HIVPhase 1NCT05627258

A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults

A Phase 1 study testing VRC-HIVMAB0115-00-AB in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Background: HIV causes AIDS, a serious disease that can lead to fatal infections. HIV infection can be controlled but not cured, nor is there a vaccine to prevent it. Antibodies may offer a promising new way to prevent HIV infection. Antibodies are proteins that are naturally made by the body to fight germs. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: HIV
What is being tested?: VRC-HIVMAB0115-00-AB
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 30 Jan 2023to 17 Jul 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

A subject must meet all of the following criteria:
Willing and able to complete the informed consent process.
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
Available for clinical follow-up through the last study visit.
18 to 60 years of age.
In good general health without clinically significant medical history.

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Physical examination without clinically significant findings within the 56 days prior to enrollment.
Adequate venous access if assigned to an IV group or adequate abdominal subcutaneous tissue if assigned to SC group.
Willing to have blood samples collected, stored indefinitely, and used for research purposes.
Laboratory Criteria within 56 days prior to enrollment:
White blood cell count (WBC): 2,500-12,000/mm3.
WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.
Platelets: 125,000 - 500,000/mm3.
Hemoglobin within institutional normal range or accompanied by PI or designee approval.
Creatinine: <= 1.1 x Upper Limit of Normal (ULN).
ALT: <= 1.25 x ULN.
AST: <= 1.25 x ULN.
Negative for HIV infection by an FDA approved method of detection.
Female-Specific Criteria:
Agrees to use an effective means of birth control from 21 days prior to enrollment through the duration of study participation.
Negative Beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.

Who cannot join

A subject will be excluded if one or more of the following conditions apply:
Woman who is breast-feeding or planning to become pregnant during study participation.
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.
Receipt of any investigational study product within 28 days prior to enrollment (Note: Emergency Use Authorization of a COVID-19 vaccine is not exclusionary).

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Receipt of an investigational HIV vaccine or anti-HIV monoclonal antibody.
Receipt of any live attenuated vaccine within 28 days prior to enrollment.
Receipt of any vaccine within 2 weeks prior to enrollment.
Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
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, infectious disease, autoimmune disease, psychiatric disorder, heart disease, or cancer.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: VRC 615: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB-0115-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults

Background:

HIV causes AIDS, a serious disease that can lead to fatal infections. HIV infection can be controlled but not cured, nor is there a vaccine to prevent it. Antibodies may offer a promising new way to prevent HIV infection. Antibodies are proteins that are naturally made by the body to fight germs. One antibody (VRC01.23LS) has been tested in the lab and was found to block HIV-like viruses. Researchers want to find out if it is safe to inject VRC01.23LS into people.

Objective:

To test the safety of VRC01.23LS in healthy adults.

Eligibility:

Healthy people aged 18 to 60 years.

Design:

Participants were divided into 6 groups:

Some got 1 dose of VRC01.23LS. They visited the clinic up to 14 times in 24 weeks.

Some got 3 doses, each 12 weeks apart. They had 25 clinic visits over 48 weeks.

For some participants, the drug was given through a tube attached to a needle inserted into a vein in the arm. This took about 30 to 90 minutes. Others received the drug as an injection under the skin in a fatty area of the belly, arm, or thigh; each dose may have needed up to 3 individual injections.

Participants stayed in the clinic up to 8 hours on the days they received VRC01.23LS.

Participants received a thermometer and measuring tool. They checked their temperature daily for 7 days after they received the study drug. They measured any redness, swelling, or bruising at the injection site.

Read the detailed description

Study Design:

This first-in-human, open-label study evaluated VRC01.23LS (VRCHIVMAB0115- 00-AB) in a dose-escalation design to examine safety, tolerability, dose, and pharmacokinetics (PK) in healthy adults. The primary hypothesis was that subcutaneous (SC) and intravenous (IV) administrations of VRC01.23LS will be safe and well-tolerated in healthy adults. A secondary hypothesis was that VRC01.23LS will be detectable in human sera with a definable half-life.

Study Products:

The VRC01.23LS broadly neutralizing monoclonal antibody (bnAb) targets the CD4 binding site in the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve the antibody half-life in vivo. VRC01.23LS was developed by the VRC/NIAID/NIH and manufactured under cGMP regulations at the VRC Pilot Plant operated under contract by the Vaccine Clinical Materials Program (VCMP), Leidos Biomedical Research, Inc., Frederick. MD.

