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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01993706
First received: November 21, 2013
Last updated: October 16, 2014
Last verified: September 2014
  Purpose

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.

Condition Intervention Phase
HIV Infection
Monoclonal Antibody, Human
HIV Antibodies
VRC01 Monoclonal Antibody
Neutralizing Antibody
Drug: VRC-HIVMAB060-00-AB
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: VRC 602: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIV MAB060-00-AB (VRC01),Administered Intravenously or Subcutaneously to Healthy Adults

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • This is a Phase 1 study with primary outcomes of safety and pharmacokinetics [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: VRC-HIVMAB060-00-AB
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

A volunteer must meet all of the following criteria:

  1. Able and willing to complete the informed consent process.
  2. 18 to 50 years of age.
  3. Based on history and examination, must be in general good health without history of any of the conditions listed in the exclusion criteria.
  4. 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.]
  5. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
  6. 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:

  7. 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.
  8. Negative <=-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.

EXCLUSION CRITERIA:

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

  1. Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
  2. Weight > 115 kg or < 53 kg.
  3. History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence.
  4. Hypertension that is not well controlled.
  5. Woman who is breast-feeding, or planning to become pregnant during the 16 weeks of study participation.
  6. Receipt of any investigational study agent within 28 days prior to enrollment or any past receipt of an investigational HIV vaccine.
  7. Any other chronic or clinically significant medical condition that in the opinion of 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, autoimmune disease, psychiatric disorders, heart disease, or cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01993706

Contacts
Contact: Jamie G Saunders, R.N. (301) 451-9626 vaccines@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Julie E Ledgerwood, D.O. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01993706     History of Changes
Other Study ID Numbers: 140019, 14-I-0019
Study First Received: November 21, 2013
Last Updated: October 16, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Broadly HIV-1 Neutralizing Activity
Healthy Adults
Placebo
HIV Prevention
Monoclonal Antibodies
Antibodies

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Antibodies
Antibodies, Monoclonal
Immunoglobulins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014