Trial reportPloS one2014
A phase I clinical study of a live attenuated Bordetella pertussis vaccine--BPZE1; a single centre, double-blind, placebo-controlled, dose-escalating study of BPZE1 given intranasally to healthy adult male volunteers.
Trial report in PloS one, 2014. 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 70 papers, 3 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 1, Single Centre, Dose-escalating, Placebo-controlled Study of a Genetically Modified B. Pertussis Strain Given as a Single Intranasal Dose to Healthy Adult Male Volunteers
Phase Ib (High Dose), Single Centre, Dose-escalating, Placebo-controlled, Randomized Study of a Live Attenuated B. Pertussis Strain Given as a Single Intranasal Dose to Healthy Adult Volunteers
Who cites it
70 citing papers in PubMed, 3 syntheses or guidelines pooled it, 141 citations in OpenAlex.
- Pasteurian Contributions to the Study ofToxins · 2023Pooled it
- Mucosal Immunization Against Pertussis: Lessons From the Past and Perspectives.Frontiers in immunology · 2021Pooled it
- The effectiveness and safety of pertussis booster vaccination for adolescents and adults: A systematic review and meta-analysis.Medicine · 2019Pooled it
- Controlled Human Infection With Bordetella pertussis Induces Asymptomatic, Immunizing Colonization.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020Trial
- Live attenuated pertussis vaccine BPZE1 induces a broad antibody response in humans.The Journal of clinical investigation · 2020Trial
- Pertussis-specific memory B-cell and humoral IgG responses in adolescents after a fifth consecutive dose of acellular pertussis vaccine.Clinical and vaccine immunology : CVI · 2014Trial
- Development of High-Throughput Serum Bactericidal Assays forVaccines · 2026Article
- SphB1 export system for antigen presentation to the respiratory tract by a live pertussis vaccine.Applied microbiology and biotechnology · 2026Article
- BPZE1 vaccination induces IL-17NPJ vaccines · 2026Article
- Mechanisms of natural and vaccine-induced immunity to Bordetella pertussis.PLoS pathogens · 2026Review
- Flow Cytometric Assessment of Pertactin- and Tetanus Toxoid-Specific B-Cell Kinetics After Tdap Booster Vaccination in Healthy Adults.Vaccines · 2026Article
- Pathogens as commensals: microbial priming of the immune system and heterologous protection.Microbiology (Reading, England) · 2026Review
- Respiratory immunization using antibiotic-inactivated Bordetella pertussis confers T cell-mediated protection against nasal infection in mice.Nature microbiology · 2025Article
- Review
- Article
- Pertussis before, during and after Covid-19.EMBO molecular medicine · 2025Review
- Human challenge models for vaccine development-strengths, limitations, and expansion into endemic settings: a HIC-Vac meeting report.Immunotherapy advances · 2025Review
- Pertussis resurgence: epidemiological trends, pathogenic mechanisms, and preventive strategies.Frontiers in immunology · 2025Review
- Exploiting subtractive genomics to identify novel drug targets and new immunogenic candidates againstFrontiers in bioinformatics · 2025Article
- Review
10 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 7 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAcellular pertussis vaccines do not control pertussis. A new approach to offer protection to infants is necessary. BPZE1, a genetically modified Bordetella pertussis strain, was developed as a live attenuated nasal pertussis vaccine by genetically eliminating or detoxifying 3 toxins.
methodsWe performed a double-blind, placebo-controlled, dose-escalating study of BPZE1 given intranasally for the first time to human volunteers, the first trial of a live attenuated bacterial vaccine specifically designed for the respiratory tract. 12 subjects per dose group received 10³, 10⁵ or 10⁷ colony-forming units as droplets with half of the dose in each nostril. 12 controls received the diluent. Local and systemic safety and immune responses were assessed during 6 months, and nasopharyngeal colonization with BPZE1 was determined with repeated cultures during the first 4 weeks after vaccination.
resultsColonization was seen in one subject in the low dose, one in the medium dose and five in the high dose group. Significant increases in immune responses against pertussis antigens were seen in all colonized subjects. There was one serious adverse event not related to the vaccine. Other adverse events were trivial and occurred with similar frequency in the placebo and vaccine groups.
conclusionsBPZE1 is safe in healthy adults and able to transiently colonize the nasopharynx. It induces immune responses in all colonized individuals. BPZE1 can thus undergo further clinical development, including dose optimization and trials in younger age groups.
trial registrationClinicalTrials.gov NCT01188512.
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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.