Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB091-00-AB (N6LS), Administered Intravenously or Subcutaneously to Healthy Adults
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|ClinicalTrials.gov Identifier: NCT03538626|
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : October 15, 2018
Human Immunodeficiency Virus (HIV) infection is a serious disease. It has no cure or vaccine to prevent it. Using antibodies is one way to prevent HIV infection that seems promising. Antibodies are naturally made by the body to fight germs so people stay healthy. Researchers want to see if the antibody N6LS, made artificially in the lab, can prevent HIV infection.
To see if the antibody N6LS is safe and well-tolerated.
Healthy people ages 18-50
Participants will be assigned to 1 of 6 groups.
Group 1-4 participants will have about 13 visits over about 24 weeks. They will get N6LS once.
Group 5-6 participants will have about 26 visits over about 48 weeks. They will get N6LS 3 times.
Visits that involve receiving N6LS may be up to 8 hours. Follow up visits are about 30 minutes. Female participants will have pregnancy tests at each one.
Some participants will get N6LS through a thin tube in an arm vein. A pump will give N6LS directly into the vein for about 30 minutes. A tube in a vein in the other arm will collect blood.
Some participants will get the antibody as an injection into the fatty tissue of the belly, arm, or thigh.
Participants will have blood taken at every visit.
Participants will get a measuring tool and thermometer. They will check their temperature every day for 3 days after they get N6LS. They will check the injection site and measure any redness, swelling, or bruising.
Non-N6LS visits will be about 2 hours. Participants will report any health changes and how they have been feeling.
|Condition or disease||Intervention/treatment||Phase|
|HIV Antibodies||Biological: VRC-HIVMAB091-00-AB||Phase 1|
VRC 609: APhase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB091-00-AB (N6LS), Administered Intravenously or Subcutaneously to Healthy Adults
This is the first study in healthy adults of the N6LS monoclonal antibody (MAb). It is a dose-escalation study to examine safety, tolerability, dose, and pharmacokinetics (PK) of N6LS. The hypothesis is that N6LS administration to healthy adults will be safe by the intravenous (IV) and subcutaneous (SC) routes. A secondary hypothesis is that N6LS will be detectable in human sera with a definable half-life.
N6LS (VRC-HIVMAB091-00-AB ) is a human MAb targeted to the HIV-1 CD4 binding site. It was developed by the VRC/NIAID/NIH and manufactured under current Good Manufacturing Practice (cGMP) regulations at the VRC Vaccine Pilot Plant operated under contract by the Vaccine Clinical Materials Program (VCMP), Leidos Biomedical Research, Inc., Frederick, MD. The product is provided as a sterile aqueous buffered solution in 10 mL glass vials at a concentration of 100 +/- 10 mg/mL and volume of 6.25 +/- 0.10 mL.
Subjects: Healthy adults, 18-50 years of age.
This open-label study will include 6 dose groups to assess N6LS given as a single IV infusion at the 5, 20, or 40 mg/kg dose level (Groups 1, 3,4); a single SC injection at the 5 mg/kg dose level (Group 2); or in 3 administrations, 12 weeks apart by SC injection at the 5 mg/kg dose level (Group 5), or by IV infusion at the 20 mg/kg dose level (Group 6). Enrollments will initially open with Groups 1, 2 and 5; followed by the sequential activation of Groups 3, 4, and 6.
Subject study participation will be approximately 24 weeks for subjects in Groups 1 to 4 and 48 weeks for subjects in Groups 5 and 6.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB091-00-AB (N6LS), Administered Intravenously or Subcutaneously to Healthy Adults (VRC 609)|
|Actual Study Start Date :||June 21, 2018|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||May 1, 2020|
5 mg/kg IV
5 mg/kg SC
20 mg/kg IV
40 mg/kg IV
- To evaIuate the safety and tolerabiIity of N6LS administered as a single dose at 5 mg/kg IV, 20 mg/kg IV, 40 mg/kg IV,or 5 mg/kg SC to heaIthy aduIts [ Time Frame: Day O to week 24 ]
- To evaluate the safety and tolerability of N6LSa dministered at 5mg/kg SC or 20mg/kg IV by repeat dosing every 12 weeks for a total of 3 injections/infusions in healthy adults. [ Time Frame: Day 0 to week 48 ]
- To evaluate the pharmacokinetics of N6LS at each dose level through 24 weeks after the last dose. [ Time Frame: Day 0 to week 24 ]
- To determine whether anti-drug antibody (ADA) to N6LS can be detected in sera of N6LS recipients atbaseline, 4-weeks post each product administration, and at the last study visit. [ Time Frame: Day 0 to week 48 ]
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): NCT03538626
|Contact: Jamie G Saunders, R.N.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: VRC Clinic 301-451-8715 email@example.com|
|Principal Investigator:||Martin R Gaudinski, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|