Last reviewed · How we verify

NCT04212091

Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants

Completed Phase 1 Results posted Last updated 13 December 2024
What this trial tests

Phase 1 trial testing PGT121.414.LS in HIV Infections in 33 participants. Completed in 18 January 2023.

Timeline
10 November 2020
Primary endpoint
18 January 2023
18 January 2023

Quick facts

Lead sponsorNational Institute of Allergy and Infectious Diseases (NIAID)
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingnone
Primary purposeprevention
Enrollment33
Start date10 November 2020
Primary completion18 January 2023
Estimated completion18 January 2023
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 50, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness Primary · Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224

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

GroupValue95% CI
Group 1: Vaccine3
Group 2: Vaccine3
Group 3: Vaccine3
Group 4: Vaccine3
Group 5: Vaccine4
Group 6: Vaccine3
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine4
Group 6: Vaccine7
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine2
Group 6: Vaccine0
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration Primary · Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224

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

Erythema/Redness
GroupValue95% CI
Group 1: Vaccine3
Group 2: Vaccine3
Group 3: Vaccine3
Group 4: Vaccine3
Group 5: Vaccine10
Group 6: Vaccine4
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine4
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine2
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Induration/Swelling
GroupValue95% CI
Group 1: Vaccine3
Group 2: Vaccine3
Group 3: Vaccine3
Group 4: Vaccine3
Group 5: Vaccine10
Group 6: Vaccine4
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine4
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine2
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Erythema and/or Induration
GroupValue95% CI
Group 1: Vaccine3
Group 2: Vaccine3
Group 3: Vaccine3
Group 4: Vaccine3
Group 5: Vaccine10
Group 6: Vaccine4
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine4
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine2
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Primary · Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224

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 following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant

Malaise and/or fatigue
GroupValue95% CI
Group 1: Vaccine3
Group 2: Vaccine1
Group 3: Vaccine2
Group 4: Vaccine2
Group 5: Vaccine4
Group 6: Vaccine5
Group 1: Vaccine0
Group 2: Vaccine2
Group 3: Vaccine1
Group 4: Vaccine1
Group 5: Vaccine4
Group 6: Vaccine4
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine2
Group 6: Vaccine1
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Myalgia
GroupValue95% CI
Group 1: Vaccine3
Group 2: Vaccine3
Group 3: Vaccine3
Group 4: Vaccine2
Group 5: Vaccine8
Group 6: Vaccine9
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine1
Group 5: Vaccine2
Group 6: Vaccine1
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Headache
GroupValue95% CI
Group 1: Vaccine3
Group 2: Vaccine2
Group 3: Vaccine1
Group 4: Vaccine3
Group 5: Vaccine3
Group 6: Vaccine8
Group 1: Vaccine0
Group 2: Vaccine1
Group 3: Vaccine2
Group 4: Vaccine0
Group 5: Vaccine5
Group 6: Vaccine2
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine2
Group 6: Vaccine0
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Nausea
GroupValue95% CI
Group 1: Vaccine2
Group 2: Vaccine3
Group 3: Vaccine3
Group 4: Vaccine3
Group 5: Vaccine7
Group 6: Vaccine9
Group 1: Vaccine1
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine3
Group 6: Vaccine1
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Chills
GroupValue95% CI
Group 1: Vaccine3
Group 2: Vaccine3
Group 3: Vaccine3
Group 4: Vaccine3
Group 5: Vaccine8
Group 6: Vaccine10
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine2
Group 6: Vaccine0
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Arthralgia
GroupValue95% CI
Group 1: Vaccine3
Group 2: Vaccine3
Group 3: Vaccine3
Group 4: Vaccine3
Group 5: Vaccine8
Group 6: Vaccine10
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine2
Group 6: Vaccine0
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Urticaria
GroupValue95% CI
Group 1: Vaccine3
Group 2: Vaccine3
Group 3: Vaccine3
Group 4: Vaccine3
Group 5: Vaccine10
Group 6: Vaccine10
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Generalized Pruritus
GroupValue95% CI
Group 1: Vaccine3
Group 2: Vaccine3
Group 3: Vaccine3
Group 4: Vaccine3
Group 5: Vaccine10
Group 6: Vaccine10
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L Primary · Measured during Screening, Days 0, 112, 168

