Sabin Vaccine Institute, Baylor College of Medicine, Texas Children’s Hospital form aliance

    The Sabin Vaccine Institute, Baylor College of Medicine, and Texas Children’s Hospital today announced an agreement “to move Sabin’s vaccine development program to Texas Children’s and BCM as part of the recruitment of world renowned neglected diseases expert Dr. Peter Hotez.” The action includes “establishment of the first national school of tropical medicine in the United States at BCM.” Dr. Hotez will serve as the founding dean and “the entire Sabin Vaccine Institute vaccine development program will relocate to Texas Children’s and BCM, while the Sabin Vaccine Institute’s advocacy and education programs will remain at the institute’s headquarters in Washington, D.C.” Dr. Hotez will continue to serve as president. The institutions noted that the collaborative program “represents a significant expansion of efforts to develop and test vaccines for a range of diseases affecting low-income populations in the United States and worldwide.” Representatives of BCM and Texas Children’s will be joining the Board of the Sabin Vaccine Institute.

http://sabin.org/news-resources/releases/2011/06/08/bcm-texas-children%E2%80%99s-announce-recruitment-dr-peter-hotez-and-team

Foundation for Vaccine Research launched

The Foundation for Vaccine Research was launched by “fourteen leading scientists and advocacy experts in vaccines and infectious diseases…to advance and accelerate vaccine research and development against infectious diseases.” The new foundation will be headquartered in Washington, DC. With the mission to “raise global awareness of the need for increased, long-term, flexible funding for vaccine research against HIV/AIDS, tuberculosis, malaria, and other infectious diseases, including neglected tropical diseases, as well as universal vaccines for influenza and a vaccine to avert pandemic influenza.”

The Foundation’s activities “will focus on persuading opinion leaders, policymakers inside and outside government, and other decision makers of the benefits and safety of vaccines and the merits of increased investment in vaccine research. The Foundation will seek to mobilize resources internationally and on a large scale to finance vaccine research globally, with a special focus on securing new assets and the development of innovative financing mechanisms. The Foundation will also conduct televised fundraising events and benefit concerts, with 100 percent of publicly donated funds going directly to teams of scientists and their institutions. The Foundation will also engage with the anti-vaccine movement to persuade them of the benefits of vaccines.”

The leadership of the new Foundation includes:

– Galit Alter, PhD, Assistant Professor in Medicine, Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard University; Director, Ragon Institute Imaging Core; Director, Harvard Center for AIDS Research (CFAR) Immunology Core, Boston, USA

– Patrice Debre, MD, PhD, Professor of Immunology, University of Pierre and Marie Curie, Pitie-Salpetriere Hospital, Paris, France

– Jose M. Gatell MD, PhD, Professor of Medicine, Senior Consultant & Head, Infectious Diseases & AIDS Units, Clinical Institute of Medicine & Dermatology, Founder and Co-Director of the Catalan HIV Vaccine Project (HIVACAT), Hospital Clinic de Barcelona, University of Barcelona, Spain

– Peter Hale, Founder, The It’s Time Campaign, Washington, DC, USA

– Sylvie Le Gall, PhD, Assistant Professor of Medicine, Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard University; Director, Ragon Institute Education and Training Platform, Boston, USA

– Ronald C. Desrosiers, PhD, Professor of Microbiology and Molecular Genetics, Harvard Medical School; Director, New England Primate Research Center, Boston, USA

– Willem Hanekom, Professor of Immunology; Co-Director, South African TB Vaccine Initiative (SATVI), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, South Africa

– Professor Gregory Hussey, Deputy Dean: Research, Faculty of Health Sciences; Founder and Director, Vaccines for Africa, University of Cape Town, South Africa

– Paul A. Offit, MD, Chief, Division of Infectious Diseases, Maurice R. Hilleman Professor of Vaccinology, Children’s Hospital of Philadelphia, Philadelphia, USA

– Gregory A. Poland, MD, MACP, FIDSA, Mary Lowell Leary Professor of Medicine, Infectious Diseases, Molecular Pharmacology and Experimental Therapeutics; Director, Mayo Vaccine Research Group; Director, Translational Immunovirology and Biodefense; Editor-in-Chief, VACCINE; Mayo Clinic, Rochester, MN, USA

– Mauro Schechter, MD, PhD, Professor of Infectious Diseases, Head, Projeto Praca Onze, Hospital Escola Sao Francisco de Assis, Federal University of Rio de Janeiro, Brazil

Guillaume Stewart-Jones, PhD, Principal Investigator, Weatherall Institute of Molecular Medicine, University of Oxford, John Radcliffe Hospital, Oxford, UK

– Professor Simon Wain-Hobson, PhD, Chief, Molecular Retrovirology, Institut Pasteur, Paris, France

– Robin A. Weiss, PhD, Professor of Viral Oncology, Division of Infection and Immunity, University College London, UK

The Foundation said it will incorporate the “It’s Time Campaign,” an advocacy and campaign organization based in Washington, which will become a program of the new Foundation and its main fundraising arm. The Foundation said it will also finance vaccine research directly. Funding sources will include the It’s Time Campaign’s internet-based campaign, televised fundraising events, benefit concerts, and other initiatives undertaken by the Foundation.

http://www.prnewswire.com/news-releases/scientists-launch-vaccine-research-foundation-123459359.html

Twitter Watch: Week to 13 June 2011

Twitter Watch
A selection of items of interest this week from a variety of twitter feeds. This capture is highly selective and by no means intended to be exhaustive.

