Mack Anna G, Halperin Donna M, Selig Bailey M, Condran Brian R, Halperin Scott A
Canadian Center for Vaccinology, Dalhousie University, IWK Health, Nova Scotia Health, Halifax, Nova Scotia, Canada.
Rankin School of Nursing, St. Francis Xavier University, Antigonish, Nova Scotia, Canada.
PLoS One. 2025 Aug 6;20(8):e0328378. doi: 10.1371/journal.pone.0328378. eCollection 2025.
Controlled human infection model (CHIM) trials are useful tools for accelerating vaccine development through the deliberate infection of healthy volunteers in a controlled environment to study the course of disease in humans. CHIM trials may pose physical, psychological, and social harms to participants. Participants are subjected to long inpatient stays and daily sample collection, which may be uncomfortable. Very little is known about the CHIM trial participant experience and decision-making process.
We conducted a modified grounded theory study, embedded within the Canadian Center for Vaccinology (CCfV)'s Bordetella pertussis CHIM trial. Twenty six participants engaged in semi-structured interviews at four time periods throughout their year-long involvement in the CHIM trial, using a constant comparative approach of simultaneous data collection and analysis. This process continued until saturation was reached and an emerging theoretical model was constructed depicting the CHIM trial participant experience over time.
The emergent conceptual model centered around the core category "A Trusting Partnership", depicting the evolution of the participant-researcher relationship throughout the experience. Establishing trust was critical during the decision-making phase, facilitated through transparent researcher-participant communication and consideration of past experiences and values. Supporting the trusting partnership during the inpatient isolation phase was facilitated through ongoing researcher-participant engagement and emotional support. During outpatient participation, maintaining the trusting partnership was achieved through effective communication, consistent follow-up care, and recognition of participants' contributions. Quality improvement (QI) recommendations were identified across all phases of CHIM trial participation.
Researcher-participant trust is an integral component of the CHIM trial participant experience. QI recommendations should be taken into consideration when planning and coordinating future CHIM trials.
人体感染控制模型（CHIM）试验是通过在可控环境中故意感染健康志愿者来研究人类疾病进程，从而加速疫苗研发的有用工具。CHIM试验可能会对参与者造成身体、心理和社会伤害。参与者需要长时间住院并每日采集样本，这可能会带来不适。目前对于CHIM试验参与者的经历和决策过程知之甚少。
我们开展了一项改良的扎根理论研究，该研究嵌入加拿大疫苗学中心（CCfV）的百日咳博德特氏菌CHIM试验中。26名参与者在参与为期一年的CHIM试验的四个时间段内接受了半结构化访谈，采用数据收集与分析同步的持续比较法。这一过程持续进行，直至达到饱和状态，并构建了一个新出现的理论模型，描绘了CHIM试验参与者随时间推移的经历。
新出现的概念模型围绕核心类别“信任伙伴关系”展开，描述了参与者与研究人员之间关系在整个经历中的演变。在决策阶段，通过研究人员与参与者之间透明的沟通以及对过往经历和价值观的考量，建立信任至关重要。在住院隔离阶段，通过研究人员与参与者之间持续的互动和情感支持，促进了信任伙伴关系的维持。在门诊参与阶段，通过有效的沟通、持续一致的后续护理以及对参与者贡献的认可，维持了信任伙伴关系。在CHIM试验参与的所有阶段都确定了质量改进（QI）建议。
研究人员与参与者之间的信任是CHIM试验参与者经历的一个不可或缺的组成部分。在规划和协调未来的CHIM试验时，应考虑QI建议。