Subjects:

Healthy adults, 18-60 years of age

Study Plan:

This open-label study included 6 groups to evaluate VRC01.23LS administered as a single dose or as repeated doses, given 12 weeks apart as shown in the table below. Enrollment began with the 5 mg/kg dose groups, and enrollment in subsequent dose groups proceeded after dose-escalation safety reviews. Assessment of safety included solicited reactogenicity, clinical observation, and monitoring of hematological and metabolic parameters at clinical visits throughout the study.

Conditions: HIV
Being tested: VRC-HIVMAB0115-00-AB
Keywords: Monoclonal Antibody, CD4 Binding, HIV envelope, First in Human, Broadly Neutralizing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VRC-HIVMAB0115-00-ABBiological
VRC01.23LS, a broadly neutralizing monoclonal antibody targeting the HIV-1 envelope CD4 binding site.

Study groups in NCT05627258
Study group	Role	What they receive
Group 1	Experimental	5 mg/kg IV single administration Receives: Biological: VRC-HIVMAB0115-00-AB
Group 2	Experimental	5 mg/kg SC single administration Receives: Biological: VRC-HIVMAB0115-00-AB
Group 3	Experimental	20 mg/kg IV single administration Receives: Biological: VRC-HIVMAB0115-00-AB
Group 4	Experimental	40 mg/kg IV single administration Receives: Biological: VRC-HIVMAB0115-00-AB
Group 5	Experimental	5 mg/kg SC repeat dosing Receives: Biological: VRC-HIVMAB0115-00-AB
Group 6	Experimental	20 mg/kg IV repeat dosing Receives: Biological: VRC-HIVMAB0115-00-AB

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Participants recorded the occurrence of solicited local symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017)
Measured: 7 days after product administration
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Participants recorded the occurrence of solicited systemic symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017
Measured: 7 days after product administration
Number of Participants With Serious Adverse Events Following Product Administration
SAEs were recorded from receipt of product administration through the last study visit at Week 24 for participants in Groups 1, 2, 3, 4. SAEs were recorded from receipt of product administration through the last study visit at Week 48 for participants in Groups 5 or 6. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Measured: Day 0 after product administration through Day 168, up to Week 24 for participants in Groups 1-4. Day 0 after product administration through Day 336, up to Week 48, for participants in Group 5 and 6.
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration
Unsolicited AEs and attribution assessments were recorded in the study database from receipt of study product administration through the visit scheduled for 4 weeks after study product administration. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Measured: Day 0 through 28 days post product administration, up to Week 4
Number of Participants With New Chronic Medical Conditions Following Product Administration
New chronic medical conditions that required ongoing medical management were recorded from receipt of study product administration through the last expected study visit at Week 24 for Groups 1-4 and through Week 48 for Groups 5-6. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Measured: Day 0 after product administration through Day 140, up to Week 24 for Groups 1-4. Day 0 after product administration through Day 336, up to Week 48 for Groups 5-6
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
Abnormal lab results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included pregnancy test, hematology and chemistry labs, and HIV Serology diagnostic test. Institutional lab normal ranges as well as the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 - July 2017 were used.
Measured: Day 0 after product administration through Day 140, up to Week 24 for Groups 1-4. Day 0 after product administration through Day 336, up to Week 48, for Groups 5-6

Secondary outcomes (5)

Pharmacokinetic (PK) Parameters of VRC01.23LS: Maximum Observed Serum Concentration (Cmax)
Cmax is the peak serum concentration that VRC01.23LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.
Measured: Baseline through 24 weeks after VRC01.23LS product administration
Pharmacokinetic (PK) Parameters of VRC01.23LS: Time to Reach Maximum Observed Serum Concentration (Tmax)
Tmax is the time it takes to reach Cmax of VRC01.23LS after it has been administered; it is determined based on the summary PK curve for each dose group.
Measured: Baseline through 24 weeks after VRC01.23LS product administration
Pharmacokinetic (PK) Parameters of VRC01.23LS: Beta Half-life (T1/2b)
Beta half-life (T1/2b) is the time required for half of the VRC01.23LS product to be eliminated from the serum.
Measured: Baseline through 24 weeks after VRC01.23LS product administration
Pharmacokinetic (PK) Parameters of VRC01.23LS: Clearance Rate
Clearance is the rate of VRC01.23LS elimination divided by the plasma VRC01.23LS concentration; determined based on the summary pharmacokinetic (PK) curve for each study group. Clearance following a SC administration is calculated as Clearance (CL)/Bioavailability (F).
Measured: Baseline through 24 weeks after VRC01.23LS product administration
Pharmacokinetic (PK) Parameters of VRC01.23LS: Volume of Distribution
Theoretical volume that would be necessary to contain the total amount of administered drug at the same concentration as observed in plasma. It represents the degree to which a drug is distributed in body tissue rather than the plasma and calculated based in the PK curve for each study group. Volume of distribution following a SC administration is calculated as Volume of distribution (V)/Bioavailability (F).
Measured: Baseline through 24 weeks after VRC01.23LS product administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 202317 Jul 2024

First posted25 Nov 2022
Study start30 Jan 2023
Primary completion17 Jul 2024
Study completion17 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05627258
Sponsor's protocol ID: 10000889
Other IDs: 000889-I
Status last verified: 18 Sep 2024
First submitted: 23 Nov 2022
Last updated: 22 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Please refer to protocol Section 9.3.4.

