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HIV-1Phase 1NCT02840474

Phase 1, Open-label, Single Dose Study to Examine Safety, Tolerability, Pharmacokinetics and Virologic Impact of VRC01LS or VRC07-523LS in HIV-infected Viremic Adults

A Phase 1 study testing VRC-HIVMAB080-00-AB and VRC-HIVMAB075-00-AB in people with HIV-1, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

Background: The human body uses antibodies as one way to help fight infection. VRC01LS and VRC07-523LS are antibodies directed against the HIV virus. Researchers want to see if they are safe and well tolerated. In Part A of the study, the researchers studied VRC01LS. Part A of the study was completed in 2017. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
HIV-1
What is being tested?
VRC-HIVMAB080-00-AB and VRC-HIVMAB075-00-AB
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
7 sitesin 2 countries
Study dates
24 Apr 2017to 15 Jan 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A participant must meet all of the following criteria:
  • Able and willing to complete the informed consent process.
  • 18-70 years old
  • Available for clinic visits for 48 weeks after study product administration.
  • HIV-1 infected and clinically stable. [Note: Documented HIV-1 infection by HIV enzyme immunoassay (EIA) performed by a Clinical Laboratory Improvement Amendments (CLIA) certified outside lab within 28 days of enrollment is acceptable.]
  • At least one plasma viral load >=500 copies/mL within 28 days of enrollment. A plasma viral load within 28 days and closest to the day of enrollment, that is detectable but not greater than 100,000 copies/mL. [Note: outside laboratory results will be acceptable].
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  • A CD4+ count >=350 cells/microliter (mcL) on 2 of 3 consecutive testing occasions (or on 2 of 2 sequential tests) within 28 days prior to enrollment. [Note: outside laboratory results will be acceptable].
  • In general good health as assessed by a study clinician and under the care of a primary health care provider for medical management of HIV infection while participating in the study. Willing to give consent to contact and send laboratory results to the participant's primary health provider.
  • Willing to have blood samples collected, stored indefinitely, and used for various research purposes.
  • Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
  • Screening laboratory values within 28 days prior to enrollment must meet the following criteria:
  • Absolute neutrophil count >=800/mcL
  • Platelets >=100,000/mcL
  • Hemoglobin >=10.0 g/dL
  • Creatinine less than or equal to 1.31 mg/dL
  • Alanine aminotransferase (ALT) less than or equal to 2.5 x upper limit of normal (ULN)
  • Negative Hepatitis B Surface Antigen (HBsAg)
  • Undetectable Hepatitis C Viral Load (HCV RNA)
  • [Note: Documented negative HBsAg and HCV RNA performed by an outside CLIA certified lab within 28 days of enrollment are acceptable.]
  • Female-Specific Criteria:
  • If a woman is sexually active with a male partner and has no history of hysterectomy, tubal ligation, or menopause, she must agree to use either a prescription birth control method or a barrier birth control method from the time of study enrollment until the last study visit, or have a monogamous partner who has had a vasectomy.
  • 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 participant will be excluded if one or more of the following conditions apply:
  • Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
  • Prior use of antiretroviral therapy.
  • Ongoing AIDS-related opportunistic infection (including oral thrush).
  • Active drug or alcohol use or dependence in the opinion of the site investigator that would interfere with adherence to study requirements.
  • Any history of a severe allergic reaction, including generalized urticaria, angioedema or anaphylaxis prior to enrollment, that has a reasonable risk of recurrence during the study.
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  • Physical finding on examination considered clinically significant.
  • Hypertension that is not well controlled.
  • Weight >115 kg (253 pounds).
  • Breast-feeding.
  • Receipt of any investigational study product within 28 days prior to enrollment.
  • Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer.

