AzTrials
AzTrials

HIV InfectionsPhase 1NCT05184452

A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants

A Phase 1 study testing PGDM1400LS (5mg/kg, IV), PGDM1400LS (20mg/kg, IV) and PGDM1400LS (20mg/kg, SC) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in 4 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

Part A: The purpose of this part of the study is to understand how the body's immune system responds to a new lab-made antibody against HIV. The study is looking to see if the way the antibody is given affects the immune response. 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?
PGDM1400LS (5mg/kg, IV), PGDM1400LS (20mg/kg, IV) and PGDM1400LS (20mg/kg, SC)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
13 sitesin 4 countries
Study dates
15 Nov 2021to 19 Jul 2023
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

  • Age of 18 through 50 years
  • Access to a participating 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.
  • Good general health as shown by medical history, physical exam, and screening laboratory tests
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  • 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 Appendix J and Appendix K).
  • Hemoglobin
  • ≥ 11.0 g/dL for volunteers who were assigned female sex at birth
  • ≥ 13.0 g/dL for volunteers who were assigned male sex at birth and transgender males who have been on hormone therapy for more than 6 consecutive months
  • ≥ 12.0 g/dL for transgender females who have been on hormone therapy for more than 6 consecutive months
  • For transgender volunteers who have been on hormone therapy for less than 6 consecutive months, determine hemoglobin eligibility based on the sex assigned at birth
  • White blood cell count = 2,500 to 12,000 cells/mm3
  • WBC differential either within institutional normal range or with site clinician approval
  • Platelets = 125,000 to 550,000 cells/mm3
  • Chemistry panel: alanine aminotransferase (ALT) < 1.25 times the institutional upper limit of normal (ie, < 1.25 times the reference range upper limit) and creatinine < 1.1 times the institutional upper limit of normal (ie, <1.1 times the reference range upper limit)
  • Negative HIV-1 and -2 blood test: US volunteers must have a negative FDA-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA). Non-US sites may use locally available assays that have been approved by HVTN and HPTN Laboratory Operations
  • Negative Hepatitis B surface antigen (HBsAg)
  • Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
  • Negative or trace urine protein
  • Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test(s) performed within 48 hours prior to initial study product administration. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
  • 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 visit. Effective contraception is defined as using one of the following methods: Condoms (internal and external) with or without a spermicide, Diaphragm or cervical cap with spermicide, Intrauterine device (IUD), Hormonal contraception, Tubal ligation, or Any other contraceptive method approved by the HVTN 140/HPTN 101 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); or,
  • Not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy or bilateral oophorectomy; or,
  • Be sexually abstinent.
  • 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

Who cannot join

  • Weight < 35kg or > 115 kg
  • Blood products received within 120 days before first study product administration, unless eligibility for earlier enrollment is determined by the HVTN 140/HPTN 101 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-Network HIV antibody testing during the planned duration of the HVTN 140/HPTN 101 study
  • Pregnant or breastfeeding
  • HIV vaccine(s) received in a prior HIV vaccine trial. Volunteers who have received control/placebo in an HIV vaccine trial are not excluded.
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  • SARS-CoV-2 vaccine(s) received within 7 days prior to HVTN 140/HPTN 101 enrollment or planned within 7 days after enrollment.
  • Receipt of humanized or human mAbs, whether licensed or investigational.
  • Previous receipt of mAbs VRC01, VRC01LS, VRC07-523LS, PGDM1400, PGT121, PGT121.414.LS.
  • Immunosuppressive medications received within 30 days before first study product administration (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatological condition; or [4] a single course of oral/parenteral prednisone or equivalent at doses < 20 mg/day and length of therapy < 14 days)
  • Serious adverse reactions to PGDM1400LS, VRC07-523LS, or PGT121.414.LS formulation components (see Section 8.2) including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain.
  • Immunoglobulin received within 60 days before first study product administration (for mAb see criterion 8 above)
  • 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 CRS investigator, is likely not subject to exacerbation and likely not to complicate Solicited and Unsolicited AE assessments.)
  • Immunodeficiency
  • 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:
  • Symptoms consistent with COVID-19 or known SARS-CoV-2 infection,
  • 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 or subcutaneous 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 injection or 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.
  • Any medical, psychiatric, or skin condition (eg, tattoos), or occupational responsibility that, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence, assessment of safety or Solicited AEs, or a participant'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 had either of the following: Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids; 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 in this protocol as consistently ≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm Hg systolic and ≤ 100 mm Hg diastolic. For these volunteers, blood pressure must be ≤ 140 mm Hg systolic and ≤ 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 ≥ 150 mm Hg at enrollment or diastolic blood pressure ≥ 100 mm Hg at enrollment.
  • Bleeding disorder diagnosed by a clinician (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 3 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 generalized urticaria, angioedema, or anaphylaxis (Not exclusionary: angioedema or anaphylaxis to a known trigger with at least 5 years since last reaction to demonstrate satisfactory avoidance of trigger).

