Challenges in conducting a community-based influenza vaccine trial in a rural community in northern India

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.

KEYWORDS:

• Challenges
• influenza
• low and middle income countries
• vaccine trial

Disclosure of potential conflicts of interest

No potential conflicts of interest were disclosed.

Disclaimer

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of All India Institute of Medical Sciences or Centers for Disease Control and Prevention.

Acknowledgments

We acknowledge the support of all the investigators and co-investigators of this trial, our research staff, study participants and their parents and guardians, and other members of the community who helped us in conducting this trial. Clinical Trial Registry No: CTRI/2015/06/005902.

Authors' contribution

RK, RA, VVN, SS, KEL, SKK, LD, SJ and AK were all involved in the planning of the study and development of the study protocols, tools and manuals. RK, RA, VVN, SKK were involved in field implementation of the trial activities. LD led the team performing the virological studies. RK, SS, KEL, SJ and AK drafted the manuscript and incorporated the comments of all the authors. All the authors have read and approved the manuscript. AK is Guarantor of the Paper.

Additional information

Funding

This work was supported by the Centers for Disease Control and Prevention, Atlanta, USA [U01 IP000492].