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States6 sites

  • University of Alabama HIV Clinic Clinical Research Site, AIDS Clinical Trials Group (ACTG)

    Birmingham, Alabama, 35294

  • University of Cincinnati University Hospital, AIDS Clinical Trials Group (ACTG)

    Cincinnati, Ohio, 45267

  • Ohio State University Clinical Research Site, AIDS Clinical Trials Group (ACTG)

    Columbus, Ohio, 43210

  • UCLA CARE Center, AIDS Clinical Trials Group (ACTG)

    Los Angeles, California, 90035

  • Hospital of the University of Pennsylvania Clinical Research Site, AIDS Clinical Trials Group (ACTG)

    Philadelphia, Pennsylvania, 19104-6056

  • Washington University Therapeutics, AIDS Clinical Trials Group (ACTG)

    St Louis, Missouri, 63110

Other trials in United States

Puerto Rico1 site

  • Puerto Rico AIDS Clinical Trials Unit, AIDS Clinical Trials Group (ACTG)

    San Juan, PR, 00935

Other trials in Puerto Rico

About this study

Official title: VRC 607-ACTG A5378: A Phase 1, Single Dose Study of the Safety and Virologic Effect of an HIV-1 Specific Broadly Neutralizing Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS) or VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously to HIV-Infected Adults.

Background:

The human body uses antibodies as one way to help fight infection. VRC01LS and VRC07-523LS are antibodies directed against the HIV virus. Researchers want to see if they are safe and well tolerated. In Part A of the study, the researchers studied VRC01LS. Part A of the study was completed in 2017. In Part B, the researchers studied VRC07-523LS. Depending on which antibody received, researchers studied the amount of VRC01LS or VRC07-523LS in the body and how it changes over time. They evaluated the effect of antibodies on CD4+ (Cluster of Differentiation 4) lymphocyte count and HIV viral load, and checked to see if people who get VRC01LS or VRC07-523LS develop an immune response to it.

Read more

Objective:

To see if VRC01LS and VRC07-523LS are safe and well tolerated.

Eligibility:

Adults ages 18-70 who are HIV infected but otherwise healthy.

Design:

Participants received the study drug one time by IV infusion. A needle guided a thin tube into a vein. The study drug mixed with salt water was dripped into the vein over about 30 minutes.

Participants were monitored for 30 minutes after the infusion.

Blood samples were taken at the following times:

  • Once before the infusion
  • 5 times in the 4 hours after the infusion
  • 1 time 24 hours after infusion. Some participants may have had 3 optional blood draws in the time period between 4 and 24 hours.

For 3 days after the infusion, participants recorded their temperature and reactogenicity symptoms in a diary.

There were a total of 23 study visits over 48 weeks. Ten visits were in the first 4 weeks. At all visits, participants answered health questions and gave blood samples.

Read the detailed description

Study Design:

Open-label, single dose study to examine safety, tolerability, pharmacokinetics and virologic impact of VRC01LS or VRC07-523LS in HIV-infected viremic adults.

Study Hypotheses:

This is the first study of VRC01LS or VRC07-523LS in HIV-infected viremic adults. The primary hypothesis is that both VRC01LS and VRC07-523LS will be safe for intravenous administration to HIV-1-infected adults. The secondary hypothesis is that VRC01LS and VRC07-523LS will be detectable in human sera with a definable half-life.

Product Description:

VRC-HIVMAB080-00-AB (VRC01LS) and VRC-HIVMAB075-00-AB (VRC07-523LS) are human monoclonal antibodies (MAbs) targeted to the CD4+ binding site of HIV-1. Both MAbs are modifications of the VRC01 MAb (which has been shown to be safe and to have antiviral activity in human studies) with the addition of the "LS", a 2-amino acid mutation designed to improve the half-life of the antibody. These MAbs were developed and manufactured by VRC/NIAID/NIH under current Good Manufacturing Practice (cGMP) at the VRC Vaccine Pilot Plant operated under contract by the Vaccine Clinical Materials Program (VCMP), Leidos Biomedical Research, Inc., Frederick, MD. Vials were provided at 100 mg/mL.

Participants:

HIV-1-infected viremic adults; 18-70 years of age.

Study Plan:

This study assessed VRC01LS or VRC07-523LS administered at 40 mg/kg IV in HIV-infected viremic participants. Participants enrolled in one of two parts: Part A (VRC01LS) or Part B (VRC07-523LS). A total of 7 participants were enrolled in Part A and received VRC01LS and a total of 9 participants were enrolled in Part B and received VRC07-523LS. Safety lab samples, HIV viral load, CD4+ lymphocyte count, pharmacokinetic (PK) samples, and blood samples for detection of human anti-VRC01LS antibody (Part A) and human anti-VRC07-523LS antibody (Part B) were drawn at baseline and intervals throughout the study. Participants recorded in a daily diary reactogenicity symptoms for 3 days after study product administration and were queried at each study visit for adverse events. Participants were strongly encouraged to initiate 3-drug anti-retroviral therapy (ART), prescribed by their primary HIV clinician; not study-provided, any time after completing the day 14 study evaluations.

