Evidence map›Paper›PMID 39696004›Full record

Trial reportBMC infectious diseases2024

Replacing serum with dried blood microsampling for pharmacokinetics, viral neutralisation and immunogenicity bioanalysis supporting future paediatric development of RSM01, a candidate respiratory syncytial virus neutralising monoclonal antibody.

Joleen T White, Jonne Terstappen, Micha Levi, Andrijana Radivojevic, Robert Noble, Aparna B Anderson, Gwendolyn Wise-Blackman, Michael W Dunne

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05118386 (A Phase 1 Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of RSM01, a Monoclonal Antibody Targeting Respiratory Syncytial Virus, in Healthy Adults), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05118386 phase1completednot on this map

A Phase 1 Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of RSM01, a Monoclonal Antibody Targeting Respiratory Syncytial Virus, in Healthy Adults

TypeinterventionalSponsorGates Medical Research InstituteRan2021 to 2022Enrolled56ConditionsRSV InfectionArmsRSM01, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

8 authors.

Joleen T WhiteBill & Melinda Gates Medical Research Institute, Cambridge, MA, USA. Joleen.white@gatesmri.org.
Jonne TerstappenCenter for Translational Immunology, University Medical Centre Utrecht, Utrecht, The Netherlands.
Micha LeviBill & Melinda Gates Medical Research Institute, Cambridge, MA, USA.
Andrijana RadivojevicintiGROWTH LLC, Miami, FL, USA.
Robert NobleBill & Melinda Gates Medical Research Institute, Cambridge, MA, USA.
Aparna B AndersonBill & Melinda Gates Medical Research Institute, Cambridge, MA, USA.
Gwendolyn Wise-BlackmanBioData Solutions, Lawrence, KS, USA.
Michael W DunneBill & Melinda Gates Medical Research Institute, Cambridge, MA, USA.

Funding

Gates Foundation INV-008522
6 · The paper itself

Abstract

backgroundVirus neutralising antibodies in serum are considered key correlates of protection for vaccines and monoclonal antibodies against respiratory syncytial virus (RSV). RSM01 is a novel, highly-potent, half-life-extended and fully-human monoclonal antibody candidate targeting the RSV prefusion F protein. Currently in Phase 1 development, RSM01 is primarily being developed to potentially provide an effective and affordable RSV prevention strategy in low- and middle-income countries. To evaluate the ability of dried blood collection to generate data sets and conclusions comparable to serum collection, we compared pharmacokinetics (PK) of RSM01, immunogenicity, and virus neutralisation for dried capillary blood samples with serum samples.

methodsRSM01 PK, anti-drug antibodies (ADA), and RSV-neutralising antibodies from the Phase 1 trial were analyzed and compared between matched serum and dried blood samples. Deming regression analysis was performed using baseline-corrected values to evaluate correlation between measurements in liquid serum versus dried blood.

resultsThe analysis showed good correlation (R

conclusionsBoth RSM01 concentrations and RSV neutralising activity showed a strong correlation between the serum and blood measurements. ADA measurements also had an agreement of > 90% for individual samples and overall participant status. Our results demonstrate that dried blood is a suitable specimen type for collection and evaluation in the RSM01 clinical development program and shows promise as a useful approach to reduce patient burden in clinical trials, particularly for infants in low- and middle-income countries.

trial registrationClinicaltrials.gov NCT05118386 November 12, 2021.

Indexed as

Antibodies, MonoclonalAntibodies, NeutralizingAntibodies, ViralDried Blood Spot TestingRespiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsAntibodies, Monoclonal, HumanizedFemaleHumansInfantMaleAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingAntibodies, ViralAntidrug antibodiesDried bloodMonoclonal antibodyNeutralising antibodiesPatient-centeredPharmacokineticsProphylaxisRespiratory syncytial virusViral neutralising activityVolumetric absorptive microsampling

Identifiers

PMID39696004
PMCPMC11653551

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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.