Evidence map›Paper›PMID 41592842›Full record

ArticleBMJ open2026

Phase II multicentre double-blind randomised controlled trial of a Bivalent VaccInation against

Margarete Paganotti Vicentine, Naina McCann, Oisin Hennigan, Noshi Maria, Claudia I Juarez Molina, Stanislava Koleva, Mohammod K Islam, Elizabeth Jones, Amy Flaxman, Nicole Day and 16 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

26 authors.

Margarete Paganotti VicentineUniversity of Oxford Oxford Vaccine Group, Oxford, UK margarete.paganottivicentine@paediatrics.ox.ac.uk.ORCID http://orcid.org/0009-0003-6995-147X
Naina McCannUniversity of Oxford Oxford Vaccine Group, Oxford, UK.ORCID http://orcid.org/0000-0001-5864-1175
Oisin HenniganUniversity of Oxford Oxford Vaccine Group, Oxford, UK.
Noshi MariaUniversity of Oxford Oxford Vaccine Group, Oxford, UK.
Claudia I Juarez MolinaUniversity of Oxford Oxford Vaccine Group, Oxford, UK.
Stanislava KolevaUniversity of Oxford Oxford Vaccine Group, Oxford, UK.
Mohammod K IslamUniversity of Oxford Oxford Vaccine Group, Oxford, UK.ORCID http://orcid.org/0000-0003-4450-246X
Elizabeth JonesUniversity of Oxford Oxford Vaccine Group, Oxford, UK.
Amy FlaxmanUniversity of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0001-6460-1372
Nicole DayUniversity of Oxford Oxford Vaccine Group, Oxford, UK.
Allison MacDonaldUniversity of Oxford Oxford Vaccine Group, Oxford, UK.
Mehreen AdnanUniversity of Oxford Oxford Vaccine Group, Oxford, UK.
Nisha SinghUniversity of Oxford, Oxford, UK.
Sophie VernonUniversity of Oxford Oxford Vaccine Group, Oxford, UK.
Eleanor WilsonUniversity of Oxford Oxford Vaccine Group, Oxford, UK.
Anirudha Vyankatesh PoteySerum Institute of India Private Limited, Pune, India.
Abhijeet DharmadhikariSerum Institute of India Private Limited, Pune, India.
Sanket GaidhaneSerum Institute of India Private Limited, Pune, India.
Prasad S KulkarniSerum Institute of India Private Limited, Pune, India.
Hannah RobinsonUniversity of Oxford Oxford Vaccine Group, Oxford, UK.
Parvinder AleyUniversity of Oxford Oxford Vaccine Group, Oxford, UK.
Young Chan KimUniversity of Oxford Oxford Vaccine Group, Oxford, UK.ORCID http://orcid.org/0000-0003-2847-9407
Brian AngusUniversity of Oxford Oxford Vaccine Group, Oxford, UK.ORCID http://orcid.org/0000-0003-3598-7784
Xinxue LiuUniversity of Oxford Oxford Vaccine Group, Oxford, UK.ORCID http://orcid.org/0000-0003-1107-0365
Maheshi Nirmala RamasamyUniversity of Oxford Oxford Vaccine Group, Oxford, UK.ORCID http://orcid.org/0000-0002-2119-951X
Andrew J PollardUniversity of Oxford Oxford Vaccine Group, Oxford, UK.ORCID http://orcid.org/0000-0001-7361-719X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEnteric fever, primarily caused by METHODS AND ANALYSIS: This is a phase II multicentre, double-blind, randomised controlled trial assessing the efficacy and immunogenicity of a bivalent conjugate vaccine candidate, Serum Institute of India Typhoid Conjugate Vaccine (Bivalent) (SII-TCV(B)), against SPA using a CHIM in healthy UK adults aged 18-55 years. A total of 192 participants will be randomised 1:1 to receive either SII-TCV(B) or a licensed Vi-polysaccharide typhoid vaccine (Vi-PS). All participants will be orally challenged with S. Paratyphi A (strain NVGH308) 28 days postvaccination. Participants will be monitored closely for 14 days and treated at 14 days postchallenge or promptly on diagnosis, according to prespecified criteria. The primary objective is to evaluate vaccine efficacy of SII-TCV(B) against paratyphoid infection using a CHIM. The coprimary immunogenicity objective is to assess non-inferiority of the typhoid IgG response compared with a licensed Vi-PS control. ETHICS AND DISSEMINATION: The study has received ethical approval from the Berkshire Research Ethics Committee (24/SC/0309) and regulatory approval from the UK Medicines and Healthcare products Regulatory Agency. Results will be disseminated via peer-reviewed publications and scientific meetings. TRIAL REGISTRATION NUMBER: ISRCTN65855590.

Indexed as

Paratyphoid FeverSalmonella paratyphi ASalmonella typhiTyphoid FeverTyphoid-Paratyphoid VaccinesAdolescentAdultAntibodies, BacterialClinical Trials, Phase II as TopicDouble-Blind MethodFemaleHumansMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicAntibodies, BacterialTyphoid-Paratyphoid VaccinesVaccines, ConjugateAdultsClinical TrialImmunogenicity, VaccineRandomized Controlled TrialTyphoid-Paratyphoid VaccinesVaccinationVaccine EfficacyVaccines, CombinedVaccines, Conjugate

Identifiers

PMID41592842
PMCPMC12853460

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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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.