An efficient clinical trial of the polio vaccine was critical for the emergency approval of the sponsor vaccine against the second wild strain. Then, solve the delicate health situation in Africa due to the high number of children infected with a variant that was thought to have been eliminated, but that increased again after the low vaccination coverage in the continent.
With the PFS software and TrialPal App, Integra IT enabled the results compilation of a Phase II oral polio vaccine trial (OPV). The study took place in two Caribbean and one European Union country to evaluate the safety and immunogenicity of two new candidate oral polio vaccines in children aged 1 to 5 years who were healthy or vaccinated with bOPV-IPV.
Why was it necessary to conduct this trial?
In 2016, the trivalent polio vaccine was withdrawn from the market and replaced with a bivalent vaccine, which eliminated the vaccination intended to combat the second wild strain, which by that time was considered to be already eradicated. (WHO: History of the Polio Vaccine).
The situation changed in 2018 when, due to low vaccination coverage in African countries, a health emergency arose due to the number of children with cases of poliomyelitis from the second wild-type strain.
Therefore, this trial was proposed; which was essential for approving the vaccine in record time and thus solving the health emergency in Africa.
How was the polio vaccine trial conducted?
This study was conducted in three countries: Panama, Dominican Republic, and Lithuania. Nearly 1200 participants were enrolled, and the information was collected via the PFS tool developed by Integra IT.
Follow-ups, Labs, Vigilant-e, the TrialPal App, and other tools provided by our company within the PFS led the operation of the trial. Thanks to the versatility of PFS, it was possible to set up the information of 22 groups in total, each one with specialized visits according to the protocol assigned.
How did Integra IT tools contribute?
The use of PFS and the Integra IT Electronic Diary allowed the safety committee to perform surveillance follow-ups over the 24 hours following the vaccination up to the last subject in the safety cohort. Additionally, the study enrollment times were considerably reduced, and the outcomes were vital to quickly submit the vaccine for which approval was being requested.
The PFS developed by Integra IT made it possible to obtain information with security and transparency thanks to the recording of symptoms made by the user or captured via a direct call or at a face-to-face consultation. Furthermore, the system allowed coding participants per household, this way reducing time in follow-up calls and visits.
The results of serum and stool samples, entered into the PFS were organized per type and origin for better processing, analysis, and follow-up, and were available directly to the researchers in the Lab Module and in each patient profile. Real-time digitization of this information allowed access in an agile and timely manner for the interests of stakeholders.
Results: An efficient clinical trial
Around 37,000 samples were collected in this project, and the data collected across the sources were delivered and exported as required.
Integra IT provided the sending reports feature in this project to empower the trial team to make quick and actionable decisions that drove measurable and traceable indicators. The sponsors requested to receive periodic reports on the responses obtained in the eDiary and on the status of the samples. We worked on query automatization and formulas in order to reduce errors, optimize time and deliver accurate data.
Moreover, all of this helped in decision-making and process improvement during the course of the project and in obtaining the expected outcomes. The results and experience gained in this project in terms of operational matters were used as a reference to conduct studies in a more agile manner in the face of poliomyelitis, which is a disabling and life-threatening disease caused by the poliovirus.