Implications of the licensure of a partially efficacious malaria vaccine on evaluating second-generation vaccines.
BMC Med
; 11: 232, 2013 Oct 30.
Article
em En
| MEDLINE
| ID: mdl-24228861
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.
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
1_ASSA2030
/
2_ODS3
/
3_ND
/
4_TD
Base de dados:
MEDLINE
Assunto principal:
Ensaios Clínicos como Assunto
/
Vacinas Antimaláricas
/
Malária
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Aspecto:
Ethics
Limite:
Humans
País/Região como assunto:
Oceania
Idioma:
En
Revista:
BMC Med
Ano de publicação:
2013
Tipo de documento:
Article