Evidence map›Paper›PMID 29438562›Full record

Trial reportJournal of the Pediatric Infectious Diseases Society2019

Randomized Controlled Trial of the Safety and Immunogenicity of Revaccination With Tetanus-Diphtheria-Acellular Pertussis Vaccine (Tdap) in Adults 10 Years After a Previous Dose.

Scott A Halperin, Catherine Donovan, Gary S Marshall, Vitali Pool, Michael D Decker, David R Johnson, David P Greenberg, Tdap Booster Investigators

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the Pediatric Infectious Diseases Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01439165 (Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 16% 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.

NCT01439165 phase4completednot on this map

Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2011 to 2017Enrolled1,330ConditionsTetanus, Diphtheria, Pertussis, Whooping CoughArmsTetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine, Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Article
  4. Review
  5. Article
  6. Review
  7. Article
  8. Observational
  9. Review
  10. Review
  11. ERRATA CORRIGE.Journal of preventive medicine and hygiene · 2021
    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

8 authors at 6 institutions in 2 countries.

Scott A HalperinDepartments of Pediatrics and Microbiology and Immunology, Dalhousie University, Halifax, Nova Scotia.
Catherine DonovanDepartment of Health and Community Services, Government of Newfoundland and Labrador, St. John's, Newfoundland.
Gary S MarshallDepartment of Pediatrics, University of Louisville School of Medicine, Kentucky.
Vitali PoolSanofi Pasteur, Swiftwater, Pennsylvania.
Michael D DeckerSanofi Pasteur, Swiftwater, Pennsylvania.
David R JohnsonSanofi Pasteur, Swiftwater, Pennsylvania.
David P GreenbergSanofi Pasteur, Swiftwater, Pennsylvania.
Tdap Booster Investigators
Sanofi (United States) · USDalhousie University · CAMemorial University of Newfoundland · CAUniversity of Louisville · USUniversity of Pittsburgh · USVanderbilt University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundReduced-antigen-content tetanus, diphtheria, and acellular pertussis (Tdap) vaccine is recommended in many countries for boosting immunity in adolescents and adults. Although immunity to these antigens wanes with time, currently available Tdap products are not labeled for repeat administration in the United States.

methodsWe performed an observer-blinded, randomized controlled trial in 1330 adults aged 18 to <65 years who received either the Tdap (n = 1002) or tetanus-diphtheria (Td) (n = 328) vaccine 8 to 12 years after a dose of Tdap vaccine administered previously. Solicited adverse events following immunization were documented for 7 days after vaccination, and serious adverse events and adverse events of medical significance were documented for 6 months after vaccination. Levels of antibodies against component vaccine antigens were measured before and 1 month after vaccination.

resultsA solicited adverse event was reported by 87.7% of Tdap and 88.0% of Td vaccine recipients. We found no significant differences in the rates of injection-site reactions, systemic reactions, or serious adverse events between the vaccine groups. A robust antibody response to each pertussis antigen in the Tdap-vaccinated group was found; postvaccination-to-prevaccination geometric mean antibody concentration ratios were 8:1 (pertussis toxoid), 5.9 (filamentous hemagglutinin), 6.4 (pertactin), and 5.2 (fimbriae 2 and 3). Postvaccination geometric mean concentrations of tetanus antibody (4.20 and 4.74 IU/mL, respectively) and diphtheria antibody (10.1 and 12.6 IU/mL, respectively) were similar in the Tdap and Td groups, and the rates of seroprotection against tetanus and diphtheria were >99% in both groups.

conclusionsA second dose of Tdap vaccine in adults approximately 10 years after a previous dose was well tolerated and immunogenic. These data might facilitate consideration of providing Tdap booster doses to adults.

Indexed as

Adhesins, BacterialAdolescentAdultAntibodies, BacterialAntibody FormationAntigens, BacterialBacterial Outer Membrane ProteinsCanadaDiphtheriaDiphtheria-Tetanus-acellular Pertussis VaccinesFemaleFimbriae, BacterialHumansImmunization, SecondaryImmunogenicity, VaccineInjection Site ReactionAdhesins, BacterialAntibodies, BacterialAntigens, BacterialBacterial Outer Membrane ProteinsDiphtheria-Tetanus-acellular Pertussis Vaccinesfilamentous hemagglutinin adhesin, Bordetella pertussispertactinpertussis toxoidToxoidsVirulence Factors, Bordetellaand acellular pertussis vaccineboosterdiphtheriapertussisTdaptetanus

Identifiers

PMID29438562
PMCPMC6510947
OpenAlexW2793884390

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.