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Open Access Highly Accessed Opinion

Implications of the licensure of a partially efficacious malaria vaccine on evaluating second-generation vaccines

Freya JI Fowkes123*, Julie A Simpson2 and James G Beeson145

Author Affiliations

1 Macfarlane Burnet Institute of Medical Research, 85 Commercial Road, Melbourne, Victoria 3004, Australia

2 Centre for Molecular, Environmental, Genetic and Analytic Epidemiology, University of Melbourne, 207 Bouverie Street, Melbourne, Victoria 3010, Australia

3 Department of Epidemiology and Preventive Medicine and Department of Infectious Diseases, Monash University, Commercial Road, Melbourne, Victoria 3004, Australia

4 Department of Microbiology, Monash University, Melbourne, Victoria, Australia

5 Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia

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BMC Medicine 2013, 11:232  doi:10.1186/1741-7015-11-232

Published: 30 October 2013

Abstract

Background

Malaria is a leading cause of morbidity and mortality, with approximately 225 million clinical episodes and >1.2 million deaths annually attributed to malaria. Development of a highly efficacious malaria vaccine will offer unparalleled possibilities for disease prevention and remains a key priority for long-term malaria control and elimination.

Discussion

The Malaria Vaccine Technology Roadmap’s goal is to 'develop and license a first-generation malaria vaccine that has protective efficacy of more than 50%’. To date, malaria vaccine candidates have only been shown to be partially efficacious (approximately 30% to 60%). However, licensure of a partially effective vaccine will create a number of challenges for the development and progression of new, potentially more efficacious, malaria vaccines in the future. In this opinion piece we discuss the methodological, logistical and ethical issues that may impact on the feasibility and implementation of superiority, non-inferiority and equivalence trials to assess second generation malaria vaccines in the advent of the licensure of a partially efficacious malaria vaccine.

Conclusions

Selecting which new malaria vaccines go forward, and defining appropriate methodology for assessment in logistically challenging clinical trials, is crucial. It is imperative that the scientific community considers all the issues and starts planning how second-generation malaria vaccines will advance in the advent of licensure of a partially effective vaccine.

Keywords:
Malaria; Vaccine; Clinical trials