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
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