Does Repeat Influenza Vaccination Constrain Influenza Immune Responses and Protection

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Biological
Study Type: Observational
SUMMARY

The objectives of this study are to understand the long-term consequences of repeated annual influenza vaccination among healthcare workers (HCWs) and to use statistical and mathematical modelling to elucidate the immunological processes that underlie vaccination responses and their implications for vaccination effectiveness. These objectives will be achieved by pursuing three specific aims: To study the immunogenicity and effectiveness of influenza vaccination by prior vaccination experience To characterize immunological profiles associated with vaccination and infection To evaluate the impact of immunity on vaccination effectiveness. Under Aim 1, a cohort of hospital workers will be recruited and followed for up to 4 years to assess their pre- and post-vaccination and post-season antibody responses, and their risk of influenza infection. These outcomes will be compared by vaccination experience, classified as frequently vaccinated (received ≥3 vaccines in the past 5 years), infrequently vaccinated (<3 vaccinations in past 5 years), vaccinated once, vaccine naïve and unvaccinated. In Aim 2, intensive cellular and serological assessments will be conducted to dissect the influenza HA-reactive B cell and antibody response, and build antibody landscapes that typify the different vaccination groups. In Aim 3, the data generated in Aims 1 and 2 will be used to develop a mathematical model that considers prior infection, vaccination history, antibody kinetics, and antigenic distance to understand the effects of repeated vaccination on vaccine effectiveness. Completion of the proposed research will provide evidence to inform decisions about continued support for influenza vaccination programs among HCWs and general policies for annual influenza vaccination, as well as much needed clarity about the effects of repeated vaccination. In March-April 2020 pursuant to the SARS-CoV-2 global pandemic an administrative supplement added a SARS-CoV-2 protocol addendum for follow-up of COVID-19 infections amongst our HCW participant cohort. The following objectives were added: To estimate risk factors and correlates of protection for SARS-CoV-2 infection amongst HCW To characterize viral kinetics and within-host viral dynamics of SARS-CoV-2 infecting HCW To characterize immunological profiles following infection by SARS-CoV-2 To characterize immunological profiles following vaccination for SARS-CoV-2.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Eligible participants will be recruited from 1 of 6 participating hospitals and will meet the following criteria:

• Personnel (including staff, honorary staff, students and volunteers) located at a participating hospital or healthcare service at the time of recruitment who would be eligible for the hospital's free vaccination programme

• Be aged ≥18 years old and ≤60 years old;

• Have a mobile phone that can receive and send SMS messages;

• Willing and able to provide blood samples;

• Available for follow-up over the next 7 months;

• Able and willing to complete the informed consent process.

• There are no restrictions on the type of healthcare worker (HCW) that can be recruited into the study in terms of their job role. HCWs can be any hospital staff, including clinical, research, administrative and support staff.

Locations
Other Locations
Australia
Women's and Children's Hospital
Recruiting
Adelaide
Queensland Children's Hospital
Recruiting
Brisbane
The Alfred
Recruiting
Melbourne
Perth Children's Hospital
Recruiting
Nedlands
John Hunter Hospital
Recruiting
New Lambton Heights
The Children's Hospital at Westmead
Recruiting
Westmead
Contact Information
Primary
Sheena Sullivan, MPH, PhD
sheena.sullivan@influenzacentre.org
+61 3 9342 9317
Backup
Annette Fox, PhD
annette.fox@unimelb.edu.au
+61 3 9342 9300
Time Frame
Start Date: April 2, 2020
Estimated Completion Date: November 1, 2023
Participants
Target number of participants: 1500
Treatments
Healthcare Workers
Eligible participants will be recruited from 1 of 6 participating hospitals in Australia and will meet the following criteria: personnel (including staff, honorary staff, students and volunteers) located at a participating hospital or healthcare service at the time of recruitment who would be eligible for the hospital's free vaccination programme; be aged ≥18 years old and ≤60 years old; have a mobile phone that can receive and send SMS messages; willing and able to provide blood samples; available for follow-up over the next 7 months; able and willing to complete the informed consent process.~There are no restrictions on the type of healthcare worker (HCW) that can be recruited into the study in terms of their job role. HCW will be any hospital staff, including clinical, research, administrative and support staff.
Sponsors
Collaborators: University of Newcastle, Australia, University of Adelaide, Sydney Children's Hospitals Network, The University of Queensland, London School of Hygiene and Tropical Medicine, The University of Western Australia, The Alfred
Leads: University of Melbourne

This content was sourced from clinicaltrials.gov

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