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Protocol Details

VRC 615: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB-0115-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 18 Years
Max Age: 60 Years

Referral Letter Required


Population Exclusion(s)



Immune Response;
First in Human;
Broadly Neutralizing

Recruitment Keyword(s)




Investigational Drug(s)

VRC01.23LS (VRC-HIVMAB0115-00-AB)

Investigational Device(s)



Biological/Vaccine: VRC-HIVMAB0115-00-AB

Supporting Site

National Institute of Allergy and Infectious Diseases


HIV causes AIDS, a serious disease that can lead to fatal infections. HIV infection can be controlled but not cured, nor is there a vaccine to prevent it. Antibodies may offer a promising new way to prevent HIV infection. Antibodies are proteins that are naturally made by the body to fight germs. One antibody (VRC01.23LS) has been tested in the lab and was found to block HIV-like viruses. Researchers want to find out if it is safe to inject VRC01.23LS into people.


To test the safety of VRC01.23LS in healthy adults.


Healthy people aged 18 to 60 years.


Participants will be divided into 6 groups:

Some will get 1 dose of VRC01.23LS. They will visit the clinic up to 14 times in 24 weeks.

Some will get 3 doses, each 12 weeks apart. They will have 25 clinic visits over 48 weeks.

For some participants, the drug will be given through a tube attached to a needle inserted into a vein in the arm. This will take about 30 minutes. Others will receive the drug as an injection under the skin in a fatty area of the belly, arm, or thigh; each dose may need up to 3 individual injections.

Participants will stay in the clinic up to 8 hours on the days they receive VRC01.23LS.

Participants will receive a thermometer and measuring tool. They will check their temperature daily for 7 days after they receive the study drug. They will measure any redness, swelling, or bruising at the injection site.

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A subject must meet all of the following criteria:

1. Willing and able to complete the informed consent process.

2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.

3. Available for clinical follow-up through the last study visit.

4. 18 to 60 years of age.

5. In good general health without clinically significant medical history.

6. Physical examination without clinically significant findings within the 56 days prior to enrollment.

7. Adequate venous access if assigned to an IV group or adequate abdominal subcutaneous tissue if assigned to SC group.

8. Willing to have blood samples collected, stored indefinitely, and used for research purposes.

Laboratory Criteria within 56 days prior to enrollment:

9. White blood cell count (WBC): 2,500-12,000/mm3.

10. WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.

11. Platelets: 125,000 - 500,000/mm3.

12. Hemoglobin within institutional normal range or accompanied by PI or designee approval.

13. Creatinine: <= 1.1 x Upper Limit of Normal (ULN).

14. ALT: <= 1.25 x ULN.

15. AST: <= 1.25 x ULN.

16. Negative for HIV infection by an FDA approved method of detection.

Female-Specific Criteria:

17. Agrees to use an effective means of birth control from 21 days prior to enrollment through the duration of study participation.

18. Negative Beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.


A subject will be excluded if one or more of the following conditions apply:

1. Woman who is breast-feeding or planning to become pregnant during study participation.

2. Weight > 115 kg.

3. Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the study.

4. Hypertension that is not well controlled.

5. Receipt of any investigational study product within 28 days prior to enrollment (Note: Emergency Use Authorization of a COVID-19 vaccine is not exclusionary).

6. Receipt of an investigational HIV vaccine or anti-HIV monoclonal antibody.

7. Receipt of any live attenuated vaccine within 28 days prior to enrollment.

8. Receipt of any vaccine within 2 weeks prior to enrollment.

9. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.

10. Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer, including but not limited to: diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of: drug or alcohol abuse, asthma, infectious disease, autoimmune disease, psychiatric disorder, heart disease, or cancer.

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Gaudinski MR, Coates EE, Houser KV, Chen GL, Yamshchikov G, Saunders JG, Holman LA, Gordon I, Plummer S, Hendel CS, Conan-Cibotti M, Lorenzo MG, Sitar S, Carlton K, Laurencot C, Bailer RT, Narpala S, McDermott AB, Namboodiri AM, Pandey JP, Schwartz RM, Hu Z, Koup RA, Capparelli E, Graham BS, Mascola JR, Ledgerwood JE; VRC 606 Study Team. Safety and pharmacokinetics of the Fc-modified HIV-1 human monoclonal antibody VRC01LS: A Phase 1 open-label clinical trial in healthy adults. PLoS Med. 2018 Jan 24;15(1):e1002493. doi: 10.1371/journal.pmed.1002493. PMID: 29364886; PMCID: PMC5783347.

Gaudinski MR, Houser KV, Doria-Rose NA, Chen GL, Rothwell RSS, Berkowitz N, Costner P, Holman LA, Gordon IJ, Hendel CS, Kaltovich F, Conan-Cibotti M, Gomez Lorenzo M, Carter C, Sitar S, Carlton K, Gall J, Laurencot C, Lin BC, Bailer RT, McDermott AB, Ko SY, Pegu A, Kwon YD, Kwong PD, Namboodiri AM, Pandey JP, Schwartz R, Arnold F, Hu Z, Zhang L, Huang Y, Koup RA, Capparelli EV, Graham BS, Mascola JR, Ledgerwood JE; VRC 605 study team. Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial. Lancet HIV. 2019 Oct;6(10):e667-e679. doi: 10.1016/S2352-3018(19)30181-X. Epub 2019 Aug 28. PMID: 31473167.

Kwon YD, Asokan M, Gorman J, Zhang B, Liu Q, Louder MK, Lin BC, McKee K, Pegu A, Verardi R, Yang ES, Program VP, Carlton K, Doria-Rose NA, Lusso P, Mascola JR, Kwong PD. A matrix of structure-based designs yields improved VRC01-class antibodies for HIV-1 therapy and prevention. MAbs. 2021 Jan-Dec;13(1):1946918. doi: 10.1080/19420862.2021.1946918. PMID: 34328065; PMCID: PMC8331036.

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Principal Investigator

Referral Contact

For more information:

Lesia K. Dropulic, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)

VRC Clinic
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Vaccine Research Center
National Institutes of Health (NIH)
Bethesda, MD 20892

(301) 451-8715

VRC Clinic
National Institute of Allergy and Infectious Diseases (NIAID)
Vaccine Research Center
National Institutes of Health (NIH)
Bethesda, MD 20892

(301) 451-8715

Clinical Trials Number:


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