Drugs

VRC01

VRC01

Other Names: VRC-HIVMAB060-00-AB, VRC-HIVMAB080-00-AB, VRC01LS Drug Class: Therapeutic Vaccines (Broadly Neutralizing Antibodies) Registry Number: 1412901-55-3 (CAS) Organization: NIAID Vaccine Research Center (VRC) Phase of Development: VRC01 is in Phase II development as a therapeutic vaccine. (VRC01 is also being studied for HIV prevention.)

(Compound details obtained from ChemIDplus Advanced,1 Current Opinion in Virology article,2 Science Translational Medicine article,3 and Treatment Action Group website4)

What is VRC01?

What is VRC01?

VRC01 is an investigational vaccine being studied as a possible strategy to treat people living with HIV.4 VRC01 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.5 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 VRC01 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.4,6–8

In addition to being studied as a therapeutic HIV vaccine, researchers are also trying to find out if VRC01 can prevent HIV infection in people who do not have the virus.9 This record focuses on the study of VRC01 as a therapeutic HIV vaccine.

Which clinical trials are studying VRC01?

Which clinical trials are studying VRC01?

Study Names: ACTG A5340; NCT02463227
Phase: I
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate the safety of VRC01 and the ability of VRC01 to prevent or delay viral rebound during a treatment interruption of antiretroviral therapy (ART).10,11 A treatment interruption of ART is a planned break from HIV medicines to evaluate how well an investigational drug can maintain control of a participant’s viral load during a clinical trial.

Study Names: NIH 15-I-0140; NCT02471326
Phase: I
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate the safety of VRC01 and the ability of VRC01 to prevent or delay viral rebound during a treatment interruption of ART.10,12

Study Names: RV 397; NCT02664415
Phase: II
Status: This study has been completed.
Location: Thailand
Purpose: The purpose of this study was to evaluate the safety of VRC01 and efficacy of VRC01 in preventing viral rebound during a treatment interruption of ART.13,14

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

The following studies, which have either been completed or are currently recruiting participants, are investigating VRC01 or a long-acting form of VRC01 (called VRC01LS) as treatment for HIV:
  • ACTG A5342 (NCT02411539), a completed Phase I study that assessed the safety of VRC01 and its effects on HIV persistence in adults with who had viral suppression on ART and who had started on ART during chronic HIV infection.15,16
  • NCT02591420, a Phase I study that will evaluate the safety and antiviral effects of VRC01 when given alone and when given with ART in adults with early acute HIV infection. This study is currently recruiting participants.17
  • ACTG A5378 (NCT02840474), a Phase I trial that will evaluate the safety and antiviral effects of VRC01LS and another long-acting vaccine called VRC07 523LS in adults with HIV who have never received ART. This study is currently recruiting participants.18
  • IMPAACT 2008 (NCT03208231), a Phase I/II trial looking at the safety of VRC01 and its effect on the latent HIV reservoir in infants with HIV who are initiating ART. This study is currently recruiting participants.19

What side effects might VRC01 cause?

What side effects might VRC01 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 VRC01 listed above.

ACTG A5340 (NCT02463227) and NIH 15-I-0140 (NCT02471326):

In both studies, no serious side effects related to VRC01 were reported. Two participants in the A5340 trial experienced mild VRC01-related side effects: one participant had hardening of the skin at the injection site and the other participant had itchiness at the injection site. During the NIH trial, there were no side effects reported during or immediately after treatment.10

RV 397 (NCT02664415):

During this trial, 1 participant dropped out of the study because of a serious side effect (hives) that occurred during their first dose of VRC01. Other side effects that occurred with intravenous infusions of either VRC01 or placebo included fatigue, nausea, pain at the infusion site, headache, and bruising at the infusion site. Most of these side effects were mild, with the exception of 1 case of moderate infusion-site bruising in a participant receiving VRC01.13,14

Because VRC01 is still being studied, information on possible side effects of the vaccine is not complete. As testing of VRC01 continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying VRC01?

Where can I get more information about clinical trials studying VRC01?