Trial locations and contacts

13 sites in 4 countries.

13 sites in 4 countries

United States5 sites

  • The Hope Clinic of the Emory Vaccine Center

    Atlanta, Georgia, 30030

  • Vanderbilt Vaccine (VV)

    Nashville, Tennessee, 37232

  • New Jersey Medical School Clinical Research Center CRS

    Newark, New Jersey, 07103

  • Bridge HIV CRS

    San Francisco, California, 94102

  • George Washington University

    Washington D.C., District of Columbia, 20037-1894

Other trials in United States

South Africa4 sites

  • CAPRISA eThekweni Clinical Research Site

    Berea, Durban, 4001

  • Groote Schuur Hospital

    Cape Town, Western Cape, 7925

  • Ward 21 Clinical Research Site

    Hillbrow, Johannesburg, 2001

  • Soweto HVTN CRS

    Soweto, 1862

Other trials in South Africa

Zimbabwe3 sites

  • Seke South Clinical Research Site

    Chitungwiza, Harare

  • Milton Park CRS

    Milton Park, Harare

  • Spilhaus CRS

    Milton Park, Harare

Other trials in Zimbabwe

Kenya1 site

  • Kenya Medical Research Institute (KEMRI)

    Kericho

Other trials in Kenya

About this study

Official title: A Phase 1 Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants

Part A:

The purpose of this part of the study is to understand how the body's immune system responds to a new lab-made antibody against HIV. The study is looking to see if the way the antibody is given affects the immune response. The study will also look at whether the antibody is safe to give to people and does not make them too uncomfortable.

Part B:

The purpose of this part of the study is to understand how the body's immune system responds to lab-made antibodies against HIV when they are given in combination at different doses. The study also wants to see if the way the antibodies are given affects the immune response.

Read the detailed description

The HIV Vaccine Trials Network (HVTN) and the HIV Prevention Trials Network (HPTN) are conducting this study to test a combination of different antibodies against HIV. HIV is the virus that causes AIDS. Antibodies are made by the body as one way to respond to or fight infection. Researchers can also make antibodies in laboratories and give them to people by infusions into a vein or under the skin.

There are 2 parts of this study, Part A and Part B. About 15 people will take part in Part A of this study to test one study antibody. After early safety results from Part A are obtained, a decision will be made as to whether or not to do Part B of the study. Part B of the study would test a combination of 3 antibodies. If it is decided to move forward with Part B, 80 more people will join.

Conditions
HIV Infections
Being tested
PGDM1400LS (5mg/kg, IV), PGDM1400LS (20mg/kg, IV), PGDM1400LS (20mg/kg, SC), PGDM1400LS (40mg/kg, IV), PGDM1400LS (40mg/kg, SC)
Medical subject headings
HIV Infections

