Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT06054269
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-29
First Post:
2023-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Trial to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among HCP
Sponsor:
Centers for Disease Control and Prevention
Organization:
Study Overview
Official Title:
Randomized Controlled Trial, Double Blind, Phase III, to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among Health Care Personnel (EDUCATE)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
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:
EDUCATE
Brief Summary:
This randomized, double-blinded trial will assess humoral immune responses to adjuvanted, egg-based quadrivalent influenza vaccines compared to standard dose, egg-based quadrivalent influenza vaccines among healthcare personnel (HCP). The trial will be conducted at two sites in Lima, Peru during 2022 and 2023.
Detailed Description:
The trial will be conducted at two hospital sites in Lima, Peru during 2022-2023 among HCP who were previously enrolled in the Cohort study of Influenza and other Respiratory Viruses among HCP in Peru (cohort size: approximately 1500 participants). The minimum number of participants to be enrolled is 248 in total (142 subjects per vaccine group), and the aim is to enroll approximately 800 participants (400 subjects per vaccine group). The study design is a randomized, double-blind vaccine trial. Eligible HCP at each site who consent to participate will be randomized 1:1 to receive either a single dose of adjuvanted egg-based quadrivalent influenza vaccine (AD, FLUAD Quadrivalent by Seqirus, 15 µg of hemagglutinin \[HA\] from each strain) or standard dose, egg-based quadrivalent influenza vaccine (SD, FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain).
Participants will be invited to come to the study site to be screened for eligibility to participate in the clinical trial. After they consent to participate and sign informed consent form, participants will visit the site for medical assessment and vaccination. Additional brief medical adverse event assessments will be performed on days 3 and 7. Participants will be followed up to twice per week via SMS or phone calls to assess if they become sick with a respiratory event. In the event they become sick, they will be asked questions about their illness through an acute illness survey and a mid-turbinate nasal swab specimen will be collected and tested for influenza virus. Additional surveys will be administered on day 28 post-vaccination as well as at the end of the influenza season.
Participants will have blood collected just prior to vaccination (Day 0) and at approximately 28 days and 6 months post-vaccination (or at the end of influenza virus circulation as determined by active surveillance data) to evaluate humoral immune responses to vaccination. After these specimens are tested, differences in seroconversion and seroprotection between AD and SD vaccination groups will be assessed. In addition, we multivariable modelling will be used to assess risk factors for poor immunogenicity and to assess possible effects of repeated vaccination.
As an optional sub-study, indicators of cell-mediated immune (CMI) responses to influenza vaccination will be examined. This part of the study, which is optional to participants, will require collection of additional blood samples at prior to vaccination (Day 0) and at 7 and 28 days post-vaccination.
Participants will be invited to come to the study site to be screened for eligibility to participate in the clinical trial. After they consent to participate and sign informed consent form, participants will visit the site for medical assessment and vaccination. Additional brief medical adverse event assessments will be performed on days 3 and 7. Participants will be followed up to twice per week via SMS or phone calls to assess if they become sick with a respiratory event. In the event they become sick, they will be asked questions about their illness through an acute illness survey and a mid-turbinate nasal swab specimen will be collected and tested for influenza virus. Additional surveys will be administered on day 28 post-vaccination as well as at the end of the influenza season.
Participants will have blood collected just prior to vaccination (Day 0) and at approximately 28 days and 6 months post-vaccination (or at the end of influenza virus circulation as determined by active surveillance data) to evaluate humoral immune responses to vaccination. After these specimens are tested, differences in seroconversion and seroprotection between AD and SD vaccination groups will be assessed. In addition, we multivariable modelling will be used to assess risk factors for poor immunogenicity and to assess possible effects of repeated vaccination.
As an optional sub-study, indicators of cell-mediated immune (CMI) responses to influenza vaccination will be examined. This part of the study, which is optional to participants, will require collection of additional blood samples at prior to vaccination (Day 0) and at 7 and 28 days post-vaccination.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: