Evidence map›Paper›PMID 28679495›Full record

Trial reportClinical and vaccine immunology : CVI2017

Dose Selection for an Adjuvanted Respiratory Syncytial Virus F Protein Vaccine for Older Adults Based on Humoral and Cellular Immune Responses.

Judith Falloon, H Keipp Talbot, Craig Curtis, John Ervin, Diane Krieger, Filip Dubovsky, Therese Takas, Jing Yu, Li Yu, Stacie L Lambert and 2 more

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

Trial report in Clinical and vaccine immunology : CVI, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02289820 (A Phase 1b Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults), which is not on this map. Cited by 22 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 3 pooled it
2.8field-weighted citation impact, top 9% 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.

NCT02289820 phase1completednot on this map

A Phase 1b Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults

TypeinterventionalSponsorMedImmune LLCRan2015 to 2016Enrolled363ConditionsRespiratory Syncytial Virus (RSV)ArmsMEDI7510, IIV
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Vaccines for the common cold.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Article
  10. From setbacks to success: lessons from the journey of RSV vaccine development.Therapeutic advances in vaccines and immunotherapy · 2024
    Review
  11. Article
  12. Article
  13. Precision Vaccine Adjuvants for Older Adults: A Scoping Review.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Article
  14. Review
  15. Article
  16. A multifaceted approach to RSV vaccination.Human vaccines & immunotherapeutics · 2018
    Review
  17. Article
  18. Adjuvanted influenza vaccines.Human vaccines & immunotherapeutics · 2018
    Review
  19. Review
  20. 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

12 authors at 2 institutions in 1 country.

Judith FalloonMedImmune, Gaithersburg, Maryland, USA FalloonJ@MedImmune.com.
H Keipp TalbotVanderbilt University Medical Center, Nashville, Tennessee, USA.
Craig CurtisCompass Research, Orlando, Florida, USA.
John ErvinCenter for Pharmaceutical Research, Kansas City, Missouri, USA.
Diane KriegerMiami Research Associates, Miami, Florida, USA.
Filip DubovskyMedImmune, Gaithersburg, Maryland, USA.
Therese TakasMedImmune, Gaithersburg, Maryland, USA.
Jing YuMedImmune, Gaithersburg, Maryland, USA.
Li YuMedImmune, Gaithersburg, Maryland, USA.
Stacie L LambertMedImmune, Mountain View, California, USA.
Tonya VillafanaMedImmune, Gaithersburg, Maryland, USA.
Mark T EsserMedImmune, Gaithersburg, Maryland, USA.
Vanderbilt University Medical Center · USCompass Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This is the second phase 1 study of a respiratory syncytial virus (RSV) vaccine containing RSV fusion protein (sF) adjuvanted with glucopyranosyl lipid A (GLA) in a squalene-based 2% stable emulsion (GLA-SE). In this randomized, double-blind study, 261 subjects aged ≥60 years received inactivated influenza vaccine (IIV), a vaccine containing 120 μg sF with escalating doses of GLA (1, 2.5, or 5 μg) in SE, or a vaccine containing 80 μg sF with 2.5 μg GLA in SE. Subjects receiving 120 μg sF with 2.5 or 5 μg GLA were also randomized to receive IIV or placebo. Immunity to RSV was assessed by detection of microneutralizing, anti-F immunoglobulin G, and palivizumab-competitive antibodies and F-specific gamma interferon enzyme-linked immunosorbent spot assay T-cell responses. Higher adjuvant doses increased injection site discomfort, but at the highest dose, the reactogenicity was similar to that of IIV. Significant humoral and cellular immune responses were observed. The 120 μg sF plus 5.0 μg GLA formulation resulted in the highest responses in all subjects and in older subjects. These results confirm previous observations of vaccine tolerability, safety, and immunogenicity and were used to select the 120 μg sF plus 5.0 μg GLA formulation for phase 2 evaluation. (This study has been registered at ClinicalTrials.gov under registration no. NCT02289820.).

Indexed as

Adjuvants, ImmunologicImmunity, CellularImmunity, HumoralAdultAgedAged, 80 and overAntibodies, NeutralizingAntibodies, ViralDose-Response Relationship, ImmunologicDouble-Blind MethodEnzyme-Linked Immunospot AssayFemaleGlucosidesHumansImmunogenicity, VaccineImmunoglobulin GAdjuvants, ImmunologicAntibodies, NeutralizingAntibodies, ViralF protein, human respiratory syncytial virusglucopyranosyl lipid-AGlucosidesImmunoglobulin GInfluenza VaccinesInterferon-gammaLipid ARespiratory Syncytial Virus VaccinesViral Fusion Proteinsadjuvantadultcell-mediated immunityrespiratory syncytial virusTLR-4 agonistvaccine

Identifiers

PMID28679495
PMCPMC5585697
OpenAlexW2724742338

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.