What participants receive

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

  • PGDM1400LS (5mg/kg, IV)Drug

    5 mg/kg to be administered via IV infusion

  • PGDM1400LS (20mg/kg, IV)Drug

    20 mg/kg to be administered via IV infusion

  • PGDM1400LS (20mg/kg, SC)Drug

    20 mg/kg to be administered via SC infusion

  • PGDM1400LS (40mg/kg, IV)Drug

    40 mg/kg to be administered via IV infusion

  • PGDM1400LS (40mg/kg, SC)Drug

    40 mg/kg to be administered via SC infusion

  • PGDM1400LS (1.4g, IV)Drug

    1.4gram to be administered via IV infusion

  • PGDM1400LS (1.4g, SC)Drug

    1.4gram to be administered via SC infusion

  • VRC07-523LS (20mg/kg, IV)Drug

    VRC07-523LS 20mg/kg administered via IV infusion

  • VRC07-523LS (20mg/kg, SC)Drug

    VRC07-523LS 20mg/kg administered via SC infusion

  • VRC07-523LS (1.4g, IV)Drug

    VRC07-523LS 1.4g administered via IV infusion

  • VRC07-523LS (1.4g, SC)Drug

    VRC07-523LS 1.4g administered via SC infusion

  • VRC07-523LS (40mg/kg, IV)Drug

    VRC07-523LS 40mg/kg administered via IV infusion

  • PGT121.414.LS (20mg/kg, IV)Drug

    PGT121.414.LS 20mg/kg administered via IV infusion

  • PGT121.414.LS (20mg/kg, SC)Drug

    PGT121.414.LS 20mg/kg administered via SC infusion

  • PGT121.414.LS (1.4g, IV)Drug

    PGT121.414.LS 1.4g administered via IV infusion

  • PGT121.414.LS (1.4g, SC)Drug

    PGT121.414.LS 1.4g administered via SC infusion

  • PGT121.414.LS (40mg/kg, IV)Drug

    PGT121.414.LS 40mg/kg administered via IV infusion

Study groups in NCT05184452
Study groupRoleWhat they receive
PGDM1400LS 5 mg/kg IVExperimentalParticipants will receive PGDM1400LS 5 mg/kg by intravenous (IV) infusion at Month 0
Receives: Drug: PGDM1400LS (5mg/kg, IV)
PGDM1400LS 20 mg/kg IVExperimentalParticipants will receive PGDM1400LS 20 mg/kg by IV infusion at Month 0
Receives: Drug: PGDM1400LS (20mg/kg, IV)
PGDM1400LS 20 mg/kg SCExperimentalParticipants will receive PGDM1400LS 20 mg/kg by subcutaneous (SC) infusion at Month 0
Receives: Drug: PGDM1400LS (20mg/kg, SC)
PGDM1400LS 40 mg/kg IVExperimentalParticipants will receive PGDM1400LS 40 mg/kg by IV infusion at Month 0
Receives: Drug: PGDM1400LS (40mg/kg, IV)
PGDM1400LS 40 mg/kg SCExperimentalParticipants will receive PGDM1400LS 40 mg/kg by SC infusion at Month 0
Receives: Drug: PGDM1400LS (40mg/kg, SC)
PGDM1400LS 20mg/kg + VRC07-523LS 20mg/kg + PGT121.414.LS 20 mg/kg IVExperimentalParticipants will receive PGDM1400LS 20mg/kg + VRC07-523LS 20mg/kg + PGT121.414.LS 20 mg/kg by IV infusion sequentially in this order at Month 0 and Month 4
Receives: Drug: PGDM1400LS (20mg/kg, IV); Drug: VRC07-523LS (20mg/kg, IV); Drug: PGT121.414.LS (20mg/kg, IV)
PGDM1400LS 20mg/kg + VRC07-523LS 20mg/kg + PGT121.414.LS 20 mg/kg SCExperimentalParticipants will receive PGDM1400LS 20mg/kg + VRC07-523LS 20mg/kg + PGT121.414.LS 20 mg/kg by SC infusion sequentially in this order at Month 0 and Month 4
Receives: Drug: PGDM1400LS (20mg/kg, SC); Drug: VRC07-523LS (20mg/kg, SC); Drug: PGT121.414.LS (20mg/kg, SC)
PGDM1400LS 1.4gram + VRC07-523LS 1.4gram + PGT121.414.LS 1.4gram IVExperimentalParticipants will receive PGDM1400LS 1.4gram + VRC07-523LS 1.4gram + PGT121.414.LS 1.4gram by IV infusion sequentially in this order at Month 0 and Month 4
Receives: Drug: PGDM1400LS (1.4g, IV); Drug: VRC07-523LS (1.4g, IV); Drug: PGT121.414.LS (1.4g, IV)
PGDM1400LS 1.4gram + VRC07-523LS 1.4gram + PGT121.414.LS 1.4gram SCExperimentalParticipants will receive PGDM1400LS 1.4gram + VRC07-523LS 1.4gram + PGT121.414.LS 1.4gram by SC infusion sequentially in this order at Month 0 and Month 4
Receives: Drug: PGDM1400LS (1.4g, SC); Drug: VRC07-523LS (1.4g, SC); Drug: PGT121.414.LS (1.4g, SC)
PGDM1400LS 40mg/kg + VRC07-523LS 40mg/kg + PGT121.414.LS 40 mg/kg IVExperimentalParticipants will receive PGDM1400LS 40mg/kg + VRC07-523LS 40mg/kg + PGT121.414.LS 40 mg/kg by IV infusion sequentially in this order at Month 0 and Month 4
Receives: Drug: PGDM1400LS (40mg/kg, IV); Drug: VRC07-523LS (40mg/kg, IV); Drug: PGT121.414.LS (40mg/kg, IV)

