The Typhoid Conjugate Vaccine Trial in Nepal (TyVAC-Nepal) was a typhoid vaccination trial that took place between 2017 and 2020. The trial was a part of the Typhoid Vaccine Acceleration Consortium (TyVAC), which aims to reduce the global burden of typhoid fever by accelerating the introduction of typhoid conjugate vaccine in low-resource settings.
Public and community engagement was integral to each aspect and stage of the trial: set-up and during and after the vaccination phase. It enabled us to provide information and give support to trial participants (children and their parents/guardians). It was also an essential channel of communication with everyone involved in the trial: women’s and mothers’ and youth groups, community leaders, public health officials, elected representatives (at a national, regional, and local level), as well as teachers and students from local schools.
Typhoid fever is a bacterial infection that can spread throughout the body, affecting many organs. Without swift treatment, it can cause serious complications and can be fatal. It is highly contagious. Worldwide there are nearly 12 million cases of typhoid annually, resulting in more than 128,000 deaths. It is estimated that 75% of these cases are in South Asia. Children under 15 are disproportionately impacted by typhoid. Drug-resistant typhoid is also an increasing threat. It is therefore a major health threat in Nepal.
A total of 20,019 children from nine months to 16 years of age from Lalitpur, Kathmandu were enrolled in the TyVAC-Nepal trial. Participants either received the typhoid conjugate vaccine or a control vaccine (Group A meningococcal vaccine). At the end of the trial, all participants were offered the alternate vaccine.
There was a dedicated trial engagement team as part of the trial. Public, community, and stakeholder engagement took place prior to, during vaccination and after vaccination. Before the study had gained approval and could start, we worked with public health officials, and elected representatives (at a national, regional, and local level) to obtain permission to approach community stakeholders. Prior to and during vaccination, the aim of engagement was to inform participants and other stakeholders about the study and to discuss the importance of vaccination. After they had been vaccinated all participants were actively followed over 2 years for safety and vaccine efficacy. This was done through follow-up contact and visits to special trial clinics. Engagement activity involved informing participants about the study clinics, addressing and alleviating their concerns, and sharing study updates.
Several challenges were encountered during vaccination and the follow-up. These arose from misinformation, misconception, and fear in the community around clinical trials. Direct and continuous interaction with community stakeholders, including parents/guardians of the targeted population, enabled the trial team to build trust around the trial and contributed to the community’s willingness to be involved.
220 public engagement activities were conducted in community and school settings as part of the trial.
During the vaccination phase engagement involved:
