VRC01 is in Phase 2 development as a broadly neutralizing antibody for HIV treatment. (VRC01 is also being studied for HIV prevention.)
(Compound details obtained from ChemIDplus Advanced,1 Science Translational Medicine article,2 Treatment Action Group website,3 and Treatment Action Group Pipeline Report 20194)
What is VRC01?
VRC01 is an investigational drug that is being studied as a possible strategy to treat people living with HIV. VRC01 belongs to a group of HIV drugs called broadly neutralizing antibodies (bNAbs).3
How do broadly neutralizing antibodies work?
Antibodies are proteins that themakes to fight
Some people with HIV naturally produce rare types of HIV antibodies called
Researchers are investigating whether giving bNAbs to people with HIV can help them maintain undetectable levels of HIV without the need for daily antiretroviral therapy. Additionally, some bNAbs are being studied because they may be able to reduce the size of the.7,9
Researchers are also trying to find out if VRC01 can prevent HIV infection in people who do not have the virus.4 This record focuses on the study of VRC01 as a treatment for HIV.
Which clinical trials are studying VRC01?
Study Names: Tatelo Study; NCT03707977
Status: This study is currently recruiting participants.
Purpose: The purpose of this study is to evaluate the efficacy of VRC01LS and the investigational bNAb 10-1074 in maintaining in children receiving early treatment.10
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 in participants undergoing a of ART.11
For more details on the studies listed above, see the Health Professional version of this drug summary.Additional studies investigating HIV treatment with VRC01 or a long acting form of VRC01 (called VRC01LS) have been or are being conducted. Some of these studies include:
- NCT02591420: A Phase 1 study evaluating 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 evaluated the safety and antiviral effects of VRC01LS and another long-acting bNAb called VRC07 523LS in adults with HIV who had never received ART. This study has been completed.13
- NCT03831945: A Phase 1 trial evaluating whether the combination of VRC01 plus 10-1074 can control levels in virologically suppressed adults undergoing structured treatment interruptions of ART. This study is currently recruiting participants.14
- IMPAACT 2008 (NCT03208231) and IMPAACT P1115 (NCT02140255): Two Phase 1/2 trials evaluating the use of VRC01 with ART in infants with HIV. NCT03208231 is ongoing but not recruiting participants. NCT02140255 is currently recruiting participants.15,16
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 severe side effect (hives) that occurred during their first of VRC01. Other side effects that occurred with infusions of either VRC01 or were mild, with the exception of one case of moderate infusion-site bruising in a participant receiving VRC01.11,17
Because VRC01 is still being studied, information on possible side effects of the drug 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.
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 4, 2020
- Lynch RM, Boritz E, Coates EE, et al. Virologic effects of broadly neutralizing antibody VRC01 administration during chronic HIV-1 infection. Sci Trans Med. 2015;7(319):319ra206. doi:10.1126/scitranslmed.aad5752
- Treatment Action Group. Research toward a cure trials. June 2020. http://www.treatmentactiongroup.org/cure/trials. Accessed August 4, 2020
- Jefferys R. HIV vaccines, passive immunization, and antibody gene transfer. Treatment Action Group Pipeline Report 2019. 2019. https://www.treatmentactiongroup.org/wp-content/uploads/2019/09/pipeline_hiv_vax_immune_gene_transfer_2019.pdf. Accessed August 4, 2020
- HIV Vaccine Trials Network (HVTN). Using antibodies for HIV prevention. https://www.hvtn.org/en/science/hiv-vaccine-basics/why-hiv-vaccine1.html. Accessed August 4, 2020
- Snow B. The rise of broadly neutralizing antibodies. AIDS Vaccine Advocacy Coalition (AVAC). Published May 17, 2018. https://www.avac.org/blog/rise-broadly-neutralizing-antibodies. Accessed August 4, 2020
- National Institute of Allergy and Infectious Diseases (NIAID). Sustained ART-free HIV remission. https://www.niaid.nih.gov/diseases-conditions/sustained-art-free-hiv-remission. Accessed August 4, 2020
- National Institute of Allergy and Infectious Diseases (NIAID). Future directions for HIV treatment research. https://www.niaid.nih.gov/diseases-conditions/future-hiv-treatment. Accessed August 4, 2020
- Grobben M, Stuart RA, van Gils MJ. The potential of engineered antibodies for HIV-1 therapy and cure. Curr Opin Virol. 2019;38:70-80. doi:10.1016/j.coviro.2019.07.007
- 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 4, 2020
- 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 Accessed August 4, 2020
- National Institute of Allergy and Infectious Diseases (NIAID). Safety and virologic effect of a human monoclonal antibody (VRC01) 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 Accessed August 4, 2020
- National Institute of Allergy and Infectious Diseases (NIAID). 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 Accessed August 4, 2020
- National Institute of Allergy and Infectious Diseases (NIAID). Combination therapy with VRC-HIVMAB060-00-AB (VRC01) and 10-1074 in HIV-infected individuals undergoing sequential treatment interruptions. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 5, 2019. NLM Identifier: NCT03831945. https://clinicaltrials.gov/ct2/show/NCT03831945. Accessed August 4, 2020
- National Institute of Allergy and Infectious Diseases (NIAID). Evaluating the safety and antiviral activity of monoclonal antibody VRC01 in HIV-infected infants receiving combination antiretroviral therapy. 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 4, 2020
- National Institute of Allergy and Infectious Diseases (NIAID). Very early intensive treatment of HIV-infected infants to achieve hiv remission: a Phase I/II proof of concept study. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 13, 2014. NLM Identifier: NCT02140255. https://clinicaltrials.gov/ct2/show/NCT02140255. Accessed August 4, 2020
- Crowell TA, Colby DJ, Pinyakorn S, et al. Safety and efficacy of VRC01 broadly neutralising antibodies in adults with acutely treated HIV (RV397): a Phase 2, randomised, double-blind, placebo-controlled trial. Lancet HIV. 2019;6(5):e297-e306. doi:10.1016/S2352-3018(19)30053-0
Last Reviewed: August 4, 2020