“At first, I was very afraid”—a qualitative description of participants’ views and experiences in the first Human Infection Study in Malawi

Abstract

Background: Human infection studies (HIS) involve deliberately infecting healthy volunteers with a pathogen in a controlled environment to understand infection and support the development of effective vaccines or treatments. HIS research is expanding to many low and middle-income settings to accelerate vaccine development. Given the implementation of the first HIS research to establish the experimental human pneumococcal carriage model’s feasibility, we sought to understand the participant’s opinions and experiences. Methods: We used a qualitative, descriptive approach to understand participants perceptions and experiences on HIS participation. Sixteen healthy adult participants were invited to participate in in-depth exit interviews to discuss their experiences, motivations and concerns. Results: Our findings showed that the likelihood of participation in HIS research rests on three essential conditions: motivation to participate, compensation and advocacy. The motivation and decision to participate was based on reasons including altruism, patriotism, monetary and material incentives, and while compensation was deemed appropriate, concerns about unanticipated research-related risks were raised. Participant advocate groups were recommended for increasing awareness and educating others in the broader community about HIS research. Conclusions: Participants’ experiences of HIS in Malawi provide the basis of what can be acceptable in HIS research in lower-income countries and areas where study procedures could be adjusted.

The influence of pneumococcal conjugate vaccine-13 on nasal colonisation in a controlled human infection model of pneumococcal carriage in Malawi: a double-blinded randomised controlled trial protocol

“…• Dose escalation: We will adopt a stepwise approach to escalating the inoculation dose: 20,000 (n=40) → 80,000 (n=140) → 160,000 (n=20). We previously demonstrated successful carriage and safety at the 20,000 and 80,000 doses in our feasibility study 7 – 9 and the 160,000 has been safely used in the Liverpool with no adverse events 12 .…”

“…This study is based on the foundation of our ethically approved feasibility study 7 – 9 and will utilise standard operating procedures successfully validated in Malawi. The study follows a logical sequence and the detailed schedule of visits (12 scheduled visits - Visit A to Visit L) and procedures carried out at each visit are described in Table 1 .…”

“…Based on successful transfer of procedures, we are confident that our clinical and laboratory procedures are sufficiently robust to test vaccine efficacy. Our robust social science led exploration of acceptability has demonstrated that participants feel safe, cared for and were proud to be involved with this research programme 9 .…”

“…This included extensive stakeholder consultation 14 and detailed exploration of community knowledge and views regarding the CHIM of pneumococcal carriage in Malawi 15 . Following on from this, we interviewed participants during our feasibility study to assess acceptability and determine ways to optimise their experience 9 .…”