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

ALT (SGPT) (U/L)- Screening
GroupValue95% CI
Group 1: Vaccine14.011.0 – 23.0
Group 2: Vaccine14.012.0 – 18.0
Group 3: Vaccine14.014.0 – 24.0
Group 4: Vaccine17.012.0 – 19.0
Group 5: Vaccine13.012.0 – 18.0
Group 6: Vaccine16.011.0 – 24.0
ALT (SGPT) (U/L)- Day 0/Enrollment
GroupValue95% CI
Group 1: Vaccine17.011.0 – 25.0
Group 2: Vaccine13.012.0 – 16.0
Group 3: Vaccine15.014.0 – 23.0
Group 4: Vaccine14.013.0 – 17.0
Group 5: Vaccine15.013.0 – 23.0
Group 6: Vaccine15.512.0 – 22.0
ALT (SGPT) (U/L)- Day 112
GroupValue95% CI
Group 1: Vaccine13.010.0 – 21.0
Group 2: Vaccine15.010.0 – 19.0
Group 3: Vaccine14.013.0 – 21.0
Group 4: Vaccine15.012.0 – 19.0
Group 5: Vaccine15.013.0 – 18.0
Group 6: Vaccine18.09.0 – 26.0
ALT (SGPT) (U/L)- Day 168
GroupValue95% CI
Group 1: Vaccine12.012.0 – 20.0
Group 2: Vaccine17.011.0 – 18.0
Group 3: Vaccine15.012.0 – 20.0
Group 4: Vaccine13.013.0 – 21.0
Group 5: Vaccine20.015.0 – 21.0
Group 6: Vaccine15.011.0 – 19.0
AST (U/L)- Day 0/Enrollment
GroupValue95% CI
Group 1: Vaccine18.014.0 – 23.0
Group 2: Vaccine20.019.0 – 22.0
Group 3: Vaccine18.016.0 – 19.0
Group 4: Vaccine19.014.0 – 20.0
Group 5: Vaccine19.016.0 – 23.0
Group 6: Vaccine17.013.0 – 24.0
AST (U/L)- Day 112
GroupValue95% CI
Group 1: Vaccine16.015.0 – 19.0
Group 2: Vaccine21.015.0 – 24.0
Group 3: Vaccine16.013.0 – 22.0
Group 4: Vaccine15.015.0 – 32.0
Group 5: Vaccine19.017.0 – 20.0
Group 6: Vaccine19.015.0 – 24.0
AST (U/L)- Day 168
GroupValue95% CI
Group 1: Vaccine15.014.0 – 19.0
Group 2: Vaccine23.019.0 – 23.0
Group 3: Vaccine15.014.0 – 21.0
Group 4: Vaccine15.012.0 – 24.0
Group 5: Vaccine19.018.0 – 21.0
Group 6: Vaccine17.015.0 – 18.0
Alkaline Phosphatase(U/L)- Day 0/Enrollment
GroupValue95% CI
Group 1: Vaccine55.052.0 – 77.0
Group 2: Vaccine46.043.0 – 59.0
Group 3: Vaccine57.036.0 – 72.0
Group 4: Vaccine63.040.0 – 72.0
Group 5: Vaccine61.554.0 – 76.0
Group 6: Vaccine58.050.0 – 75.0
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL Primary · Measured during Screening, Days 0, 112, 168

