Challenges in conducting a community-based influenza vaccine trial in a rural community in northern India
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 wil...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2018-08-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2018.1460182 |
| _version_ | 1797677484945178624 |
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| author | Rakesh Kumar Ritvik Amarchand Venkatesh Vinayak Narayan Siddhartha Saha Kathryn E. Lafond Suresh K. Kapoor Lalit Dar Seema Jain Anand Krishnan |
| author_facet | Rakesh Kumar Ritvik Amarchand Venkatesh Vinayak Narayan Siddhartha Saha Kathryn E. Lafond Suresh K. Kapoor Lalit Dar Seema Jain Anand Krishnan |
| author_sort | Rakesh Kumar |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T22:45:49Z |
| format | Article |
| id | doaj.art-895c0786b73a4ca88463b86ae837e464 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:45:49Z |
| publishDate | 2018-08-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-895c0786b73a4ca88463b86ae837e4642023-09-22T08:38:21ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2018-08-011481909191310.1080/21645515.2018.14601821460182Challenges in conducting a community-based influenza vaccine trial in a rural community in northern IndiaRakesh Kumar0Ritvik Amarchand1Venkatesh Vinayak Narayan2Siddhartha Saha3Kathryn E. Lafond4Suresh K. Kapoor5Lalit Dar6Seema Jain7Anand Krishnan8All India Institute of Medical Sciences, Ansari NagarAll India Institute of Medical Sciences, Ansari NagarAll India Institute of Medical Sciences, Ansari NagarCenters for Disease Control and PreventionCenters for Disease Control and PreventionCentre for Chronic Disease ControlAll India Institute of Medical Sciences, Ansari NagarCenters for Disease Control and PreventionAll India Institute of Medical Sciences, Ansari NagarEvidence 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.http://dx.doi.org/10.1080/21645515.2018.1460182challengesinfluenzalow and middle income countriesvaccine trial |
| spellingShingle | Rakesh Kumar Ritvik Amarchand Venkatesh Vinayak Narayan Siddhartha Saha Kathryn E. Lafond Suresh K. Kapoor Lalit Dar Seema Jain Anand Krishnan Challenges in conducting a community-based influenza vaccine trial in a rural community in northern India Human Vaccines & Immunotherapeutics challenges influenza low and middle income countries vaccine trial |
| title | Challenges in conducting a community-based influenza vaccine trial in a rural community in northern India |
| title_full | Challenges in conducting a community-based influenza vaccine trial in a rural community in northern India |
| title_fullStr | Challenges in conducting a community-based influenza vaccine trial in a rural community in northern India |
| title_full_unstemmed | Challenges in conducting a community-based influenza vaccine trial in a rural community in northern India |
| title_short | Challenges in conducting a community-based influenza vaccine trial in a rural community in northern India |
| title_sort | challenges in conducting a community based influenza vaccine trial in a rural community in northern india |
| topic | challenges influenza low and middle income countries vaccine trial |
| url | http://dx.doi.org/10.1080/21645515.2018.1460182 |
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