Evidence map›Paper›PMID 38608171›Full record

ArticleHuman vaccines & immunotherapeutics2024

Development and validation of a 6-plex Luminex-based assay for measuring human serum antibodies to group B streptococcus capsular polysaccharides.

Michelle A Gaylord, Melissa Larrier, Donna Giordano-Schmidt, Christopher D Grube, Suddham Singh, Ha H Nguyen, Andrew McKeen, Charles Y Tan, Annaliesa S Anderson, Warren V Kalina and 2 more

Open access · goldAbstract read
In one paragraph

Article in Human vaccines & immunotherapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
6.0field-weighted citation impact, top 3% 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.

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

7 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Maternal and Newborn Group BOpen forum infectious diseases · 2026
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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.

Michelle A GaylordVaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
Melissa LarrierVaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
Donna Giordano-SchmidtVaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
Christopher D GrubeVaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
Suddham SinghVaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
Ha H NguyenGlobal Biometrics & Data Management, Pfizer Inc, Pearl River, New York, USA.
Andrew McKeenGlobal Biometrics & Data Management, Pfizer Inc, Pearl River, New York, USA.
Charles Y TanGlobal Biometrics & Data Management, Pfizer Inc, Collegeville, PA, USA.
Annaliesa S AndersonVaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
Warren V KalinaVaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
Danka PavliakovaVaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
Peter C GiardinaVaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
Pfizer (United States) · USZimmer Biomet (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Six serotypes (Ia, Ib, II, III, IV, and V) cause nearly all group B streptococcal (GBS) disease globally. Capsular polysaccharide (CPS) conjugate vaccines aim to prevent GBS disease, however, licensure of a vaccine would depend on a standardized serological assay for measuring anti-CPS IgG responses. A multiplex direct Luminex-based immunoassay (dLIA) has been developed to simultaneously measure the concentration of serum IgG specific for the six prevalent GBS CPS serotypes. Assay validation was performed using serum samples obtained from human subjects vaccinated with an investigational 6-valent GBS CPS conjugate vaccine. Results for the assay are expressed as IgG concentrations (µg/mL) using a human serum reference standard composed of pooled sera from vaccinated subjects. The lower limits of quantitation (LLOQ) for all serotypes covered in the 6-plex GBS IgG dLIA fell within the range of 0.002-0.022 µg/mL IgG. Taken together, the 6-plex GBS IgG dLIA platform is specific for the six GBS serotypes included in Pfizer's investigational vaccine, has a wide dilution adjusted assay range, and is precise (<18.5% relative standard deviation) for all serotypes, and, therefore, is suitable for quantitatively measuring vaccine-induced or naturally acquired serotype-specific anti-CPS IgG responses against GBS.

Indexed as

LicensurePolysaccharidesHumansImmunoglobulin GStreptococcus agalactiaeVaccines, ConjugateImmunoglobulin GPolysaccharidesVaccines, Conjugatecapsular polysaccharideconjugate vaccinegroup B streptococcusIgGimmunoassayLuminexserotypeStreptococcus agalactiae

Identifiers

PMID38608171
PMCPMC11018021
OpenAlexW4394769988

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.