Drugs

3BNC117

3BNC117

Other Names: 3BNC117-LS Drug Class: Therapeutic Vaccines (Broadly Neutralizing Antibodies) Registry Number: 1412902-17-0 (CAS) Organization: Rockefeller University Phase of Development: 3BNC117 is in Phase II development as a therapeutic HIV vaccine. (3BNC117 is also being studied for HIV prevention.)

(Compound details obtained from ChemIDplus Advanced,1 Current Opinion in Virology article,2 Nature article,3 Treatment Action Group website,4 and ClinicalTrials.gov5)

What is 3BNC117?

What is 3BNC117?

3BNC117 is an investigational vaccine being studied as a possible strategy to treat people living with HIV.6

3BNC117 belongs to a group of HIV vaccines called therapeutic HIV vaccines. 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.7 Therapeutic vaccines work by strengthening the immune system to recognize and eliminate HIV from the body. To learn more, read the AIDSinfo fact sheet What is a Therapeutic HIV Vaccine?.

There are several types of therapeutic vaccines currently being studied to treat HIV. The 3BNC117 vaccine contains a powerful immune protein called a broadly neutralizing antibody (bNAb). bNAbs can block many types of HIV from entering healthy cells and may also activate other immune cells to help destroy HIV-infected cells.8–11

In addition to being studied as a therapeutic HIV vaccine, researchers are also trying to find out if 3BNC117 can prevent HIV infection in people who do not have the virus.5 This record focuses on the study of 3BNC117 as a therapeutic HIV vaccine.

Which clinical trials are studying 3BNC117?

Which clinical trials are studying 3BNC117?

Study Name: NCT02588586
Phase: Phase I/I
Status:  This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate the safety of 3BNC117 and its ability to delay or prevent an increase in viral load levels during a treatment interruption of ART.12

Study Name: NCT02446847
Phase: IIa
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate the safety and drug properties of 3BNC117. The study also examined how well 3BNC117 could delay or prevent an increase in viral load levels during a treatment interruption of ART.3,13 

Study Names: ROADMAP; NCT02850016
Phase: IIa
Status: This study is currently recruiting.
Purpose: The purpose of this study is to compare the efficacy of romidepsin plus 3BNC117 to the efficacy of romidepsin alone on delaying or preventing an increase in viral load during a treatment interruption of ART.14

Study Names: eCLEAR; NCT03041012
Phase: II
Status: This study is currently recruiting. 
Purpose: The purpose of this study is to evaluate whether the early administration of romidepsin and/or 3BNC117 in people who have never taken HIV medicines before who are going to start them can limit the size of the latent HIV reservoir.15

The following studies, all of which are currently recruiting participants, will continue to evaluate 3BNC117 as treatment for HIV: 

  • NCT03526848, a Phase I study that will assess whether 3BNC117 and 10-1074 can control an increase in viral load in adults with HIV during a treatment interruption of ART.16
  • NCT03571204 and NCT02825797, a Phase I and Ib study evaluating whether 3BNC117 and 10-1074 can control viral load levels in individuals with HIV who are currently not taking HIV medicines and in individuals with HIV who stop taking HIV medicines during a treatment interruption.17,18
  • NCT03554408, a Phase I study investigating the safety and pharmacokinetics of 10-1074-LS (long-acting form of 10-1074) when given alone and when given in combination with 3BNC117-LS in adults with and without HIV.19

What side effects might 3BNC117 cause?

What side effects might 3BNC117 cause?

In the Phase IIa trial (NCT02446847) discussed under the previous question, most side effects that occurred during the study were temporary and mild. Some participants experienced modest drops in their CD4 counts during the study, but most had their counts return to normal levels by Week 12.3

Because 3BNC117 is still being studied, information on possible side effects of the vaccine is not complete. As testing of 3BNC117 continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying 3BNC117?

Where can I get more information about clinical trials studying 3BNC117?

More information about 3BNC117-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.

Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a clinical trial is right for you. For information, visit NIH Clinical Research Trials and You.