GAVIAlliance GAVI Alliance
GAVI’s Pledging Conference gets off to a flying start http://ht.ly/5g1c7 #4mlives #vaccines

GAVIAlliance GAVI Alliance
“Melinda and I very committed to vaccines. It is as much fun as writing code” @billgates #4mlives

PATHtweets PATH
Tackling chronic disease—our work on cervical cancer will be spotlighted at Global Health Council conference. http://ow.ly/5fgVE #ghc2011

sabinvaccine Sabin Vaccine Inst.
In advance of @GAVIAlliance pledging mtg Dr Ciro de Quadros offers support with “A Lesson from Smallpox Eradication”: http://bit.ly/iYOMbL

ECDevelopment EC Development
by GAVIAlliance
Piebalgs will announce an extra €10 million to provide life-saving vaccines @GAVIAlliance in London #4mlives http://bit.ly/9JMs9e

AIDSvaccine IAVI
@IAVISeth on strengthening continuum from R&D to eradication to deliver on #vaccines‘ promise http://bit.ly/kWQ12H #globalhealth #AIDS2011

TheLancet The Lancet
New Decade of Vaccines Series launched in London today. Read the papers here bit.ly/jj239B

PublicHealth APHA
Though child vaccination rates are high, parents need more education about vaccines, says new study: http://goo.gl/8MjxO

GAVIAlliance GAVI Alliance

#FACT: Every 20 seconds, a child dies of a vaccine-preventable disease. #infographic: http://on.fb.me/klwV1i #health #GAVI

USAID USAID
“The most transformative new breakthroughs we have at our disposal are vaccines,ʺ says USAID’s @RajShah #FrontLines http://1.usa.gov/m5nIn7

MalariaVaccine PATH MVI
GSK, J&J to trial next-generation malaria vaccine | @Reuters reut.rs/mNMyFe #malaria #vaccine

NICE: Cost-Effectiveness Assessment

Annals of Internal Medicine
June 7, 2011; 154 (11)
http://www.annals.org/content/current

National Clinical Guideline Centre Cost-Effectiveness Assessment for the National Institute for Health and Clinical Excellence
David Wonderling, Laura Sawyer, Elisabetta Fenu, Kate Lovibond, and Philippe Laramée
Ann Intern Med June 7, 2011 154:758-765;

Abstract
The National Clinical Guideline Centre (NCGC) develops evidence-based clinical guidelines on behalf of the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom. The U.K. Department of Health has commissioned NICE to make recommendations on the basis of both clinical effectiveness and cost-effectiveness. This article describes how cost-effectiveness is evaluated and accounted for in NCGC guidelines. Six recent case studies are presented, in which consideration of cost-effectiveness has informed recommendations in various ways for clinical guidelines on alcohol use disorders, chronic obstructive pulmonary disease, glaucoma, lower urinary tract symptoms, non–ST-segment elevation myocardial infarction and unstable angina, and venous thromboembolism prophylaxis. Some of the challenges faced in trying to account for cost-effectiveness in clinical guidelines are outlined, as well as some of the difficulties in adapting cost-effectiveness guidelines for other settings.

Poliomyelitis-Related Case-Fatality Ratio in India, 2002–2006

Clinical Infectious Diseases
Volume 53 Issue 1 July 1, 2011
http://www.journals.uchicago.edu/toc/cid/current

ARTICLES AND COMMENTARIES
Sucheta J. Doshi, Hardeep S. Sandhu, Linda V. Venczel, Karen J. Hymbaugh, Jagadish M. Deshpande, Mark A. Pallansch, Sunil Bahl, Jay D. Wenger, and Steve L. Cochi
Poliomyelitis-Related Case-Fatality Ratio in India, 2002–2006
Clin Infect Dis. (2011) 53(1): 13-19 doi:10.1093/cid/cir332

Abstract
Background. On the basis of studies from developed countries, the case-fatality ratio (CFR) of poliomyelitis generally ranges from 2%–5% among children <5 years of age to 10%–30% among adults. However, little information is available for poliomyelitis-related CFR in developing countries. We conducted a study to determine the CFR in India, 1 of the 4 remaining countries with endemic wild poliovirus (WPV) circulation, during outbreaks of WPV infection during 2002 and 2006 and during the inter-epidemic years of 2003–2005.

Methods. We conducted a descriptive analysis with use of data from the acute flaccid paralysis surveillance system in India. Variables analyzed included age, caregiver-reported vaccination status, date of paralysis onset, laboratory results, final case classification, and survival outcome. Our analysis also accounted for surveillance changes that occurred in 2005, impacting case definitions and final classification.

Results. In 2006, 45 deaths occurred among 676 WPV cases in India, yielding a CFR of 6.7%. By comparison, in 2002, there were 66 deaths among 1600 reported WPV cases (CFR, 4.2%) and during 2002–2005, CFR was 1.5%–5.2%. All 45 deaths were among 644 (95%) WPV cases in children aged <5 years (CFR, 7.0%). Among those who died, 33 (73%) were children aged <2 years (CFR, 7.1%).

Conclusions. The CFR among children aged <2 years in India is high compared with previously published Cars for young children, in part because of improved case finding through enhanced surveillance techniques. Fatal cases emphasize the lethal nature of the disease and the importance of achieving polio eradication in India.

Improved investment approach for HIV/AIDS

The Lancet  
Jun 11, 2011  Volume 377  Number 9782  Pages 1977 – 2054
http://www.thelancet.com/journals/lancet/issue/current

Health Policy
Towards an improved investment approach for an effective response to HIV/AIDS
Bernhard Schwartländer, John Stover, Timothy Hallett, Rifat Atun, Carlos Avila, Eleanor Gouws, Michael Bartos, Peter D Ghys, Marjorie Opuni, David Barr, Ramzi Alsallaq, Lori Bollinger, Marcelo de Freitas, Geoffrey Garnett, Charles Holmes, Ken Legins, Yogan Pillay, Anderson Eduardo Stanciole, Craig McClure, Gottfried Hirnschall, Marie Laga, Nancy Padian, on behalf of the Investment Framework Study Group

Preview
Substantial changes are needed to achieve a more targeted and strategic approach to investment in the response to the HIV/AIDS epidemic that will yield long-term dividends. Until now, advocacy for resources has been done on the basis of a commodity approach that encouraged scaling up of numerous strategies in parallel, irrespective of their relative effects. We propose a strategic investment framework that is intended to support better management of national and international HIV/AIDS responses than exists with the present system.

Student utilization: university 2009 H1N1 clinic

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 29, Issues 29-30  pp. 4647-4874 (24 June 2011)

Regular papers
Student utilization of a university 2009 H1N1 vaccination clinic
Pages 4687-4689
T.S. Sunil, Lisa K. Zottarelli

Abstract
The 2009 H1N1 influenza resulted in widespread outbreaks on college campuses. Once sufficient quantity of vaccine became available, many universities held vaccination clinics for students. We sought to examine factors associated with participation in an on-campus vaccination effort. A self-administered questionnaire was completed by students in January 2010. Our results suggest a high degree of awareness of the 2009 H1N1 virus among students. The odds of being vaccinated were higher for students who believed the H1N1 virus was a greater public health threat and for students who had friends and family that were vaccinated after controlling for sex, ethnicity, age, and living conditions.

HPV immunization: perceptions among Swedish school nurses

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 29, Issue 28  pp. 4535-4646 (20 June 2011)

Challenges and opportunities of a new HPV immunization program: Perceptions among Swedish school nurses
Pages 4576-4583
Maria Gottvall, Tanja Tydén, Margareta Larsson, Christina Stenhammar, Anna T. Höglund

Abstract
Aim
To investigate school nurses’ perceptions of HPV immunization, and their task of administering the vaccine in a planned school-based program in Sweden. Method: Data were collected through five focus group interviews with school nurses (n = 30). The interviews were recorded, transcribed verbatim and analyzed using content analysis.

Findings
The theme Positive attitude to HPV immunization despite many identified problems and challenges summarizes the results. The school nurses saw the program as a benefit in that the free school-based HPV immunization program could balance out social inequalities. However, they questioned whether this new immunization program should be given priority given their already tight schedule. Some also expressed doubts regarding the effect of the vaccine. It was seen as challenging to obtain informed consent as well as to provide information regarding the vaccine. The nurses were unsure of whether boys and their parents should also be informed about the immunization.

Conclusion
Although some positive aspects of the new HPV immunization program were mentioned, the school nurses primarily identified problems and challenges; e.g. regarding priority setting, informed consent, culture and gender. In order to achieve a good work environment for the school nurses, and obtain a high coverage rate for the HPV immunization, these issues need to be taken seriously, be discussed and acted upon.

Pregnant women, newborns and HPV vaccine

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 29, Issue 28  pp. 4535-4646 (20 June 2011)

Willingness of pregnant women to vaccinate themselves and their newborns with the HPV vaccine
Pages 4618-4622
Katherine P. Heyman, Michael J. Worley Jr, Melissa K. Frey, Robin T. Kessler, Diane C. Bodurka, Brian M. Slomovitz

Abstract
Objective
To evaluate the willingness of pregnant women to accept the HPV vaccine for their newborns as well as themselves.

Methods
An 18-item questionnaire was distributed to antepartum women. Demographic data about the respondent’s current pregnancy and her knowledge of HPV and the HPV vaccine was collected. Information about the respondent’s HPV and HPV vaccine status as well as her acceptance of the vaccine for herself during pregnancy and her newborn son and/or daughter after delivery was also collected.

Results
Three hundred surveys were completed and available for review. Only 6 respondents (2%) had received the HPV vaccine. Despite the small group of patients who had previously been vaccinated, 112 respondents (37.3%) stated that they would receive the HPV vaccine during pregnancy if recommended by an obstetrician. 99 respondents (33%) stated that they would vaccinate their newborn female infant and 83 (27.7%) stated would vaccinate their male infants.

Conclusion
Providing the HPV vaccine to pregnant women as well as newborns could be an important way to increase the patient population who is protected against HPV. A percentage of pregnant women are willing to accept the vaccine for themselves and their newborns.

Influenza vaccine: pregnant women in resource-constrained countries

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 29, Issue 27 pp. 4431-4534 (15 June 2011)

Reviews
Influenza vaccine for pregnant women in resource-constrained countries: A review of the evidence to inform policy decisions
Pages 4439-4452
Justin R. Ortiz, Janet A. Englund, Kathleen M. Neuzil

Abstract
Seasonal influenza is responsible for three to five million severe cases of disease annually, and up to 500,000 deaths worldwide. Pregnant women and infants suffer disproportionately from severe outcomes of influenza. The excellent safety profile and reliable immunogenicity of inactivated influenza vaccine support WHO recommendations that pregnant women be vaccinated to decrease complications of influenza disease during pregnancy. Nevertheless, influenza vaccine is not routinely used in most low-and middle-income countries and is not widely used in pregnant women worldwide.

Two recent prospective, controlled trials of maternal influenza vaccination in Bangladesh and US Native American reservations demonstrated that inactivated influenza vaccine given to pregnant women can decrease laboratory-confirmed influenza virus infection in their newborn children. These studies support consideration of the feasibility of targeted influenza vaccine programs in resource-constrained countries.

Platforms exist for the delivery of influenza vaccine to pregnant women worldwide. Even in the least developed countries, an estimated 70% of women receive antenatal care, providing an opportunity for targeted influenza vaccination. Challenges to the introduction of maternal influenza vaccination in resource-constrained countries exist, including issues regarding vaccine formulation, availability, and cost. Nonetheless, maternal influenza vaccination remains an important and potentially cost-effective approach to decrease influenza morbidity in two high-risk groups – pregnant women and young infants.

Adult women’s attitudes about vaccination: conjoint analysis

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 29, Issue 27 pp. 4431-4534 (15 June 2011)

Regular Papers
The effects of vaccine characteristics on adult women’s attitudes about vaccination: A conjoint analysis study
Pages 4507-4511
Melissa S. Stockwell, Susan L. Rosenthal, Lynne A. Sturm, Rose M. Mays, Rita M. Bair, Gregory D. Zimet

Abstract
The number of current and future vaccines for adults has been steadily increasing. Yet, vaccine coverage rates for adult vaccinations have historically been low, and less is known about how adults in the mid-adult age range make vaccine decisions for themselves. The purpose of this study was to assess which vaccine characteristics affect vaccine decision-making among mid-adult women. Adult women, aged 27–55 (n = 258) rated 9 hypothetical vaccine scenarios, each of which was defined along 4 dimensions: mode of transmission (STI or non-STI), severity of infection (curable, chronic, or fatal), vaccine efficacy (50%, 70%, or 90%), and availability of behavioral methods for prevention (available or not available). Ratings ranged from 0 to 100. Conjoint analysis was used to assess the effect of relative preferences for the vaccine scenario characteristics on participant ratings of scenarios. The mean vaccine scenario rating was 78.2. Nearly half (40%, n = 104) of participants rated all nine scenarios the same, with the majority of those (84%) holding strongly positive views. Conjoint analysis of the other 154 participants who discriminated between scenarios indicated that the main drivers for vaccine acceptability were severity of the disease and the efficacy of the vaccine to prevent the disease. Mode of transmission and availability of a preventative behavioral measure did not play a significant role. Future studies should further assess how women’s understanding of severity of the disease and efficacy of the vaccine to prevent disease may be useful for increasing vaccine acceptability.

UNICEF transparency: vaccine prices

    UNICEF said it is improving transparency around vaccine supply by making vaccine prices available on its website. As the largest buyer of children’s vaccines, UNICEF noted that the action is in line with its “commitment to ensure that vaccine supply is sustainable and affordable.” Information on market dynamics that influence vaccine uptake “will be more publicly available, starting with prices at which companies sell vaccines to UNICEF.” Shanelle Hall, Director of Supply Division, UNICEF, said, “Transparency is a core principle in itself and will support governments and partners in making more informed decisions. Transparency will also help foster a competitive, diverse supplier base for global public goods.”

UNICEF said it “undertook a consultation with all suppliers to ensure understanding and acceptance of the new policy prior to publishing vaccine prices online.  All recent and future tenders include a clause that enables UNICEF to make awarded vaccine prices publicly available, in addition to pricing and contracting information already in the public domain on UNICEF’s website.” The procurement of vaccines is UNICEF’s largest procurement activity, worth US$757 million in 2010. Last year, UNICEF provided 2.5 billion doses of vaccines to 99 countries, reaching an estimated 58 per cent of the world’s children.

http://www.unicef.org/media/media_58692.html

UNICEF Vaccine Price Data [full text]

UNICEF has a significant role within vaccine procurement for children. In recognition of this and in an attempt to be fully transparent UNICEF is now publishing a retrospective of vaccine prices.
This overview has been prepared following consultations with vaccine suppliers to UNICEF on making pricing information more transparent. A few suppliers are at this stage not able to share their price information but we hope to add this information in the future.
The vaccine prices received by UNICEF from industry are based on the UNICEF mandate, UNICEF aggregated quantities, commercial terms, reliability of forecasts, timelines of payment, and long standing relationship with industry.

Awarded Prices
The below links provide an overview of prices contracted with suppliers by UNICEF per vaccine.

http://www.unicef.org/supply/index_57476.html

UNICEF: Rich/poor disparaites grow – moral failure

UNICEF said Executive Director Anthony Lake joined world leaders at a meeting hosted by the Government of Japan “to discuss how focusing investment on the most vulnerable can improve human security and accelerate global progress toward meeting the Millennium Development Goals.” A Plenary session of the meeting “discussed the disturbing evidence that disparities between the richest and poorest children have widened, even as the world has made progress since the 2000 Millennium Declaration.”  Director Lake said, “Progress, measured by national averages, can conceal huge local disparities, and statistical success can mask moral failure. We need to come together as a global community and fully commit ourselves to reaching the hardest to reach…With the 2015 deadline for achieving the MDGs fast approaching, we must find new ways to do more with the resources we have, achieving not only more money for development, but also more development for the money.”

http://www.unicef.org/media/media_58756.html

Twitter Watch: Week to 6 June 2011

Twitter Watch
A selection of items of interest this week from a variety of twitter feeds. This capture is highly selective and by no means intended to be exhaustive.

PIH Partners In Health
“Health care programs can and should be made w/ the system as a whole in mind” http://ow.ly/58MKg #HIV #AIDS #Haiti

PATHtweets PATH

Read our China program leader Jack Zhang’s comments on China’s emerging role in #globalhealth and vaccine production. http://ow.ly/577IJ

GAVIAlliance GAVI Alliance
Vaccine alliance seeks $3.7 bln from London meeting http://ht.ly/56wlL

Transmission Elasticity

Clinical Infectious Diseases
Volume 52 Issue 12 June 15, 2011
http://www.journals.uchicago.edu/toc/cid/current

ARTICLES AND COMMENTARIES
Pieter Uys, Ben J. Marais, Simon Johnstone-Robertson, John Hargrove, and Robin Wood
Transmission Elasticity in Communities Hyperendemic for Tuberculosis
Clin Infect Dis. (2011) 52(12): 1399-1404 doi:10.1093/cid/cir229

Abstract
Backround. Despite consistently meeting international performance targets for tuberculosis case detection and treatment success, areas where tuberculosis is hyperendemic fail to achieve the predicted epidemiological impact. In this article, we explore the anomalous relationship between defined performance targets and actual reduction in tuberculosis transmission.

Methods. In areas where tuberculosis is endemic, poorly ventilated social gathering places such as shebeens (informal alcohol drinking places), minibus taxis, and clinic waiting rooms are all potential transmission hot spots. We modeled the transmission reduction achieved by removal of infectious persons in settings with different tuberculosis prevalence rates to demonstrate the concept of transmission elasticity. We then applied this concept to real-life data from a hyperendemic community in Cape Town, South Africa.

Results. In a hyperendemic area, reducing the number of infectious people by a given percentage results in a smaller percentage decrease in the annual risk of infection (ARI) compared with a nonendemic area; for example, removing 10% of infectious persons could result in as little as a 5% reduction in the ARI. With use of real-life data and removal of 60% of infectious individuals with tuberculosis, as would be achieved by meeting current performance targets of 70% case detection and 85% cure, the estimated ARI reduction is 50%.

Conclusions. The relationship between the number of infectious people removed and the decrease in ARI is nonlinear. The concept of transmission elasticity has important implications for the formulation of universal performance targets, since hyperendemic areas would require more stringent targets to achieve comparable transmission reduction.

Phacilitate Vaccine Forum

Human Vaccines
Volume 7, Issue 6  June 2011
http://www.landesbioscience.com/journals/vaccines/toc/volume/7/issue/5/

Meeting Report
How will diagnostics create new opportunities for prophylactic and therapeutic vaccines?
Niranjan Y. Sardesai

The Phacilitate Vaccine Forum in Washington DC (Jan 24-26, 2011) brought together vaccine stakeholders from industry, government and non-government organizations to discuss broad current issues covering the spectrum of vaccine policy, funding, research and clinical development, manufacturing, regulatory, and post marketing safety and surveillance. While the conference is held annually and the topics generally discussed reflect the emerging trends, case studies, and best practices of current interest to the vaccine industry, this year’s meeting had a new plenary session focusing on the intersection of diagnostics and vaccine development. The session was chaired by Dr. Una Ryan (President and CEO, Diagnostics for All) with the provocative title “How will diagnostics create new opportunitites for prophylactic and therapeutic vaccines?” and was followed by a panel discussion amongst industry leaders discussing the key diagnostic applications gaining interest in the vaccine industry. A common theme running through the session was the increasingly significant role of companion diagnostics and immune monitoring to facilitate and accelerate vaccine development. Indeed the recent examples from pneumococcal and meningococcal vaccine development where the developers and regulatory agencies have considered the use of diagnostic assays and immune markers to assess efficacy of the candidate vaccines in regards to licensure strategies for expanding the serotypes covered, can be considered as breakthrough events for the diagnostics developers. As such the meeting and the session was timely in presenting current progress and for soliciting a convergence of opinions amongst the vaccine industry and the regulatory agencies.

Synthetic biology: innovative vaccines

Human Vaccines
Volume 7, Issue 6  June 2011
http://www.landesbioscience.com/journals/vaccines/toc/volume/7/issue/5/

Commentary
Synthetic biology: Impact on the design of innovative vaccines
Kathrin Kindsmüller and Ralf Wagner

Conventional vaccine design strategies mainly focus on live-attenuated vaccines, inactivated microorganisms, and subunits thereof comprising purified components or recombinantly expressed proteins, mostly formulated with adjuvants. Although generally very efficient, these approaches are suboptimal or unfeasible for some infectious diseases. Over the past years new technologies to vaccine development have evolved, often utilizing design principles and construction technologies of synthetic biology. The contribution of synthetic biology to vaccine development comprises algorithms for accelerated in silico identification of relevant protein candidates, in silico design of novel immunogens with improved expression, safety and immunogenicity profiles as well as in silico design of (1) nucleic acid based, (2) vectored and (3) live-attenuated vaccines. Furthermore, synthetic biology enables economic and rapid chemical synthesis of DNA encoding the immunogens designed in silico, and their efficient assembly with delivery systems to obtain vectored vaccines. Altogether, synthetic biology can help to develop improved vaccine candidates in considerably less time compared to conventional approaches.

Strategic Approach to Therapeutic Cancer Vaccines

JAMA   
June 8, 2011, Vol 305, No. 22, pp 2257-2368
http://jama.ama-assn.org/current.dtl

Commentaries
A Strategic Approach to Therapeutic Cancer Vaccines in the 21st Century
Matthew M. Davis, Elias J. Dayoub
JAMA. 2011;305(22):2343-2344.doi:10.1001/jama.2011.814

Extract: First 150 words
Prophylactic vaccines have forever reduced the burden of disease in the United States and around the world. 1 One of the critical keys to success for prophylactic vaccines was that scientists set their sights on high-burden infectious diseases—frequently with high incidence, and often with high rates of mortality and morbidity and minimally effective therapeutic options at the time vaccines were developed.

Now, in the midst of a golden era of continuing prophylactic vaccine successes, 2 therapeutic vaccines for cancer are being developed. Currently available treatments with surgery, chemotherapy, and radiation therapy help about 2 of every 3 patients diagnosed with cancer survive for at least 5 years in the United States, 3 but many of those patients experience treatment complications and morbidities that reduce their quality of life. Therapeutic vaccines that trigger individuals’ targeted immune response against tumor-specific antigens and tumor-associated antigens may offer patients with cancer dual benefits of …

RTS,S/AS01E: Blood Stage Immunity in Young Children

Journal of Infectious Diseases
Volume 204 Issue 1   July 1, 2011
http://www.journals.uchicago.edu/toc/jid/current

MAJOR ARTICLES AND BRIEF REPORTS: PARASITES
Philip Bejon, Jackie Cook, Elke Bergmann-Leitner, Ally Olotu, John Lusingu, Jedidah Mwacharo, Johan Vekemans, Patricia Njuguna, Amanda Leach, Marc Lievens, Sheetij Dutta, Lorenz von Seidlein, Barbara Savarese, Tonya Villafana, Martha M. Lemnge, Joe Cohen, Kevin Marsh, Patrick H. Corran, Evelina Angov, Eleanor M. Riley, and Chris J. Drakeley

Effect of the Pre-erythrocytic Candidate Malaria Vaccine RTS,S/AS01E on Blood Stage Immunity in Young Children
J Infect Dis. (2011) 204(1): 9-18 doi:10.1093/infdis/jir222

Abstract [Free full text]
Background. RTS,S/AS01E is the lead candidate malaria vaccine and confers pre-erythrocytic immunity. Vaccination may therefore impact acquired immunity to blood-stage malaria parasites after natural infection.

Methods. We measured, by enzyme-linked immunosorbent assay, antibodies to 4  Plasmodium falciparum merozoite antigens (AMA-1, MSP-142, EBA-175, and MSP-3) and by growth inhibitory activity (GIA) using 2 parasite clones (FV0 and 3D7) at 4 times on 860 children who were randomized to receive with RTS,S/AS01E or a control vaccine.

