Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults
NCT ID: NCT04173819
Last Updated: 2025-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
225 participants
INTERVENTIONAL
2019-01-25
2023-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group 1
Single Agent, abdominal subcutaneous injection, 10:2 ratio for Ab:placebo
3BNC117-LS-J
300mg
Placebo
Buffer Solution
Group 2
Single agent, abdominal subcutaneous injection 10:2 ratio for Ab:placebo
10-1074-LS-J
300mg
Placebo
Buffer Solution
Group 3
Single agent intravenous injection 10:2 ratio for Ab:placebo
3BNC117-LS-J
300mg
Placebo
0.9% Saline
Group 4
Single agent intravenous injection 10:2 ratio for Ab:placebo
10-1074-LS-J
300mg
Placebo
0.9% Saline
Group 5
Combined agent intravenous injection 10:2 ratio for Ab:placebo
Combination 3BNC117-LS-J and 10-1074-LS-J
30mg/kg of each
Placebo
0.9% Saline
Group 6
Subcutaneous injection combined ratio 1 with loading dose 30:3 ratio of Ab:Placebo
Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 1
Total \~300 mg (\< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2
Placebo
Buffer Solution
Group 7
Subcutaneous injection in abdomen combined ratio 2 with loading dose 30:3 ratio of Ab:Placebo
Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 2
Total \~300 mg (\< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2
Placebo
Buffer Solution
Group 8
Subcutaneous injection in abdomen combined ratio 3 with loading dose 30:3 ratio of Ab:Placebo
Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 3
Total \~300 mg (\< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2
Placebo
Buffer Solution
Group 9
Subcutaneous injection in abdomen combined ratio 2 without loading dose 30:3 ratio of Ab:Placebo
Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 2
Total \~300 mg (\< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2
Placebo
Buffer Solution
Group 10
Subcutaneous injection in arm combined ratio 2 without loading dose 30:3 ratio of Ab:Placebo
Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 2
Total \~300 mg (\< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2
Placebo
Buffer Solution
Interventions
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3BNC117-LS-J
300mg
10-1074-LS-J
300mg
Combination 3BNC117-LS-J and 10-1074-LS-J
30mg/kg of each
Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 1
Total \~300 mg (\< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2
Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 2
Total \~300 mg (\< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2
Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 3
Total \~300 mg (\< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2
Placebo
0.9% Saline
Placebo
Buffer Solution
Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age on the day of screening and have not reached their 46th birthday on the day of the first administration
* Willing to undergo HIV testing, risk reduction counseling and receive HIV test results; committed to maintaining low-risk behavior for the trial duration
* Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
* All male and female participants of reproductive potential who are engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception from enrollment until 9 months after the last administration
* Willing to forgo donations of blood, or any other tissues during the study following confirmation of study eligibility and, for those who test HIV-positive due to antibody-induced seropositivity, until the anti-HIV antibody titers become undetectable on HIV tests used in the community
Exclusion Criteria
* Reported risk for HIV infection within 6 months prior to investigational product administration, as defined by: Unprotected sexual intercourse with a known HIV-infected person, a partner known to be at high risk for HIV infection and/or a casual partner (i.e. no continuing established relationship), engaged in sex work, frequent excessive daily alcohol use or frequent binge drinking or any other use of illicit drugs, history of newly-acquired syphilis, gonorrhea, non-gonococcal urethritis, HSV-2, chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B or hepatitis C, three or more sexual partners
* Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator makes the participant unsuitable for participation in the study
* Infectious disease diagnosis: Hepatitis B infection as measured by HbsAg and/or PCR, Hepatitis C infection (US: HCV RNA positive, or interferon-alpha treatment for hepatitis C infection in the past year, or interferon-alpha-free treatment for hepatitis C infection completed in the past 6 months; Africa: HCV Ab positive and/or PCR positive), active syphilis (positive RPR confirmed by TPHA)
* Receipt of blood transfusion or blood-derived products within the previous 3 months
* Participation in another clinical trial of an investigational product currently, within the previous 3 months or expected participation during this study (Concurrent participation in an observational trial not requiring blood or tissue sample collection is not an exclusion)
* Psychiatric condition that compromises safety of the participant and precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years
* Body mass index (BMI) \>40
* Active tuberculosis
18 Years
45 Years
ALL
Yes
Sponsors
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Fred Hutchinson Cancer Center
OTHER
Rockefeller University
OTHER
Brigham and Women's Hospital
OTHER
International AIDS Vaccine Initiative
NETWORK
Responsible Party
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Principal Investigators
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Marina Caskey, MD
Role: STUDY_CHAIR
Rockefeller University
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
The Rockefeller University
New York, New York, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Partners in Health Research and Development
Thika, Kiambu County, Kenya
Kenya AIDS Vaccine Initiative - Institute of Clinical Research
Nairobi, , Kenya
Center for Family Health Research
Kigali, , Rwanda
Wits Reproductive Health and HIV Institute
Johannesburg, , South Africa
Uganda Virus Research Institute
Entebbe, , Uganda
Infectious Diseases Institute Kasangati
Kampala, , Uganda
Countries
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Related Links
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Related Info
Other Identifiers
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IAVI C100
Identifier Type: -
Identifier Source: org_study_id
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