Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546423
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Study of the Infectivity Safety and Immunogenicity of Two Recombinant Live-Attenuated BHPIV3 Vectored Vaccines Expressing the Fusion Glycoprotein of HMPV Delivered by Nasal Spray to HPIV3-Seropositive Children 24 to 60 Months of Age
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase I Study of the Infectivity Safety and Immunogenicity of Two Recombinant Live-Attenuated BovineHuman Parainfluenza Virus Type 3 BHPIV3 Vectored Vaccines Expressing the Fusion Glycoprotein of Human Metapneumovirus HMPV Delivered by Nasal Spray to HPIV3-Seropositive Children 24 to 60 Months of Age
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HPIV3 and HMPV are viruses that can cause breathing problems in children The goal of this clinical trial is to look at the safety of 2 experimental HPIV3HMPV vaccines in HPIV3-seropositive children 24 months to 60 months of age Children will receive BHPIV3HMPV-PreF-A vaccine BHPIV3HMPV-F-B365 vaccine or placebo and participants will not know which study product they have received
The main goals of the study are to find out whether these vaccines are well-tolerated and infectious in HPIV3-seropositive children
The general procedures include daily temperature measurements and daily contact with the participant for the first 28 days giving a single dose of one of the 2 study vaccines or placebo delivered by nasal sprayer about 9 in-person visits a physical examination 7 clinical assessments 2 blood samples 9 nasal swabs and monthly contacts with the participant between Days 29-180
Additional visits may occur if the child has a respiratory illness fever or ear infections The illness visit will include a nasal swab and a clinical assessment
The main goals of the study are to find out whether these vaccines are well-tolerated and infectious in HPIV3-seropositive children
The general procedures include daily temperature measurements and daily contact with the participant for the first 28 days giving a single dose of one of the 2 study vaccines or placebo delivered by nasal sprayer about 9 in-person visits a physical examination 7 clinical assessments 2 blood samples 9 nasal swabs and monthly contacts with the participant between Days 29-180
Additional visits may occur if the child has a respiratory illness fever or ear infections The illness visit will include a nasal swab and a clinical assessment
Detailed Description:
This is a blinded randomized placebo-controlled study design will be used to evaluate the safety and immunogenicity of the study product in HPIV3-seropositive participants The study will be performed in approximately 25 HPIV3-seropositive children 24 months to 60 months of age Subjects will be block randomized to receive a single dose of 1056 PFU of BHPIV3HMPV-PreF-A 1056 PFU of BHPIV3HMPV-F-B365 or placebo in a 221 ratio Enrollment will be continuous unless stopping rules are met or other safety concerns occur During the enrollment period the Data and Safety Monitoring Board DSMB will perform unblinded safety reviews After completion of the Day 28 visit of the last participant an unblinded review of all participants will be performed by the DSMB
The first 28 days after inoculation are considered the Acute Phase of the study and the participants parentsguardians will be contacted daily during the Acute Phase These contacts will consist either of an in-person evaluation of interim medical history clinical assessment and nasal swab or an interim medical history conducted by a mutually agreed upon communication method If a child develops a respiratory or febrile illness or otitis media during the acute phase an in-person evaluation will be performed During the Acute Phase the participants will be evaluated for adverse events AEs or serious adverse events SAEs Between Days 29 and 180 parentsguardians will be asked to contact study staff to report Medically Attended Adverse Events MAAEs which will be reported per protocol Between days 29-180 study staff will contact the participants parentsguardians monthly and on Day 180 7 days after inoculation to capture any previously unreported MAAEs
Clinical assessments will be completed and nasal swabs will be obtained on study Days 0 3 4 5 6 7 10 14 and 28 and whenever febrile or respiratory illnesses or otitis media solicited AEs are reported during the first 28 days following inoculation The nasal swab will be tested for vaccine virus for respiratory pathogens that are considered adventitious agents including wild-type HPIV3 and HMPV and for mucosal IgG and IgA antibody as listed in the schedule of events
The first 28 days after inoculation are considered the Acute Phase of the study and the participants parentsguardians will be contacted daily during the Acute Phase These contacts will consist either of an in-person evaluation of interim medical history clinical assessment and nasal swab or an interim medical history conducted by a mutually agreed upon communication method If a child develops a respiratory or febrile illness or otitis media during the acute phase an in-person evaluation will be performed During the Acute Phase the participants will be evaluated for adverse events AEs or serious adverse events SAEs Between Days 29 and 180 parentsguardians will be asked to contact study staff to report Medically Attended Adverse Events MAAEs which will be reported per protocol Between days 29-180 study staff will contact the participants parentsguardians monthly and on Day 180 7 days after inoculation to capture any previously unreported MAAEs
Clinical assessments will be completed and nasal swabs will be obtained on study Days 0 3 4 5 6 7 10 14 and 28 and whenever febrile or respiratory illnesses or otitis media solicited AEs are reported during the first 28 days following inoculation The nasal swab will be tested for vaccine virus for respiratory pathogens that are considered adventitious agents including wild-type HPIV3 and HMPV and for mucosal IgG and IgA antibody as listed in the schedule of events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None