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: Pain and/or Tenderness

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

    Measured: Measured through Month Measured through 3 days after each vaccine dose at T1-T5: Day 0 and T6-T10: Days 0, 112

  2. Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration

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

    Measured: Measured through Month Measured through 3 days after each vaccine dose at T1-T5: Day 0 and T6-T10: Days 0, 112

  3. 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, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented

    Measured: Measured through Month Measured through 3 days after each vaccine dose at T1-T5: Day 0 and T6-T10: Days 0, 112

  4. Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)

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

    Measured: Measured during Screening, Days 0, 56, 112*, 168, and 280* Days with * are only available for T6-T10

  5. Chemistry and Hematology Laboratory Measures - Creatinine

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

    Measured: Measured during Screening, Days 0, 56, 112*, 168, and 280* Days with * are only available for T6-T10

  6. Chemistry and Hematology Laboratory Measures - Hemoglobin

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

    Measured: Measured during Screening, Days 0, 56, 112*, 168, and 280* Days with * are only available for T6-T10

  7. Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count

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

    Measured: Measured during Screening, Days 0, 56, 112*, 168, and 280* Days with * are only available for T6-T10

  8. Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)

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

    Measured: Measured during Screening, Days 0, 56, 112*, 168, and 280* Days with * are only available for T6-T10

  9. Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).

    The number (percentage) of participants with lab grade >= 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm

    Measured: Measured during Screening, Days 0, 56, 112*, 168, and 280* Days with * are only available for T6-T10

  10. 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: Measured through Month 4

  11. Number of Participants With Early Termination of Study and Reason for Early Termination

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

    Measured: Measured through Month 6 in Part A and Month 10 in Part B

  12. Serum Concentration Levels of PGDM1400LS Among Participants Who Received All Scheduled Product Administrations

    Serum concentrations of PGDM1400LS at prespecified timepoints among participants who received all scheduled product administrations

    Measured: Measured during Days 0, 0.0417 (1hr post 1st infusion), 3, 6, 28, 56, 112, 112.0417 (1hr post 2nd infusion)*, 168, 224*, and 280* Days with * are only available for T6-T10

  13. Serum Concentration Levels of PGT121.414LS Among Participants Who Received All Scheduled Product Administrations

    Serum concentrations of PGT121.414.LS at prespecified timepoints among participants who received all scheduled product administrations

    Measured: Measured during Days 0, 0.0417 (1hr post 1st infusion), 3, 6, 28, 56, 112, 112.0417 (1hr post 2nd infusion), 168, 224, and 280

  14. Serum Concentration Levels of VRC07-523LS Among Participants Who Received All Scheduled Product Administrations

    Serum concentrations of VRC07-523LS at prespecified timepoints among participants who received all scheduled product administrations

    Measured: Measured during Days 0, 0.0417 (1hr post 1st infusion), 3, 6, 28, 56, 112, 112.0417 (1hr post 2nd infusion), 168, 224, and 280

  15. Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for

    Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for Parts A and B

    Measured: Measured during Days 0, 3, 6, 28, 56, 112, 168, 224*, and 280* Days with * are only available for T6-T10

  16. Magnitude Breadth of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for Parts A and B

    Magnitude breadth of neutralizing activity measured with Env pseudotyped viruses specific for either PGDM1400LS, VRC07-523LS or PGT121.414LS in TZM-bl cells at prespecified timepoints among participants who received all scheduled product administrations for Parts A and B.

    Measured: Measured during Days 56 and 168* Days with * are only available for T6-T10

Secondary outcomes (3)

  1. Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.

