A sponsor approached ICON during an influenza pandemic in Mexico to conduct a randomised, placebo controlled vaccine study with an investigative pandemic H1N1 vaccine. The selected site had no previous vaccine study experience, and therefore lacked standard operating procedures (SOPs), GCP trained staff and a source for recruiting a large number of subjects. Due to the immediate demands of the public health emergency, the study required extremely accelerated timelines with an “all hands on deck” collaborative approach.

To deliver to the compressed timelines, ICON worked closely with our client, the site, the local Social Security office, a local manufacturer, the Mexican government and other stakeholders to get the study approved in a record setting 5.5 weeks. ICON and the site collaborated with local medical schools, hospitals and government officials to recruit healthy subjects at risk of contracting H1N1. To further expand the enrollment, ICON and the site organised to bus in first responders, EMTs, police officers, hospital staff and other pertinent personnel from other regions of Mexico to participate in the study.

To keep the study on track and ensure GCP, ICON rotated teams of 6-15 Spanish speaking staff, including CRAs and Clinical Trial Managers, who were constantly on-site throughout the study to oversee the daily activities of study execution to ensure GCP, protocol compliance and collection of quality data. In addition, a project manager from the US also stayed on-site for six weeks, providing constant engagement with the ICON team and clinical site to keep tasks on track.

Because of the constant engagement and creative approaches of all stakeholders the study approval and start up process was completed in 5.5 weeks and subject recruitment of 4,560 subjects was completed ahead of schedule. ICON’s close oversight and collaboration with the site also supported the GCP training of site staff, parallel development of site SOPs, and organisation of detailed site logistics for recruitment, protocol compliance, vaccine management, sample management and data entry. And finally, to support the study needs, ICON was able to set up an EDC database in 22 days (vs the standard of 6-8 weeks) which ensured the EDC was live at the time of first subject vaccinated.