VRC 607/A5378 Study Schema:

  • Part: A; Participants: 7; Product: VRC01LS; Administration Schedule (Day 0): 40 mg/kg IV.
  • Part: B; Participants: 9; Product: VRC07-523LS; Administration Schedule (Day 0): 40 mg/kg IV.
  • Total Participants: 16

Study Duration:

Participants were followed for 48 weeks after study product administration.

Conditions
HIV-1
Being tested
VRC-HIVMAB080-00-AB, VRC-HIVMAB075-00-AB
Keywords
HIV Viral Load, Antiviral, CD4 Count, HIV-1 Infection, Broadly Neutralizing Antibody

What participants receive

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

  • VRC-HIVMAB080-00-ABBiological

    Also called VRC01LS

    VRC01LS is an investigational human monoclonal antibody targeted to the CD4+ binding site of HIV-1.

  • VRC-HIVMAB075-00-ABBiological

    Also called VRC07-523LS

    VRC07-523LS is an investigational human monoclonal antibody targeted to the CD4+ binding site of HIV-1.

Study groups in NCT02840474
Study groupRoleWhat they receive
Part A: VRC01LS (40 mg/kg)ExperimentalVRC-HIVMAB080-00-AB (VRC01LS) - (40 mg/kg) - administered intravenously (IV) at Day 0
Receives: Biological: VRC-HIVMAB080-00-AB
Part B: VRC07-523LS (40 mg/kg)ExperimentalVRC-HIVMAB075-00-AB (VRC07-523LS) - (40 mg/kg) - administered IV at Day 0
Receives: Biological: VRC-HIVMAB075-00-AB

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 for 3 Days After VRC01LS or VRC07-523LS Administration

    Participants recorded the occurrence of solicited symptoms on a diary card for 3 days after the 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 U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 [November 2014].

    Measured: 3 days after study product administration

  2. Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 3 Days After VRC01LS or VRC07-523LS Administration

    Participants recorded the occurrence of solicited symptoms on a diary card for 3 days after the 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 U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 [November 2014].

    Measured: 3 days after study product administration

  3. Number of Participants With Abnormal Laboratory Measures of Safety

    Any abnormal laboratory results recorded as unsolicited AEs are summarized. Labs included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, white blood cell (WBC) and red blood cell (RBC) counts, and neutrophil, lymphocyte, monocyte, eosinophil and basophil percents and counts) and chemistry (alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and creatinine). Complete blood count (CBC) and platelet results were collected at screening, Day 0 prior to study product administration (baseline), and Days 2 and 7, Weeks 2-8, 12, 16, 20, 24, 36 and 48 after product administration. Creatinine, ALT, AST and ALP results were collected at screening, baseline, and Days 2 and 7, Weeks 2, 4, 12, 24, 36 and 48 after product administration. Institutional laboratory normal ranges as well as the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 [November 2014] were used.

    Measured: Through 48 weeks after study product administration

  4. Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs)

    Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the study product administration through the visit scheduled for 56 days (or 8 weeks) after study product administration. At other time periods greater than 56 days (or 8 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 that required ongoing medical management 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: Through 56 days after study product administration

  5. Number of Participants With Serious Adverse Events (SAEs)

    SAEs were recorded from receipt of the study product administration through the last expected study visit at Week 48. The relationship between a SAE and the study product was assessed by the investigator on the basis of his or her 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: Through 48 weeks after study product administration

Secondary outcomes (11)

  1. Area Under the Curve For the Last Study Visit (AUC(Last))

    The AUC(last) represents the area under the curve (AUC) from zero (dosing) to the time of the last measurable drug concentration at the last study visit after study product administration; it is determined based on the summary PK curve for each study group.

    Serum samples were collected pre-infusion (baseline), end of infusion (0h), 30 min, 1 hr-4 hr, 24 hr, 48 hr and Days 7, 14, 21, 28, 35, 42, 49, 56, 84, 112, 140, 168, 252 and 336 (Week 48) post-infusion.

