Evidence map›Paper›PMID 40890131›Full record

Trial reportNature communications2025

Hyaluronidase-enhanced subcutaneous delivery of bNAbs: a phase 1 randomized controlled clinical trial in HIV-uninfected women.

Sharana Mahomed, Farzana Osman, Martin Beliveau, Roberto Heredia-Ortiz, Kevin Carlton, Jennifer Wang, Madeeha Mughal, Kwang Low, Sandeep Narpala, Bob C Lin and 5 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Sharana MahomedCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa. Sharana.Mahomed@caprisa.org.ORCID http://orcid.org/0009-0005-1449-160X
Farzana OsmanCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.
Martin BeliveauCertara, Montreal, QC, Canada.
Roberto Heredia-OrtizCertara, Montreal, QC, Canada.
Kevin CarltonVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Jennifer WangVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Madeeha MughalVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Kwang LowVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Sandeep NarpalaVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Bob C LinVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Mike CastroVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.ORCID http://orcid.org/0000-0002-8045-1754
Leonid SerebryannyyVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Richard A KoupVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Quarraisha Abdool KarimCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.ORCID http://orcid.org/0000-0002-0985-477X
Salim S Abdool KarimCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.ORCID http://orcid.org/0000-0002-4986-2133

Funding

European and Developing Countries Clinical Trials Partnership (EDCTP) RIA2017S
6 · The paper itself

Abstract

Broadly neutralizing antibodies (bNAbs) offer a promising strategy for HIV prevention. Subcutaneous (SC) administration is more feasible than intravenous delivery but may be limited by prolonged administration times and multiple injections. Here we report a pharmacokinetic (PK) modelling study, an unspecified exploratory analysis that involved 57 HIV-negative African women (median age 25 years; BMI range 18.1-39.3 kg/m²) enrolled in the CAPRISA 012B trial (PACTR202003767867253, total participants n = 76). A predefined sub-analysis directly comparing the 20 mg/kg dose level of ENHANZE™ drug product (EDP) versus no-EDP was conducted in a subset of participants (n = 5 with EDP, n = 5 without). CAP256V2LS and VRC07-523LS-potent HIV-1 bNAbs targeting conserved envelope epitopes-were administered SC with and without EDP. The primary outcome of this sub-analysis was duration of administration. Secondary outcomes included PK and safety. Among the subset of participants (n = 10), EDP significantly reduced median administration time from 49.5 to 10.0 minutes and reduced injections per dose from 3 to 1. CAP256V2LS and VRC07-523LS concentrations at 24 weeks post-dose, were 4.8- and 3.0-fold higher, respectively, with EDP. CAP256V2LS exposure (AUC) increased by 40%, despite a 30% decrease in Cmax. EDP was well tolerated with no safety concerns. These findings support EDP-enhanced SC delivery as a scalable and simplified strategy for long-acting antibody-based HIV prevention.

Indexed as

Antibodies, NeutralizingHIV-1HIV AntibodiesHIV InfectionsHyaluronoglucosaminidaseAdultFemaleHumansInjections, SubcutaneousYoung AdultAntibodies, NeutralizingHIV AntibodiesHyaluronoglucosaminidase

Identifiers

PMID40890131
PMCPMC12402148

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.