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

Creatinine (g/dL)- Screening
GroupValue95% CI
Group 1: Vaccine1.0200.86000 – 1.1700
Group 2: Vaccine.60000.46000 – .83000
Group 3: Vaccine.97000.85000 – 1.0400
Group 4: Vaccine.73000.72000 – .87000
Group 5: Vaccine.78500.63000 – .86000
Group 6: Vaccine.89000.78000 – .95000
Creatinine (g/dL)- Day 0/Enrollment
GroupValue95% CI
Group 1: Vaccine.90000.80000 – 1.0800
Group 2: Vaccine.70000.58000 – .71000
Group 3: Vaccine.94000.78000 – 1.1200
Group 4: Vaccine.75000.66000 – .97000
Group 5: Vaccine.78000.71000 – .85000
Group 6: Vaccine.82000.71000 – 1.0000
Creatinine (g/dL)- Day 112
GroupValue95% CI
Group 1: Vaccine.91000.68000 – 1.1500
Group 2: Vaccine.68000.59000 – .81000
Group 3: Vaccine.94000.78000 – 1.3100
Group 4: Vaccine.81000.78000 – .99000
Group 5: Vaccine.80000.77000 – .88000
Group 6: Vaccine.79000.65000 – .97000
Creatinine (g/dL)- Day 168
GroupValue95% CI
Group 1: Vaccine.81000.61000 – 1.0800
Group 2: Vaccine.71000.60000 – .82000
Group 3: Vaccine.90000.85000 – 1.0300
Group 4: Vaccine.82000.68000 – .96000
Group 5: Vaccine.82000.70000 – .92000
Group 6: Vaccine.83000.79000 – .97000
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL Primary · Measured during Screening, Days 0, 112, 168

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

Hemoglobin (g/dL)- Screening
GroupValue95% CI
Group 1: Vaccine14.112.7 – 16.7
Group 2: Vaccine13.111.1 – 13.7
Group 3: Vaccine13.813.0 – 16.4
Group 4: Vaccine12.911.3 – 14.9
Group 5: Vaccine13.612.1 – 14.7
Group 6: Vaccine14.113.5 – 14.8
Hemoglobin (g/dL)- Day 0/Enrollment
GroupValue95% CI
Group 1: Vaccine13.511.4 – 17.7
Group 2: Vaccine12.911.2 – 13.2
Group 3: Vaccine13.412.4 – 16.7
Group 4: Vaccine12.411.5 – 15.0
Group 5: Vaccine12.612.1 – 14.6
Group 6: Vaccine14.213.0 – 15.0
Hemoglobin (g/dL)- Day 112
GroupValue95% CI
Group 1: Vaccine13.912.5 – 16.6
Group 2: Vaccine12.912.4 – 13.7
Group 3: Vaccine14.212.5 – 14.4
Group 4: Vaccine12.710.1 – 14.1
Group 5: Vaccine12.611.5 – 14.7
Group 6: Vaccine14.112.9 – 15.4
Hemoglobin (g/dL)- Day 168
GroupValue95% CI
Group 1: Vaccine13.512.1 – 17.3
Group 2: Vaccine13.312.2 – 13.5
Group 3: Vaccine14.011.8 – 14.8
Group 4: Vaccine12.310.9 – 14.4
Group 5: Vaccine12.712.4 – 14.3
Group 6: Vaccine14.213.5 – 14.6
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm Primary · Measured during Screening, Days 0, 112, 168

