Evaluating the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC01 and VRC01LS in the Serum and Mucosa of Healthy, HIV-Uninfected Adults

Completed · Phase 1

Conditions studied: HIV Infections

In brief

This study will evaluate the safety, pharmacokinetics, and antiviral activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of healthy, HIV-uninfected adults.

Key facts

Study ID

NCT02797171

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

80

Starts

2017-03-01

Expected to finish

2019-06-05

Last updated by the study team

2024-03-20

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• General and Demographic Criteria:
• Age of 18 to 50 years
• Weight less than or equal to 115 kg
• Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study
• Ability and willingness to provide informed consent
• Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to enrollment with verbal demonstration of understanding of all questionnaire items answered incorrectly
• Agrees not to enroll in another study of an investigational research agent until completion of the last study visit
• Good general health as shown by medical history, physical exam, and screening laboratory tests
• HIV-Related Criteria:
• Willingness to receive HIV test results
• Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling
• Assessed by the clinic staff as being at "low risk" for HIV infection [low risk guidelines are found on the protocol home page on the HVTN Members' site (https://members.hvtn.org/protocols/hvtn116)] and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
• Laboratory Inclusion Values:
• Hemogram/CBC
• Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male
• White blood cell count equal to 2,500 to 12,000 cells/mm\^3
• Total lymphocyte count greater than or equal to 800 cells/mm\^3
• Remaining differential either within institutional normal range or with site physician approval
• Platelets equal to 125,000 to 550,000/mm\^3
• Chemistry
• Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal
• Virology
• Negative HIV-1 and -2 blood test: U.S. volunteers must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA). Non-U.S. sites may use locally available assays that have been approved by HVTN Laboratory Operations.
• Negative hepatitis B surface antigen (HBsAg)
• Negative anti-hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive

You may not qualify if…

• General
• Blood products received within 120 days before first infusion, unless eligibility for earlier enrollment is determined by the HVTN 116 PSRT
• Investigational research agents received within 30 days before first infusion
• Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 116 study
• Pregnant or breastfeeding
• Active duty U.S. military personnel with the potential of being deployed during the study
• Vaccines and Other Injections
• HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 116 PSRT will determine eligibility on a case-by-case basis.
• Non-HIV experimental vaccine(s) received within the last 6 months in a prior vaccine trial. Exceptions may be made for some vaccines and vaccine trials. For volunteers who have received an experimental vaccine(s) less than 6 months ago, eligibility for enrollment will be determined by the HVTN 116 PSRT on a case-by-case basis.
• Live attenuated vaccines other than influenza vaccine received within 10 days before first infusion or scheduled within 10 days after first infusion (e.g., measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
• Previous receipt of humanized or human mAbs whether licensed or investigational
• Immune System
• Immunosuppressive medications received within 30 days before first infusion. (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; or [3] topical corticosteroids for mild, uncomplicated dermatitis)
• Serious adverse reactions to VRC01 and VRC01LS formulation components such as sodium citrate, sodium chloride, and L-arginine hydrochloride, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain
• Autoimmune disease (Not exclusionary: mild, well-controlled psoriasis)
• Immunodeficiency
• Clinically Significant Medical Conditions
• Untreated or incompletely treated syphilis infection
• Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
• A process that would affect the immune response,
• A process that would require medication that affects the immune response,
• Any contraindication to repeated infusions or blood draws, including perceived inability to establish venous access
• A condition that requires regular use of any anticoagulant medications (not including aspirin or NSAIDs),
• A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period,
• A condition or process for which signs or symptoms could be confused with reactions to study product, or

Where it is running

• Case Clinical Research Site — Cleveland, Ohio, United States
• Penn Prevention CRS — Philadelphia, Pennsylvania, United States
• Seattle Vaccine and Prevention CRS — Seattle, Washington, United States
• Groote Schuur HIV CRS — Cape Town, Western Cape, South Africa

Full record on ClinicalTrials.gov

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