Public engagement during a typhoid conjugate vaccine trial in Lalitpur, Nepal- experience, challenges and lessons
Ashata Dahal1, Mila Shakya1, Dikshya Pant2
1Patan Academy of Health Sciences, Oxford University Clinical Research Unit-Nepal, Lalitpur, Nepal.
Insights
Public engagement strategies were crucial for the successful implementation of a Typhoid Conjugate Vaccine (TCV) trial in Nepal. Community interaction built trust, addressed concerns, and ensured participation in this vital public health initiative.
Area of Science:
- Public Health
- Vaccinology
- Clinical Trials
Background:
- Typhoid fever poses a significant public health challenge in Nepal.
- Generating evidence on the efficacy and safety of vaccines is critical for disease control.
Purpose of the Study:
- To evaluate the impact of a new Typhoid Conjugate Vaccine (TCV) through a Phase 3 clinical trial.
- To assess the safety and efficacy of TCV in a pediatric population in Nepal.
Main Methods:
- A double-blind, randomized controlled trial involving 20,000 children aged 9 months to 16 years.
- Active follow-up for safety and efficacy over two years using passive surveillance.
- Community engagement activities across multiple tiers, from policymakers to parents.
Main Results:
- Challenges in trial implementation were overcome through targeted public engagement.
- Community interaction fostered trust, addressed misinformation, and encouraged participation.
- Direct engagement facilitated study adaptation based on community feedback.
Conclusions:
- Public engagement is essential for the successful execution of vaccine trials in communities facing health challenges.
- Building trust and addressing concerns through continuous interaction are key to community willingness and participation.
- Effective public engagement strategies can mitigate challenges and support public health initiatives like TCV vaccination.
Abstract:
Typhoid is a public health problem in Nepal. To generate evidence on the impact of Typhoid Conjugate Vaccine (TCV), a phase 3, double-blind, randomized controlled trial was conducted in Lalitpur, Nepal. 20,000 children aged between 9 months and ≤16 years were vaccinated with a new TCV, or control vaccine. Participants were actively followed for safety and efficacy over 2 years through passive surveillance (PS) clinics. Several challenges were encountered during vaccination and PS stemming from misinformation, misconception, and fear around clinical trials in the community. Public engagement (PE) activities were conducted across various tiers moving from decision makers in the first tier; to elected local representatives in the second tier; ending with interaction in community with parents/guardians of the targeted population. Prior and during vaccination, engagement was conducted to inform about the study and discuss the importance of vaccination. Post-vaccination, engagement was conducted to inform about PS clinics, alleviate study concerns and share study updates. Direct and continuous interaction with community stakeholders, including parents/guardians of the targeted population contributed to build trust around the study and community willingness to be involved. It helped to raise awareness, drive away misconceptions, and allowed adaptation according to feedback from community members.
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