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

Neutrophils (1000 cells/cubic mm)- Screening
GroupValue95% CI
Group 1: Vaccine5.051.80 – 9.42
Group 2: Vaccine4.313.80 – 4.92
Group 3: Vaccine2.832.07 – 4.90
Group 4: Vaccine4.202.05 – 7.33
Group 5: Vaccine3.922.80 – 5.39
Group 6: Vaccine3.502.37 – 5.12
Neutrophils (1000 cells/cubic mm)- Day 0/Enrollment
GroupValue95% CI
Group 1: Vaccine2.601.70 – 3.95
Group 2: Vaccine3.593.29 – 5.80
Group 3: Vaccine2.881.63 – 4.20
Group 4: Vaccine3.702.40 – 6.09
Group 5: Vaccine4.012.53 – 4.36
Group 6: Vaccine3.322.22 – 4.52
Neutrophils (1000 cells/cubic mm)- Day 112
GroupValue95% CI
Group 1: Vaccine3.801.90 – 5.06
Group 2: Vaccine4.202.66 – 4.38
Group 3: Vaccine2.111.84 – 3.80
Group 4: Vaccine3.501.99 – 5.26
Group 5: Vaccine3.652.59 – 5.77
Group 6: Vaccine3.263.06 – 5.32
Neutrophils (1000 cells/cubic mm)- Day 168
GroupValue95% CI
Group 1: Vaccine4.512.50 – 5.93
Group 2: Vaccine4.374.04 – 5.20
Group 3: Vaccine2.421.88 – 4.90
Group 4: Vaccine3.202.01 – 5.72
Group 5: Vaccine3.713.17 – 4.50
Group 6: Vaccine2.882.59 – 4.39
Lymphocytes (1000 cells/cubic mm)- Screening
GroupValue95% CI
Group 1: Vaccine2.141.17 – 2.20
Group 2: Vaccine2.061.86 – 2.30
Group 3: Vaccine2.101.23 – 4.15
Group 4: Vaccine2.001.66 – 2.70
Group 5: Vaccine2.061.70 – 2.30
Group 6: Vaccine1.681.24 – 1.91
Lymphocytes (1000 cells/cubic mm)- Day 0/Enrollment
GroupValue95% CI
Group 1: Vaccine2.262.22 – 2.60
Group 2: Vaccine1.551.46 – 2.20
Group 3: Vaccine1.901.44 – 3.04
Group 4: Vaccine1.981.68 – 2.00
Group 5: Vaccine1.681.40 – 2.28
Group 6: Vaccine1.891.33 – 2.30
Lymphocytes (1000 cells/cubic mm)- Day 112
GroupValue95% CI
Group 1: Vaccine2.201.72 – 2.40
Group 2: Vaccine1.661.31 – 2.80
Group 3: Vaccine2.121.96 – 2.20
Group 4: Vaccine1.991.46 – 2.10
Group 5: Vaccine1.761.48 – 2.06
Group 6: Vaccine1.811.47 – 1.92
Lymphocytes (1000 cells/cubic mm)- Day 168
GroupValue95% CI
Group 1: Vaccine2.101.75 – 2.59
Group 2: Vaccine1.991.89 – 2.70
Group 3: Vaccine2.401.44 – 2.70
Group 4: Vaccine1.651.56 – 2.30
Group 5: Vaccine1.681.55 – 2.24
Group 6: Vaccine1.861.67 – 2.10
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm Primary · Measured during Screening, Days 0, 112, 168

