ArticleThe Journal of infectious diseases2021
Safety, Tolerability, and Pharmacokinetics of a Long-Acting Broadly Neutralizing Human Immunodeficiency Virus Type 1 (HIV-1) Monoclonal Antibody VRC01LS in HIV-1-Exposed Newborn Infants.
Article in The Journal of infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02256631 (Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous), which is not on this map. Cited by 37 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.
Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous (SC) VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
Who cites it
37 citing papers in PubMed, 50 citations in OpenAlex.
- Trial
- Characterizing HIV drug resistance in cases of vertical transmission in the VESTED randomized antiretroviral treatment trial.Journal of acquired immune deficiency syndromes (1999) · 2024Trial
- Broadly neutralizing antibody treatment maintained HIV suppression in children with favorable reservoir characteristics in Botswana.Science translational medicine · 2023Trial
- Learned young: HIV-1 germline-targeting vaccination in infants.Current opinion in HIV and AIDS · 2026Review
- The Importance of Pediatric Nonhuman Primate Models in Translational HIV Research.Journal of medical primatology · 2026Review
- Broadly neutralizing antibodies for treatment of HIV in children in the Global South: rationale and challenges.Frontiers in pediatrics · 2026Review
- Review
- Eliminating interactions with the viral Fc receptor improves antibody-mediated protection against neonatal HSV infection in mice.Science translational medicine · 2025Article
- Review
- Virologic effects of broadly neutralizing antibodies VRC01LS and VRC07-523LS on chronic HIV-1 infection.JCI insight · 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
- Cost-effectiveness of broadly neutralizing antibodies for HIV prophylaxis for infants born in settings with high HIV burdens.PloS one · 2025Article
- Human Immunodeficiency Virus and Breastfeeding: Clinical Considerations and Mechanisms of Transmission in the Modern Era of Combined Antiretroviral Therapy.Clinics in perinatology · 2024Review
- Optimising Paediatric HIV Treatment: Recent Developments and Future Directions.Paediatric drugs · 2024Review
- Preventing perinatal HIV acquisition; current gaps and future perspectives.Current opinion in HIV and AIDS · 2024Review
- Broadly neutralizing antibodies for HIV prevention: a comprehensive review and future perspectives.Clinical microbiology reviews · 2024Review
- 3D human tissue models and microphysiological systems for HIV and related comorbidities.Trends in biotechnology · 2024Review
- Preventing breast milk HIV transmission using broadly neutralizing monoclonal antibodies: One size does not fit all.Immunity, inflammation and disease · 2024Article
- Caregivers of children with HIV in Botswana prefer monthly IV Broadly Neutralizing Antibodies (bNAbs) to daily oral ART.PloS one · 2024Article
- Challenges with pediatric antiretroviral therapy administration: Qualitative perspectives from caregivers and HIV providers in Kenya.PloS one · 2024Article
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 12 institutions in 3 countries.
Funding
Abstract
backgroundPerinatal human immunodeficiency virus type 1 (HIV-1) continues to occur due to barriers to effective antiretroviral prevention that might be mitigated by long-acting broadly neutralizing monoclonal antibodies (bNAbs).
methodsAn extended half-life bNAb, VRC01LS, was administered subcutaneously at 80 mg/dose after birth to HIV-1-exposed, nonbreastfed (cohort 1, n = 10) and breastfed (cohort 2, n = 11) infants. Cohort 2 received a second dose (100 mg) at 12 weeks. All received antiretroviral prophylaxis. VRC01LS levels were compared to VRC01 levels determined in a prior cohort.
resultsLocal reactions (all grade ≤2) occurred in 67% and 20% after dose 1 and dose 2, respectively. The weight-banded dose (mean 28.8 mg/kg) of VRC01LS administered subcutaneously achieved a mean (standard deviation) plasma level of 222.3 (71.6) µg/mL by 24 hours and 44.0 (11.6) µg/mL at week 12, prior to dose 2. The preestablished target of ≥50 µg/mL was attained in 95% and 32% at weeks 8 and 12, respectively. The terminal half-life was 37-41 days. VRC01LS level after 1 dose was significantly greater (P <.002) than after a VRC01 dose (20 mg/kg). No infants acquired HIV-1.
conclusionsVRC01LS was well tolerated with pharmacokinetics that support further studies of more potent long-acting bNAbs as adjunct treatment with antiretrovirals to prevent infant HIV-1 transmission.
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.