Drugs

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 an investigational vaccine?

What is an investigational vaccine?

An investigational vaccine is one that is under study and is not approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. Medical research studies are conducted to evaluate the safety and effectiveness of an investigational vaccine. These research studies are also called clinical trials. Once an investigational vaccine has been proven safe and effective in clinical trials, FDA may approve the vaccine for sale in the United States.

To learn more about investigational vaccines and investigational drugs, read the AIDSinfo What is an Investigational HIV Drug? fact sheet.

What is THV01?

What is THV01?

THV01 is an investigational vaccine that is being studied as a therapeutic vaccine for HIV.4 A therapeutic HIV vaccine is a type of vaccine that’s designed to improve the body’s immune response to HIV in a person who already has HIV.5

HIV researchers are developing and testing therapeutic vaccines for various goals:
  • To slow down the progression of HIV infection.
  • To eliminate the need for antiretroviral therapy (ART) while still keeping undetectable levels of HIV. (ART is the recommended treatment for HIV infection and involves using a combination of different HIV medicines to prevent HIV from replicating.)
  • As part of a combination strategy that includes HIV medicines and a therapeutic vaccine to eliminate all HIV from the body.

The AIDSinfo fact sheet What is a Therapeutic HIV Vaccine? has more information on therapeutic HIV vaccines.6,7

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

How are clinical trials of investigational vaccines conducted?

How are clinical trials of investigational vaccines conducted?

Clinical trials are conducted in phases. Each phase has a different purpose and helps researchers answer different questions.9

  • Phase I trials: Researchers test an investigational vaccine in a small group of people (20–80) for the first time. The purpose is to evaluate its safety, identify side effects, and determine if the vaccine produces an immune response in the body.
  • Phase II trials: The investigational vaccine is administered to a larger group of people (100–300). Researchers further evaluate the vaccine’s safety and ability to produce an immune response in the body. Some effectiveness data on the health benefits of the vaccine may also be collected.
  • Phase III trials: The investigational vaccine is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the investigational vaccine to be used safely.9,10

In most cases, an investigational vaccine must be proven effective and must show continued safety in a Phase III clinical trial to be considered for approval by FDA for sale in the United States. Some vaccines go through FDA’s accelerated approval process and are approved before a Phase III clinical trial is complete. After a vaccine is approved by FDA and made available to the public, researchers track its safety in Phase IV trials to seek more information about the vaccine’s risks, benefits, and optimal use.9

Some clinical trials are categorized as “a” or “b,” such as “Phase Ia” or “Phase IIb.” These different subphases typically mean that a study is researching certain types of information or using a certain type of participant population.

In what phase of testing is THV01?

In what phase of testing is THV01?

THV01 is currently being studied in a Phase I/IIa clinical trial.3

What are some studies on THV01?

What are some studies on THV01?

Study Name: THV01-11-01; NCT02054286
Sponsor: Theravectys S.A.
Phase: I/IIa
Status: This study is ongoing, but not recruiting participants.
Location: Belgium and France
Participants:

  • Participants are adults who have subtype B HIV. Participants have been receiving certain approved ART regimens that consist of 3 HIV drugs from 2 different drug classes for more than a year before the start of the study.
  • For more than 60 days before the start of the study, participants have been receiving 2 nucleoside reverse transcriptase inhibitors and a combination of the HIV drugs darunavir and ritonavir or lopinavir and ritonavir.
  • Participants have never had viral load levels greater than 150,000 copies/mL, except during the earliest stage of HIV infection. (Viral load is the amount of HIV in a blood sample.) For the 12 months before the start of the study, participants have had viral load levels of 50 copies/mL or less.
  • Participants have had CD4 counts of 300 cells/mm3 or more since HIV diagnosis. (A CD4 count is a laboratory test that measures the number of CD4 cells in a sample of blood and is an important indicator of immune function.) Between diagnosis and the start of ART, participants have had at least 1 CD4 count less than 500 cells/mm3. At the start of the study, participants have CD4 counts of 600 cells/mm3 or more.
Purpose: The purpose of this study is to examine the safety and effectiveness of 3 different dose levels of THV01 when compared to a placebo. (A placebo is an inactive drug that is identical in appearance to the active drug being studied.)3,11

For more details on the study mentioned above, see the Health Professional version.

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 3 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 the AIDSinfo database of ClinicalTrials.gov 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.

How can I find more information about participating in a clinical trial?

How can I find more information about participating in a clinical trial?

Participating in a clinical trial can provide benefits. For example, a volunteer participant can benefit from new research treatments before they are widely available. Participants also receive regular and careful medical attention from a research team that includes doctors and other health professionals. However, clinical trials may also involve risks of varying degrees, such as unpleasant, serious, or even life-threatening side effects from the treatment being studied.9

Your health care provider can help you decide whether participating in a clinical trial is right for you. For more information, visit NIH Clinical Research Trials and You.

References

References

  1. Treatment Action Group website. Research toward a cure trials. Available at: http://www.treatmentactiongroup.org/cure/trials. Last accessed on April 18, 2018. [Archived at WebCite]
  2. Theravectys website. Clinical Trials. Available at: http://www.theravectys.com/clinical-trials/. Last accessed on April 18, 2018. [Archived at WebCite]
  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 and 19, 2015; Vancouver, Canada. Poster PE62. Available at: http://www.iasociety.org/Web/WebContent/File/HIV_Cure_Symposium_2015/Posters2/PE62_Toussaint.pdf. Last accessed on April 18, 2018. [Archived at WebCite]
  4. Clayden P, Collins S, Frick M, et al. HIV i-BASE/Treatment Action Group. 2016 pipeline report. July 2016. Available at: http://www.pipelinereport.org/sites/default/files/2016%20Pipeline%20Report%20Full.pdf. Last accessed on April 18, 2018.
  5. The History of Vaccines website. The development of HIV vaccines. Available at: https://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Last accessed on April 18, 2018.
  6. Smith PL, Tanner H, Dalgleish A. Developments in HIV-1 immunotherapy and therapeutic vaccination. F1000Prime Rep. 2014 Jun 2;6:43. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4047951/. Last accessed on April 18, 2018.
  7. Graziani GM, Angel JB. Evaluating the efficacy of therapeutic HIV vaccines through analytical treatment interruptions. J Int AIDS Soc. 2015 Nov 9;18: 20497. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4641978/. Last accessed on April 18, 2018.
  8. HIV Vaccine Trials Network website. Types of vaccines. Available at: https://www.hvtn.org/en/science/hiv-vaccine-basics/types-vaccines.html. Last accessed on April 18, 2018.
  9. National Institutes of Health (NIH). NIH clinical research trials and you. Available at: https://www.nih.gov/health-information/nih-clinical-research-trials-you. Last accessed on April 18, 2018.
  10. Hudgens MG, Gilbert PB, Self SG. Endpoints in vaccine trials. Stat Methods Med Res. 2004 Apr;13(2):89-114. Available at: http://journals.sagepub.com/doi/pdf/10.1191/0962280204sm356ra. Last accessed on April 18, 2018.
  11. 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. Available at: https://clinicaltrials.gov/ct2/show/NCT02054286. Last accessed on April 18, 2018.

Last Reviewed: April 9, 2018