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

WBC (1000 cells/cubic mm)- Screening
GroupValue95% CI
Group 1: Vaccine7.804.50 – 10.90
Group 2: Vaccine7.206.80 – 7.30
Group 3: Vaccine7.703.71 – 8.00
Group 4: Vaccine7.504.33 – 10.30
Group 5: Vaccine6.375.09 – 8.02
Group 6: Vaccine5.464.20 – 7.95
WBC (1000 cells/cubic mm)- Day 0/Enrollment
GroupValue95% CI
Group 1: Vaccine5.604.70 – 6.80
Group 2: Vaccine5.705.60 – 8.70
Group 3: Vaccine6.703.51 – 6.90
Group 4: Vaccine6.204.61 – 9.00
Group 5: Vaccine6.285.44 – 7.43
Group 6: Vaccine5.634.69 – 7.27
WBC (1000 cells/cubic mm)- Day 112
GroupValue95% CI
Group 1: Vaccine6.604.70 – 7.40
Group 2: Vaccine6.904.60 – 7.60
Group 3: Vaccine4.804.59 – 6.90
Group 4: Vaccine6.404.70 – 7.60
Group 5: Vaccine5.954.54 – 8.06
Group 6: Vaccine5.895.10 – 6.82
WBC (1000 cells/cubic mm)- Day 168
GroupValue95% CI
Group 1: Vaccine6.905.00 – 9.50
Group 2: Vaccine7.306.50 – 8.70
Group 3: Vaccine6.103.75 – 8.40
Group 4: Vaccine6.104.36 – 8.20
Group 5: Vaccine6.735.12 – 6.95
Group 6: Vaccine6.384.71 – 9.10
Platelets (1000 cells/cubic mm)- Screening
GroupValue95% CI
Group 1: Vaccine234203 – 281
Group 2: Vaccine307251 – 353
Group 3: Vaccine252250 – 274
Group 4: Vaccine303195 – 372
Group 5: Vaccine297268 – 314
Group 6: Vaccine253234 – 365
Platelets (1000 cells/cubic mm)- Day 0/Enrollment
GroupValue95% CI
Group 1: Vaccine229185 – 254
Group 2: Vaccine273222 – 379
Group 3: Vaccine244241 – 290
Group 4: Vaccine296183 – 297
Group 5: Vaccine273260 – 287
Group 6: Vaccine271259 – 293
Platelets (1000 cells/cubic mm)- Day 112
GroupValue95% CI
Group 1: Vaccine246221 – 330
Group 2: Vaccine271240 – 403
Group 3: Vaccine291266 – 294
Group 4: Vaccine296189 – 339
Group 5: Vaccine290249 – 307
Group 6: Vaccine284255 – 323
Platelets (1000 cells/cubic mm)- Day 168
GroupValue95% CI
Group 1: Vaccine226187 – 253
Group 2: Vaccine313248 – 380
Group 3: Vaccine266237 – 331
Group 4: Vaccine296178 – 406
Group 5: Vaccine297265 – 317
Group 6: Vaccine291256 – 334
Number of Participants Reporting Unsolicited Adverse Events (AEs) Primary · Measured through Month 24

The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm

GroupValue95% CI
Group 1: Vaccine2
Group 2: Vaccine2
Group 3: Vaccine1
Group 4: Vaccine2
Group 5: Vaccine2
Group 6: Vaccine0
Group 1: Vaccine1
Group 2: Vaccine0
Group 3: Vaccine1
Group 4: Vaccine0
Group 5: Vaccine6
Group 6: Vaccine8
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine0
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation Primary · Measured through Month 8

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

GroupValue95% CI
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine1
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine3
Group 6: Vaccine0
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine0
Group 6: Vaccine1
Group 1: Vaccine3
Group 2: Vaccine3
Group 3: Vaccine3
Group 4: Vaccine3
Group 5: Vaccine7
Group 6: Vaccine8
Number of Participants With Early Study Termination and Reason for Early Study Termination Primary · Measured through Month 16

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

GroupValue95% CI
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine1
Group 6: Vaccine0
Group 1: Vaccine0
Group 2: Vaccine0
Group 3: Vaccine0
Group 4: Vaccine0
Group 5: Vaccine1
Group 6: Vaccine1
Group 1: Vaccine3
Group 2: Vaccine3
Group 3: Vaccine3
Group 4: Vaccine3
Group 5: Vaccine8
Group 6: Vaccine9
PGT121.414.LS and VRC07523LS Serum Concentrations Primary · Days 0, 0.0417, 1, 2, 3, 6, 14, 28, 56, 84, 112, 112.0417, 140, 168, 196, 224, 224.0417, 252, 280, 336, 392, 448

Serum concentrations of PGT121.414.LS and VRC07-523LS at prespecified timepoints among participants who received all scheduled product administrations