    Measured: Administration (0h) to 48 weeks after study product administration

  2. Clearance Rate of VRC01LS or VRC07-523LS Administered at 40 mg/kg IV

    Rate of study product elimination divided by the plasma concentration; determined based on the summary PK curve for each study group. Serum samples were collected pre-infusion (baseline), end of infusion (0h), 30 min, 1 hr-4 hr, 24 hr, 48 hr and Days 7, 14, 21, 28, 35, 42, 49, 56, 84, 112, 140, 168, 252 and 336 (Week 48) post-infusion.

    Measured: Administration (0h) to 48 weeks after study product administration

  3. Maximum Observed Serum Concentration (Cmax) of VRC01LS or VRC07-523LS Administered at 40 mg/kg IV

    Cmax is the peak serum concentration that the study product achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group. Serum samples were collected pre-infusion (baseline), end of infusion (0h), 30 min, 1 hr-4 hr, 24 hr, 48 hr and Days 7, 14, 21, 28, 35, 42, 49, 56, 84, 112, 140, 168, 252 and 336 (Week 48) post-infusion.

    Measured: Through 48 weeks after study product administration

  4. Half-life (T1/2) of VRC01LS or VRC07-523LS Administered at 40 mg/kg IV

    Half-life (T1/2) is the time required for half of the study product to be eliminated from the serum. Serum samples were collected pre-infusion (baseline), end of infusion (0h), 30 min, 1 hr-4 hr, 24 hr, 48 hr and Days 7, 14, 21, 28, 35, 42, 49, 56, 84, 112, 140, 168, 252 and 336 (Week 48) post-infusion.

    Measured: Through 48 weeks after study product administration

  5. Mean Serum Concentration of VRC01LS or VRC07-523LS Administered at 40 mg/kg IV

    The mean of individual subject serum concentrations by administered study group. Serum samples were collected pre-infusion (baseline), end of infusion (0h), 30 min, 1 hr-4 hr, 24 hr, 48 hr and Days 7, 14, 21, 28, 35, 42, 49, 56 and 84 post-infusion.

    Measured: Day 28 and Day 84 after study product administration

  6. Time to Reach Maximum Observed Serum Concentration (Tmax) of VRC01LS or VRC07-523LS Administered at 40 mg/kg IV

    Tmax is the time it takes to reach Cmax of study product after it has been administered; it is determined based on the summary PK curve for each study group.

    Serum samples were collected pre-infusion (baseline), end of infusion (0h), 30 min, 1 hr-4 hr, 24 hr, 48 hr and Days 7, 14, 21, 28, 35, 42, 49, 56, 84, 112, 140, 168, 252 and 336 (Week 48) post-infusion.

    Measured: Through 48 weeks after study product administration

  7. Number of Participants Who Produced Anti-drug Antibodies to VRC01LS or VRC07-523LS Administered at 40 mg/kg IV

    Presence of anti-drug antibodies to VRC01LS or VRC07-523LS was evaluated.

    Measured: Day 28 and Day 56 after study product administration

  8. Log10 Change in Viral Load (VL) From Baseline to Nadir (Lowest Detectable Value) Prior to Antiretroviral Therapy (ART) Initiation

    Baseline VL (log10) was the average of VL (log10) at the enrollment and pre-administration study visits. Nadir (lowest detectable) values were calculated pre-ART. For participants who didn't get ART, nadir was calculated as the minimum VL (log10) from baseline through the last visit.

    Measured: Baseline through 48 weeks after study product administration

  9. Day of Nadir (Lowest Detectable) VL Prior to ART Initiation

    Nadir values were calculated pre-ART. For participants who didn't get ART, nadir was calculated from baseline through the last visit.

    Measured: Baseline through 48 weeks after study product administration

  10. Overall Change in CD4+ Lymphocyte Count From Baseline to Peak Prior to ART Initiation

    The pre-administration study visit was considered the baseline visit. Peak values were calculated pre-ART. For participants who didn't get ART, peak was calculated as the maximum CD4+ lymphocyte counts from baseline through the last visit.

