Evidence map›Paper›PMID 30689507›Full record

Trial reportHuman vaccines & immunotherapeutics2019

A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants.

R Rupp, D Hurley, S Grayson, J Li, K Nolan, R D McFetridge, J Hartzel, C Abeygunawardana, M Winters, H Pujar and 2 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
6.9field-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.

NCT02037984 phase1 / phase2completednot on this map

A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults and Infants

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2014 to 2016Enrolled341ConditionsStreptococcus Pneumoniae Infection, Pneumococcal InfectionsArmsPrevnar 13®, V114 1x:1x:1x, V114 2x:2x:2x, V114 2x:1x:2x, V114 1x:1x:2x
NCT02531373 phase1 / phase2completednot on this map

A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2017Enrolled338ConditionsPneumococcal InfectionsArmsV114 Medium Dose, V114 High Dose, V114 Medium Dose with Alternative Carrier Protein, V114 High Dose with Alternative Carrier Protein, Prevnar 13™
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 60 citations in OpenAlex.

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  10. [The new 15-valent pneumococcal conjugate vaccine for the prevention ofJournal of preventive medicine and hygiene · 2023
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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 3 institutions in 1 country.

R Ruppa University of Texas Medical Branch , Galveston , TX , USA.
D Hurleyb Wasatch Pediatrics, Cottonwood Office , Murray , UT , USA.
S Graysonc Merck & Co., Inc ., Kenilworth , NJ , USA.
J Lic Merck & Co., Inc ., Kenilworth , NJ , USA.
K Nolanc Merck & Co., Inc ., Kenilworth , NJ , USA.ORCID 0000-0001-5030-7930
R D McFetridgec Merck & Co., Inc ., Kenilworth , NJ , USA.
J Hartzelc Merck & Co., Inc ., Kenilworth , NJ , USA.
C Abeygunawardanac Merck & Co., Inc ., Kenilworth , NJ , USA.
M Wintersc Merck & Co., Inc ., Kenilworth , NJ , USA.
H Pujarc Merck & Co., Inc ., Kenilworth , NJ , USA.
P Bennerc Merck & Co., Inc ., Kenilworth , NJ , USA.
L Museyc Merck & Co., Inc ., Kenilworth , NJ , USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USCotton (United States) · USThe University of Texas Medical Branch at Galveston · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTwo new formulations of an investigational 15-valent pneumococcal conjugate vaccine (PCV15-A and PCV15-B) were developed using 2 different protein-polysaccharide conjugation processes and evaluated in separate phase I/II studies (NCT02037984 [V114-004] and NCT02531373 [V114-005]) to assess optimal concentrations of pneumococcal polysaccharide (PnPs) and Aluminum Phosphate Adjuvant.

methodsVarious lots of PCV15-A and PCV15-B containing different concentrations of PnPs and/or adjuvant were compared to PCV13 in young adults and infants. Adults received single dose and infants received 4 doses at 2, 4, 6, and 12-15 months of age. Adverse events (AEs) were collected after each dose. Serotype-specific immunoglobulin G (IgG) concentrations and opsonophagocytic activity (OPA) were measured prior and 30 days postvaccination in adults, at 1 month postdose 3 (PD3), pre-dose4, and postdose 4 (PD4) in infants.

resultsSafety profiles were comparable across vaccination groups. At PD3, serotype-specific IgG GMCs were generally lower for either PCV15 formulation than PCV13 for most shared serotypes. PCV15 consistently elicited higher antibody responses to the 2 serotypes unique to the vaccine (22F and 33F) and serotype 3 for which PCV13 was shown to be ineffective. Except for serotypes 6A and 6B, no dose-response effect was observed with increasing concentrations of PnPs and/or adjuvant.

conclusionPCV15 is safe and induces IgG and OPA responses to all 15 serotypes in the vaccine. No significant differences in antibody responses were observed with increases in PnPs and/or Aluminum Phosphate Adjuvant.

Indexed as

Immunogenicity, VaccineAdolescentAdultAntibodies, BacterialDose-Response Relationship, ImmunologicHealthy VolunteersHumansImmunoglobulin GInfantMiddle AgedPneumococcal InfectionsPneumococcal VaccinesStreptococcus pneumoniaeVaccines, ConjugateYoung AdultAntibodies, BacterialImmunoglobulin GPneumococcal VaccinesVaccines, ConjugateimmunogenicityPneumococcal conjugate vaccinesafety

Identifiers

PMID30689507
PMCPMC6988874
OpenAlexW2911852415

What OpenQuestion holds

Textmetadata
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.