Evidence map›Paper›PMID 29373476›Full record

Trial reportThe Pediatric infectious disease journal2018

Safety, Tolerability and Pharmacokinetics of MEDI8897, an Extended Half-life Single-dose Respiratory Syncytial Virus Prefusion F-targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants.

Joseph B Domachowske, Anis A Khan, Mark T Esser, Kathryn Jensen, Therese Takas, Tonya Villafana, Filip Dubovsky, M Pamela Griffin

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Pediatric infectious disease journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04625725 (A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies), which is not on this map. Cited by 119 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
119citing papers in PubMed, 7 pooled it
19.4field-weighted citation impact, top 1% of its field
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.

NCT04625725 phase3completednot on this mapstarted 2020, after this paper: background citation

A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19.

TypeinterventionalSponsorAstraZenecaRan2020 to 2023Enrolled5,197ConditionsCOVID-19ArmsAZD7442, Placebo
3 · Its place in the literature

Who cites it

119 citing papers in PubMed, 7 syntheses or guidelines pooled it, 225 citations in OpenAlex.

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59 more citing papers are in PubMed but not listed here.

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 at 1 institution in 1 country.

Joseph B DomachowskeFrom the Division of Infectious Diseases, Department of Pediatrics, SUNY Upstate Medical University, Syracuse, New York.
Anis A KhanMedImmune (AstraZeneca), Gaithersburg, Maryland.
Mark T EsserMedImmune (AstraZeneca), Gaithersburg, Maryland.
Kathryn JensenMedImmune (AstraZeneca), Gaithersburg, Maryland.
Therese TakasMedImmune (AstraZeneca), Gaithersburg, Maryland.
Tonya VillafanaMedImmune (AstraZeneca), Gaithersburg, Maryland.
Filip DubovskyMedImmune (AstraZeneca), Gaithersburg, Maryland.
M Pamela GriffinMedImmune (AstraZeneca), Gaithersburg, Maryland.
SUNY Upstate Medical University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMEDI8897 is a recombinant human monoclonal antibody being developed for prophylaxis of serious respiratory syncytial virus (RSV) disease in all infants.

methodsIn this phase 1b/2a dose-escalation study, healthy preterm infants with a gestational age of 32-35 weeks were randomized to receive a single intramuscular injection of MEDI8897 (10, 25 or 50 mg) or placebo. Safety, pharmacokinetics, RSV-neutralizing antibody and antidrug antibody (ADA) assessments were performed during the 360-day follow-up period. Infants who experienced medically attended lower respiratory tract infections (LRTIs) were tested for RSV.

resultsMEDI8897 serum half-life ranged from 62.5-72.9 days. On day 151, 87% of infants in the 50 mg group had serum concentrations above the 90% effective concentration target level of 6.8 µg/mL, and 90% showed a ≥4-fold rise from baseline in serum RSV-neutralizing antibody levels. Adverse events (AEs) were reported in 17 of 18 (94.4%) placebo and 66 of 71 (93.0%) MEDI8897 recipients. Three MEDI8897 recipients experienced 5 serious AEs (3 LRTIs, 2 febrile seizures). ADA was detected at any time postbaseline in 28.2% of MEDI8897 recipients and at day 361 only in 26.5% of subjects. ADA response was not associated with AEs. Five (7%) MEDI8897 recipients experienced medically attended LRTIs through day 150; 1 tested positive for RSV (10 mg group).

conclusionsMEDI8897 had a favorable safety profile in healthy preterm infants. The extended half-life of MEDI8897 and demonstrated RSV-neutralizing activity support protection from RSV for the duration of a typical 5-month season after a single 50 mg intramuscular (IM) dose.

Indexed as

Antibodies, Monoclonal, HumanizedAntibodies, NeutralizingAntibodies, ViralAntiviral AgentsDose-Response Relationship, DrugDouble-Blind MethodFemaleGestational AgeHalf-LifeHumansInfantInfant, PrematureInjections, IntramuscularMaleRespiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingAntibodies, ViralAntiviral AgentsF protein, human respiratory syncytial virusViral Fusion Proteins

Identifiers

PMID29373476
PMCPMC6133204
OpenAlexW2785431220

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.