Publications

Gaudinski MR, Coates EE, Houser KV, Chen GL, Yamshchikov G, Saunders JG, Holman LA, Gordon I, Plummer S, Hendel CS, Conan-Cibotti M, Lorenzo MG, Sitar S, Carlton K, Laurencot C, Bailer RT, Narpala S, McDermott AB, Namboodiri AM, Pandey JP, Schwartz RM, Hu Z, Koup RA, Capparelli E, Graham BS, Mascola JR, Ledgerwood JE; VRC 606 Study Team. Safety and pharmacokinetics of the Fc-modified HIV-1 human monoclonal antibody VRC01LS: A Phase 1 open-label clinical trial in healthy adults. PLoS Med. 2018 Jan 24;15(1):e1002493. doi: 10.1371/journal.pmed.1002493. eCollection 2018 Jan.
PubMed 29364886
Gaudinski MR, Houser KV, Doria-Rose NA, Chen GL, Rothwell RSS, Berkowitz N, Costner P, Holman LA, Gordon IJ, Hendel CS, Kaltovich F, Conan-Cibotti M, Gomez Lorenzo M, Carter C, Sitar S, Carlton K, Gall J, Laurencot C, Lin BC, Bailer RT, McDermott AB, Ko SY, Pegu A, Kwon YD, Kwong PD, Namboodiri AM, Pandey JP, Schwartz R, Arnold F, Hu Z, Zhang L, Huang Y, Koup RA, Capparelli EV, Graham BS, Mascola JR, Ledgerwood JE; VRC 605 study team. Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial. Lancet HIV. 2019 Oct;6(10):e667-e679. doi: 10.1016/S2352-3018(19)30181-X. Epub 2019 Aug 28.
PubMed 31473167
Kwon YD, Asokan M, Gorman J, Zhang B, Liu Q, Louder MK, Lin BC, McKee K, Pegu A, Verardi R, Yang ES, Program VP, Carlton K, Doria-Rose NA, Lusso P, Mascola JR, Kwong PD. A matrix of structure-based designs yields improved VRC01-class antibodies for HIV-1 therapy and prevention. MAbs. 2021 Jan-Dec;13(1):1946918. doi: 10.1080/19420862.2021.1946918.
PubMed 34328065

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: VRC 615: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB-0115-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults
ClinicalTrials.gov ID: NCT05627258
Acronym / sponsor ID: 10000889
Conditions: HIV
Keywords: Monoclonal Antibody, CD4 Binding, HIV envelope, First in Human, Broadly Neutralizing
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: 30 Jan 2023 (actual)
Primary completion: 17 Jul 2024 (actual)
Study completion: 17 Jul 2024 (actual)
First posted: 25 Nov 2022 (actual)
Results: Posted 22 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Background:

Objective:

To test the safety of VRC01.23LS in healthy adults.

Eligibility:

Healthy people aged 18 to 60 years.

Design:

Participants were divided into 6 groups:

Some got 1 dose of VRC01.23LS. They visited the clinic up to 14 times in 24 weeks.

Some got 3 doses, each 12 weeks apart. They had 25 clinic visits over 48 weeks.

Participants stayed in the clinic up to 8 hours on the days they received VRC01.23LS.

Detailed description

Study Design:

Study Products:

Subjects:

Healthy adults, 18-60 years of age

Study Plan:

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Group 1	Experimental	Biological: VRC-HIVMAB0115-00-AB5 mg/kg IV single administration
Group 2	Experimental	Biological: VRC-HIVMAB0115-00-AB5 mg/kg SC single administration
Group 3	Experimental	Biological: VRC-HIVMAB0115-00-AB20 mg/kg IV single administration
Group 4	Experimental	Biological: VRC-HIVMAB0115-00-AB40 mg/kg IV single administration
Group 5	Experimental	Biological: VRC-HIVMAB0115-00-AB5 mg/kg SC repeat dosing
Group 6	Experimental	Biological: VRC-HIVMAB0115-00-AB20 mg/kg IV repeat dosing

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (21 listed)

Willing and able to complete the informed consent process.
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
Available for clinical follow-up through the last study visit.
18 to 60 years of age.
In good general health without clinically significant medical history.

Key exclusion criteria (11 listed)

Woman who is breast-feeding or planning to become pregnant during study participation.
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.
Receipt of any investigational study product within 28 days prior to enrollment (Note: Emergency Use Authorization of a COVID-19 vaccine is not exclusionary).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VRC-HIVMAB0115-00-ABVRC01.23LS, a broadly neutralizing monoclonal antibody targeting the HIV-1 envelope CD4 binding site.	Biological	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6

Primary outcome

Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Time frame: 7 days after product administration
Participants recorded the occurrence of solicited local symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017)
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Time frame: 7 days after product administration
Participants recorded the occurrence of solicited systemic symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017
Number of Participants With Serious Adverse Events Following Product Administration
Time frame: Day 0 after product administration through Day 168, up to Week 24 for participants in Groups 1-4. Day 0 after product administration through Day 336, up to Week 48, for participants in Group 5 and 6.
SAEs were recorded from receipt of product administration through the last study visit at Week 24 for participants in Groups 1, 2, 3, 4. SAEs were recorded from receipt of product administration through the last study visit at Week 48 for participants in Groups 5 or 6. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration
Time frame: Day 0 through 28 days post product administration, up to Week 4
Unsolicited AEs and attribution assessments were recorded in the study database from receipt of study product administration through the visit scheduled for 4 weeks after study product administration. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Number of Participants With New Chronic Medical Conditions Following Product Administration
Time frame: Day 0 after product administration through Day 140, up to Week 24 for Groups 1-4. Day 0 after product administration through Day 336, up to Week 48 for Groups 5-6
New chronic medical conditions that required ongoing medical management were recorded from receipt of study product administration through the last expected study visit at Week 24 for Groups 1-4 and through Week 48 for Groups 5-6. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
Time frame: Day 0 after product administration through Day 140, up to Week 24 for Groups 1-4. Day 0 after product administration through Day 336, up to Week 48, for Groups 5-6
Abnormal lab results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included pregnancy test, hematology and chemistry labs, and HIV Serology diagnostic test. Institutional lab normal ranges as well as the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 - July 2017 were used.

5 secondary outcomes

Pharmacokinetic (PK) Parameters of VRC01.23LS: Maximum Observed Serum Concentration (Cmax)
Time frame: Baseline through 24 weeks after VRC01.23LS product administration
Pharmacokinetic (PK) Parameters of VRC01.23LS: Time to Reach Maximum Observed Serum Concentration (Tmax)
Time frame: Baseline through 24 weeks after VRC01.23LS product administration
Pharmacokinetic (PK) Parameters of VRC01.23LS: Beta Half-life (T1/2b)
Time frame: Baseline through 24 weeks after VRC01.23LS product administration
Pharmacokinetic (PK) Parameters of VRC01.23LS: Clearance Rate
Time frame: Baseline through 24 weeks after VRC01.23LS product administration
Pharmacokinetic (PK) Parameters of VRC01.23LS: Volume of Distribution
Time frame: Baseline through 24 weeks after VRC01.23LS product administration

Results and safety

Results posted to the registry on 22 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	4	1
Group 2	3	3
Group 3	3	2
Group 4	3	3
Group 5	5	3
Group 6	5	5

Primary outcome: Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration

Time frame: 7 days after product administration. Count of participants. Unit: Participants

Measure	Group 1 n = 3	Group 2 n = 3	Group 3 n = 3	Group 4 n = 3	Group 5 n = 5	Group 6 n = 5
Pain/Tenderness: None	3	2	2	3	3	4
Pain/Tenderness: Mild	0	1	1	0	1	1
Pain/Tenderness: Moderate	0	0	0	0	1	0
Pain/Tenderness: Severe	0	0	0	0	0	0
Swelling: None	3	2	2	3	5	5
Swelling: Mild	0	0	1	0	0	0
Swelling: Moderate	0	0	0	0	0	0
Swelling: Severe	0	1	0	0	0	0

Population analysed: Population included all enrolled participants who received study product and provided safety data (via diary card and/or laboratory results) following vaccine administration (N=22). One participant in Group 1 did not receive study product due to onset of a panic attack after IV insertion.

