Trial reportThe Journal of infectious diseases2022
Safety and Pharmacokinetics of Monoclonal Antibodies VRC07-523LS and PGT121 Administered Subcutaneously for Human Immunodeficiency Virus Prevention.
Trial report in The Journal of infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05890963 (Phase 1b Single Dose Clinical Trial of a Novel Long-Acting Bispecific Antibody in People With HIV to Inform Development for HIV Pre- and Post-Exposure Prophylaxis), which is not on this map. Cited by 29 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 1b Single Dose Clinical Trial of a Novel Long-Acting Bispecific Antibody in People With HIV to Inform Development for HIV Pre- and Post-Exposure Prophylaxis
Who cites it
29 citing papers in PubMed, 31 citations in OpenAlex.
- 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.The lancet. HIV · 2026Trial
- Decision-making and acceptability of subcutaneously administered broadly neutralising monoclonal antibodies for HIV prevention amongst CAPRISA 012A trial participants in Durban, South Africa.Scientific reports · 2025Trial
- Trial
- Safety and antiviral effect of a triple combination of HIV-1 broadly neutralizing antibodies: a phase 1/2a trial.Nature medicine · 2024Trial
- Trial
- Proof-of-Concept Development and Preclinical Evaluation of a Microarray Patch Platform for Codelivery of Multiple Broadly Neutralizing Antibodies for HIV Prevention.Molecular pharmaceutics · 2026Article
- A case of transient hepatocellular injury in an HIV monoclonal antibody trial.International journal of STD & AIDS · 2026Article
- Systemic Inflammation as a Modulator of FcRn-dependent IgG Pharmacokinetics: Implications for Broadly Neutralising Antibody Efficacy in HIV Prevention.Current HIV/AIDS reports · 2026Review
- Quantitative Prediction of Human Pharmacokinetics for Fc-Engineered Therapeutic Monoclonal Antibodies With Increased FcRn Binding Mutations After Subcutaneous Injection.Clinical and translational science · 2026Article
- Model-based assessment of VRC07-523LS dosing in infants through population pharmacokinetic -pharmacodynamic modelling in adults and infants.The Journal of antimicrobial chemotherapy · 2026Article
- Broadly neutralizing antibodies for treatment of HIV in children in the Global South: rationale and challenges.Frontiers in pediatrics · 2026Review
- LC-MS/MS method for quantifying the HIV-1 broadly neutralizing antibody PGT 121.414.LS in human serum.Journal of chromatography. B, Analytical technologies in the biomedical and life sciences · 2025Article
- Distinct modes of evolution drive HIV escape from two broadly neutralizing antibodies.bioRxiv : the preprint server for biology · 2025Article
- Dose finding in early-phase human immunodeficiency virus type 1 prevention monoclonal antibody clinical trials.Clinical trials (London, England) · 2025Review
- HIV diagnosis during acute infection: implications of long-acting preexposure prophylaxis and other evolving challenges.Current opinion in HIV and AIDS · 2025Review
- Article
- Pharmacokinetic interaction assessment of an HIV broadly neutralizing monoclonal antibody VRC07-523LS: a cross-protocol analysis of three phase 1 trials in people without HIV.BMC immunology · 2025Article
- Safety, Tolerability, and Pharmacokinetics of Long-Acting Broadly Neutralizing HIV-1 Monoclonal Antibody VRC07-523LS in Newborn Infants Exposed to HIV-1.Journal of the Pediatric Infectious Diseases Society · 2025Article
- Meeting Summary for Keystone Symposia on HIV Cure: Antiretroviral Therapy (ART)-Free Control of HIV Infection in Durban, South Africa, 2025.Pathogens & immunity · 2025Article
- Broadly neutralizing antibodies for HIV prevention: a comprehensive review and future perspectives.Clinical microbiology reviews · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 7 institutions in 2 countries.
Funding
Abstract
backgroundEffective, long-acting prevention approaches are needed to reduce human immunodeficiency virus (HIV) incidence. We evaluated the safety and pharmacokinetics of VRC07-523LS and PGT121 administered subcutaneously alone and in combination as passive immunization for young women in South Africa.
methodsCAPRISA 012A was a randomized, double-blinded, placebo-controlled, dose-escalation phase 1 trial. We enrolled 45 HIV-negative women into 9 groups and assessed safety, tolerability, pharmacokinetics, neutralization activity, and antidrug antibody levels. Pharmacokinetic modeling was conducted to predict steady-state concentrations for 12- and 24-weekly dosing intervals.
resultsVRC07-523LS and PGT121, administered subcutaneously, were safe and well tolerated. Most common reactogenicity events were injection site tenderness and headaches. Nine product-related adverse events were mild and transient. Median VRC07-523LS concentrations after 20 mg/kg doses were 9.65 μg/mL and 3.86 μg/mL at 16 and 24 weeks. The median week 8 concentration after the 10 mg/kg PGT121 dose was 8.26 μg/mL. Modeling of PGT121 at 20 mg/kg showed median concentrations of 1.37 μg/mL and 0.22 μg/mL at 16 and 24 weeks. Half-lives of VRC07-523LS and PGT121 were 29 and 20 days. Both antibodies retained neutralizing activity postadministration and no antidrug antibodies were detected.
conclusionsSubcutaneous administration of VRC07-523LS in combination with optimized versions of PGT121 or other antibodies should be further assessed for HIV prevention.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.