Evidence map›Paper›PMID 33676782›Full record

ReviewVaccine2021

Vaccines based on replication incompetent Ad26 viral vectors: Standardized template with key considerations for a risk/benefit assessment.

Jerome Custers, Denny Kim, Maarten Leyssen, Marc Gurwith, Frank Tomaka, James Robertson, Esther Heijnen, Richard Condit, Georgi Shukarev, Dirk Heerwegh and 7 more

Open access · hybridAbstract readReview
In one paragraph

Review in Vaccine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 1 pooled it
10.1field-weighted citation impact, top 1% 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

53 citing papers in PubMed, 1 synthesis or guideline pooled it, 80 citations in OpenAlex.

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  15. [Platform technologies in vaccine development].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2025
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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

17 authors at 5 institutions in 3 countries.

Jerome CustersJanssen Vaccines & Prevention, Leiden, the Netherlands.
Denny KimJanssen Research & Development, Titusville, NJ, USA.
Maarten LeyssenJanssen Vaccines & Prevention, Leiden, the Netherlands.
Marc GurwithBrighton Collaboration, A Program of the Task Force for Global Health, Decatur, GA, USA.
Frank TomakaJanssen Research & Development, Titusville, NJ, USA.
James RobertsonIndependent Adviser, United Kingdom.
Esther HeijnenJanssen Vaccines & Prevention, Leiden, the Netherlands.
Richard ConditDepartment of Molecular Genetics and Microbiology, University of Florida, Gainesville, FL, USA.
Georgi ShukarevJanssen Vaccines & Prevention, Leiden, the Netherlands.
Dirk HeerweghJanssen Pharmaceutica NV, Beerse, Belgium.
Roy van HeesbeenJanssen Vaccines & Prevention, Leiden, the Netherlands.
Hanneke SchuitemakerJanssen Vaccines & Prevention, Leiden, the Netherlands.
Macaya DouoguihJanssen Vaccines & Prevention, Leiden, the Netherlands.
Eric EvansBrighton Collaboration, A Program of the Task Force for Global Health, Decatur, GA, USA.
Emily R SmithBrighton Collaboration, A Program of the Task Force for Global Health, Decatur, GA, USA.
Robert T ChenBrighton Collaboration, A Program of the Task Force for Global Health, Decatur, GA, USA.
Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG)
Janssen (Netherlands) · NLThe Task Force for Global Health · USJanssen (United States) · USJanssen (Belgium) · BEUniversity of Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Replication-incompetent adenoviral vectors have been under investigation as a platform to carry a variety of transgenes, and express them as a basis for vaccine development. A replication-incompetent adenoviral vector based on human adenovirus type 26 (Ad26) has been evaluated in several clinical trials. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) was formed to evaluate the safety and features of recombinant viral vector vaccines. This paper reviews features of the Ad26 vectors, including tabulation of safety and risk assessment characteristics of Ad26-based vaccines. In the Ad26 vector, deletion of E1 gene rendering the vector replication incompetent is combined with additional genetic engineering for vaccine manufacturability and transgene expression optimization. These vaccines can be manufactured in mammalian cell lines at scale providing an effective, flexible system for high-yield manufacturing. Ad26 vector vaccines have favorable thermostability profiles, compatible with vaccine supply chains. Safety data are compiled in the Ad26 vaccine safety database version 4.0, with unblinded data from 23 ongoing and completed clinical studies for 3912 participants in five different Ad26-based vaccine programs. Overall, Ad26-based vaccines have been well tolerated, with no significant safety issues identified. Evaluation of Ad26-based vaccines is continuing, with >114,000 participants vaccinated as of 4th September 2020. Extensive evaluation of immunogenicity in humans shows strong, durable humoral and cellular immune responses. Clinical trials have not revealed impact of pre-existing immunity to Ad26 on vaccine immunogenicity, even in the presence of Ad26 neutralizing antibody titers or Ad26-targeting T cell responses at baseline. The first Ad26-based vaccine, against Ebola virus, received marketing authorization from EC on 1st July 2020, as part of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen. New developments based on Ad26 vectors are underway, including a COVID-19 vaccine, which is currently in phase 3 of clinical evaluation.

Indexed as

COVID-19EbolavirusViral VaccinesAnimalsCOVID-19 VaccinesGenetic VectorsHumansRisk AssessmentSARS-CoV-2COVID-19 VaccinesViral VaccinesBenefit/riskReplication-incompetent Ad26SafetyVaccineViral vector

Identifiers

PMID33676782
PMCPMC7532807
OpenAlexW3090889278

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.