Challenges in conducting a community-based influenza vaccine trial in a rural community in northern India

Figures & data

Figure 1. Gantt chart depicting the timeline of approvals for a vaccine trial in Ballabgarh, India.

Table 1. Summary of lessons learned during a vaccine trial in Ballabgarh, India.

Domain	Lesson learned	Suggestions for improvement
Regulatory approvals	• Multiple sequential clearances are required before trial initiation, which is a time-consuming process that can delay start of the trial.	• Simultaneously plan and prepare other trials logistics to maintain the trial timeline.
	• Placebo-controlled trials are discouraged by some regulatory authorities.	• Prepare for continuous dialogue with regulatory authorities in getting timely clearance.
Serious adverse event (SAE) reporting	• Reporting of SAEs within a stipulated timeframe, particularly those that occur after safety surveillance window i.e., 42 days, requires intensive surveillance, which is often not possible in community setting.	• Establish close contact with study participants including availability of study physicians over phone to help in timely identification and thus reporting of SAEs.
Causality assessment and compensation for trial related injuries	• Delayed assessment of “relatedness” of injury puts undue financial burden on investigators/sponsors of the trial, which are required to bear cost of treatment including hospitalization until health issue is deemed to be “unrelated” to the intervention.	• Provide continuous medical care to study subjects in the community to prevent some of the hospitalizations, thereby reducing the financial liability of investigators/sponsors.
		• Develop mechanisms to expedite the assessment of “relatedness” of adverse events during the trial.
Informed consent	• Additional manpower and logistics are required for audio-visual recording and storage of consent information.	• Factor in these logistics while planning clinical trials in terms of procurement of equipment, training, and sensitization of trial participants.
Recruitment	• Pockets of resistance due to apprehension regarding vaccination may lead to attrition in enrollment.	• Maintain and sustain community engagement to help reduce attrition in subject enrollment.
Supplies and cold chain	• Short timeframe for procurement and delivery of vaccines and supplies between approvals and initiation of the trial poses an additional challenge for timely start of vaccination activities.	• Follow up regularly with manufacturers/suppliers to ensure timely supply of vaccine and supplies including placebo.
	• Extremely hot conditions in summer months and erratic power supply present challenges in maintaining cold chain.	• Dedicate detailed attention to maintaining the cold chain in the field including the following: ensuring round the clock power supply, advance planning (procuring extra ice gel packs/temp loggers/backup power sources), shifting the time of vaccination to morning hours, vaccine temperature monitoring in the field camp, and documentation of cold chain performance.