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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.
Verified November 2013 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: March 14, 2014
Last verified: November 2013

November 21, 2013
March 14, 2014
November 2013
July 2014   (final data collection date for primary outcome measure)
This is a Phase 1 study with primary outcomes of safety and pharmacokinetics [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01993706 on ClinicalTrials.gov Archive Site
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Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), Administered Intravenously or Subcutaneously to Healthy Adults
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

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.

VRC 602 is the first study of the VRC-HIVMAB060-00-AB (VRC01) monoclonal antibody (MAb) in healthy adults. It is a dose-escalation study to examine safety, tolerability, and pharmacokinetics of VRC01. The hypothesis is that VRC01 will be safe for administration to healthy adults by the intravenous (IV) and subcutaneous (SC) routes and will not elicit hypersensitivity reactions. The SC route evaluation will be placebo-controlled and conducted double-blinded to evaluate safety and tolerability of VRC01 and placebo (VRC-PLAMAB068-00-AB).

Healthy adults 18-50 years of age will be enrolled. There are 3 dose escalation groups for IV administration and 1 blinded, placebo-controlled group for SC administration. The doses are 5 mg/kg, 20 mg/kg, and 40 mg/kg for the IV administration, and 5 mg/kg of VRC01 or placebo for the SC administration.

Each group is expected to include 3-5 participants. Each participant will receive two infusions of VRC01 or placebo. The infusions are administered in an inpatient unit and an overnight stay at the NIH Clinical Center is required. No more than one subject per day in each group will receive the first IV infusion of the study product, and no more than one subject per week will receive the first SC administration for the first 6 subjects in Group 4. For each subject the study participation will last about 16 weeks. Blood and mucosal samples will be collected and stored for research purposes.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • HIV Infection
  • Monoclonal Antibody, Human
  • HIV Antibodies
  • VRC01 Monoclonal Antibody
  • Neutralizing Antibody
Drug: VRC-HIVMAB060-00-AB
N/A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
July 2014
July 2014   (final data collection date for primary outcome measure)
  • 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.
Both
18 Years to 50 Years
Yes
Contact: Jamie G Saunders, R.N. (301) 451-9626 vaccines@nih.gov
United States
 
NCT01993706
140019, 14-I-0019
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Julie E Ledgerwood, D.O. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP