Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05847322
Status:
RECRUITING
Last Update Posted:
2023-12-01
First Post:
2023-03-07
Brief Title:
Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks
Sponsor:
University of Southampton
Organization:
University of Southampton
Study Overview
Official Title:
A Human Controlled Infection Study to Establish Safety of Infection With Bordetella Pertussis With Antibiotic Therapy Delayed for up to 6 Weeks
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary objective- To assess the safety of nasal inoculation of healthy volunteers with B pertussis with antibiotic therapy given to eradicate colonisation at 6 weeks after inoculation or at symptom onset whichever occurs first
Secondary objectives - To measure the rate of natural clearance of carriage of B pertussis following nasal inoculation
To assess the kinetics of B pertussis colonisation density following nasal inoculation
To describe the microevolution of B pertussis and adaptation of the resident microbiome during B pertussis carriage
To measure B pertussis-specific antibody and cellular immunological responses in healthy volunteers during colonisation with B pertussis - To identify biomarkers that correlate with natural clearance of B pertussis carriage after induced B pertussis colonisation
To detect transmission of B pertussis to bedroom contacts of inoculated volunteers during prolonged asymptomatic colonisation
Secondary objectives - To measure the rate of natural clearance of carriage of B pertussis following nasal inoculation
To assess the kinetics of B pertussis colonisation density following nasal inoculation
To describe the microevolution of B pertussis and adaptation of the resident microbiome during B pertussis carriage
To measure B pertussis-specific antibody and cellular immunological responses in healthy volunteers during colonisation with B pertussis - To identify biomarkers that correlate with natural clearance of B pertussis carriage after induced B pertussis colonisation
To detect transmission of B pertussis to bedroom contacts of inoculated volunteers during prolonged asymptomatic colonisation
Detailed Description:
This is a prospective controlled human challenge study Challenge group The challenge volunteers will be healthy volunteers aged 18-55 years not having close contact with people having increased risk of severe pertussis complications or increased risk of transmitting to vulnerable individuals Eligible volunteers must be willing to abide by infection control measures during social contact and to attend immediately if they become symptomatic People who live in institutions in which multiple people share dormitory facilities such as boarding schools or military barracks will be excluded
The standard inoculum a dose of 105 cfu determined in Phase A of the Bp human challenge study will be used Participants will be followed up weekly and colonisation will be measured in nasal washes If culture of the nasal wash taken at week 5 following nasal inoculation is positive for B pertussis then eradication therapy will be given at week 6 Early eradication therapy will be given if a participant presents with symptoms of early B pertussis disease
Recruitment will continue until 10 challenge volunteers have been colonised and then completed study participation to week 6 as per protocol Volunteers who withdraw from the study early or have colonisation cleared with antibiotic treatment given for any reason will be replaced Assuming a colonisation fraction of at least 30 and allowing for study withdrawal the investigator expect a maximum number of 36 volunteers to be inoculated
Contact group A group of contact volunteers maximum 36 individuals will be enrolled to assess transmission by monitoring for colonisation with the challenge strain of B pertussis These contact volunteers will be bedroom sharers of challenge volunteers and will give informed consent for their participation in the study prior to inoculation of the corresponding challenge volunteer Eradication therapy will be given at week 6 if the culture of nasal wash is positive for B pertussis at week 5 Early eradication therapy will be given if a contact volunteer presents with symptoms of early B pertussis disease
Challenge and contact volunteers will be required to agree to infection control measures prior to enrolment in the study Part of this agreement will be to refrain from bedroom sharing or intimate contact with any individual other than one declared and consented bedroom contact They will avoid contact with children or people vulnerable to whooping cough such as unimmunised or partially immunised children and infants aged 1 year and pregnant women
The standard inoculum a dose of 105 cfu determined in Phase A of the Bp human challenge study will be used Participants will be followed up weekly and colonisation will be measured in nasal washes If culture of the nasal wash taken at week 5 following nasal inoculation is positive for B pertussis then eradication therapy will be given at week 6 Early eradication therapy will be given if a participant presents with symptoms of early B pertussis disease
Recruitment will continue until 10 challenge volunteers have been colonised and then completed study participation to week 6 as per protocol Volunteers who withdraw from the study early or have colonisation cleared with antibiotic treatment given for any reason will be replaced Assuming a colonisation fraction of at least 30 and allowing for study withdrawal the investigator expect a maximum number of 36 volunteers to be inoculated
Contact group A group of contact volunteers maximum 36 individuals will be enrolled to assess transmission by monitoring for colonisation with the challenge strain of B pertussis These contact volunteers will be bedroom sharers of challenge volunteers and will give informed consent for their participation in the study prior to inoculation of the corresponding challenge volunteer Eradication therapy will be given at week 6 if the culture of nasal wash is positive for B pertussis at week 5 Early eradication therapy will be given if a contact volunteer presents with symptoms of early B pertussis disease
Challenge and contact volunteers will be required to agree to infection control measures prior to enrolment in the study Part of this agreement will be to refrain from bedroom sharing or intimate contact with any individual other than one declared and consented bedroom contact They will avoid contact with children or people vulnerable to whooping cough such as unimmunised or partially immunised children and infants aged 1 year and pregnant women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 68737 | OTHER | ERGO | None |