    Measured: Baseline through 48 weeks after study product administration

  11. Day of Peak CD4+ Lymphocyte Count Prior to ART Initiation

    Peak values were calculated pre-ART. For participants who didn't get ART, peak was calculated as the maximum CD4+ counts from baseline through the last visit.

    Measured: Baseline through 48 weeks after study product administration

Timeline

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

  1. First posted21 Jul 2016 (estimated)
  2. Study start24 Apr 2017
  3. Primary completion15 Jan 2020
  4. Study completion15 Jan 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
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02840474
Sponsor's protocol ID
160147
Other IDs
16-I-0147, 30089
Status last verified
Dec 2024
First submitted
19 Jul 2016
Last updated
30 Jan 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ledgerwood JE, Coates EE, Yamshchikov G, Saunders JG, Holman L, Enama ME, DeZure A, Lynch RM, Gordon I, Plummer S, Hendel CS, Pegu A, Conan-Cibotti M, Sitar S, Bailer RT, Narpala S, McDermott A, Louder M, O'Dell S, Mohan S, Pandey JP, Schwartz RM, Hu Z, Koup RA, Capparelli E, Mascola JR, Graham BS; VRC 602 Study Team. Safety, pharmacokinetics and neutralization of the broadly neutralizing HIV-1 human monoclonal antibody VRC01 in healthy adults. Clin Exp Immunol. 2015 Dec;182(3):289-301. doi: 10.1111/cei.12692. Epub 2015 Sep 24.

    PubMed 26332605

  • Lynch RM, Boritz E, Coates EE, DeZure A, Madden P, Costner P, Enama ME, Plummer S, Holman L, Hendel CS, Gordon I, Casazza J, Conan-Cibotti M, Migueles SA, Tressler R, Bailer RT, McDermott A, Narpala S, O'Dell S, Wolf G, Lifson JD, Freemire BA, Gorelick RJ, Pandey JP, Mohan S, Chomont N, Fromentin R, Chun TW, Fauci AS, Schwartz RM, Koup RA, Douek DC, Hu Z, Capparelli E, Graham BS, Mascola JR, Ledgerwood JE; VRC 601 Study Team. Virologic effects of broadly neutralizing antibody VRC01 administration during chronic HIV-1 infection. Sci Transl Med. 2015 Dec 23;7(319):319ra206. doi: 10.1126/scitranslmed.aad5752.

    PubMed 26702094

  • Ko SY, Pegu A, Rudicell RS, Yang ZY, Joyce MG, Chen X, Wang K, Bao S, Kraemer TD, Rath T, Zeng M, Schmidt SD, Todd JP, Penzak SR, Saunders KO, Nason MC, Haase AT, Rao SS, Blumberg RS, Mascola JR, Nabel GJ. Enhanced neonatal Fc receptor function improves protection against primate SHIV infection. Nature. 2014 Oct 30;514(7524):642-5. doi: 10.1038/nature13612. Epub 2014 Aug 13.

    PubMed 25119033

  • Happe M, Lynch RM, Fichtenbaum CJ, Heath SL, Koletar SL, Landovitz RJ, Presti RM, Santana-Bagur JL, Tressler RL, Holman LA, Novik L, Roa JC, Rothwell RS, Strom L, Wang J, Hu Z, Conan-Cibotti M, Bhatnagar AM, Dwyer B, Ko SH, Belinky F, Namboodiri AM, Pandey JP, Carroll R, Basappa M, Serebryannyy L, Narpala SR, Lin BC, McDermott AB, Boritz EA, Capparelli EV, Coates EE, Koup RA, Ledgerwood JE, Mascola JR, Chen GL, Tebas P; VRC 607/A5378 Study Team. Virologic effects of broadly neutralizing antibodies VRC01LS and VRC07-523LS on chronic HIV-1 infection. JCI Insight. 2025 Feb 24;10(4):e181496. doi: 10.1172/jci.insight.181496.

    PubMed 39989458

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRC-HIVMAB080-00-AB and VRC-HIVMAB075-00-AB in people with HIV-1, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in 2 countries.

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 22 inclusion and 12 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 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Puerto Rico. 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 23 Feb 2021). 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 for 3 Days After VRC01LS or VRC07-523LS Administration (time frame: 3 days after study product administration). The study lists 5 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 NCT02840474, which also lists 4 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 30 Jan 2025.

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