Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), Administered Intravenously or Subcutaneously to Healthy Adults

NCT01993706 | Completed Phase 1

• 2 other identifiers: 14001914-I-0019
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- VRC01 is a manmade antibody directed against the human immunodeficiency virus (HIV). Antibodies fight infection. Researchers eventually want to know if VRC01 helps prevent or treat HIV infection. In this study they want to know if the study drug is safe if taken in a vein or under the skin. Taking VRC01 in this study will not protect against HIV infection. Objectives: \- To see if VRC01 and placebo are safe and well tolerated. Eligibility: \- Healthy adults 18 to 50 years old. Design:

• Participants will be screened with medical history, physical exam, and lab tests.
• Participants will be randomly divided into 4 groups. VRC01 or the placebo will be given in weeks 1 and 4. Blood samples will be taken several times after each VRC01 or placebo dose.
• Three groups will receive VRC01 by needle into a vein with an IV pump. It will take about 1 hour and it is done in the hospital.
• One group will receive either VRC01 or the placebo by needle into the fatty tissue under the skin, usually the belly. It will take up to 20 minutes and it is done in the hospital.
• Participants will stay in the hospital overnight after receiving the medication and have about 14 clinic visits over 4 months. Most clinic visits last about 2 hours.
• Participants will keep a symptom diary after receiving the medicatino.
• Participants can volunteer to have mouth, rectal, and genital samples taken throughout the study.
• The study will last 8 months.

Conditions

HIV Infection; Monoclonal Antibody, Human; HIV Antibodies; VRC01 Monoclonal Antibody; Neutralizing Antibody

Keywords

Broadly HIV-1 Neutralizing Activity; Healthy Adults; Placebo; HIV Prevention; Monoclonal Antibodies; Antibodies

Outcome Measures

Primary Outcomes (1)

• This is a Phase 1 study with primary outcomes of safety and pharmacokinetics

  2 years

Interventions

VRC-HIVMAB060-00-AB DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A volunteer must meet all of the following criteria:
• Able and willing to complete the informed consent process.
• to 50 years of age.

You may not qualify if:

• Willing to have blood samples collected, stored indefinitely, and used for research purposes. \[Note: Donation of mucosal samples is encouraged but not mandatory for eligibility.\]
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• Screening laboratory values within 84 days prior to enrollment must meet the following criteria:
• WBC 2,500-12,000/mm3
• WBC differential either within institutional normal range or accompanied by the Principal Investigator or designee approval.
• Platelets equal to 125,000 400,000/mm3
• Hemoglobin within institutional normal range or accompanied by the Principal Investigator or designee approval.
• Creatinine less than or equal to 1.1 x ULN
• ALT less than or equal to 1.25 x ULN
• Negative HIV serology
• FEMALE SPECIFIC CRITERIA:
• If a woman is sexually active with a male partner and has no history of hysterectomy, tubal ligation or menopause, she must agree to use a prescription birth control method or a barrier birth control method from the time of study enrollment until the last study visit, or have a monogamous partner who has previously undergone a vasectomy.
• Negative \<=-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.
• A volunteer will be excluded if one or more of the following conditions apply:
• Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Wu X, Wang C, O'Dell S, Li Y, Keele BF, Yang Z, Imamichi H, Doria-Rose N, Hoxie JA, Connors M, Shaw GM, Wyatt RT, Mascola JR. Selection pressure on HIV-1 envelope by broadly neutralizing antibodies to the conserved CD4-binding site. J Virol. 2012 May;86(10):5844-56. doi: 10.1128/JVI.07139-11. Epub 2012 Mar 14.

  PMID: 22419808 BACKGROUND

• Wu X, Yang ZY, Li Y, Hogerkorp CM, Schief WR, Seaman MS, Zhou T, Schmidt SD, Wu L, Xu L, Longo NS, McKee K, O'Dell S, Louder MK, Wycuff DL, Feng Y, Nason M, Doria-Rose N, Connors M, Kwong PD, Roederer M, Wyatt RT, Nabel GJ, Mascola JR. Rational design of envelope identifies broadly neutralizing human monoclonal antibodies to HIV-1. Science. 2010 Aug 13;329(5993):856-61. doi: 10.1126/science.1187659. Epub 2010 Jul 8.

  PMID: 20616233 BACKGROUND

• Lynch RM, Tran L, Louder MK, Schmidt SD, Cohen M; CHAVI 001 Clinical Team Members; Dersimonian R, Euler Z, Gray ES, Abdool Karim S, Kirchherr J, Montefiori DC, Sibeko S, Soderberg K, Tomaras G, Yang ZY, Nabel GJ, Schuitemaker H, Morris L, Haynes BF, Mascola JR. The development of CD4 binding site antibodies during HIV-1 infection. J Virol. 2012 Jul;86(14):7588-95. doi: 10.1128/JVI.00734-12. Epub 2012 May 9.

  PMID: 22573869 BACKGROUND

• Ledgerwood JE, Coates EE, Yamshchikov G, Saunders JG, Holman L, Enama ME, DeZure A, Lynch RM, Gordon I, Plummer S, Hendel CS, Pegu A, Conan-Cibotti M, Sitar S, Bailer RT, Narpala S, McDermott A, Louder M, O'Dell S, Mohan S, Pandey JP, Schwartz RM, Hu Z, Koup RA, Capparelli E, Mascola JR, Graham BS; VRC 602 Study Team. Safety, pharmacokinetics and neutralization of the broadly neutralizing HIV-1 human monoclonal antibody VRC01 in healthy adults. Clin Exp Immunol. 2015 Dec;182(3):289-301. doi: 10.1111/cei.12692. Epub 2015 Sep 24.

  PMID: 26332605 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

VRC01 monoclonal antibody

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Julie E Ledgerwood, D.O.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 25, 2013
• Study Start: November 19, 2013
• Primary Completion: February 27, 2015
• Study Completion: February 27, 2015
• Last Updated: December 17, 2019

Record last verified: 2015-02-27

Locations

US (1)