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VRC 610: Phase I Safety and Pharmacokinetics Study to Evaluate a Human Monoclonal Antibody (MAB) VRC-HIVMAB095-00-AB (10E8VLS) Administered Alone or Concurrently With MAB VRC-HIVMAB075-00-AB (VRC07-523LS) Via Subcutaneous Injection in 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: NCT03565315
Recruitment Status : Terminated (Sponsor/PI voluntarily paused and stopped study after observing several Grade 2 and a Grade 3 redness local reactogenicity reactions at 10E8VLS injection sites)
First Posted : June 21, 2018
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
The Emmes Company, LLC
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) infection is a serious disease. There is no cure or vaccine to prevent infection. Using antibodies might be a good way to treat or prevent HIV. Antibodies are naturally made by the body to fight germs. Researchers want to test if two antibodies made artificially in a lab can help to prevent HIV infection. The antibodies are 10E8VLS and VRC07-523LS.

Objective:

To see if 10E8VLS and VRC07-523LS are safe and well-tolerated and how long they stay in the blood.

Eligibility:

Healthy adults ages 18-60

Design:

Participants will be screened in another protocol.

Participants may choose to be in 1 of 4 groups:

Group 1 will get 1 dose of 10E8VLS.

Group 2 will get 3 doses of 10E8VLS.

Group 3 will get 1 dose of both 10E8VLS and VRC07-523LS.

Group 4 will get 3 doses of both 10E8VLS and VRC07-523LS.

Participants in Groups 1 and 3 will have about 13 visits over 24 weeks.

Participants in Groups 2 and 4 will have about 26 visits over 48 weeks.

Participants will be weighed before each dose. Women may have a pregnancy test. They will have blood collected.

A small needle will inject each dose into fatty tissue of the belly, upper arm, or thigh. Participants will get between 1 and 8 injections per dose depending on their weight. Heavier participants will get more injections.

Participants will get a ruler and thermometer. They will check their temperature for 3 days after injection(s). They will measure any redness, swelling, or bruising at the injection site.

At non-injection visits, participants will have blood drawn and be checked for health changes or problems.


Condition or disease Intervention/treatment Phase
Healthy Adult Immune Response Biological: VRC-HIVMAB095-00-AB (10E8VLS) Biological: VRC-HIVMAB075-00-AB (VRC07-523LS) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: VRC 610: Phase I Safety and Pharmacokinetics Study to Evaluate a Human Monoclonal Antibody (MAB) VRC-HIVMAB095-00-AB (10E8VLS) Administered Alone or Concurrently With MAB VRC-HIVMAB075-00-AB (VRC07-523LS) Via Subcutaneous Injection in Healthy Adults
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Group 1: 10E8VLS 5 mg/kg SC Single Dose
5 mg/kg SC; Day 0
Biological: VRC-HIVMAB095-00-AB (10E8VLS)
10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.

Experimental: Group 2: 10E8VLS 5 mg/kg SC Multiple Doses
5 mg/kg SC; Day 0, Week 12, Week 24
Biological: VRC-HIVMAB095-00-AB (10E8VLS)
10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.

Experimental: Group 3: 10E8VLS+VRC07-523LS 5 mg/kg SC Single Dose
5 mg/kg SC; Day 0
Biological: VRC-HIVMAB095-00-AB (10E8VLS)
10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.

Biological: VRC-HIVMAB075-00-AB (VRC07-523LS)
VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Experimental: Group 4: 10E8VLS+VRC07-523LS 5 mg/kg SC Multiple Doses
5 mg/kg SC; Day 0, Week 12, Week 24
Biological: VRC-HIVMAB095-00-AB (10E8VLS)
10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.

Biological: VRC-HIVMAB075-00-AB (VRC07-523LS)
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 [ Time Frame: Through 24 weeks post administration. ]
    5 mg/kg SC dose of 10E8VLS administered once, or three- times by repeat dosing every 12 weeks,to healthy adults

  2. To evaluate the safety and tolerability [ Time Frame: Through 24 weeks post administration. ]
    5 mg/kg/MAb SC dose of 10E8VLS and VRC07-523LS administered once, or three- times by repeat dosing every 12 weeks, to healthy adults.


Secondary Outcome Measures :
  1. To evaluate the pharmacokinectics [ Time Frame: Through 24 weeks post administration. ]
    The pharmacokinetics of 10E8VLS will be evaluated in recipients administered 10E8VLS once or three times.

  2. To evaluate the pharmacokinetics of 10E8VLS and VRC07-523LS [ Time Frame: Through 24 weeks post administration. ]
    The pharmacokinetics of 10E8VLS and VRC07-523LS will be evaluated in recipients administered 10E8VLS and VRC07-523LS once or three times.



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.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

    1. Willing and able to complete the informed consent process.
    2. 18 to 60 years of age.
    3. Based on history and examination, in good general health and 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.
    5. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
    6. Screening laboratory criteria within 84 days prior to enrollment must meet the following criteria:
  • White blood cell count (WBC): 2,500-12,000/mm^3.
  • WBC differential: Within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.
  • Platelets: 125,000 - 400,000/mm^3.
  • Hemoglobin: Within institutional normal range or accompanied by PI or designee approval.
  • Creatinine: less than or equal to 1.1 x Upper Limit of Normal (ULN).
  • Aspartate aminotransferase (AST): less than or equal to 1.25 x ULN
  • Alanine aminotransferase (ALT): less than or equal to 1.25 x ULN.
  • Negative for HIV infection by an FDA approved method of detection.
  • Negative for Hepatitis B core antibody (HBcAb) and Hepatitis C virus antibody (HCV Ab).

Female-Specific Criteria:

7) 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.

8) 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:

  1. Woman who is breast-feeding, or planning to become pregnant during the study.
  2. Prior receipt of licensed or investigational monoclonal antibody.
  3. Weight > 115 kg.
  4. Any 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 during the study.
  5. Hypertension that is not well controlled.
  6. Receipt of any investigational study agent within 28 days prior to enrollment.
  7. Any other chronic or clinically significant 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/II, 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): NCT03565315


Locations
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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)
The Emmes Company, LLC
Investigators
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Principal Investigator: Martin R Gaudinski, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  Study Documents (Full-Text)

Documents provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Additional Information:
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03565315    
Other Study ID Numbers: 180113
18-I-0113 ( Other Identifier: NIH )
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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) ):
HIV Prevention
Broadly Neutralizing Monoclonal Antibodies
First in Human Study
Anti-Drug Antibody Response to 10E8VLS or VRC07-523LS