1):20497.
  9. HIV Vaccine Trials Network website. Types of vaccines. https://www.hvtn.org/en/science/hiv-vaccine-basics/types-vaccines.html. Accessed March 28, 2019.
  10. Theravectys S.A. A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination at 5.10E+6 TU (transducing unit) , 5.10E+7 TU (transducing unit) or 5.10E+8 TU (transducing unit) doses to placebo in HIV-1 clade B infected patients under highly active antiretroviral therapy (HAART). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 1, 2014. NLM Identifier: NCT02054286. https://clinicaltrials.gov/ct2/show/NCT02054286. Accessed March 28, 2019.

Last Reviewed: March 28, 2019

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