Trial reportThe Lancet. Infectious diseases2026
Safety and immunogenicity of a conjugate vaccine candidate against Salmonella enterica serovars Typhi and Paratyphi A in healthy adults in Europe: a phase 1 randomised controlled trial.
Trial report in The Lancet. Infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers.
What it found
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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.
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.
Who cites it
3 citing papers in PubMed.
- Development and validation of immunological assays for preclinical evaluation of a novel bivalent typhoid conjugate vaccine.Human vaccines & immunotherapeutics · 2026Article
- Recent developments in typhoidal and non-typhoidal Salmonella vaccines.Current opinion in infectious diseases · 2026Review
- Development of an 8-valentFrontiers in immunology · 2026Article
Corrections and comments
- Erratum issued
Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEnteric fever caused by Salmonella enterica serovars Typhi and Paratyphi A remains a major concern. No vaccines are licensed against Salmonella Paratyphi A. We aimed to assess the safety and immunogenicity of an investigational conjugate vaccine against Salmonella Typhi and Paratyphi A (Vi-CRM
methodsIn this observer-masked, randomised, controlled, dose-escalation, single-centre, phase 1 trial done during Nov 28, 2022, to April 2, 2024, at the Centre for Evaluation of Vaccination in Belgium, healthy adults (aged 18-50 years) were randomly assigned (2:1 or 2:2:1 across different steps using sealed envelopes following a randomisation schedule generated by an independent statistician) to receive two intramuscular doses (on day 1 and day 169) of one of four Vi-CRM
findings96 participants were randomly assigned, 12 to each low-dose group, 24 to each full-dose group, and 24 to the control group. The incidence of solicited administration-site events (mostly pain) ranged from six (50% [95% CI 21·1-78·9]) of 12 participants in the low-dose without aluminium hydroxide group to 23 (96% [78·9-99·9]) of 24 in the full-dose with aluminium hydroxide group, versus 22 (92% [73·0-99·0]) of 24 in the control group. Solicited systemic events (mostly fatigue, headache, and myalgia) ranged from eight (67% [34·9-90·1]) of 12 in the low-dose groups to 20 (83% [62·6-95·3]) of 24 in the full-dose with aluminium hydroxide group, versus 21 (88% [67·6-97·3]) of 24 in the control group. The incidence of unsolicited adverse events (mostly nasopharyngitis) ranged from seven (58% [27·7-84·8]) of 12 in the low-dose without aluminium hydroxide group to ten (83% [51·6-97·9]) of 12 in the low-dose with aluminium hydroxide group, versus 14 (58% [36·6-77·9]) of 24 in the control group. Most safety laboratory results were within reference ranges. No SAEs occurred. After dose 1 (ie, at day 29), full-dose without aluminium hydroxide and full-dose with aluminium hydroxide induced the highest anti-Vi IgG responses (GMR 53·01 [95% CI 31·94-87·99] and 31·55 [18·74-53·11], respectively) versus control (4·50 [2·93-6·90]). Full-dose without aluminium hydroxide and low-dose without aluminium hydroxide induced the highest anti-O:2 IgG responses after dose 1 (GMR 162·61 [91·17-290·04] and 114·19 [44·83-290·86], respectively), versus control (1·27 [1·02-1·60]). 89-100% and 82-100% of participants (lowest percentages for low-dose with aluminium hydroxide) had anti-Vi IgG ≥4·3 μg/mL at day 29 (in initially seronegative participants) and ≥4-fold anti-O:2 IgG increase from baseline, respectively, versus 13 (54% [95% CI 32·8-74·4]) and one (4% [0·1-21·1]) of 24 participants in the control group, respectively. The second dose did not boost the responses.
interpretationVi-CRM
fundingWellcome Trust.
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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.