Evidence map›Paper›PMID 39460303›Full record

ArticleVaccines2024

Safety and Humoral Immunogenicity of Different Dose Levels of Ad26.COV2.S as a 2-Dose Regimen in COVID-19 Vaccine-Naïve Healthy Adults: A Phase 3 Randomized Clinical Trial.

Veronica V Rezelj, Fred Paddenburg, Marie Enajite Diegbe, Julius Nangosyah, Emil C Reisinger, Weihong Hu, Carla Truyers, Gert Scheper, Mathieu Le Gars, Jenny Hendriks and 4 more

Abstract read
In one paragraph

Article in Vaccines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Trial
  2. 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

14 authors.

Veronica V RezeljJanssen Vaccines & Prevention, 2301 CN Leiden, The Netherlands.ORCID 0000-0003-1571-8325
Fred PaddenburgVimef Holding B.V., 3311 GE Dordrech, The Netherlands.
Marie Enajite DiegbeJanssen Vaccines & Prevention, 2301 CN Leiden, The Netherlands.
Julius NangosyahCytel Global Headquarters, Cambridge, MA 02139, USA.
Emil C ReisingerRostock University Medical Center, 18057 Rostock, Germany.
Weihong HuCytel Global Headquarters, Cambridge, MA 02139, USA.
Carla TruyersJanssen Research and Development, 2340 Beerse, Belgium.
Gert ScheperJanssen Vaccines & Prevention, 2301 CN Leiden, The Netherlands.ORCID 0000-0003-2316-756X
Mathieu Le GarsJanssen Vaccines & Prevention, 2301 CN Leiden, The Netherlands.
Jenny HendriksJanssen Vaccines & Prevention, 2301 CN Leiden, The Netherlands.
Frank StruyfJanssen Research and Development, 2340 Beerse, Belgium.
Macaya DouoguihJanssen Vaccines & Prevention, 2301 CN Leiden, The Netherlands.
Hanneke SchuitemakerJanssen Vaccines & Prevention, 2301 CN Leiden, The Netherlands.
Javier Ruiz-GuiñazúJanssen Research and Development, 2340 Beerse, Belgium.

Funding

Janssen Vaccines & Prevention B.V not applicable
6 · The paper itself

Abstract

backgroundThis study aimed to support the end-of-shelf life specification (2.5 × 10

methodsThis randomized, double-blind Phase 3 study evaluated immunogenicity, reactogenicity, and safety of several Ad26.COV2.S dose levels (range 1.25 to 9 × 10

resultsSpike-binding antibody responses 28 days post-dose 1 were non-inferior for the 9 × 10

conclusionsThis study highlights the challenges associated with conducting clinical studies in a rapidly evolving environment and underscores the importance of platform data that can guide initial vaccine specifications such as shelf life during accelerated vaccine development. The present study supports the end-of-shelf life specifications for the approved Ad26.COV2.S dose, and could provide useful information in future vaccine developments using adenovirus vector vaccines.

Indexed as

Ad26.COV2.SadultCOVID-19immunogenicityneutralizing antibodiessafetyspike-binding antibodiesvaccine

Identifiers

PMID39460303
PMCPMC11511116

What OpenQuestion holds

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LicenceCC BY
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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.