A Phase 1 interventional study of BPZE1 and Placebo in Pertussis, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 1 site in Sweden. Open to male participants aged 19 Years to 31 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Phase 1, Interventional, and Prevention
The purpose of this study is to evaluate the safety and immunogenicity of a new live attenuated vaccine against whooping-cough. It is a phase1, single centre, dose-escalating, placebo-controlled study on a genetically modified B. pertussis strain given as a single intranasal dose to healthy adult male volunteers.
Effective vaccines are needed to protect young infants (from 0 to 6 months, today the most vulnerable age group), preferably after a single administration very early in life. The successful outcome of this project would constitute an important milestone towards nasal vaccination of infants, possibly at birth with a novel, single-dose pertussis vaccine. Our ultimate aim is to protect infants in the most vulnerable age group, before the regular vaccination schedule using already available vaccines is applied. The ultimate aim is thus not to replace current vaccination schedules with available vaccines, but to add a first nasal vaccination to protect very early in life.
238 studies on the registry are indexed under Whooping Cough; 15 are open to participants now.
This study's enrollment of 48 is below the median of 375 across 180 interventional studies indexed under Whooping Cough.
Browse Whooping Cough studies →Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 375 studies on the registry; 82 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subject will be included in the study if he meets all the following criteria:
Exclusion Criteria:
If any of the following criteria are met, the subject must not be included in the study:
1,000 colony forming units (cfu) of BPZE1
Biological: BPZE1
100,000 colony forming units (cfu) of BPZE1
Biological: BPZE1
10,000,000 colony forming units (cfu) of BPZE1
Biological: BPZE1
Formulation buffer
Biological: Placebo
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 Dose 2 x 0.1 mL (0.1 mL per nostril).
Individuals will get placebo once intranasally. Dose 2 x 0.1 mL (0.1 mL per nostril).
General safety and local tolerability in the respiratory tract of a single ascending dose of the genetically modified B. pertussis strain
To determine * general safety, i. e. general well-being of the volunteers and any symptoms felt by the volunteers with onset within one month after vaccine administration. * vital signs: Blood pressure, heart rate, respiratory rate, oral temperature. * abnormalities in the following laboratory data: Haemoglobin, total and differential white blood cell count, platelets (thrombocytes). * specific side effects: Local symptoms from the respiratory tract: Sneezing, swollen nose, cough, bleeding from the nose, pain or other symptoms from the ear, symptoms from the eyes (redness, secretion).
Time frame: 6 months
Attachment of the BPZE1 strain to the nasopharyngeal mucosa
Detection of colonizing BPZE1 bacteria in nasopharyngeal culture
Time frame: Up to 50 days after vaccination
Immunogenicity
Immune responses will be determined by serum IgG and IgA, IgG and IgA in saliva and nasopharyngeal aspirate, cytokines and numbers of effector and memory T and B cells after stimulation with the various B. pertussis antigens.
Time frame: 6 months
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Institut National de la Santé Et de la Recherche Médicale, France