Results. Antibody concentrations to AMA-1, EBA-175, and MSP-1 42 decreased with age during the first year of life, then increased to 32 months of age. Anti–MSP-3 antibody concentrations gradually increased, and GIA gradually decreased up to 32 months. Vaccination with RTS,S/AS01E resulted in modest reductions in AMA-1, EBA-175, MSP-142, and MSP-3 antibody concentrations and no significant change in GIA. Increasing anti-merozoite antibody concentrations and GIA were prospectively associated with increased risk of clinical malaria.

Conclusions. Vaccination with RTS,S/AS01E reduces exposure to blood-stage parasites and, thus, reduces anti-merozoite antigen antibody concentrations. However, in this study, these antibodies were not correlates of clinical immunity to malaria. Instead, heterogeneous exposure led to confounded, positive associations between increasing antibody concentration and increasing risk of clinical malaria.

Early Estimate: Effectiveness of Quadrivalent Meningococcal Conjugate Vaccine

The Pediatric Infectious Disease Journal
June 2011 – Volume 30 – Issue 6  pp: A9-A10,451-542,e88-e108
http://journals.lww.com/pidj/pages/currenttoc.aspx

Original Studies
Early Estimate of the Effectiveness of Quadrivalent Meningococcal Conjugate Vaccine
MacNeil, Jessica R.; Cohn, Amanda C.; Zell, Elizabeth R.; Schmink, Susanna; Miller, Elaine; Clark, Thomas; Messonnier, Nancy E.; for the Active Bacterial Core surveillance (ABCs) Team and MeningNet Surveillance Partners
Pediatric Infectious Disease Journal. 30(6):451-455, June 2011.
doi: 10.1097/INF.0b013e31820a8b3c

Abstract:
Background: In January 2005, a quadrivalent meningococcal conjugate vaccine (MenACWYD) was licensed for use in the United States. The Advisory Committee on Immunization Practices recommends MenACWYD for all adolescents 11 to 18 years of age and others at increased risk for meningococcal disease.

Methods: Reports of breakthrough meningococcal disease after vaccination with MenACWYD were collected. A simulation approach was used to estimate the expected number of cases in vaccinated persons.

Results: Between 2005 and 2008, 14 breakthrough cases, including 3 deaths occurred. At a vaccine effectiveness (VE) of 90%, 7 breakthrough cases would be expected (range, 1–17); at VE of 85%, 11 cases (range, 2–30); at VE of 80%, 15 cases (range, 5–28); and at VE of 75%, 18 cases (range, 7–32) would be expected. The probability of the ≥14 observed cases occurring was 2.9% at VE of 90%, 29.3% at VE of 85%, 66.1% at VE of 80%, and 83.0% at VE of 75%.

Conclusions: This report provides an early estimate of MenACWYD effectiveness within 3 to 4 years after vaccination, and suggests that MenACWYD effectiveness is 80% to 85%, similar to the VE reported for meningococcal polysaccharide vaccine.

H influenzae Type b–N meningitidis C/Y Conjugate Vaccine in Infants

Pediatrics
June 2011, VOLUME 127 / ISSUE 6
http://pediatrics.aappublications.org/current.shtml

Articles
Immunogenicity and Safety of H influenzae Type b–N meningitidis C/Y Conjugate Vaccine in Infants
Kristina A. Bryant, Gary S. Marshall, Colin D. Marchant, Noris Pavia-Ruiz, Terry Nolan, Stephen Rinderknecht, Mark Blatter, Emmanuel Aris, Pascal Lestrate, Dominique Boutriau, Leonard R. Friedland, and Jacqueline M. Miller
Pediatrics 2011; 127:e1375-e1385

Abstract
BACKGROUND: Meningococcal disease incidence is highest in children younger than 2 years of age, yet there is no US-licensed vaccine for this age group. A phase III study evaluated the immunogenicity and safety of an investigational Haemophilus influenzae type b (Hib)–Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY).

MATERIALS AND METHODS: A total of 4180 infants were randomly assigned to receive the HibMenCY at the ages of 2, 4, 6, and 12 to 15 months or the licensed Hib tetanus toxoid conjugate vaccine (ActHIB) at 2, 4, and 6 months and Hib conjugated to N meningitidis outer membrane protein (PedvaxHIB) at 12 to 15 months. Routinely scheduled vaccines were coadministered. Serum bactericidal activity using human complement and anti–polyribosylribitol phosphate antibodies were assessed in 991 subjects. Local and systemic adverse reactions were recorded for 4 days after each dose.

RESULTS: The percentage of HibMenCY recipients with serum bactericidal assay using human complement titers of 1:8 or higher after dose 3 was 98.8% for N meningitidis serogroup C (MenC) and 95.8% for N meningitidis serogroup Y (MenY). After dose 4, the percentages were 98.5% and 98.8%, respectively. The percentage of HibMenCY recipients with postdose 3 anti-polyribosylribitol phosphate antibody levels of ≥1.0 μg/mL was noninferior to that of control (96.3% vs 91.2%). After dose 4, MenC and MenY serum bactericidal assay using human complement antibody titers increased 12-fold over pre–dose 4 levels. Incidence of pain, redness, and swelling at the HibMenCY injection sites tended to be lower than with Hib type b after the first 3 doses and after the fourth dose. Rates of systemic symptoms were similar across groups.

CONCLUSIONS: The HibMenCY was immunogenic against MenC and MenY and induced anti–polyribosylribitol phosphate antibody levels noninferior to those of licensed Hib conjugate vaccine. The safety profile of the HibMenCY was clinically acceptable and comparable to Hib conjugate vaccine.

Principles of Pediatric Patient Safety

Pediatrics
June 2011, VOLUME 127 / ISSUE 6
http://pediatrics.aappublications.org/current.shtml

Principles of Pediatric Patient Safety: Reducing Harm Due to Medical Care
Steering Committee on Quality Improvement and Management and Committee on Hospital Care
Pediatrics 2011; 127:1199-1210

Abstract
Pediatricians are rendering care in an environment that is increasingly complex, which results in multiple opportunities to cause unintended harm. National awareness of patient safety risks has grown in the 10 years since the Institute of Medicine published its report To Err Is Human, and patients and society as a whole continue to challenge health care providers to examine their practices and implement safety solutions. The depth and breadth of harm incurred by the practice of medicine is still being defined as reports continue to uncover a variety of avoidable errors, from those that involve specific high-risk medications to those that are more generalizable, such as patient misidentification. Pediatricians in all venues must have a working knowledge of patient-safety language, advocate for best practices that attend to risks that are unique to children, identify and support a culture of safety, and lead efforts to eliminate avoidable harm in any setting in which medical care is rendered to children.

Children’s preferences: influenza vaccine attributes

Vaccine
Volume 29, Issue 26 pp. 4299-4430 (10 June 2011)
http://www.sciencedirect.com/science/journal/0264410X

Regular Papers
A survey of children’s preferences for influenza vaccine attributes
Pages 4334-4340
Emuella M. Flood, Kellie J. Ryan, Matthew D. Rousculp, Kathleen M. Beusterien, Stan L. Block, Matthew C. Hall, Parthiv J. Mahadevia

Abstract
Background
While annual influenza vaccination is recommended by the CDC for children 6 months and older, vaccination rates remain suboptimal. For healthy, US children 2 years of age and older, influenza vaccine is available as an intramuscular injection (TIV) or an intranasal spray (LAIV), respectively. Little is known about children’s experiences and preferences for influenza vaccine attributes.

Objective
To examine preferences for influenza vaccine attributes and their relative importance among children.

Methods
A quantitative web-survey was administered to children aged 8–12 years sampled from a standing online panel representative of the US population. Children were stratified by age, gender and parent’s influenza vaccination behavior. The survey included questions to ascertain children’s preferences for influenza vaccine attributes, including efficacy, chance of common side effects, and mode of administration. It included conjoint (trade-off) questions in which children traded-off different attributes in their choice between two influenza vaccines with differing features. We also surveyed children’s comprehension of and ability to complete the conjoint questions.

Results
544 children completed the survey (response rate 37%). Children most frequently selected efficacy as the most important vaccine attribute followed by mode of administration (45% and 31%, respectively). When asked for their preference to receive influenza vaccine as a “shot” or a “nose spray”, the majority (69%) preferred the nose spray. An evaluation of children’s ability to complete the conjoint survey demonstrated that 85% of the sample was able to complete the conjoint tasks. Analysis of the conjoint responses demonstrated that mode of administration and efficacy had the greatest impact on preferences, with a relative importance of 40.5% and 30.6%, respectively. In a direct comparison of vaccine profiles representing the efficacy, side effects, and other characteristics of LAIV and TIV, 79% of children preferred the LAIV-like profile.

Conclusion
Children in the sample had consistent opinions regarding influenza vaccine attributes and consider vaccine efficacy and mode of administration to be important. Children can be informed participants in influenza prevention and can be included in discussions regarding influenza vaccination.

Vaccine-preventable pediatric influenza pneumonia: Thailand

Vaccine
Volume 29, Issue 26 pp. 4299-4430 (10 June 2011)
http://www.sciencedirect.com/science/journal/0264410X

Regular Papers
A method for estimating vaccine-preventable pediatric influenza pneumonia hospitalizations in developing countries: Thailand as a case study
Pages 4416-4421
Fatimah S. Dawood, Alicia M. Fry, Charung Muangchana, Wiwan Sanasuttipun, Henry C. Baggett, Supamit Chunsuttiwat, Susan A. Maloney, James Mark Simmerman

Abstract
The burden of influenza in children is increasingly appreciated; some middle-income countries are considering support for influenza vaccine programs. To support decision-making, methods to estimate the potential impact of proposed programs are needed. Using Thailand as a case-study, we present a model that uses surveillance data, published vaccine effectiveness estimates, and vaccination coverage assumptions to estimate the impact of influenza vaccination on pediatric influenza pneumonia hospitalizations. Approximately 56,000 influenza pneumonia hospitalizations occur annually among children aged <18 years in Thailand; 23,700 (41%) may be vaccine-preventable. Vaccination of 85% of Thai children aged 7 months–4 years might prevent 30% of all pediatric influenza pneumonia hospitalizations in Thailand.