ClinicalTrials.gov
ClinicalTrials.gov Menu

VRC 605: Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523lS), Administered Intravenously or Subcutaneously to Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03015181
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief Summary:

Background:

Human immunodeficiency virus (HIV) is a global health threat. The body uses antibodies to fight infection. VRC07-523LS is an antibody directed against HIV. It may be used to prevent mother-to-child transmission of HIV. It may also prevent sexual transmission of HIV and treat HIV-1 infected people.

Objective:

To test the safety, tolerability, dose, and pharmacokinetics of VRC07-523LS in healthy adults.

Eligibility:

Healthy people ages 18-50

Design:

Participants will be screened with:

Medical history

Physical exam

Blood and urine tests

Participants will be assigned to 1 of 7 groups:

Groups 1-5 will get the drug at 1 visit and then be observed for 24 weeks.

Groups 6 and 7 will get the drug at 1 visit every 12 weeks, for a total of 3 doses over 48 weeks.

Participants will get the drug in 1 of 2 ways:

Infusion into a vein over at least 30 minutes. Participants will have blood tests 1, 3, and 6 hours after the infusion. They will have 1-3 visits during that week. Those in Group 7 will have 4-5 visits in the week after their second and third doses.

Injection into the fatty tissue under the skin. Participants will have blood tests before the injection. They will have 1-3 visits during that week. Those in Group 6 will have 4-5 visits after the second and third doses.

Visits include:

Physical exam

Blood and urine tests

Optional oral swabs to collect saliva

Participants will keep a diary of their temperature and symptoms for 3 days after each dose.


Condition or disease Intervention/treatment Phase
HIV Prevention Biological: VRC-HIVMAB075-00-AB Phase 1

Detailed Description:

This is the first study of the VRC-HIVMAB075-00-AB (VRC07-523LS) monoclonal antibody (MAb) in healthy adults. It is a phase 1, dose-escalation study to examine safety, tolerability, dose, and pharmacokinetics of VRC07-523LS. The hypothesis is that VRC07-523LS will be safe for administration to healthy adults by the intravenous (IV) and subcutaneous (SC) routes.

Healthy adults 18-50 years of age will be enrolled. There are 4 open-label, dose escalations of VRC07- 523LS from 1 mg/kg IV to 40 mg/kg IV, 1 route escalation from IV to SC, and 2 open-label groups to assess repeat dosing. Groups 1-5 are expected to include 3 subjects and Groups 6-7 are expected to enroll 5 subjects. Subjects will be followed for 24 weeks after the last study product administration.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: VRC 605: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or Subcutaneously to Healthy Adults
Actual Study Start Date : February 21, 2017
Actual Primary Completion Date : August 27, 2018
Actual Study Completion Date : August 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Grp 1 and Grp 2
Group 1:1mg/kg IV on Day 0; Group 2:5mg/kg IV on Day 0
Biological: VRC-HIVMAB075-00-AB
VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Experimental: Grp 3 and Grp 6
Group 3: 5mg/kg SC on Day 0; Group 6: 5mg/kg SC on Day 0, Week 12 & Week 24
Biological: VRC-HIVMAB075-00-AB
VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Experimental: Grp 4 and Grp 7
Group 4: 20mg/kg IV on Day 0; Group 7: 20mg/kg IV on Day 0, Week 12 & Week 24
Biological: VRC-HIVMAB075-00-AB
VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Experimental: Grp 5
40mg/kg IV on Day 0
Biological: VRC-HIVMAB075-00-AB
VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.




Primary Outcome Measures :
  1. To evaluate the safety and tolerability of VRC-HIVMAB075-00-AB administered as a single dose at 1mg/kg IV, 5mg/kg IV, 20mg/kg IV, 40 mg/kg IV, and 5mg/kg SC to healthy adults. [ Time Frame: Through 24 weeks of study participation. ]
  2. To evaluate the safety and tolerability of VRC-HIVMAB075-00-AB administered at 20mg/kg IV by repeat dosing every 12 weeks for a total of 3 infusions to healthy adults. [ Time Frame: Through 48 weeks of study participation. ]
  3. To evaluate the safety and tolerability of VRC-HIVMAB075-00-AB administered at 5mg/kg SC by repeat dosing every 12 weeks for a total of 3 injections to healthy adults. [ Time Frame: Through 48 weeks of study participation ]

Secondary Outcome Measures :
  1. To evaluate the pharmacokinetics of VRC-HIVMAB075-00-AB at each dose level. [ Time Frame: Through 24 weeks after the last dose. ]
  2. To determine whether anti-drug antibody (ADA) to VRC07-523LS can be detected in recipients of VRC-HIVMAB075-00-AB. [ Time Frame: Through 24 weeks after the last dose. ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

A volunteer must meet all of the following criteria:

  • Able and willing to complete the informed consent process.
  • 18 to 50 years of age.
  • Based on history and examination, must be in good general health and without history of any of the conditions listed in the exclusion criteria.
  • Willing to have blood samples collected, stored indefinitely, and used for research purposes.
  • Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
  • Willing to adhere to reduced risk sexual behavior during study participation.
  • Screening laboratory values within 84 days prior to enrollment must meet the following criteria:

    • WBC 2,500-12,000/mm^3.
    • WBC differential either within institutional normal range or accompanied by the PI or designee approval.
    • Platelets = 125,000 - 400,000/mm^3.
    • Hemoglobin within institutional normal range.
    • Creatinine less than or equal to 1.1 x ULN.
    • ALT less than or equal to 1.25 x ULN.
  • Negative for HIV infection by the FDA approved method of detection.
  • Female-Specific Criteria:

    • If a woman is of reproductive potential and sexually active with a male partner, then she agrees to use an effective means of birth control from the time of study enrollment until the last study visit, or to be monogamous with a partner who has had a vasectomy.
    • Negative Beta-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:

  • Previous receipt of licensed or investigational monoclonal antibody.
  • Weight >115 kg.
  • 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.
  • Hypertension that is not well controlled.
  • Woman who is breast-feeding, or planning to become pregnant during the study participation.
  • Receipt of any investigational study agent within 28 days prior to enrollment.
  • 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, autoimmune disease, psychiatric disorders, heart disease, or cancer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015181


Locations
United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Martin R Gaudinski, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03015181     History of Changes
Other Study ID Numbers: 170030
17-I-0030
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Broadly Neutralizing
HIV Prevention
Anti-Drug Antibody
HIV-1
Immune Response

Additional relevant MeSH terms:
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs