Long-term impact of a vaccine on a population a high risk of pneumococcal disease

1. Long-term impact of a vaccine on a population a high risk of pneumococcal disease A double-blinded, controlled study of the efficacy, immunogenicity, safety and tolerability, and effectiveness of a pneumococcal conjugate vaccine containing seven serotypes (6B, 14, 19F, 23F, 18C, 4 and 9V) compared to a control meningococcal c vaccine in Navajo and Apache Indian infants. (NNR.97.18)

2. Background

3. Who are we? Johns Hopkins Center for American Indian Health Baltimore: Coordinating Center White Mountain Apache Reservation: Field Sites Navajo Nation: Field Sites

4. What is a pneumococcus? • A bacteria • More than 90 types of pneumococcus • Can cause serious disease • Most diseases caused by only a few types • Disease is more common during the winter months • Types of pneumococcus that cause disease in one population or location may be different from types causing disease in another population or location pneumococcus

5. Meninges Sinus Enters via nose Ear drum Lung BloodVessel Bone How does pneumococcus get into the body and cause disease? Lung

6. What diseases are caused by pneumococcus? Ear infections Pneumonia Meningitis Infections of the blood

7. Where in the world is pneumococcal disease a problem? Rates of pneumococcal disease among children less than 2 years of age Rates are 3-10 fold those of in general US

8. Young children have high rates of pneumococcal disease… Incidence of IPD (per 100,000) by Race/Ethnicity

9. …so do the elderly.

10. How can pneumococcal disease be prevented? **By giving our children life saving vaccines… …but first we have to make sure they are safe and prevent disease

11. Some information about the pneumococcal vaccine • Official name: 7-valent pneumococcal conjugate vaccine • Nickname: PCV7 • Prevents disease caused by the 7 most common types of pneumococcus  called “vaccine-types” refrigerator stocked with vaccine

12. Study Conduct

13. How was the pneumococcal vaccine study conducted? • Study conducted from 1997-2000 to find out if a new vaccine can prevent pneumococcal disease • 8,292 Navajo and White Mountain Apache babies enrolled

14. How was the pneumococcal vaccine study conducted? • Approvals were obtained from the Navajo and White Mountain Apache Tribes

15. How was the pneumococcal vaccine study conducted? • Families gave permission for their baby to participate in the vaccine study.

16. How was the pneumococcal vaccine study conducted? • Blood specimens collected from babies to measure if the vaccine was present in the body.

17. How was the pneumococcal vaccine study conducted? • Babies followed throughout the study to see if they remained healthy.

18. How was the pneumococcal vaccine study conducted? • Data entered into electronic database and analyzed to produce study results.

19. Study Results

20. What were the PCV7 vaccine trial results?Rates of invasive pneumococcal disease among Navajo children <5y

21. Older people benefit from vaccinating children with PCV7 - 44% - 28% - 59% - 56%

22. Acknowledgements • Participants from the Navajo and White Mountain Apache tribes • Community members who supported these studies • Nurses and research program assistants • IRBs of the Navajo Nation, Phoenix Area IHS, and Johns Hopkins School of Public Health • Indian Health Service collaboration and support

23. Thank you!