Task Order (Under BARDA MCM-CSN Contract): Panblok H7 Influenza Vaccine at Three Dose Levels Adjuvanted with AS03 or MF59 Vaccine Trial (Phase 2)
Sponsor: Department of Health and Human Services (HHS)/Office of the Assistant Secretary for Preparedness and Response (ASPR)/Biomedical Advanced Research and Development Authority (BARDA)
Disease: Since 2013, influenza A (H7N9) has caused annual epidemics in China and has infected 764 humans (as of 13 September 2017, per the World Health Organization). Data from the first four H7N9 epidemics in China shows a mortality rate of approximately 40%.
Objective: Although there has been limited human-to-human transmission, the CDC Influenza Risk Assessment Tool has rated this virus as having the greatest potential to cause a pandemic and as potentially posing the greatest risk to severely impact public health. Therefore, BARDA is preparing to ready a response should the H7N9 virus spread to the United States.
Project Overview: This double-blinded phase 2 trial is assessing the safety and immunogenicity of Protein Sciences Corporation’s Panblok H7 vaccine (at 3 different dosages) with an adjuvant. Rho provided comprehensive clinical research operations support for protocol and informed consent development; regulatory submissions and consulting; investigational product management, including developing an internal randomization and kit assignment system, as well as defining kitting, labeling, and distribution processes for the investigational product services vendor; site selection and clinical monitoring; operational document creation; all-inclusive data management, from establishing an electronic data capture system to collection, validation, management, and archival of the clinical data; statistical analysis; pharmacovigilance and medical monitoring; maintenance of an electronic trial master file per the TMF Reference Model; logistical and statistical support for the safety monitoring committee; quality assurance and oversight; and clinical study report authorship.
This trial was developed and was conducted on an accelerated timeline because this data is critical for determining whether the vaccine would be safe and immunogenic in the event of a pandemic.
The 4 U.S. sites consented 424 healthy volunteers during the last week and a half of September 2017 in preparation for the randomization that was completed the first week of October 2017. The randomization goal of 360 subjects was surpassed within 3 days and 366 subjects were vaccinated. Within the next month, 357 subjects received the second and final vaccination. By early December 2017, 355 subjects had completed the primary endpoint visit (Day 50). An interim analysis to assess the immunogenicity of the vaccine (and therefore, our readiness against this H7N9 virus) was conducted on the subjects’ data collected up through their Day 50 visit. Subjects will be followed for immunogenicity through Day 212 and for safety through Day 394. The trial expects to report on immunogenicity data early Summer 2018.
- Biostatistics and Statistical Programming
- Clinical Project Management
- Project and Site Management
- Protocol Design/Development
- Safety Monitoring/Pharmacovigilance
- Data Management and Analysis
- Manuscript and Regulatory Document Submission
- Organizational and Logistical Support, Including Meeting Coordination
- Study Website Content Development and Maintenance
- Study-Related Approvals, Including IRB Submissions
- Training and Training-Related Activities
- Biospecimen Collection Kit/Supplies Management, Tracking
- Process Documentation Development (e.g., SOPS)