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 2 development as a therapeutic HIV vaccine. (3BNC117 is also being developed 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 that is 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 What is a Therapeutic HIV Vaccine? fact sheet.

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 strains 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: 2
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: 2a
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: 2a
Status: This study is ongoing, but not recruiting participants.
Location: Not available.
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: 2
Status: This study is currently recruiting participants. 
Locations: Denmark and United Kingdom
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

Study Names: TITAN; NCT03837756
Phase: 2a
Status: This study is currently recruiting participants.
Locations: Australia, Denmark, United States
Purpose: The purpose of this study is to evaluate the safety and effectiveness of lefitolimod and the bNAbs 3BNC117 and 10-1074 in delaying the time to re-initiate ART during a treatment interruption of ART.16

Study Name: NCT03719664
Phase: 2
Status: This study is currently recruiting participants.
Location: United States
Purpose: The purpose of this study is to determine the most effective dose of 3BNC117 and albuvirtide and evaluate the safety and effectiveness of this combination as long-acting maintenance treatment.17

Additional studies evaluating 3BNC117 for HIV treatment either have been conducted or will be conducted, including the following early-phase trials of 3BNC117 and 10-1074:

  • NCT02825797: A completed Phase 1b study that assessed the safety, pharmacokinetics, and antiretroviral effects of 3BNC117 and 10-1074 in adults with HIV.18
  • NCT03526848, a Phase 1 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. This study is currently recruiting participants.19
  • NCT03571204: A Phase 1 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. This study is currently recruiting participants.20
  • NCT03554408: A Phase 1 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. This study is currently recruiting participants.21
  • BEAT-2 (NCT03588715): A Phase 1 study that will evaluate whether peginterferon alfa-2b (HIV) and 3BNC117 and 10-1074 can control viral rebound and reduce the latent HIV reservoir in adults with HIV during a treatment interruption of ART. See the ClinicalTrials.gov record for this study’s status.22

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

What side effects might 3BNC117 cause?

What side effects might 3BNC117 cause?

One goal of HIV research is to identify new drugs that have fewer side effects. In the NCT02446847 study 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 more information, visit NIH Clinical Research Trials and You.

References

References

  1. United States National Library of Medicine. ChemIDplus Advanced: 3BNC117. https://chem.nlm.nih.gov/chemidplus/rn/1412902-17-0. Accessed June 5, 2019
  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 June 5, 2019
  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 June 5, 2019
  6. 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 June 5, 2019
  7. The History of Vaccines website. The development of HIV vaccines. https://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Accessed June 5, 2019
  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 June 5, 2019
  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 June 5, 2019
  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 June 5, 2019
  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 June 5, 2019
  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 June 5, 2019
  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 June 5, 2019
  16. University of Aarhus. Combining a TLR9 agonist with broadly neutralizing antibodies for reservoir reduction and immunological control of HIV infection: an investigator-initiated randomized, placebo-controlled, Phase IIa trial. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 7, 2019. NLM Identifier: NCT03837756. https://clinicaltrials.gov/ct2/show/NCT03837756. Accessed June 5, 2019
  17. Frontier Biotechnologies Inc. A Phase 2, multicenter, three-part study to establish the dosage, safety and antiviral activity of combination therapy with albuvirtide and 3BNC117 as long-acting maintenance therapy in virologically suppressed subjects with HIV-1 infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on October 22, 2018. NLM Identifier: NCT03719664. https://clinicaltrials.gov/ct2/show/NCT03719664. Accessed June 5, 2019
  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 June 5, 2019
  19. 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 June 5, 2019
  20. 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 June 5, 2019
  21. 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 June 5, 2019
  22. Luis Montaner. Pilot study on innate activation and viral control in HIV-infected adults undergoing an analytical treatment interruption after administration of pegylated interferon alpha 2b with broadly HIV-1 neutralizing antibodies (3BNC117, 10-1074). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on July 17, 20185. NLM Identifier: NCT03588715. https://clinicaltrials.gov/ct2/show/NCT03588715. Accessed June 5, 2019

Last Reviewed: June 5, 2019