References

References

  1. United States National Library of Medicine. ChemIDplus Advanced. https://chem.nlm.nih.gov/chemidplus/rn/215647-85-1. Accessed July 25, 2018.
  2. Gray GE, Laher F, Lazarus E, Ensoli B, Corey L. Approaches to preventative and therapeutic HIV vaccines. Curr Opin Virol. 2016;17:104-109.
  3. Scheid JF, Horwitz JA, Bar-On Y, et al. HIV-1 antibody 3BNC117 suppresses viral rebound in humans during treatment interruption. Nature. 2016;535(7613):556-560.
  4. Treatment Action Group website. Research toward a cure trials. http://www.treatmentactiongroup.org/cure/trials. Accessed July 25, 2018.
  5. Rockefeller University. A Phase 1 study of the safety and pharmacokinetics of the combination of 3BNC117 and 10-1074 in HIV-uninfected adults: In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 28, 2016. NLM Identifier: NCT02824536. https://clinicaltrials.gov/ct2/show/NCT02824536. Accessed July 25, 2018.
  6. Clayden P, Collins S, Frick M, et al. HIV i-BASE/Treatment Action Group. 2016 pipeline report. July 2016. http://www.pipelinereport.org/sites/default. Accessed July 25, 2018.
  7. The History of Vaccines website. The development of HIV vaccines. http://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Accessed July 25, 2018.
  8. Jefferys R, Jacobson J. Therapeutic vaccines and immune-based therapies. CUREiculum: HIV/AIDS and cure basics – Module 12. PowerPoint presentation available on the AIDS Vaccine Advocacy Coalition (AVAC) website. http://www.avac.org/sites/default/files/u16/Theraeutic_Vaccine_Module_June.pptx.  Accessed July 25, 2018.
  9. Caskey M Klein F, Lorenzi JC, et al. 3BNC117 a broadly neutralizing antibody suppresses viremia in HIV-1-infected humans. Nature. 2015;522(7557):487-491.
  10. National Institute of Allergy and Infectious Diseases (NIAID) website. A theoretical approach to HIV vaccine development | NIH: National Institute of Allergy and Infectious Diseases. https://www.niaid.nih.gov/diseases-conditions/theoretical-approach. Accessed July 25, 2018.
  11. Halper-Stromberg A, Nussenzweig MC. Towards HIV-1 remission: potential roles for broadly neutralizing antibodies. J Clin Invest. 126(2):415-423.
  12. Rockefeller University. An open label, Phase 2 study of the safety and antiretroviral activity of 3BNC117 in HIV-infected individuals on combination antiretroviral therapy. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on October 26, 2015. NLM Identifier: NCT02588586. https://clinicaltrials.gov/ct2/show/NCT02588586. Accessed July 25, 2018.
  13. Rockefeller University. A Phase 2, open label study of the safety, antiretroviral activity and pharmacokinetics of 3BNC117 during a short analytical treatment interruption in HIV-infected subjects. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US).  Registered on March 17, 2015. NLM Identifier: NCT02446847. https://clinicaltrials.gov/ct2/show/NCT02446847. Accessed July 25, 2018.
  14. Rockefeller University. A Phase 2a, randomized study of romidepsin with or without 3BNC117 to evaluate the effects on the HIV-1 reservoir (ROADMAP). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on July 26, 2016. NLM Identifier: NCT02850016. https://clinicaltrials.gov/ct2/show/NCT02850016. Accessed July 25, 2018.
  15. Aarhus University Hospital. Early administration of latency reversing therapy and broadly neutralizing antibodies to limit the establishment of the HIV-1 reservoir during initiation of antiretroviral treatment - a randomized controlled trial. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on January 20, 2017. NLM Identifier: NCT03041012. https://clinicaltrials.gov/ct2/show/NCT03041012. Accessed July 25, 2018.
  16. Rockefeller University. An open label, randomized study of the safety and antiretroviral activity of 3BNC117 and 10-1074 in HIV-infected individuals on combination antiretroviral therapy and during analytical treatment interruption. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 3, 2018. NLM Identifier: NCT03526848. https://clinicaltrials.gov/ct2/show/NCT03526848. Accessed July 25, 2018.
  17. National Institute of Allergy and Infectious Diseases (NIAID). An exploratory study of combination therapy with 3BNC117 and 10-1074 in HIV-infected individuals. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US).  Registered on June 22, 2018. NLM Identifier: NCT03571204. https://clinicaltrials.gov/ct2/show/NCT03571204. Accessed July 25, 2018.
  18. Rockefeller University. An Phase 1b study of the safety, pharmacokinetics and antiretroviral activity of the combination of 3BNC117 and 10-1074 in HIV-infected individuals. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 28, 2016. NLM Identifier: NCT02825797. https://clinicaltrials.gov/ct2/show/NCT02825797. Accessed July 25, 2018.
  19. Rockefeller University. A Phase 1, dose escalation, first-in-human study of the safety and pharmacokinetics of the subcutaneous and intravenous administration of 10-1074-LS alone and in combination with 3BNC117-LS in HIV-infected and HIV-uninfected individuals. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on July 26, 2016. NLM Identifier: NCT03554408. https://clinicaltrials.gov/ct2/show/NCT03554408. Accessed July 25, 2018.

Last Reviewed: July 25, 2018