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Protocol Details

VRC 611: A Phase 1 Safety and Pharmacokinetic Study to Evaluate a Human Monoclonal Antibody (mAb) VRC-HIVMAB0102-00-AB (CAP256V2LS) Administered via Subcutaneous and Intravenous Injection in 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: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 60 Years

Referral Letter Required


Population Exclusion(s)



HIV Prevention;
Broadly-Neutralizing Human Monoclonal Antibodies;
First in Human;
Anti-Drug Antibody Response;

Recruitment Keyword(s)




Investigational Drug(s)


Investigational Device(s)



Biological/Vaccine: VRC-HIVMAB0102-00-AB

Supporting Site

National Institute of Allergy and Infectious Diseases


HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs. Researches want to test an antibody, CAP256V2LS.


To test CAP256V2LS to see if it is safe and how the body responds to it.


Healthy people ages 18-60.


Participants will be screened with a medical history, physical exam, and blood tests. Some will have a pregnancy test.

Participants will be assigned to one of two groups. Based on their group, they will get 1 dose of CAP256V2LS in 1 of 2 ways:

-Some participants will get CAP256V2LS as an infusion. A thin tube will be placed in an arm vein. CAP256V2LS will be given into the vein using a pump.

-Some participants will get CAP256V2LS injected under the skin. A small needle will inject CAP256V2LS into the fatty tissue of the belly, arm, or thigh. They will get 1 to 4 injections.

On the day they get CAP256V2LS, participants will give blood samples at different time points. This visit will last about 8 hours.

Participants will be asked to check their temperature every day for 7 days after receiving CAP256V2LS. They will use a tool to measure any redness, swelling, or bruising they may have at the injection site.

Participants will have visits at least 2-3 times during the first week after they get CAP256V2LS. Then they will have about 9 more visits over the next 6 months. Visits will include blood tests.

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A subject must meet all of the following criteria to be included:

1. Able and willing 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. Based on medical history and physical examination, in good health and without clinically significant findings within 84 days prior to enrollment.

6. Weight 115 kg

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

Laboratory Criteria within 84 days prior to enrollment:

8. White Blood Cell (WBC) 2,500-12,000/mm3

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

10. Platelets = 125,000 500,000/mm3

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

12. Creatinine 1.1 x upper limit of normal (ULN) based on the institutional normal range

13. Alanine aminotransferase (ALT) 1.25 x ULN based on the institutional normal range

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

Criteria Specific to Women of Childbearing Potential:

15. Negative beta-human chorionic gonadotropin ( <=-HCG) pregnancy test (urine or serum) on day of enrollment, and prior to product administration

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


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. 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

3. Hypertension that is not well controlled

4. Receipt of any investigational study product within 28 days prior to enrollment. Note: SARS-CoV-2 vaccines approved by emergency use authorization are not exclusionary.

5. Receipt of any live attenuated vaccines within 28 days prior to enrollment.

6. Receipt of any vaccine within 2 weeks prior to enrollment/product administration

7. Prior receipt of a licensed or investigational monoclonal antibody

8. Prior receipt of an HIV vaccine

9. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject s ability to give informed consent.

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Ko SY, Pegu A, Rudicell RS, Yang ZY, Joyce MG, Chen X, Wang K, Bao S, Kraemer TD, Rath T, Zeng M, Schmidt SD, Todd JP, Penzak SR, Saunders KO, Nason MC, Haase AT, Rao SS, Blumberg RS, Mascola JR, Nabel GJ. Enhanced neonatal Fc receptor function improves protection against primate SHIV infection. Nature. 2014 Oct 30;514(7524):642-5. doi: 10.1038/nature13612. Epub 2014 Aug 13. PMID: 25119033; PMCID: PMC4433741.

Doria-Rose NA, Schramm CA, Gorman J, Moore PL, Bhiman JN, DeKosky BJ, Ernandes MJ, Georgiev IS, Kim HJ, Pancera M, Staupe RP, Altae-Tran HR, Bailer RT, Crooks ET, Cupo A, Druz A, Garrett NJ, Hoi KH, Kong R, Louder MK, Longo NS, McKee K, Nonyane M, O'Dell S, Roark RS, Rudicell RS, Schmidt SD, Sheward DJ, Soto C, Wibmer CK, Yang Y, Zhang Z; NISC Comparative Sequencing Program, Mullikin JC, Binley JM, Sanders RW, Wilson IA, Moore JP, Ward AB, Georgiou G, Williamson C, Abdool Karim SS, Morris L, Kwong PD, Shapiro L, Mascola JR. Developmental pathway for potent V1V2-directed HIV-neutralizing antibodies. Nature. 2014 May 1;509(7498):55-62. doi: 10.1038/nature13036. Epub 2014 Mar 2. PMID: 24590074; PMCID: PMC4395007.

Doria-Rose NA, Bhiman JN, Roark RS, Schramm CA, Gorman J, Chuang GY, Pancera M, Cale EM, Ernandes MJ, Louder MK, Asokan M, Bailer RT, Druz A, Fraschilla IR, Garrett NJ, Jarosinski M, Lynch RM, McKee K, O'Dell S, Pegu A, Schmidt SD, Staupe RP, Sutton MS, Wang K, Wibmer CK, Haynes BF, Abdool-Karim S, Shapiro L, Kwong PD, Moore PL, Morris L, Mascola JR. New Member of the V1V2-Directed CAP256-VRC26 Lineage That Shows Increased Breadth and Exceptional Potency. J Virol. 2015 Oct 14;90(1):76-91. doi: 10.1128/JVI.01791-15. PMID: 26468542; PMCID: PMC4702551.

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Principal Investigator

Referral Contact

For more information:

Richard L. Wu, 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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