Vaccine Development Studies

Utilize PPD’s industry leadership in managing drug development for Phase I-IV studies to fast-track your vaccine program. Our dedicated team provides:

• Global reach to take advantage of viral seasonality
• Efficient patient recruitment
• Standardized storage and distribution of temperature sensitive vaccines
• Expertise in coordinating the collection, storage and transportation of serum

Depth and Range of Experience

PPD has worked in vaccine development for more than 10 years, handling Phase I (adult healthy volunteers) through Phase II-IV (adult and pediatric patients) programs. We have unique expertise in hospital-based studies in early phase vaccine development that includes new adjuvants and combination vaccines, as well as later stage field-based studies in targeted populations.

Industry Leader in Monitoring

PPD has monitored a vast scope of protocols for vaccines, including more than 200 bacterial and viral vaccine protocols for the National Institutes of Health (NIH) at vaccine treatment evaluation units across the United States. More than 800 audits have been performed, including:

• Childhood illnesses
• Tropical diseases
• Recombinant bacterial antigen delivered through edible transgenic plants

Global Studies

Utilizing experienced PPD professionals, we stage field-based vaccine studies in targeted populations worldwide. We have monitored 221 sites in 48 countries (in addition to 121 sites in the United States). Our on-site staff minimizes the need to employ monitoring subcontractors.

Biodefense Research

Since 2000, PPD has engaged in biodefense programs, including smallpox vaccine development. We have monitored seven Category A biodefense protocols, and are familiar with the complexities and unique challenges of this relatively new and expanding therapeutic area.

Expertise and Facilities for Vaccine Requirements

PPD’s dedicated vaccine development team is highly skilled at managing the special handling requirements of serum:

• Importation
• Transportation and storage
• Cold-chain monitoring

Given the temperature-sensitive nature of serum, all of our vaccine storage facilities are consistently monitored 24/7, with back-to-base centralized alarm systems to protect the integrity of the serum.

Microbial Agent Experience

We have monitored trials for these infectious disease and vaccine indications:

• Bacille Calmette-Guérin (BCG) vaccine for tuberculosis (TB)
• Cholera
• Diphtheria, tetanus, pertussis (DTP) vaccine
• Escherichia coli
• Haemophilus influenza B
• Hepatitis B
• Herpes simplex
• HIV related
• Influenza/parainfluenza
• Malaria
• Meningococcus
• Mycobacterium vaccae
• Parvovirus
• Pertussis
• Pneumococcus
• Polio
• Rabies
• Rotavirus
• Respiratory syncytial virus (RSV)
• Salmonella typhi
• Shigella sonnei
• Staphylococcus aureus
• Streptococcus
• Group B streptococcus
• S. gordonii
• Yellow fever