VRC01Other 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 2 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 Treatment Action Group website,4 and Treatment Action Group HIV TB HCV Pipeline Report 20185)
What is VRC01?
VRC01 is an investigationalthat is 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.
How do therapeutic HIV vaccines work?
A What is a Therapeutic HIV Vaccine? fact sheet.is a type of vaccine that’s designed to improve the body’s to HIV in a person living with HIV.6 Therapeutic vaccines may be able to reduce the amount of HIV in the body and help keep HIV at undetectable levels without the need for the regular use of . To learn more, read the AIDSinfo
There are several types of therapeutic vaccines currently being studied to treat HIV. The VRC01 vaccine contains a powerful immunecalled a broadly neutralizing (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.4,7–9
In addition to being studied as a therapeutic HIV vaccine, researchers are also trying to find out if VRC01 can prevent HIVin people who do not have the .5 This record focuses on the study of VRC01 as a therapeutic HIV vaccine.
Which clinical trials are studying VRC01?
Study Names: RV 397; NCT02664415
Status: This study has been completed.
Purpose: The purpose of this study was to evaluate the safety of VRC01 and of VRC01 in preventing during a treatment interruption of ART.10
Study Names: ACTG A5357; NCT03739996
Status: See the record for this study’s status.
Location: United States
Purpose: The purpose of this open-label study is to evaluate the safety and of long-acting cabotegravir (CAB LA) plus a long acting form of VRC01 (called VRC01LS) and assess whether this combination can maintain in adults with HIV.11
For more details on the studies listed above, see the Health Professional version of this drug summary.The following studies are investigating VRC01 or VRC01LS as treatment for HIV:
- NCT02591420: A Phase 1 study that will evaluate the safety and effects of VRC01 when given alone and when given with ART in adults with early . This study is currently recruiting participants.12
- ACTG A5378 (NCT02840474): A that is evaluating 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 ongoing, but not recruiting participants.13
- NCT03831945: A Phase 1 trial that is evaluating whether the combination of VRC01 plus the bNAb 10-1074 can control levels in virologically suppressed adults during treatment interruptions of ART. This study is currently recruiting participants.14
- IMPAACT 2008 (NCT03208231): A Phase 1/2 trial looking at the safety of VRC01 and its effect on the in infants with HIV who are initiating ART. This study is currently recruiting participants.15
- Tatelo Study (NCT03707977): A Phase 1/2 trial looking at the impact of VRC01LS plus 10-1074 on the maintenance of HIV suppression in early ART-treated children in Botswana. See the ClinicalTrials.gov record for this study’s status.16
What side effects might VRC01 cause?
One goal of HIV research is to identify new drugs that have fewer side effects. In the RV 397 (NCT02664415) study discussed under the previous question, one participant dropped out of the study because of a serious side effect (hives) that occurred during their first of VRC01. Other side effects that occurred with infusions of either VRC01 or included fatigue, nausea, pain at the site, headache, and bruising at the infusion site. Most of these side effects were mild, with the exception of one case of moderate infusion-site bruising in a participant receiving VRC01.10,17
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?
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 NIH Clinical Research Trials and You.is right for you. For more information, visit
- United States National Library of Medicine. ChemIDplus Advanced: VRC01. https://chem.nlm.nih.gov/chemidplus/rn/1412901-55-3. Accessed August 2, 2019
- Gray GE, Laher F, Lazarus E, Ensoli B, Corey L. Approaches to preventative and therapeutic HIV vaccines. Curr Opin Virol. 2016;17:104-109.
- 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
- Treatment Action Group website. Research toward a cure trials. http://www.treatmentactiongroup.org/cure/trials. Accessed August 2, 2019
- 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 August 2, 2019
- The History of Vaccines website. The development of HIV vaccines. https://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Accessed August 2, 2019
- 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 August 2, 2019
- 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 August 2, 2019
- Halper-Stromberg A, Nussenzweig MC. Towards HIV-1 remission: Potential roles for broadly neutralizing antibodies. J Clin Invest. 126(2):415-423.
- 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 August 2, 2019
- National Institute of Allergy and Infectious Diseases (NIAID). A study of long-acting cabotegravir plus VRC01LS to maintain viral suppression in adults living with HIV-1. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on November 9, 2018. NLM Identifier: NCT03739996. https://clinicaltrials.gov/ct2/show/NCT03739996. Accessed August 2, 2019
- 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 August 2, 2019
- 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 August 2, 2019
- 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 August 2, 2019
- 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 August 2, 2019
- National Institute of Allergy and Infectious Diseases (NIAID). A clinical trial to evaluate the impact of broadly neutralizing antibodies VRC01LS and 10-1074 on maintenance of HIV suppression in a cohort of early-treated children in Botswana (dual bNAb treatment in children). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). October 12, 2018. NLM Identifier: NCT03707977. https://clinicaltrials.gov/ct2/show/NCT03707977. Accessed August 2, 2019
- 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 August 2, 2019
Last Reviewed: August 2, 2019
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