GLOBAL PNEUMOCOCCAL STRAIN BANK

With financial support from PATH, a team of investigators at the Centers for Disease Control and Prevention, Emory University, University of Alabama at Birmingham, New York Medical College and PneumoADIP at Johns Hopkins are establishing a global strain bank for Streptococcus pneumoniae that will include a collection of well-characterized invasive disease-causing strains primarily from children under 5 years of age.  This collection would include  strains that have already been characterized over the past few decades as well as strains from areas of the globe that have not been well studied at the molecular level.

The primary focus of the project is to develop a strain bank that represents the diversity of pneumococci around the world.  When fully established, the strain bank expects to screen large numbers of pneumococcal isolates, the results from which would first be shared with those groups providing strains for this project. The information once available would also be made available through the CDC website (http://www.cdc.gov/ncidod/biotech/strep/global_pneumo_strain_bank.htm).

Support for shipping costs can be arranged as funding allows.  The CDC and Emory would also assist in arranging import permits for shipment and any material transfer agreements that might be required.

PneumoADIP had the opportunity to interview the coordinator of the strain bank, Dr. Lesley McGee of the CDC, excerpts of which follow.

How will the strain bank advance the current scientific knowledge about pneumococcus?

The strain bank expects to screen large numbers of isolates by serotyping, antimicrobial susceptibility testing and multilocus sequence typing (MLST) to determine the extent of pneumococcal strain diversity in developing countries of the world.  This will increase our understanding of the population structure of S.pneumoniae.  The bank will also provide a central repository of well-annotated pneumococcal disease isolates that reflect the genetic diversity of S.pneumoniae from around the world.  This collection will be made available for future research initiatives and is expected to be very useful in the process of identifying new proteins that might become targets for new pneumococcal vaccines.

In your view, what are the public health implications of this project?

We feel that an easily accessible and well-documented bank of highly diverse disease-causing pneumococcal strains would be an invaluable resource for the research community to speed development of new vaccines for developing countries. We believe that we should expedite the supply of this diverse collection and associated information such that it will be efficiently and equally available to various scientific and public health establishments to further research and public health initiatives.

When and how will information from the strain bank be available and distributed?

Updated information on the project as well as information on the strains included in the strain bank will be made available through the Global S.pneumoniae Strain Bank website (http://www.cdc.gov/ncidod/biotech/strep/global_pneumo_strain_bank.htm) as isolates are received and characterized.  Instructions for isolate requests and shipping will also be included on the website.  We anticipate information on approximately 300 well-characterized strains to be available and posted to the website within the next few months.

How can interested persons learn more about participating?

We strongly welcome opportunities to collaborate with other pneumococcal reference centers, researchers and investigators from all countries during the initial establishment of the repository and beyond, in order to increase the scope and quality of the global pneumococcal database.

To participate and submit strains for inclusion in the bank or to find out more information about the project, please contact Lesley McGee, PhD with the Respiratory Diseases Branch at CDC (lmcgee@cdc.gov).

MEDIA

1. Expanding approvals and access for new pneumococcal conjugate vaccines

The pace of progress in expanding access to new pneumococcal conjugate vaccines is increasing as the 13-valent gained its first approval and the 10-valent vaccine’s approval list extended to 43 countries.  The government of Chile recently granted the first approval to use Wyeth’s Prevenar 13  vaccine in children age six weeks to five years.  This new 13-valent vaccine builds upon the original 7-valent Prevenar vaccine (covering serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) to broaden protection against six additional pneumococcal serotypes (1, 3, 5, 6A, 7F and 19A). Wyeth estimates that Chile will introduce the vaccine later in 2009.  Wyeth has submitted regulatory applications for Prevenar 13 in more than 50 additional countries. The U.S., Canada, Australia and South Africa have granted the vaccine priority review, with the U.S. Food and Drug Administration review expected by December 2009.

The 10-valent pneumococcal conjugate vaccine from GSK Biologicals (tradename Synflorix) has now received approvals in 43 countries.  Importantly, GSK also recently reached an agreement with Brazilian foundation, Fiocruz, to transfer knowledge and technologies relating to the manufacture of Synflorix to Brazilian facilities, an important step for assuring supply and access to children in Brazil.

2. In India, advocates push for inclusion of pneumococcal vaccine in national immunization schedule

At the recent Mangalore Pneumococcal Disease Conference, child health experts called for the inclusion of the life-saving pneumococcal conjugate vaccine (PCV) into India’s national immunization schedule (NIS) .  Jointly hosted by the Asian Strategic Alliance for Pneumococcal disease prevention (ASAP) and the Indian Academy of Paediatrics, the conference brought together pediatricians and other child health experts from India and abroad to discuss pneumococcal disease in India.  The participants agreed on the importance of PCV in preventing pneumococcal disease in young children.  Dr. Nitin Shah, chairman of ASAP-India, said, "Half of all severe cases of pneumonia and pneumonia deaths are caused by pneumococcus and almost 40% of these deaths […] are preventable by use of pneumococcal conjugate vaccine in the national immunization program."

3. Pneumococcal vaccine now available in health centers throughout Rwanda

Dr Fidele Ngabo, manager of Rwanda’s Expanded Programme of Immunization, confirmed in July that the pneumococcal vaccine is now available countrywide , stating that "it is being administered to all children under the age of one year just like they receive other vaccines."  In April 2009, Rwanda, in partnership with the GAVI Alliance and Wyeth, announced the rollout of a national pneumococcal immunization program.  The program is the first of its kind in a developing country, and was kicked off with the administration of the first pneumococcal conjugate vaccine dose in a clinic east of Kigali, Rwanda. An estimated 395,000 Rwandan children will receive the pneumococcal conjugate vaccine each year.

RESEARCH

4. Effect of alternative PCV7 schedules on nasopharyngeal carriage of pneumococcus

In order to investigate the effects of reduced-dose PCV-7 schedules on pneumococcal carriage among children, van Gils and colleagues conducted a randomized controlled trial  of 1,003 infants in The Netherlands from 2005-2008.   Infants were randomized to receive one of three interventions: 2-dose PCV-7 schedule with a dose at 2 and 4 months; 2 + 1-dose PCV-7 schedule with a dose at 2, 4, and 11 months; or no doses (control group).  Researchers assessed nasopharyngeal carriage among the infants at age 12, 18, and 24 months. Published in the July 8 issue of JAMA, the results revealed that at 12 months, the rate of nasopharyngeal carriage was significantly reduced in both the 2-dose (25%) and 2+1-dose (20%) groups, compared to the control group (38%).  Among the 2-dose group, the carriage rate remained steady at 18 months (24%), and declined further to 15% at 24 months.  The 2+1-dose resulted in an earlier further reduction, dropping to 16% at 18 months and 14% at 24 months.  Among the control group, the carriage rate remained 36-38% throughout the study.  These results led the authors to conclude that "both 2-dose and 2+1-dose schedules of PCV-7 significantly reduce vaccine serotype pneumococcal carriage in children."

5. Pneumococcal carriage among Navajo and White Mountain Apache populations

In the July 10th issue of the Pediatric Infectious Disease Journal, Miller et al describe the results of a nasopharyngeal carriage study nested in a group randomized, controlled trial of 7-valent conjugate pneumococcal vaccine (PCV-7).  The study was conducted among persons living on the Navajo and White Mountain Apache reservations in the U.S., a population with a high risk of pneumococcal disease.  Researchers collected nasopharyngeal swabs on 410 children under age 6 at the time of enrollment, and then again at 6 and 12 months following enrollment.  They found that 92% of participants were colonized with pneumococcus one or more times during the study.   Of the nasopharyngeal swab specimens collected, 63% were positive for pneumococcus, with serotypes 6A, 6B, nontypeable, 23F, 14, 19F, 19A, and 9V being the most common.  Approximately 38% of the positive specimens were vaccine serotypes.  Risk factors for pneumococcus carriage included the following: age less than 2 years, male sex, daycare attendance, and having a sibling colonized with pneumococcus.  These risk factors are largely non-modifiable, reinforcing the importance of preventive strategies, including vaccination.

6. Call to focus pneumococcal vaccination efforts on HIV-positive children

In the July 2009 issue of The Lancet, Meehan and colleagues advocate for increased efforts to immunize children living with HIV against pneumococcal disease .  HIV-positive persons have an elevated risk of pneumococcal disease.  For example, HIV-positive African children under age two were found to be at 40 times the risk of invasive pneumococcal disease compared to their HIV-negative counterparts.  The risk of pneumococcal disease among HIV-positive persons remains high throughout the lifespan and in all stages of HIV disease.  To date, efforts to expand pneumococcal vaccination have resulted in the immunization of more than 30 million infants with PCV-7, and a significant reduction in pneumococcal disease burden in countries that have introduced the vaccine into immunization schedules.  The authors suggest that immunizing older children, particularly HIV-positive children over 4 months of age, may be highly beneficial.  They conclude that "global vaccination of children against pneumococcal disease is important, but will take time; we argue that vaccinating children that are HIV-positive is more feasible and worth implementing now."

FINANCE

7. New pneumococcal vaccination cost-effectiveness model launched

Infectious disease specialists, computer scientists and decision analysts based at the University of Medicine and Dentistry of New Jersey and Johns Hopkins Bloomberg School of Public Health have developed a new Interactive Pneumococcal Conjugate Vaccination Policy Model that allows the health benefits, costs, and cost-effectiveness of childhood pneumococcal conjugate vaccine to be projected according to an evidence-based approach.  This model addresses the need for streamlined cost-effectiveness analysis tools to assist decision makers in understanding the economic and health benefits associated with vaccine introductions.  The model was developed through an expert panel process to reach consensus on the key assumptions about epidemiology, vaccine efficacy, costs and model outputs projecting the cost-effectiveness of pneumococcal conjugate vaccine.  Members of the panel were chosen for their expertise in pneumococcal epidemiology, vaccine-related health economics, public health, and/or preventive medicine, particularly in GAVI-eligible settings.  To learn more about the model and to login and try it for yourself, please click here .

8. Pricing of pneumococcal vaccine under the Advance Market Commitment

In a Letter to the Editor published in the August 29, 2009 issue of The Lancet , Tani Cernuschi clarified the pricing of pneumococcal vaccines under advance market commitments (AMC).  In a June 2009 correspondence letter published in The Lancet , Gopal Dabade and Jacob Puliyel wrote that "Given that the vaccine costs $250 per child, $250 000 will be spent to prevent…four cases of pneumonia".  Cernuschi explains that the conservative estimate for the average cost to GAVI per pneumococcal vaccine dose is US$4.25.  This estimate is derived by averaging the doses bought at $7 during the AMC period, and those bought at a maximum price of $3.50 during the post-AMC or "tail" period.  Given that three doses of the pneumococcal vaccine are needed to vaccinate one child, the cost of vaccinating 1,000 children is US$12,750, not $250,000.  Cernusci concludes that this "represents an excellent investment to help prevent one of the biggest killers of children in the poorest parts of the world."

UPCOMING EVENTS

The 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) will be held September 12-15, 2009 in San Francisco, CA.  Additional information on the conference is available at http://www.icaac.org/.

Organized by the Infection Prevention Society, the Infection Prevention 09 Annual Conference will take place in Harrogate, England September 21-23, 2009.  Visit http://www.infectionpreventionconference.org.uk/ for details on the conference.

The World Vaccine Congress will be held in Lyon, France October 5-6, 2009.  The Congress website, http://www.terrapinn.com/2009/wvcl/, provides information about the program, registration and more.

The 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-7) will take place in Tel Aviv, Israel March 14-18, 2010.  Conference details are online at http://www2.kenes.com/isppd/pages/home.aspx.  The deadline for travel grant applications is October 14, 2009.  The deadline for abstract submission is November 16, 2009.  Visa applications for travel to Israel may be a lengthy process, so participants are advised to register and begin the Visa application process as early as possible.