PGT121.414.LS-D0
GroupValue95% CI
Group 1: Vaccine0.326660.212155 – 0.408441
Group 2: Vaccine0.097650.09765 – 0.09765
Group 3: Vaccine0.097650.09765 – 0.09765
Group 4: Vaccine0.097650.09765 – 0.09765
Group 5: Vaccine0.097650.09765 – 0.09765
Group 6: Vaccine0.097650.09765 – 0.09765
PGT121.414.LS-D0.0417
GroupValue95% CI
Group 1: Vaccine63.8358463.05451 – 69.88950
Group 2: Vaccine221.7834213.0117 – 240.7665
Group 3: Vaccine554.8116521.6919 – 676.4573
Group 4: Vaccine0.097650.09765 – 0.206709
Group 5: Vaccine714.2483675.8913 – 842.2093
Group 6: Vaccine0.8683410.501508 – 1.069614
PGT121.414.LS-D1
GroupValue95% CI
Group 1: Vaccine57.1989253.42500 – 64.15473
Group 2: Vaccine164.7475152.5291 – 186.0908
Group 3: Vaccine525.8889490.3319 – 624.0825
Group 4: Vaccine15.5717910.89182 – 17.40282
Group 5: Vaccine540.5799493.9560 – 597.8813
PGT121.414.LS-D112
GroupValue95% CI
Group 1: Vaccine12.1862311.62024 – 12.73220
Group 2: Vaccine31.3854028.27068 – 36.24888
Group 3: Vaccine113.659796.48752 – 120.9419
Group 4: Vaccine10.285799.944198 – 12.06092
Group 5: Vaccine91.1243174.69536 – 104.4369
Group 6: Vaccine14.5368713.39469 – 16.86138
PGT121.414.LS-D112.0417
GroupValue95% CI
Group 5: Vaccine866.2283793.2392 – 922.8176
Group 6: Vaccine13.1508212.43524 – 15.52181
PGT121.414.LS-D14
GroupValue95% CI
Group 1: Vaccine33.5082530.85342 – 36.28367
Group 2: Vaccine93.5217589.45039 – 98.44224
Group 3: Vaccine287.3416266.9812 – 302.3751
Group 4: Vaccine27.9789922.78709 – 34.31463
Group 5: Vaccine250.1545217.2386 – 279.6561
Group 6: Vaccine45.6016840.84005 – 55.71133
PGT121.414.LS-D140
GroupValue95% CI
Group 5: Vaccine274.8957218.4848 – 327.5700
Group 6: Vaccine53.5655552.04341 – 56.40598
PGT121.414.LS-D168
GroupValue95% CI
Group 1: Vaccine6.9859776.696763 – 7.061191
Group 2: Vaccine17.0377413.97447 – 21.98945
Group 3: Vaccine70.6441158.95990 – 72.42533
Group 4: Vaccine6.4470516.015901 – 7.8547
Group 5: Vaccine196.5922165.2391 – 242.2765
Group 6: Vaccine40.6426836.83466 – 43.96372

Adverse events — posted to ClinicalTrials.gov

Time frame: Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1: Vaccine
Serious: 0/3 (0%)
Deaths: 0/3
Group 2: Vaccine
Serious: 0/3 (0%)
Deaths: 0/3
Group 3: Vaccine
Serious: 0/3 (0%)
Deaths: 0/3
Group 4: Vaccine
Serious: 0/3 (0%)
Deaths: 0/3
Group 5: Vaccine
Serious: 0/10 (0%)
Deaths: 0/10
Group 6: Vaccine
Serious: 0/10 (0%)
Deaths: 0/10
Other adverse events (63 terms — click to expand)

