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HIV InfectionsPhase 1VRC07-523LSNCT03735849

Evaluating the Safety and Pharmacokinetics of VRC07-523LS in the Sera and Mucosae of Healthy, HIV-Uninfected Adult Participants

A Phase 1 study testing VRC07-523LS in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites 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

The purpose of this study is to evaluate the safety and pharmacokinetics of a human monoclonal antibody (VRC07-523LS) in the sera and mucosae of healthy, HIV-uninfected adults. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
VRC07-523LS
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesUnited States
Study dates
18 Jan 2019to 21 Dec 2020
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • General and Demographic Criteria
  • Age of 18 to 50 years
  • 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 and completes a questionnaire prior to first study product administration 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 required protocol clinic visit
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  • 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 and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. See the study protocol for US Low risk guidelines.
  • Laboratory Inclusion Values
  • Hemogram/Complete blood count (CBC)
  • Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth. For transgender participants who have been on hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (ie, a transgender female who has been on feminizing hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for persons assigned female sex at birth).
  • White blood cell (WBC) count equal to 2,500 to 12,000 cells/mm^3
  • WBC 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) less than 1.25 times the institutional upper limit of normal and creatinine less than or equal to institutional upper limits of normal.
  • Virology
  • Negative HIV-1 and -2 blood test: US volunteers must have a negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA).
  • Negative Hepatitis B surface antigen (HBsAg)
  • Negative anti-Hepatitis C virus (anti-HCV) antibodies, or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
  • Urine
  • Normal urine:
  • Negative or trace urine protein
  • Reproductive Status
  • Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to biopsy collection and/or study product administration.
  • Reproductive status: A volunteer who was assigned female sex at birth must:
  • Agree to use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception is defined as using the following methods:
  • Condoms (male or female) with or without a spermicide,
  • Diaphragm or cervical cap with spermicide,
  • Intrauterine device (IUD),
  • Hormonal contraception, or
  • Any other contraceptive method approved by the HVTN 128 Protocol Safety Review Team (PSRT)
  • Successful vasectomy in any partner assigned male sex at birth (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy);
  • Tubal ligation
  • Or be sexually abstinent until at least 4 months following the last study product administration.
  • Volunteers who were assigned female sex at birth must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit
  • Mucosal Specimen Collection
  • Volunteers 21 years of age and older who were assigned female sex at birth: Pap smear (verified by medical records) is required within:
  • the 3 years prior to enrollment with the latest result reported as normal or ASCUS (atypical squamous cells of undetermined significance), OR
  • the 5 years prior to enrollment, with the latest result reported as normal, or ASCUS with no evidence of high risk HPV.
  • If no Pap smear was done within the last 3 years (or within the last 5 years, if high risk HPV testing was performed), the volunteer must be willing to undergo a Pap smear with the result reported (verified by medical records) as normal or ASCUS prior to sample collection.
  • Willing to have mucosal secretions and tissue biopsies collected at several timepoints
  • Willing to abstain from sexual intercourse for the required period after each biopsy collection

Who cannot join

  • General
  • Weight greater than 115 kg
  • Blood products received within 120 days before first study product administration unless eligibility for earlier enrollment is determined by the HVTN 128 PSRT
  • Investigational research agents received within 30 days before first study product administration
  • 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 study
  • Pregnant or breastfeeding
Show all 49Show fewer
  • 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 128 PSRT will determine eligibility on a case-by-case basis.
  • Previous receipt of humanized or human monoclonal antibodies (mAbs), whether licensed or investigational; the HVTN 128 PSRT will determine eligibility on a case-by-case basis.
  • Previous receipt of monoclonal antibodies against HIV
  • Immune System
  • Immunosuppressive medications received within 30 days before first infusion (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of oral/parenteral prednisone or equivalent at doses less than or equal to 20 mg/day and length of therapy less than 14 days)
  • Serious adverse reactions to VRC07-523LS formulation components (sucrose, histidine, and sorbitol; see study protocol for more information), including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain.
  • Immunoglobulin received within 90 days before first infusion unless eligibility for earlier enrollment is determined by the HVTN 128 PSRT
  • Autoimmune disease (Not excluded from participation: Volunteer with mild, stable and uncomplicated autoimmune disease that does not require immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate Solicited and Unsolicited AE assessments)
  • Immunodeficiency
  • Clinically significant medical conditions
  • 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 inability to establish venous access,
  • 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 (eg, chronic urticaria or recent infusion with evidence of residual inflammation) for which signs or symptoms could be confused with reactions to the study product, or
  • Any condition specifically listed among the exclusion criteria below.
  • Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety, Solicited AEs, or a volunteer's ability to give informed consent
  • Psychiatric condition that 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.
  • Current anti-tuberculosis (TB) therapy
  • Asthma other than mild, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report). Exclude a volunteer who:
  • Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
  • Uses moderate/high dose inhaled corticosteroids, or
  • In the past year has either of the following:
  • Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids;
  • Needed emergency care, urgent care, hospitalization, or intubation for asthma.
  • Diabetes mellitus type 1 or type 2. (Not excluded: type 2 cases controlled with diet alone or a history of isolated gestational diabetes.)
  • Hypertension:
  • If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined as consistently less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be less than or equal to 150 mm Hg systolic and less than or equal to 100 mm Hg diastolic. For these volunteers, blood pressure must be less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic at enrollment.
  • If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure greater than or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or equal to 100 mm Hg at enrollment.
  • Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
  • Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study)
  • Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years
  • Asplenia: any condition resulting in the absence of a functional spleen
  • History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
  • Mucosal Specimen Collection
  • A rectal condition (for rectal biopsies), such as an active infection or inflammation of the colorectal area (eg, an HSV-2 outbreak or inflamed hemorrhoids or colitis/diarrhea), internal hemorrhoids, or any other condition noted during screening rectal exam via anoscope or in medical history that in the opinion of the clinician represents a contraindication to mucosal sampling.
  • For those who were assigned female sex at birth (for vaginal and cervical biopsies), any condition noted during pelvic exam via speculum or in medical history that in the opinion of the clinician represents a contraindication to mucosal sampling (eg, bacterial vaginosis).
  • An active genital tract condition, such as an active infection or inflammation of the genital tract (eg, genital sores or ulcers, penile or abnormal vaginal discharge, genital warts that are symptomatic or requiring treatment) or any other condition that in the opinion of the clinician represents a contraindication to mucosal sampling.
  • Hysterectomy or bilateral oophorectomy
  • Menopause
  • Current use of anticoagulants

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Brigham and Women's Hospital Vaccine CRS (BWH VCRS)

    Boston, Massachusetts, 02115-6110

  • Seattle Vaccine and Prevention CRS

    Seattle, Washington, 98109-1024

Other trials in United States

About this study

Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of VRC-HIVMAB075-00-AB (VRC07-523LS) in the Sera and Mucosae of Healthy, HIV-1-Uninfected Adult Participants

The purpose of this study is to evaluate the safety and pharmacokinetics of a human monoclonal antibody (VRC07-523LS) in the sera and mucosae of healthy, HIV-uninfected adults.

Read the detailed description

This study will evaluate the safety and pharmacokinetics of a human monoclonal antibody (VRC07-523LS) in the sera and mucosae of healthy, HIV-uninfected adults.

Participants will be randomly assigned to one of two groups. Participants in Group 1 will receive 10 mg/kg of VRC07-523LS at Weeks 0, 16, and 32. Participants in Group 2 will receive 30 mg/kg of VRC07-523LS at Weeks 0, 16, and 32.

Study visits will occur at Weeks 0, 2, 16, 18, 32, 34, and 48. Visits may include physical examinations; blood and urine collection; rectal, cervicovaginal, and seminal secretion collection; cervical, rectal, and vaginal biopsy collection; HIV testing; risk reduction counseling; and questionnaires. Study staff will contact participants at Week 50 for follow-up safety monitoring.

Conditions
HIV Infections
Being tested
VRC07-523LS
Medical subject headings
HIV Infections

What participants receive

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

  • VRC07-523LSBiological

    Also called VRC-HIVMAB075-00-AB

    Administered by intravenous (IV) infusion

Study groups in NCT03735849
Study groupRoleWhat they receive
Pre-treatmentNo interventionBiopsy collected but was not randomized to any treatment group
Group 1: VRC07-523LSExperimentalParticipants will receive 10 mg/kg of VRC07-523LS at Weeks 0, 16, and 32.
Receives: Biological: VRC07-523LS
Group 2: VRC07-523LSExperimentalParticipants will receive 30 mg/kg of VRC07-523LS at Weeks 0, 16, and 32.
Receives: Biological: VRC07-523LS

What is being measured

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

  1. Number of Participants Reporting Local Reactogenicity Signs and Symptoms

    Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.

    Measured: Measured through 3 days after each infusion at weeks 0, 16 and 32

  2. Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

    Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented

    Measured: Measured through 3 days after each infusion at weeks 0, 16 and 32

  3. Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L

    For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

    Measured: Measured during screening, visit 4(day 14), 6 (day 126) and 8 (day 238)

  4. Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl)

    For each local laboratory measure-Hemoglobin and Creatinine (g/dl), summary statistics were presented by treatment group and time point for the overall population.

    Measured: Measured during screening, Day 14, 126, 238

  5. Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)

    For each local laboratory measure lymphocyte count, neutrophil count, platelets, white blood cells (WBC) in 1000/ cubic mm summary statistics were presented by treatment group and time point

    Measured: Measured during screening, Day 14, 126, 238

  6. Chemistry and Hematology Laboratory Measures

    Counts of lab grade >1 for ALT, creatine, hemoglobin, lymphocyte count, neutrophil, platelets, white blood cells

    Measured: Measured during screening, Day 14, 126, 238

  7. Number of Participants Reporting Adverse Events (AEs)

    Participants Max severity reported per participant over visit.

    Measured: Enrollment through week 48

  8. Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation

    The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm

    Measured: Enrollment through last scheduled dose at week 32

  9. Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints

    Pharmacokinetic - Single Molecule Counting (PK-SMC) assay were used to measure passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant mucosa (secretions and biopsies) using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the concentration of VRC07-523LS.

    Measured: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48) in secretion samples (semen, cervicovaginal, and rectal) and at Visits 2, 4, 8, 9 (Weeks -2, 2, 34, 48) in biopsy samples (rectal, cervical, and vaginal).

  10. IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints

    Pharmacokinetic - Single Molecule Counting (PK-SMC) assay were used to measure passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant mucosa (secretions and biopsies) using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the IgG-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the total IgG (ng/mL).

    Measured: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48) in secretion samples (semen, cervicovaginal, and rectal) and at Visits 2, 4, 8, 9 (Weeks -2, 2, 34, 48) in biopsy samples (rectal, cervical, and vaginal).

  11. Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints

    Pharmacokinetic - Single Molecule Counting (PK-SMC) assay were used to measure passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant mucosa (secretions and biopsies) using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the protein-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the total protein (ng/mL).

    Measured: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48) in secretion samples (semen, cervicovaginal, and rectal) and at Visits 2, 4, 8, 9 (Weeks -2, 2, 34, 48) in biopsy samples (rectal, cervical, and vaginal).

  12. Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration

    Pharmacokinetic - Binding Antibody Multiplex Assay (PK-BAMA) was used to measure levels of passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant sera using 5C9 anti-IDiotype antibody (anti-ID). Outcome measure is the concentration of VRC07-523LS.

    Measured: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48).

  13. IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration

    Pharmacokinetic - Binding Antibody Multiplex Assay (PK-BAMA) was used to measure levels of passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant sera using 5C9 anti-IDiotype antibody (anti-ID). Outcome measure is the IgG-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the average reference values for total IgG concentrations in serum in the USA (11,650,000 ng/mL).

    Measured: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48).

  14. Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration

    Pharmacokinetic - Binding Antibody Multiplex Assay (PK-BAMA) was used to measure levels of passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant sera using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the protein-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the total protein (ng/mL).

    Measured: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48).

Secondary outcomes (1)

  1. Serum Concentration of ADA in Each Group Measured at Multiple Timepoints From Baseline Through the Final Study Visit

    Anti-drug dependent antibodies were measured by an ADA assay from specimens obtained from all participants. Tier 3 titers are only available for those participants who had positive for ADA Tiers 1 and 2.

    Measured: Measured at Visits 2, 3, 5, 7, and 9 (Weeks -2, 0, 16, 32, 48). However, Tier 3 ADA titers are only assessed and reported at Visits 2 and 3 (Weeks -2 and 0) for the subset of participants who tested positive for ADA Tiers 1 and 2.

Timeline

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

  1. First posted8 Nov 2018
  2. Study start18 Jan 2019
  3. Primary completion21 Dec 2020
  4. Study completion21 Dec 2020

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03735849
Sponsor's protocol ID
HVTN 128
Other IDs
38523
Acronym
VRC07-523LS
Status last verified
May 2025
First submitted
7 Nov 2018
Last updated
5 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRC07-523LS in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites 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 46 inclusion and 49 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 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 7 Mar 2022). 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 (time frame: Measured through 3 days after each infusion at weeks 0, 16 and 32). The study lists 14 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 NCT03735849.

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 5 Jun 2025.

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