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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
48
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).
Karolinska University Hospital
Solna, Sweden
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
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