ReactionSystemGroup 1: VaccineGroup 2: VaccineGroup 3: VaccineGroup 4: VaccineGroup 5: VaccineGroup 6: Vaccine
Infusion site pain (Solicited)General disorders——————
Headache (Solicited)Nervous system disorders——————
Infusion site erythema (Solicited)General disorders——————
Infusion site swelling (Solicited)General disorders——————
Malaise (Solicited)General disorders——————
Nausea (Solicited)Gastrointestinal disorders——————
COVID-19Infections and infestations——————
Infusion related reactionInjury, poisoning and procedural complications——————
Chills (Solicited)General disorders——————
Skin lacerationInjury, poisoning and procedural complications——————
Arthralgia (Solicited)Musculoskeletal and connective tissue disorders——————
Myalgia (Solicited)Musculoskeletal and connective tissue disorders——————
DizzinessNervous system disorders——————
HeadacheNervous system disorders——————
HaematuriaRenal and urinary disorders——————
ProteinuriaRenal and urinary disorders——————
Bundle branch block leftCardiac disorders——————
Bundle branch block rightCardiac disorders——————
PalpitationsCardiac disorders——————
DiarrhoeaGastrointestinal disorders——————
HaemorrhoidsGastrointestinal disorders——————
Hiatus herniaGastrointestinal disorders——————
ToothacheGastrointestinal disorders——————
Chest discomfortGeneral disorders——————
Infusion site erythemaGeneral disorders——————
Infusion site pruritusGeneral disorders——————
Dermatophytosis of nailInfections and infestations——————
Oral herpesInfections and infestations——————
Pharyngitis streptococcalInfections and infestations——————
Upper respiratory tract infectionInfections and infestations——————
Urinary tract infectionInfections and infestations——————
Viral infectionInfections and infestations——————
Viral upper respiratory tract infectionInfections and infestations——————
Arthropod biteInjury, poisoning and procedural complications——————
ConcussionInjury, poisoning and procedural complications——————
Post procedural haematomaInjury, poisoning and procedural complications——————
Rib fractureInjury, poisoning and procedural complications——————
Skin abrasionInjury, poisoning and procedural complications——————
Alanine aminotransferase increasedInvestigations——————
Aspartate aminotransferase increasedInvestigations——————

Data from ClinicalTrials.gov NCT04212091 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous or subcutaneous infusions in healthy, HIV-uninfected adult participants.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition.
    Corey L, Gilbert PB, Juraska M, Montefiori DC, et al · · 2021 · cited 457× · PMID 33730454 · DOI 10.1056/nejmoa2031738
  2. Clinical Trials of Broadly Neutralizing Monoclonal Antibodies for Human Immunodeficiency Virus Prevention: A Review.
    Mahomed S, Garrett N, Baxter C, Abdool Karim Q, et al · · 2021 · cited 77× · PMID 32604408 · DOI 10.1093/infdis/jiaa377
  3. Broadly Neutralizing Antibodies for HIV-1 Prevention.
    Walsh SR, Seaman MS. · · 2021 · cited 73× · PMID 34354713 · DOI 10.3389/fimmu.2021.712122
  4. Broadly neutralizing monoclonal antibodies for HIV prevention.
    Miner MD, Corey L, Montefiori D. · · 2021 · cited 34× · PMID 34806308 · DOI 10.1002/jia2.25829
  5. Pharmacokinetic serum concentrations of VRC01 correlate with prevention of HIV-1 acquisition.
    Seaton KE, Huang Y, Karuna S, Heptinstall JR, et al · · 2023 · cited 30× · PMID 37300931 · DOI 10.1016/j.ebiom.2023.104590
  6. Can Broadly Neutralizing HIV-1 Antibodies Help Achieve an ART-Free Remission?
    Hsu DC, Mellors JW, Vasan S. · · 2021 · cited 30× · PMID 34322136 · DOI 10.3389/fimmu.2021.710044
  7. Safety, tolerability, pharmacokinetics, and immunological activity of dual-combinations and triple-combinations of anti-HIV monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered intravenously to HIV-uninfected adults: a phase 1 randomised trial.
    Sobieszczyk ME, Mannheimer S, Paez CA, Yu C, et al · · 2023 · cited 29× · PMID 37802566 · DOI 10.1016/s2352-3018(23)00140-6
  8. Strategies for eliciting multiple lineages of broadly neutralizing antibodies to HIV by vaccination.
    Mu Z, Haynes BF, Cain DW. · · 2021 · cited 20× · PMID 34742037 · DOI 10.1016/j.coviro.2021.09.015

Verify or expand the search:

Other trials of PGT121.414.LS

Trials testing the same drug.

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04212091.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing