PNEUMOFOCUS

BULLETIN OF GAVI'S PNEUMOADIP AT JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH
PNEUMO ADIP: PNEUMOCOCCAL VACCINES ACCELERATED DEVELOPMENT AND INTRODUCTION PLAN


Volume 1, No. 8 August, 2004
EXECUTIVE DIRECTOR'S NOTE
As we all now, August is usually a slow month because of vacations in Northern countries, and often times we may miss some of the exciting information that is published in this period. Not to worry. In case you missed it, this month’s issue includes some recent highlights in the literature related to the burden of pneumococcal disease in Mali, new vaccine efficacy data from South Africa, and from Cuba, exciting prospects for a cheaper pneumococcal conjugate vaccine. And of course, a reminder that September and October are deadline months for our Asian Field Sites solicitation and for the Small Grants program.



Orin Levine
Executive Director
FUNDING INFORMATION

Small Grants Program
PneumoADIP’s second Small Grants Program deadline is October 15th. Please visit us online at www.preventpneumo.org for more information about the program and application procedures.

Solicitation for Potential Asian Field Sites

Our website provides information about PneumoADIP’s request for letters of interest for potential sites in the Asian and Pacific regions to conduct large-scale vaccine evaluations. Brief (4 pages) letters of interest are due September 1st, 2004.

PNEUMOADIP LINKS WITH WHO REGIONAL OFFICES
Since its inception, PneumoADIP has worked closely with the World Health Organization (WHO) headquarters to coordinate efforts and develop strategy. Now PneumoADIP is working to extend those linkages to the WHO’s six regional offices. Between April and July 2004, Orin Levine, Executive Director, PneumoADIP and John Wecker, Director of PneumoADIP’s sister project for rotavirus vaccines (based at PATH – see www.rotavirusvaccine.org for more information), visited four of the six regional offices to meet with leading WHO officials. The ADIP Directors were accompanied in their visits by Drs. Thomas Cherian, Duncan Steele, Patrick Zuber and others from WHO/HQ. Visits were made to the African, European, Eastern Mediterranean, and Southeast Asian regional offices in Zimbabwe, Denmark, Egypt, and India, respectively. ADIP teams have met previously with AMRO/PAHO representatives, and a trip to the Western Pacific office in Manila is planned but not yet scheduled.

In addition to its Geneva-based headquarters, the WHO organizational structure includes a series of six regional offices corresponding to unique geographical regions, and of course, country-based offices in nearly every country of the world. These regional offices include teams of people working closely in advising, supporting, and providing technical assistance to immunization and health policy-makers in developing countries. Their unique perspective on regional and country issues makes them invaluable in the process of evaluating and introducing new vaccines.

The visits included general presentations by the ADIP Directors to introduce the ADIP concept, to provide background on disease burden and vaccine development, and to highlight areas for potential collaboration with regional offices and countries. Regional office staff provided presentations outlining the organizational structure and objectives of the regional offices and summarizing the current status of immunizations and surveillance in the regions. These plenary sessions were followed by in-depth discussions with regional office leaders on how and where the regional offices and PneumoADIP can work together more closely, particularly in the areas of surveillance, disease burden, and vaccine evaluation.

NetSPEAR: JOINING FORCES TO FIGHT PNEUMOCOCCAL DISEASE IN EAST AFRICA

Although it is one of the world’s poorest regions, East Africa has had a rich history of health research. However, until the August 2003 launch of the Network for Surveillance of Pneumococcal Disease in the East Africa Region (netSPEAR), what is likely to be a large burden of pneumococcal disease had gone largely undocumented. East Africa is likely to derive tremendous mortality benefits from pneumococcal vaccine introduction, but without information on pneumococcal disease burden the scope of this benefit remains unclear to national and regional leaders.

netSPEAR is a pneumococcal and Hib disease surveillance network – hosted by the KEMRI / Wellcome Trust Collaborative Research Programme in Nairobi, Kenya and funded by GAVI’s PneumoADIP – currently operating in nine hospitals throughout Kenya, Tanzania, Uganda, and Ethiopia. It also works closely in coordination with the WHO’s African Regional Office and its Pediatric Bacterial Meningitis network. Eventually netSPEAR aims to expand to hospitals in Burundi, Rwanda, and Eritrea for a total of seven network countries. netSPEAR’s primary goal is to provide a focal point within East Africa for sharing and compiling data on S. pneumoniae and H. influenzae that is already being collected. It will also expand the region’s capacity for effective, routine surveillance by developing clinical case definitions that precipitate sample collection and laboratory procedures that result in bacterial isolation. Once collected, the network will disseminate findings to regional network partners, including surveillance sites, Ministries of Health, multilateral organizations and donors supporting vaccination. The data will also be used to extrapolate regional estimates of pneumococcal disease burden.

In line with each goal, netSPEAR clinicians and microbiologists developed and implemented standard operating procedures for pneumococcal and Hib disease surveillance at the sites. They are currently collecting and culturing blood and CSF samples at six of the sites and will increase collection capacity as the project continues. NetSPEAR’s second annual conference for all surveillance sites will be held 15-16 November, 2004 in Nairobi.

But this type of coordinated, standardized surveillance could not happen without a strong base of investigators, doctors, and other health care personnel to carry out its vision. Their steering committee - Dr. Themba Mhlanga (WHO-AFRO), Dr. Tatu Kamau (Kenyan EPI), Professor F. Kalokola (MMC, Tanzania), Mr. T. Oluoch (KEMRI / WT), project manager Dr. M. Wamae (netSPEAR) as well as principle investigators Drs. Anthony Scott and Mike English from KEMRI / Wellcome Trust – brings together significant experience from throughout the region.

PneumoADIP looks forward to the continuing success of netSPEAR and their disease surveillance efforts which will contribute to building an evidence-based case for pneumococcal vaccine use in the region.

For more information on netSPEAR, please email Beverly Watila at bw.netspear@wtnairobi.mimcom.net or visit their website at www.netspear.org.

EXCITING NEW RESEARCH

This summer has been a busy time for research related to pneumococcal disease and vaccines. Three major studies show exciting results and promise much more to come.

In Soweto, South Africa, Shabir Madhi, Keith Klugman and the Vaccine Trialist Group demonstrated in a large, placebo-controlled, double-blind, randomized trial that a 9-valent pneumococcal conjugate vaccine prevented 31% of viral-associated pneumonia. They report their findings in the August 10th edition of Nature Medicine. Although an association between viral and bacterial pneumonia had previously been observed, this is the first randomized study to examine the hypothesis. Although protection was better in HIV negative children, the vaccine prevented viral pneumonia in both children with and without HIV infection. The authors’ findings should play an important role in decision making regarding the introduction of pneumococcal vaccines, both in terms of total cases of pneumonia prevented as well as vaccine cost-effectiveness.

From Bamako, Mali, James Campbell and colleagues report in the July 2004 edition of the Pediatric Infectious Disease Journal that invasive pneumococcal disease (IPD) is a major cause of both morbidity and mortality among children admitted to the major hospital there. The study followed an earlier investigation where the authors found that after malaria, pneumonia was the most common reason for pediatric hospitalization in Bamako. Of children enrolled in the study, 5% had IPD, with an overall case fatality rate of 24%. 91% of serotypes causing IPD in Bamako are found in the 11-valent pneumococcal conjugate vaccine.

And finally, from Cuba comes the exciting news, reported in the July 23rd issue of Science that researchers there have succeeded in developing a safe, effective synthetic conjugate Hib vaccine. Although synthetic conjugates have a number of advantages (they are purer and less costly to produce than traditional conjugate vaccines), until now no one had been successful in developing a conjugation synthesis process that could be done in large-scale volumes, as is necessary for vaccine production. And Verez-Bencomo and colleagues have gone further than simply developing the vaccine. They have gone through to phase II trials and have shown that their vaccine is comparable in immunogenicity to a licensed Hib vaccine (Vaxem-Hib from Chiron). This strategy could be employed to reduce the manufacturing costs of other vaccines, including perhaps pneumococcal conjugate vaccines.