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Immunization & Infectious Disease Study Examples

Study Examples | Key Publications | Intro

Several ongoing studies are funded under a 10-year umbrella grant of about $1 million a year for the Vaccine Safety Datalink (VSD) Project, including the following:

• Pneumococcal Adult-Dose Ranging Immunization Study (PARIS)
• Neurodevelopment of Children After Exposure as Infants to Thimerosal in Vaccines

Sanofi-Aventis Group is providing $1.8 million in funding over four years to cover both of the following studies:

• Post-Marketing Assessment of Large Local Reactions After DTaP5
• Acetaminophen vs. Ibuprofen to Prevent Local Reactions After DTaP5

Vaccine Safety Datalink (VSD) Project

Pneumococcal Adult-Dose Ranging Immunization Study (PARIS)

• Principal Investigator: Lisa A. Jackson, MD, MPH

No new vaccine has been licensed for preventing disease in seniors since the polysaccharide pneumonia shot was introduced in 1977. The same time period has seen many advances in the research and technology surrounding childhood vaccinations—including the pneumo conjugate, a pneumococcal vaccine recently approved for children up to age 6. This conjugate vaccine is effective at preventing conditions, such as meningitis, caused by the same pneumococcal bacterium implicated in pneumonia. Given the effectiveness of this conjugate vaccine in children, CHS investigators are testing it in adults. PARIS randomly assigns 220 seniors aged 70–79 to receive either the currently used polysaccharide vaccine or the new conjugate vaccine at one of four doses. Researchers are monitoring adverse effects and testing blood samples for markers of immune response.

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Neurodevelopment of Children After Exposure as Infants to Thimerosal in Vaccines

• Principal Investigator: Lisa A. Jackson, MD, MPH

The mercury derivative called thimerosal was commonly used as a preservative in childhood vaccinations between the 1940s and 1999. Since several studies have indicated a link between consumption of fish containing methyl mercury and learning disorders, the question has been raised whether exposure via vaccines to thimerosal, which contains ethyl mercury, could also lead to developmental problems in children. In a prospective study, three health plans, including Group Health, are enrolling 1,200 children aged 7–10 to explore the relationship between the amount of thimerosal in vaccines received in the first several months of life to their current level of neurological and cognitive functioning. Children will complete an extensive battery of standardized tests designed to measure their ability to listen, follow directions, learn new things, and remember.

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Sanofi-Aventis Group

Post-Marketing Assessment of Large Local Reactions After DTaP5

• Principal Investigator: Lisa A. Jackson, MD, MPH

The acellular diphtheria-tetanus-pertussis (DTaP) vaccine, licensed in 1997, contains only those parts of the bacteria that are critical to providing immunity. By contrast, the previous version—whole cellular DTP vaccine—contained the whole bacteria. The acellular shot results in less fever in 2- and 4-month-old infants than does the whole cell shot. This is significant because fever can lead to seizures—rare, but serious, adverse events associated with the DTP shot. Now CHS researchers are monitoring adverse reactions to the fifth, and final, dose of this vaccine (DTaP5), which is given to children aged 4–6 years. Group Health is enrolling 1,500 children who are due to receive their fifth dose of DTaP after having received a complete four-dose regimen of the acellular version since age 2 months. The study will document the size and duration of injection site reactions and try to identify causal factors for these reactions.

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Acetaminophen vs. Ibuprofen to Prevent Local Reactions After DTaP5

• Principal Investigator: Lisa A. Jackson, MD, MPH

Although most children's reactions to DTaP5 tend to be brief and relatively minor, a subset experience symptoms that persist for up to several weeks. Although these mostly self-limiting adverse events might be deemed acceptable given the overall benefit of the acellular vaccine, the researchers aim to move beyond simply documenting the reactions, to trying to find a means of preventing them. To this end, they have expanded the DTaP5 study to include a randomized trial: Willing participants are assigned randomly to take acetaminophen, ibuprofen, or placebo both before and after their fifth dose of DTaP. The reasoning is that if the adverse reaction has inflammatory components, ibuprofen might mediate against them.

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Study Examples | Key Publications | Intro