Trial reportPloS one2011
Safety, immunogenicity and dose ranging of a new Vi-CRM₁₉₇ conjugate vaccine against typhoid fever: randomized clinical testing in healthy adults.
Trial report in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 36 papers, 2 of them syntheses that pooled 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.
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.
A Phase I, Randomized, Single-Blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Adult Subjects 18 to 40 Years of Age.
A Phase 2, Randomized, Observer-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of Three Formulations of the Novartis Vaccines Institute for Global Health (NVGH) Glycoconjugate Vaccine Against S. Typhi in Adult Subjects 18 to 40 Years of Age
Who cites it
36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 89 citations in OpenAlex.
- Typhoid conjugate vaccines for preventing typhoid fever (enteric fever).The Cochrane database of systematic reviews · 2025Pooled it
- Vaccines for preventing typhoid fever.The Cochrane database of systematic reviews · 2018Pooled it
- A phase 3, randomized study to evaluate the safety, tolerability, and immunogenicity of V116 in children and adolescents with increased risk of pneumococcal disease (STRIDE-13).Human vaccines & immunotherapeutics · 2026Trial
- 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.The Lancet. Infectious diseases · 2026Trial
- Comparative immune response of Typbar TCV® (typhoid conjugate vaccine) in extremes of age: An Indian experience.Human vaccines & immunotherapeutics · 2025Trial
- A multicenter, single-blind, randomized, phase-2/3 study to evaluate immunogenicity and safety of a single intramuscular dose of biological E's Vi-capsular polysaccharide-CRMHuman vaccines & immunotherapeutics · 2022Trial
- Trial
- A phase 1 randomized safety, reactogenicity, and immunogenicity study of Typhax: A novel protein capsular matrix vaccine candidate for the prevention of typhoid fever.PLoS neglected tropical diseases · 2020Trial
- Safety and immunogenicity of a Vi-DT typhoid conjugate vaccine: Phase I trial in Healthy Filipino adults and children.Vaccine · 2018Trial
- Non-typhoidal Salmonella combination vaccines: clinical development plan and regulatory considerations.Vaccine · 2025Review
- Article
- Review
- Recent advances in the biosynthesis of polysaccharide-based antimicrobial glycoconjugate vaccines.Frontiers in microbiology · 2024Review
- Development and characterization of high-throughput serological assays to measure magnitude and functional immune response againstFrontiers in immunology · 2024Article
- Qualification of an enzyme-linked immunosorbent assay for quantification of anti-Vi IgG in human sera.Frontiers in immunology · 2024Article
- Vi polysaccharide and conjugated vaccines afford similar early, IgM or IgG-independent control of infection but boosting with conjugated Vi vaccines sustains the efficacy of immune responses.Frontiers in immunology · 2023Article
- A strategic model for developing vaccines against neglected diseases: An example of industry collaboration for sustainable development.Human vaccines & immunotherapeutics · 2022Review
- Impact and Control of Sugar Size in Glycoconjugate Vaccines.Molecules (Basel, Switzerland) · 2022Review
- Rotavirus spike protein ΔVP8* as a novel carrier protein for conjugate vaccine platform with demonstrated antigenic potential for use as bivalent vaccine.Scientific reports · 2021Article
- Short Vi-polysaccharide abrogates T-independent immune response and hyporesponsiveness elicited by long Vi-CRMProceedings of the National Academy of Sciences of the United States of America · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTyphoid fever causes more than 21 million cases of disease and 200,000 deaths yearly worldwide, with more than 90% of the disease burden being reported from Asia. Epidemiological data show high disease incidence in young children and suggest that immunization programs should target children below two years of age: this is not possible with available vaccines. The Novartis Vaccines Institute for Global Health developed a conjugate vaccine (Vi-CRM₁₉₇) for infant vaccination concomitantly with EPI vaccines, either starting at 6 weeks with DTP or at 9 months with measles vaccine. We report the results from a Phase 1 and a Phase 2 dose ranging trial with Vi-CRM₁₉₇ in European adults. METHODOLOGY: Following randomized blinded comparison of single vaccination with either Vi-CRM₁₉₇ or licensed polysaccharide vaccines (both containing 25·0 µg of Vi antigen), a randomised observer blinded dose ranging trial was performed in the same center to compare three concentrations of Vi-CRM₁₉₇ (1·25 µg, 5·0 µg and 12·5 µg of Vi antigen) with the polysaccharide vaccine. PRINCIPAL
findingsAll vaccines were well tolerated. Compared to the polysaccharide vaccine, Vi-CRM₁₉₇ induced a higher incidence of mild to moderate short lasting local pain. All Vi-CRM₁₉₇ formulations induced higher Vi antibody levels compared to licensed control, with clear dose response relationship.
conclusionsVi-CRM₁₉₇ did not elicit safety concerns, was highly immunogenic and is therefore suitable for further clinical testing in endemic populations of South Asia.
trial registrationClinicalTrials.gov NCT01123941 NCT01193907.
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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.