Vaccines


Clinical trial methodology and assessment methods in vaccine development differ in many respects from those in other therapeutic areas. In order to meet this need, ICON created a Vaccine Center of Excellence, a group of therapeutic experts to address the unique requirements of vaccine studies.

In the past 10 years, ICON has conducted on average: 

  • 20 - 50 Clinical vaccine trials per year
  • 300,000Subjects
  • 2,000Sites in over 40 countries

Our extensive vaccine trial experience spans across multiple therapeutic indications and all age groups including:

Indications

  • Influenza (Seasonal and Pandemic)
  • Meningitis
  • Pneumococcal
  • RSV (Respiratory Syncytial Virus)
  • Rotavirus
  • DPT – Diphtheria, Pertussis, Tetanus
  • MMRV – Measles, Mumps, Rubella, Varicella
  • Hepatitis A,B,C
  • HPV – Human Papilloma Virus
  • Herpes Zoster
  • Hib – Hemophilus influenza type B
  • Anthrax
  • Ebola
  • Rabies
  • Dengue Fever
  • Smallpox
  • C. difficile
  • Malaria
  • Tuberculosis
  • West Nile Virus
  • Shigella
  • E. coli
  • Plague
  • Leishmaniasis
  • CMV-Cytomegalovirus
  • Oncology Therapeutic Vaccines

Disciplines

  • Expert consultation and operational delivery Phase I-IV
  • Lifecycle management and outcomes research protocol development, including adaptive design
  • Regulatory consultancy with phase specific quality systems
  • Biomarker strategies
  • Imaging (Central ECG)
  • Study management
  • Medical monitoring
  • Pharmacovigilance
  • Laboratory services
  • Data management
  • Biostatistics
  • Medical writing
  • Commercial consultancy
  • Electronic Clinical Outcomes Assessment (eCOA)-ePRO development,  validation, and use in clinical trial strategy and design
  • Data Safety Monitoring Boards (DSMBs)
  • Vaccine Government Experience (DMID / TRI, NIAID / BARDA /  NIH)
  • Training via Firecrest
  • eConsent
  • Subject recruitment

Expertise and Experience

ICON has been recognized for its work in vaccine studies and has received a number of accolades within the vaccine arena

  • In 2016, Cynthia Dukes was honoured for her contribution to vaccine development as well as new treatments for infectious disease and cancer by PharmaVoice100, a listing of the life-sciences industry’s 100 most inspiring people.  
  • Winner “Best Vaccines CRO” Vaccine Industry Excellence Award at the World Vaccine Congress, 2014.  Highly Recommended Vaccines CRO, World Vaccine Congress in 2011, 2012, 2013 and 2015.
  • Cynthia Dukes recognized as 16th most influential people in the “Top 50 Influential People” in vaccines  - Vaccine Nations survey, Sep14
  • Qualified provider for Bill and Melinda Gates Foundation (GAVI).
  • Monitoring vendor for the NIH Division of Microbiology and Infectious Diseases.

Vaccine Center of Excellence

Central to our vaccine solution is our Vaccine Center of Excellence which is comprised of vaccine health experts that represent the coalescence of therapeutic, medical, scientific, vaccine development and life cycle management expertise within ICON. They deliver scientific, operational and therapeutic expertise that spans the development continuum from concept through development to post-approval activities--a truly integrated, full-service solution.

Cynthia Dukes, PA-C, MT

Cynthia Dukes

Cynthia Dukes has an extensive and diversified medical background including 30 years of clinical research experience in vaccines, oncology and infectious disease.  Cynthia began her clinical research experience in 1985 as the Clinical Team Lead at Baylor College of Medicine’s Influenza and Respiratory Disease Research Center and NIH designated Vaccine Treatment and Evaluation Unit (VTEU) where she gained valuable experience in vaccine and antiviral drug development.  During her 10-year tenure at Aventis Pasteur (now Sanofi Pasteur), she was the clinical lead or product development manager for multiple vaccines and oncology research programs.  In addition, she oversaw US Pharmacovigilance group and was the clinical lead for the Medical Information group and the Clinical Trial Materials group.   Subsequent to Aventis Pasteur she was the Sr. Director of Operations at ILEX Oncology providing oversight of up to 100 oncology studies (targeted therapies and oncology vaccines).  While at ICON the past 15 years, Cynthia has been a significant contributor to the therapeutic areas of oncology, vaccines and infectious disease.   Whilst in pharma, Cynthia participated in more than 40 INDs leading to eight product approvals, including five vaccines, 2 oncology products and one immunoglobulin.   While at ICON she has provided strategic and management oversight on numerous pivotal studies leading to the approval of 9 vaccines and 5 oncology therapies. 

Investigative Sites / Networks

Our global investigator database includes over 1,900 vaccine investigative sites across more than 40 countries. ICON has established relationships with the major vaccine site networks in the US and has experience working with numerous site networks in Asia PAC and Europe as well.  This includes ICON’s phase 1 unit in San Antonio, TX and ICON’s recent acquisition of PMG Research in December 2015 that spans 12 metropolitan areas in the US, with over 48 physician practices.   The vaccine site networks offer ICON and the Sponsor a central point of contact that also supports sites centrally with start-up activities and during the lifecycle of a study.  Through these relationships we are assured faster response time, higher site quality performance while consistently meeting / exceeding enrollment expectations.