Challenges in conducting a community-based influenza vaccine trial in a rural community in northern India.
Hum Vaccin Immunother
; 14(8): 1909-1913, 2018.
Article
em En
| MEDLINE
| ID: mdl-29617177
ABSTRACT
Evidence on influenza vaccine effectiveness from low and middle countries (LMICs) is limited due to limited institutional capacities; lack of adequate resources; and lack of interest by ministries of health for influenza vaccine introduction. There are concerns that the highest ethical standards will be compromised during trials in LMICs leading to mistrust of clinical trials. These factors pose regulatory and operational challenges to researchers in these countries. We conducted a community-based vaccine trial to assess the efficacy of live attenuated influenza vaccine and inactivated influenza vaccine in rural north India. Key regulatory challenges included obtaining regulatory approvals, reporting of adverse events, and compensating subjects for trial-related injuries; all of which were required to be completed in a timely fashion. Key operational challenges included obtaining audio-visual consent; maintaining a low attrition rate; and administering vaccines during a narrow time period before the influenza season, and under extreme heat. We overcame these challenges through advanced planning, and sustaining community engagement. We adapted the trial procedures to cope with field conditions by conducting mock vaccine camps; and planned for early morning vaccination to mitigate threats to the cold chain. These lessons may help investigators to confront similar challenges in other LMICs.
Palavras-chave
Texto completo:
1
Temas:
ECOS
/
Estado_mercado_regulacao
Bases de dados:
MEDLINE
Assunto principal:
Vacinas contra Influenza
/
Vacinação em Massa
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Serviços de Saúde Rural
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Influenza Humana
Tipo de estudo:
Clinical_trials
/
Guideline
/
Prognostic_studies
Aspecto:
Ethics
Limite:
Humans
País/Região como assunto:
Asia
Idioma:
En
Revista:
Hum Vaccin Immunother
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Índia