More information about VRC01-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: VRC01. https://chem.nlm.nih.gov/chemidplus/rn/1412901-55-3. Accessed September 14, 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. Lynch RM, Boritz E, Coates EE, et al. Virologic effects of broadly neutralizing antibody VRC01 administration during chronic HIV-1 infection. Sci Transl Med. 2015;7(319):319ra206-319ra206. doi:10.1126/scitranslmed.aad5752
  4. Treatment Action Group website. Research toward a cure trials. http://www.treatmentactiongroup.org/cure/trials. Accessed September 14, 2018.
  5. The History of Vaccines website. The development of HIV vaccines. https://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Accessed September 14, 2018.
  6. Jefferys R and 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 September 14, 2018.
  7. 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 September 14, 2018.
  8. Halper-Stromberg A, Nussenzweig MC. Towards HIV-1 remission: potential roles for broadly neutralizing antibodies. J Clin Invest. 126(2):415-423.
  9. 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 September 14, 2018.
  10. Bar KJ, Sneller MC, Harrison LJ, et al. Effect of HIV antibody VRC01 on viral rebound after treatment interruption. N Engl J Med. 2016;375(21):2037-2050. doi:10.1056/NEJMoa1608243
  11. National Institute of Allergy and Infectious Diseases (NIAID). A Phase I, open-label study of the safety, pharmacokinetics, and antiviral activity of a human monoclonal antibody, VRC-HIVMAB060-00-AB (VRC01), with broad HIV-1 neutralizing activity, administered intravenously to HIV-infected adults undergoing a brief analytical treatment interruption. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 29, 2015. NLM Identifier: NCT02463227. https://clinicaltrials.gov/ct2/show/NCT02463227. Accessed September 14, 2018.
  12. National Institute of Allergy and Infectious Diseases (NIAID). An exploratory, open-label study of VRC-HIVMAB060-00-AB (VRC01) in subjects with chronic HIV infection undergoing analytical treatment interruption. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 12, 2015. NLM Identifier: NCT02471326. https://clinicaltrials.gov/ct2/show/NCT02471326. Accessed September 14, 2018.
  13. Crowell TA, Colby DJ, Pinyakorn S, et al. HIV-specific broadly-neutralizing monoclonal antibody, VRC01, minimally impacts time to viral rebound following treatment interruption in virologically-suppressed, HIV-infected participants who initiated antiretroviral therapy during acute HIV infection. Slides presented at: International AIDS Society (IAS) Conference on HIV Science; July 23-26, 2017; Paris, France. http://programme.ias2017.org/PAGMaterial/PPT/2901_1662/RV%20397%20IAS%20Presentation%202017-07-24.pptx. Accessed September 14, 2018.
  14. National Institute of Allergy and Infectious Diseases (NIAID). Safety and therapeutic efficacy of the broadly neutralizing HIV-1 specific monoclonal antibody VRC01 during analytic treatment interruption in patients who initiated antiretroviral therapy during early acute HIV infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on January 20, 2016. NLM Identifier: NCT02664415. https://clinicaltrials.gov/ct2/show/NCT02664415. Accessed September 14, 2018.
  15. National Institute of Allergy and Infectious Diseases (NIAID). A Phase I study to evaluate the safety, tolerability, and effect of a human monoclonal antibody, VRC-HIVMAB060-00-AB (VRC01), on markers of HIV persistence in ART-treated, HIV-infected adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on April 2, 2015. NLM Identifier: NCT02411539. https://clinicaltrials.gov/ct2/show/NCT02411539. Accessed September 14, 2018.
  16. Riddler SA, Durand C, Zheng L, et al. VRC01 infusion has no effect on HIV-1 persistence in ART-suppressed chronic infection. Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 13-16, 2017; Seattle, WA. Poster 330LB. http://www.croiconference.org/sites/default/files/posters-2017/330LB_Riddler.pdf. Accessed September 14, 2018.
  17. National Institute of Allergy and Infectious Diseases (NIAID). Safety and virologic effect of a human monoclonal antibody, VRC-HIVMAB060-00-AB (VRC01), with broad HIV-1 neutralizing activity, administered intravenously to adults during early acute HIV infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on October 28, 2015. NLM Identifier: NCT02591420. https://clinicaltrials.gov/ct2/show/NCT02591420. Accessed September 14, 2018.
  18. National Institute of Allergy and Infectious Diseases (NIAID). VRC 607-ACTG A5378: a Phase 1, single dose study of the safety and virologic effect of an HIV-1 specific broadly neutralizing human monoclonal antibody, VRC-HIVMAB080-00-AB (VRC01LS) or VRC-HIVMAB075-00-AB (VRC07-523LS), administered intravenously to HIV-infected adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered July 19, 2016. NLM Identifier: NCT02840474. https://clinicaltrials.gov/ct2/show/NCT02840474. Accessed September 14, 2018.
  19. National Institute of Allergy and Infectious Diseases (NIAID). Phase I/II multisite, randomized, controlled study of monoclonal antibody VRC01 with combination antiretroviral therapy to promote clearance of HIV-1-infected cells in infants. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered June 30, 2017. NLM Identifier: NCT03208231. https://clinicaltrials.gov/ct2/show/NCT03208231. Accessed September 14, 2018.

Last Reviewed: September 14, 2018