Primary outcome: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration

Time frame: 7 days after product administration. Count of participants. Unit: Participants

Measure	Group 1 n = 3	Group 2 n = 3	Group 3 n = 3	Group 4 n = 3	Group 5 n = 5	Group 6 n = 5
Malaise: None	3	3	3	2	2	3
Malaise: Mild	0	0	0	0	3	1
Malaise: Moderate	0	0	0	1	0	1
Malaise: Severe	0	0	0	0	0	0
Myalgia: None	2	3	3	3	2	4
Myalgia: Mild	1	0	0	0	3	1
Myalgia: Moderate	0	0	0	0	0	0
Myalgia: Severe	0	0	0	0	0	0

Primary outcome: Number of Participants With Serious Adverse Events Following Product Administration

Time frame: Day 0 after product administration through Day 168, up to Week 24 for participants in Groups 1-4. Day 0 after product administration through Day 336, up to Week 48, for participants in Group 5 and 6.. Count of participants. Unit: Participants

Measure	Group 1 n = 3	Group 2 n = 3	Group 3 n = 3	Group 4 n = 3	Group 5 n = 5	Group 6 n = 5
Related to Study Product	0	0	0	0	0	0
Unrelated to Study Product	0	0	0	0	0	0
Total Number of Participants who had SAE	0	0	0	0	0	0
Total number of Participants who did not have SAE	3	3	3	3	5	5

Population analysed: Population included all enrolled participants who received study product (N=22). One participant in Group 1 did not receive study product due to onset of a panic attack after IV insertion.

Primary outcome: Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration

Time frame: Day 0 through 28 days post product administration, up to Week 4. Number. Unit: participants

Measure	Group 1 n = 3	Group 2 n = 3	Group 3 n = 3	Group 4 n = 3	Group 5 n = 5	Group 6 n = 5
Related to Study Product	0	0	1	3	2	2
Unrelated to Study Product	0	0	1	0	1	0
Total Number of Participants who had One or More Non-Serious Unsolicited AE	0	0	2	3	3	2
Total Number of Participants who had no Unsolicited AEs	3	3	1	0	2	3

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Group 2	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Group 3	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Group 4	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Group 5	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Group 6	0 of 5 (0%)	3 of 5 (60%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29364886Gaudinski MR, Coates EE, Houser KV, Chen GL, Yamshchikov G, Saunders JG, Holman LA, Gordon I, Plummer S, Hendel CS, Conan-Cibotti M, Lorenzo MG, Sitar S, Carlton K, Laurencot C, Bailer RT, Narpala S, McDermott AB, Namboodiri AM, Pandey JP, Schwartz RM, Hu Z, Koup RA, Capparelli E, Graham BS, Mascola JR, Ledgerwood JE; VRC 606 Study Team. Safety and pharmacokinetics of the Fc-modified HIV-1 human monoclonal antibody VRC01LS: A Phase 1 open-label clinical trial in healthy adults. PLoS Med. 2018 Jan 24;15(1):e1002493. doi: 10.1371/journal.pmed.1002493. eCollection 2018 Jan.
Background: PubMed 31473167Gaudinski MR, Houser KV, Doria-Rose NA, Chen GL, Rothwell RSS, Berkowitz N, Costner P, Holman LA, Gordon IJ, Hendel CS, Kaltovich F, Conan-Cibotti M, Gomez Lorenzo M, Carter C, Sitar S, Carlton K, Gall J, Laurencot C, Lin BC, Bailer RT, McDermott AB, Ko SY, Pegu A, Kwon YD, Kwong PD, Namboodiri AM, Pandey JP, Schwartz R, Arnold F, Hu Z, Zhang L, Huang Y, Koup RA, Capparelli EV, Graham BS, Mascola JR, Ledgerwood JE; VRC 605 study team. Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial. Lancet HIV. 2019 Oct;6(10):e667-e679. doi: 10.1016/S2352-3018(19)30181-X. Epub 2019 Aug 28.
Background: PubMed 34328065Kwon YD, Asokan M, Gorman J, Zhang B, Liu Q, Louder MK, Lin BC, McKee K, Pegu A, Verardi R, Yang ES, Program VP, Carlton K, Doria-Rose NA, Lusso P, Mascola JR, Kwong PD. A matrix of structure-based designs yields improved VRC01-class antibodies for HIV-1 therapy and prevention. MAbs. 2021 Jan-Dec;13(1):1946918. doi: 10.1080/19420862.2021.1946918.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Individual participant dataSharing planned: No. Please refer to protocol Section 9.3.4.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lesia K Dropulic, M.D. principal investigator

National Institute of Allergy and Infectious Diseases (NIAID)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRC-HIVMAB0115-00-AB in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration (time frame: 7 days after product administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05627258, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.