EMEA publishes new guidelines, “Guideline on Quality, Non-Clinical and Clinical Aspects of Live Recombinant Viral Vectored Vaccines” . Vaccines against infectious diseases based on a viral vector expressing the antigen infectious agent have been under development for some time.This guideline ap pplies to such live recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.

The objective of this guideline is to provide recommendations on the quality, nonclinical and clinical studies should be performed in order to obtain marketing authorisation of a live recombinant viral vector vaccine intended to use in the prophylaxis of infectious disease in humans. This guideline is intended products entering the marketing authorisation procedure. However, the principles laid down in this guideline should be considered by applicants entering into clinical trials.

In this guideline, the emphasis is placed upon safety issues, such as:

• The phenotype of recombinant virus
• The extent of pre-immunity to the vector, the extent of community induced to the vector and the potential for reuse of the vector,
• Genetic stability of the recombinant virus, reversion to the virulence or the combination with wild type strains
• Clinical follow up in healthy patient populations
• Chromosomal germline integration.

These aspects will drive the selection a number of different relevant toxicological pharmacological models. Emphasis is also placed on first in man studies as the vaccines within the scope of this guideline and novel laboratory derived viruses obtained by recombinant DNA technology and clinical assessment will represent their first contact with humans.

The guideline goes on to give detailed descriptions of what is expected in the following areas:

• Quality aspects
  • General considerations
  • Genetic development
  • Vaccine seed lots
    • General
    • Characterisation of vaccine seed lots
    • Adventitious agent safety
  • Vaccine manufacture
    • Vaccine production
    • Harvesting
    • Virus pools
    • Final bulk vaccine (drug substance)
  • Control of final vaccine (drug product)
    • Identity
    • Potency assays
    • Stability
    • Consistency of production
• Nonclinical immunological and safety requirements
  • General considerations
  • Pharmacodynamic studies (protection and immunogenicity)
  • Nonclinical safety studies (toxicity testing)
    • Single and repeated dose toxicity
    • Distribution studies
    • Reproduction and development toxicity studies
    • Local tolerance
• Clinical
  • Immunogenicity
  • Safety

These are a detailed set of guidelines that cover most of the process of development and are required reading for anybody working in the area.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug  development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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