Evidence map›Paper›PMID 27956428›Full record

Trial reportAntimicrobial agents and chemotherapy2017

Safety, Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, in Healthy Adults.

M Pamela Griffin, Anis A Khan, Mark T Esser, Kathryn Jensen, Therese Takas, Martin K Kankam, Tonya Villafana, Filip Dubovsky

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2017. 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 81 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 2 pooled it
12.2field-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

81 citing papers in PubMed, 2 syntheses or guidelines pooled it, 144 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Review
  13. Article
  14. Observational
  15. Review
  16. Article
  17. Review
  18. Review
  19. Article
  20. Article

21 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 2 institutions in 1 country.

M Pamela GriffinMedImmune (AstraZeneca), Gaithersburg, Maryland, USA griffinp@medimmune.com.
Anis A KhanMedImmune (AstraZeneca), Gaithersburg, Maryland, USA.
Mark T EsserMedImmune (AstraZeneca), Gaithersburg, Maryland, USA.
Kathryn JensenMedImmune (AstraZeneca), Gaithersburg, Maryland, USA.
Therese TakasMedImmune (AstraZeneca), Gaithersburg, Maryland, USA.
Martin K KankamVince and Associates Clinical Research, Overland Park, Kansas, USA.
Tonya VillafanaMedImmune (AstraZeneca), Gaithersburg, Maryland, USA.
Filip DubovskyMedImmune (AstraZeneca), Gaithersburg, Maryland, USA.
AstraZeneca (United States) · USAltasciences Clinical Research Vince & Associates · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Prevention of respiratory syncytial virus (RSV) illness in infants is a major public health priority, but there is no approved vaccine. Palivizumab is a monoclonal antibody that provides RSV prophylaxis but requires 5 monthly injections and is approved only for infants who experience the greatest morbidity and mortality from RSV. Thus, there remains a significant unmet medical need for prevention of RSV disease in healthy infants. MEDI8897 is a recombinant human RSV monoclonal antibody with a modified Fc region that extends its half-life and is being developed as RSV prophylaxis for all infants. In this phase 1, first-in-human, placebo-controlled study, 136 healthy adults were randomized to receive a single dose of MEDI8897 (

Indexed as

AdultAntibodies, MonoclonalAntibodies, ViralAntiviral AgentsArea Under CurveBiological AvailabilityBody Mass IndexDouble-Blind MethodDrug Administration ScheduleFemaleHealthy VolunteersHumansInjections, IntramuscularInjections, IntravenousMalePatient SafetyAntibodies, MonoclonalAntibodies, ViralAntiviral Agentshealthy adultsinfantslower respiratory tract infectionsMEDI8897pharmacokineticsrespiratory syncytial virusRSV

Identifiers

PMID27956428
PMCPMC5328523
OpenAlexW2562476421

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.