    Magnitude of neutralizing activity against a panel of Env-pseudotyped reference viruses that are sensitive to all three bnAbs in TZM-bl cells at selected timepoints for all participants in all groups regardless of how many product administrations and how much product they received

    Measured: Day 56 and Day 168* corresponding to Month 2 and Month 6* of the study. Days with * are only available for T6-T10

  2. Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B

    Anti-drug Antibodies (ADA) occurrence in each group measured at prespecified timepoints for all participants in all groups regardless of how many product administrations and how much product they received. Tier 2 responses are only generated for participants who had positive responses to Tier 1.

    Measured: Measured during Screening, Days 0, 112*, 168†, and 280* Days with † are only available for T1-T5 Days with * are only available for T6-T10

  3. Anti-drug Antibodies (ADA) Titers for Participants in Parts A and B

    Anti-drug Antibodies (ADA) tier 3 titers in each group measured at prespecified timepoints for all participants in all groups regardless of how many product administrations and how much product they received. Tier 3 titers are only available for those participants who had positive for ADA Tiers 1 and 2.

    Measured: Measured during Screening, Days 0, 112*, 168†, and 280* Days with † are only available for T1-T5 Days with * are only available for T6-T10

Timeline

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

  1. First posted11 Jan 2022
  2. Study start15 Nov 2021
  3. Primary completion19 Jul 2023
  4. Study completion19 Jul 2023

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
Sequential
Masking
None (open label)
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05184452
Sponsor's protocol ID
HVTN 140/HPTN 101
Other IDs
DAIDS DOCUMENT ID
Status last verified
Dec 2024
First submitted
26 Oct 2021
Last updated
10 Feb 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mahomed S, Paez CA, Huang Y, Seaton KE, Yu C, Gillespie K, Miner MD, Karuna ST, Gamble T, Heptinstall J, Domin E, Tang H, Zhang L, Gao F, Yacovone M, Spiegel HML, Dumond J, Anderson MA, Piwowar-Manning E, Dye BJ, Tindale I, Proulx-Burns L, Trahey M, Takuva S, Takalani A, Bailey VC, Kalams SA, Scott H, Kosgei J, Delany-Moretlwe S, Kassim S, Laher F, Chirenje ZM, Musodza Y, Mhlanga F, Mkhize N, Weiner JA, Ackerman ME, McElrath MJ, Pensiero MN, Gama L, Barouch DH, Corey L, Cohen MS, Montefiori DC, Tomaras GD, Siegel M, Kelley CF; HVTN 140/HPTN 101 Study Team. Safety, pharmacokinetics, and neutralisation activity of PGDM1400LS, VRC07-523LS, and PGT121.414.LS infused intravenously or subcutaneously (HVTN 140/HPTN 101 part B): a phase 1, randomised trial. Lancet HIV. 2026 Jul;13(7):e452-e464. doi: 10.1016/S2352-3018(25)00356-X. Epub 2026 May 11.

    PubMed 42114530

  • Seaton KE, Paez CA, Yu C, Karuna ST, Gamble T, Miner MD, Heptinstall J, Zhang L, Gao F, Yacovone M, Spiegel H, Dumond JB, Anderson M, Piwowar-Manning E, Dye B, Tindale I, Proulx-Burns L, Trahey M, Takuva S, Takalani A, Bailey VC, Kalams SA, Scott H, Mkhize NN, Weiner JA, Ackerman ME, McElrath MJ, Pensiero M, Barouch DH, Montefiori D, Tomaras GD, Corey L, Cohen MS, Huang Y, Mahomed S, Siegel M, Kelley CF; HVTN 140/HPTN 101 study team. Safety, pharmacokinetics, and neutralisation activity of PGDM1400LS, a V2 specific HIV-1 broadly neutralising antibody, infused intravenously or subcutaneously in people without HIV-1 in the USA (HVTN 140/HPTN 101 part A): a first-in-human, phase 1 randomised trial. Lancet HIV. 2025 Jun;12(6):e405-e415. doi: 10.1016/S2352-3018(25)00012-8.

    PubMed 40441807

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PGDM1400LS (5mg/kg, IV), PGDM1400LS (20mg/kg, IV) and PGDM1400LS (20mg/kg, SC) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in 4 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 28 inclusion and 39 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 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, South Africa, Zimbabwe, Kenya. 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 10 Feb 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: Pain and/or Tenderness (time frame: Measured through Month Measured through 3 days after each vaccine dose at T1-T5: Day 0 and T6-T10: Days 0, 112). The study lists 16 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 NCT05184452, which also lists 2 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 10 Feb 2025.

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