Research Timeline

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Setup

*Objectives may be revised based on findings from Stage 1 and Stage 2.
CHIM = controlled human infection model; IIV = inactivated influenza vaccine; LAIV = live attenuated influenza vaccine; RWE = real world evidence.

Initially, the MOVE Consortium will investigate possible mediators of protection for LAIV

  1. 1. Overall objective

    Determine role of NA as a mediator of protection for LAIV in the ferret model

  2. 2. Outcomes

    • Identify candidate correlate of protection for LAIV in future clinical trials
    • Data will rule NA in/out as a non-HA mechanism of protection for LAIV
    • PoC data measuring HA/NA antibody activity in ferret mucosal samples

  3. 3. Value

    NA mechanism of protection may be less susceptible to seasonal antigenic drift, allowing development of vaccines with more stable effectiveness

Key pre-clinical studies to achieve overall objective

Objectives

Study 1:
Evaluate the contribution of NA to protection against a H3N2 challenge in the ferret model

Study 2:
Assess the contribution of seasonal vaccination to protection against an HPAI challenge in the ferret model

Outcome measures

Both studies will assess a broad range of endpoints, including:

  • Systemic humoral and cellular responses to NA
  • Mucosal responses to vaccination (using novel sampling techniques)
  • Protection from heterologous challenge

HA = hemagglutinin; HPAI = highly pathogenic avian influenza; LAIV = live attenuated influenza vaccine; MOVE = Mucosal Vaccine Evaluation; NA = neuraminidase; PoC = proof of concept.

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Initially, the MOVE Consortium will investigate possible mediators of protection for LAIV

  1. 1. Overall objective

    Determine the functions of mucosal antibodies induced by LAIV

  2. 2. Outcomes

    • Tools for studying viral neutralisation by mucosal antibodies
    • Data on the breadth of antigen binding by mucosal antibodies, relative to systemic antibodies
    • Mucosal and systemic LAIV immunogenicity data in children and adults

  3. 3. Value

    Immune response features induced by LAIV can be advanced as candidate correlates of protection in clinical trials

Key clinical studies to achieve overall objective

Objectives

Study 1:
Develop new tools for studying humoral immunity in the human nose

Study 2:
Assess the types and properties of immune responses induced by LAIV in adults and children

Outcome measures

These studies will result in a new toolkit for studying LAIV, and identify new candidate mucosal correlates of protections:

  • Assays for mucosal humoral immunity to influenza
  • Mucosal responses to vaccination
  • Candidate correlates of protection for future testing

LAIV = live attenuated influenza vaccine

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