Influenza Clinical Trial
Official title:
Evaluation of Heterosubtypic Immune Responses in Older People Before and After Seasonal and Pandemic Influenza Vaccination
Vaccination is the principal means of combating epidemic and pandemic influenza. As vaccines
induce relatively strain-specific and short-lived antibody responses, annual immunisation
with regularly updated vaccine is recommended for seasonal influenza, but would not be
expected to protect against a pandemic event. In clinical trials among young adults, at
least two doses of avian influenza H5 or H9 subunit vaccine are needed to induce moderate
antibody responses. However, studies including older subjects have unexpectedly found that
some people aged over 65 yrs have pre-vaccination neutralising antibody to influenza H5 and
H9 respectively. These subjects mount a robust antibody response to single dose H5 or H9
pandemic vaccine, suggesting that they are effectively primed to at least some strains of
avian influenza.
This exploratory proposal focuses on those elderly subjects whose immune systems already
exhibit antibodies to H5 with a goal of investigating the humoral and cellular basis of the
immune response to seasonal and pandemic vaccination. We will examine neutralising antibody
responses to a range of human and non-human influenza viruses before and after seasonal and
pandemic vaccination and evaluate cellular B and T cell immune responses before and after
pandemic H5 vaccination
STUDY OBJECTIVES:
Immunological objectives
- To evaluate heterosubtypic neutralising antibody to influenza viruses in older people
- To evaluate heterosubtypic neutralising antibody responses to human and non-human
influenza viruses following seasonal influenza vaccine
- To evaluate homologous and heterosubtypic neutralising antibody responses to human and
non-human influenza viruses after MF59-adjuvanted H5N1 vaccine;
- To evaluate cellular B and T cell responses to influenza H5 in non-exposed subjects who
exhibit anti-H5 neutralising antibodies before and after seasonal (TIV) or pandemic H5
vaccination
- To identify epitopes on the influenza haemagglutinin to which anti-H5 neutralising
antibodies in sera from non-exposed subjects are directed Safety Objectives
- To evaluate safety of one or two IM doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1)
influenza vaccine, containing 7.5 μg of H5 antigen in adult subjects
- To evaluate safety of one IM dose of seasonal influenza vaccine, containing 15 μg of
H1, H3 and B antigen in adult subjects
Hypotheses:
- Heterosubtypic cross reacting antibodies to influenza exist in some elderly subjects
and can be boosted by a single dose of (a) seasonal TIV or (b) pandemic influenza
vaccination
- Heterosubtypic cross reacting antibodies to influenza do not exist in younger subjects
and cannot be induced by (a) seasonal TIV or (b) pandemic influenza vaccination
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
| Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
| Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
| Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
| Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
| Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
| Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
| Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
| Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
| Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
| Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
| Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
| Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
| Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
| Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
| Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
| Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
| Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
| Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
| Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |