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February 20, 2017 - In a report published today in the Proceedings of the National Academy of Sciences (Attenuated PfSPZ vaccine induces strain-transcending T cells and durable protection against heterologous controlled human malaria infection), investigators from the National Institute of Allergy and Infectious Diseases (NIAID), NIH and the University of Maryland School of Medicine reported that nine of fourteen subjects (64%) immunized with three doses of Sanaria® PfSPZ Vaccine were protected against homologous challenge with Plasmodium falciparum malaria 19 weeks after their last vaccine dose. Moreover, five of six of the protected subjects who underwent a subsequent heterologous challenge with Plasmodium falciparum 33 weeks after their last vaccine dose were protected. Dr. Robert A. Seder, MD, of the Vaccine Research Center, NIAID, NIH and Dr. Kirsten Lyke, MD at The University of Maryland School of Medicine led the studies. PfSPZ Vaccine was administered to the 14 subjects at a higher vaccine dose than had been given in prior studies; the research also demonstrated that the three doses were safe. PfSPZ Vaccine is comprised of live, attenuated malaria parasites. Volunteers in the clinical trial received three 0.5 mL injections of the vaccine by rapid direct venous inoculation. The clinical trial included volunteers 19 to 45 years old. Fourteen volunteers received at least three doses of PfSPZ Vaccine, 12 volunteers were control subjects. Nineteen weeks after last immunization, nine of the fourteen volunteers (64%) who received 3 doses of PfSPZ Vaccine were protected against malaria parasites similar to those in the vaccine that were transmitted by exposure to malaria-infected mosquitoes. In a subset of the protected subjects, five out of six vaccinated subjects were protected against parasites different from those in the vaccine thirty-three weeks after the final immunization. All 12 control volunteers developed malaria. Collectively, these data show that a 3-dose regimen of PfSPZ Vaccine confers durable protection against malaria parasites that are same and different than the malaria parasites from which the vaccine is made. Dr. Stanley Plotkin, former Medical and Scientific Director of the vaccine company, Aventis Pasteur, now Sanofi Pasteur, discoverer of the German measles vaccine, and perhaps the most prominent vaccinologist in the U.S. said, "For my entire career I have been hearing about the potential for a highly effective malaria vaccine that protects through induction of strain-transcending killer T cells. This paper indicates that PfSPZ Vaccine induces this type of immunity. This is an enormously important finding. The next step is to refine the immunization regimen to achieve even higher levels of protection, and I am optimistic this team of investigators will succeed." African children are hardest hit by malaria. The World Health Organization estimates that in 2015 malaria caused 214M clinical episodes and 438,000 deaths worldwide; others have estimated up to 730,500 malaria deaths in 2015. This enormous morbidity and mortality occurs despite investment of billions of dollars in malaria control efforts. Malaria is also a concern for tourists, diplomats, business travelers, aid workers, industrial workers, and military personnel worldwide. Professor Chris Plowe, Founding Director, Institute for Global Health, University of Maryland School of Medicine said, "Because of the spread of drug resistance, we're dangerously close to having truly untreatable malaria. A highly effective vaccine is desperately needed to move faster toward elimination and to prevent losing ground to resistance. These results confirming that a single-strain whole organism vaccine can be effective against diverse strains of malaria are an important step toward having an immunization regimen that can be used for mass vaccination campaigns to eliminate malaria from populations and prevent infection in individual travelers." Adel Mahmoud, former President of Merck Vaccines, and Sanaria and Foundation for Vaccine Research Director said, "Vaccines are the most highly efficient interventions for control and elimination of infectious diseases. The world needs a highly effective malaria vaccine. Sanaria's PfSPZ-based vaccines are the only malaria vaccines to have shown >90% protective efficacy at any point after the last dose of vaccine. This report moves Sanaria one step closer to establishing an immunization regimen that provides the long-term, high-level protection against malaria that we so desperately need to achieve elimination of this deadly parasite, which has been the scourge of humanity for so many millenia." About Sanaria Inc.: Sanaria's mission is to commercialize whole-parasite malaria vaccines that confer high level, long-lasting protection against malaria, and use these vaccines to prevent malaria in individuals and eliminate malaria from entire regions. Sanaria is based in Rockville, Maryland. This news release contains certain forward-looking statements that involve known and unknown risks and uncertainties, which may cause actual results to differ materially from anticipated results or achievements expressed or implied by the statements made. Such statements include the availability of an effective vaccine, the expectations for eliminating malaria, and beliefs concerning the suitability of a successful vaccine. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the Company's ability to raise sufficient funds, the regulatory approval process, clinical trials results, the Company's patent portfolio, dependence on key personnel and other risks associated with vaccine development. For further information contact Alexander Hoffman,, 301-339-0092 or Jamie Baum, newsPRos, PR Counsel, 847-502-3825,

Grabenstein J.D.,Merck Vaccines | Klugman K.P.,Emory University | Klugman K.P.,University of Witwatersrand
Clinical Microbiology and Infection | Year: 2012

Sir Almroth Wright coordinated the first trial of a whole-cell pneumococcal vaccine in South Africa from 1911 to 1912. Wright started a chain of events that delivered pneumococcal vaccines of increasing clinical and public-health value, as medicine advanced from a vague understanding of the germ theory of disease to today's rational vaccine design. Early whole-cell pneumococcal vaccines mimicked early typhoid vaccines, as early pneumococcal antisera mimicked the first diphtheria antitoxins. Pneumococcal typing systems developed by Franz Neufeld and others led to serotype-specific whole-cell vaccines. Pivotally, Alphonse Dochez and Oswald Avery isolated pneumococcal capsular polysaccharides in 1916-17. Serial refinements permitted Colin MacLeod and Michael Heidelberger to conduct a 1944-45 clinical trial of quadrivalent pneumococcal polysaccharide vaccine (PPV), demonstrating a high degree of efficacy in soldiers against pneumococcal pneumonia. Two hexavalent PPVs were licensed in 1947, but were little used as clinicians preferred therapy with new antibiotics, rather than pneumococcal disease prevention. Robert Austrian's recognition of high pneumococcal case-fatality rates, even with antibiotic therapy, led to additional trials in South Africa, the USA and Papua New Guinea, with 14-valent and 23-valent PPVs licensed in 1977 and 1983 for adults and older children. Conjugation of polysaccharides to proteins led to several pneumococcal conjugate vaccines licensed since 2000, enabling immunization of infants and young children and resultant herd protection for all ages. Today, emergence of disease caused by pneumococcal serotypes not included in various vaccine formulations fuels research into conserved proteins or other means to maximize protection against more than 90 known pneumococcal serotypes. © 2012 The Authors. Clinical Microbiology and Infection © 2012 European Society of Clinical Microbiology and Infectious Diseases.

Grabenstein J.D.,Merck Vaccines
Vaccine | Year: 2013

For millennia, humans have sought and found purpose, solace, values, understanding, and fellowship in religious practices. Buddhist nuns performed variolation against smallpox over 1000 years ago. Since Jenner developed vaccination against smallpox in 1796, some people have objected to and declined vaccination, citing various religious reasons. This paper reviews the scriptural, canonical basis for such interpretations, as well as passages that support immunization. Populous faith traditions are considered, including Hinduism, Buddhism, Jainism, Judaism, Christianity, and Islam. Subjects of concern such as blood components, pharmaceutical excipients of porcine or bovine origin, rubella strain RA 27/3, and cell-culture media with remote fetal origins are evaluated against the religious concerns identified.The review identified more than 60 reports or evaluations of vaccine-preventable infectious-disease outbreaks that occurred within religious communities or that spread from them to broader communities. In multiple cases, ostensibly religious reasons to decline immunization actually reflected concerns about vaccine safety or personal beliefs among a social network of people organized around a faith community, rather than theologically based objections per se. Themes favoring vaccine acceptance included transformation of vaccine excipients from their starting material, extensive dilution of components of concern, the medicinal purpose of immunization (in contrast to diet), and lack of alternatives. Other important features included imperatives to preserve health and duty to community (e.g., parent to child, among neighbors). Concern that 'the body is a temple not to be defiled' is contrasted with other teaching and quality-control requirements in manufacturing vaccines and immune globulins.Health professionals who counsel hesitant patients or parents can ask about the basis for concern and how the individual applies religious understanding to decision-making about medical products, explain facts about content and processes, and suggest further dialog with informed religious leaders. Key considerations for observant believers for each populous religion are described. © 2013 Elsevier Ltd.

Gerberding J.L.,Merck Vaccines
Infection Control and Hospital Epidemiology | Year: 2010

Healthcare epidemiology is a robust and adaptable profession with the noble mission of protecting patients and their healthcare providers from infectious diseases and other threats. Change is the constant that links the successes of our field in each decade of our history. Although it is not possible to predict what specific challenges the next decade will bring, the themes of the Sixth Decennial International Conference in 2020 are likely to reflect the most prominent drivers of change that are affecting our profession, including globalization, sustainability, and consumer empowerment. © 2010 by The 5th Decennial on Healthcare-Associated Infections, LLC. All rights reserved.

Staprans S.I.,Merck Vaccines | Feinberg M.B.,Merck Vaccines | Shiver J.W.,Merck And Co. | Casimiro D.R.,Merck And Co.
Current Opinion in HIV and AIDS | Year: 2010

Purpose of review: To consider how nonhuman primate (NHP) model systems can best contribute to HIV vaccine development. Recent Findings: We review the traditional roles of NHP model systems in vaccine development and compare this with how NHP models have been used in HIV vaccine research and development. Comparisons of the immune responses elicited by cellular immune response-inducing vaccines in macaques and humans illustrate the value of primate studies for the relative ranking of HIV vaccine concepts for their likely immunogenicity in humans. The unusual structures (e.g. long complementarity-determining regions) of known broadly neutralizing HIV antibodies (bNAbs) suggest that it is critical to test candidate env immunogens in NHPs, whose germline antibody repertoires resemble those of humans. Recent clinical efficacy trial results question the utility of existing NHP challenge models in predicting HIV vaccine efficacy in humans, and highlight the need to further develop models in which acquisition of infection can be reliably evaluated. When evaluated in models using low virus dose challenges that better approximate human sexual exposure to HIV - some vaccine and passive NAb interventions appear to protect against acquisition of infection. Summary: NHP models have important roles in the preclinical evaluation, optimization, and ranking of novel HIV immunogens. The apparent vaccine efficacy observed using low virus dose challenge models provides an opportunity to investigate the correlates of protection. © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Since publication of a 1997 review of the immunogenicity and safety data for pneumococcal polysaccharide vaccines (PPSVs), dozens of additional studies have been published, involving larger cohorts, longer observation periods, and more specific assays. Additionally, a 13-valent pneumococcal conjugate vaccine (PCV) has been licensed for adults. This paper reviews adult studies assessing antibody persistence for ≥3 years after pneumococcal vaccination, and adult studies of immunogenicity and safety after revaccination. This review emphasizes the currently registered PPSV23 formulations containing 25-μg polysaccharide per serotype, for which far more long-term data are available. Broadly, IgG and functional antibody levels after PPSV23 in adults persist above concentrations in unvaccinated adults for at least 5-10 years in most studies. The few exceptions involve populations of non-ambulatory adults or those with confounding host-factor issues. Revaccination with PPSV23 5-10 years after a previous dose consistently and substantially increases both IgG and functional antibody levels. There is an inverse association between circulating antibody level just before primary or revaccination and subsequent antibody increase. Although injection-site reactions (e.g., pain, swelling, redness) were reported more commonly after PPSV23 revaccination than after primary vaccination in most studies, these reactions typically resolved within 5 days. We interpret the contemporary literature as supporting pneumococcal revaccination as a means to sustain anti-pneumococcal antibodies at levels greater than among unvaccinated adults. PPSV23 is a broad-spectrum public-health tool to help prevent serious pneumococcal diseases across the adult lifespan. © 2012 Elsevier Ltd.

Dalrymple D.W.,Dalrymple and Associates LLC | Grabenstein J.D.,Merck Vaccines
Vaccine | Year: 2014

The US Government (USG) can date its involvement with immunization to military and civilian efforts in 1777 and 1813 to prevent smallpox. USG involvement began accelerating with federal licensing of vaccine and antibody manufacturers in 1903. In addition to ongoing regulation of manufacturing and product quality, military and civilian arms of the USG have led research efforts into new or improved vaccines. These efforts have included diseases endemic in the United States, as well as medical countermeasures targeted against biological weapons, influenza pandemics, and emerging infectious diseases. Especially since the 1950s, the USG has provided increasing levels of funding to purchase vaccines and conduct vaccination programs. These programs have focused largely on children, although vaccination programs for adults have been expanded somewhat in recent years. Multiple agencies of the USG have convened various panels of accomplished external experts who have generated widely regarded recommendations on vaccine safety and efficacy and optimal immunization practices. USG programs for safety assessment, injury compensation, liability protection, and disease surveillance have been developed to assess needs, evaluate safety questions, ensure vaccine supply, and foster confidence in vaccination efforts. Debates on the extent of government involvement date back to the 1890s and continue today. Several pivotal expansions of government involvement followed disease outbreaks or manufacturing accidents. This historical survey describes each of the major US federal programs in these categories, including references to applicable law. © 2014 Elsevier Ltd.

Chen J.,Abbott Laboratories | Heyse J.F.,Merck And Co. | Heaton P.,Novartis | Kuter B.J.,Merck Vaccines
American Journal of Epidemiology | Year: 2010

The relation between the risk of intussusception and age at the time of receipt of the first dose of rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) has been studied extensively on the basis of Centers for Disease Control and Prevention (CDC) matched case-control study data, using various statistical methods, including conditional logistic regression and quadratic smoothing splines. However, different conclusions have been reported in published analyses regarding the dependence of the risk of intussusception on age at first dose. The authors reanalyzed the CDC matched case-control data set using unrestricted and restricted quadratic smoothing spline methods for various exposure windows (i.e., intervals postvaccination). These analyses indicated that the use of different models may lead to different conclusions. The restricted quadratic smoothing spline with appropriately chosen knot locations showed a statistically significant increased risk of intussusception associated with RRV-TV for the exposure window 3-14 days after the first dose at an age as young as 49 days, the youngest age in the data set at which vaccine was administered; this implies an increased risk of intussusception associated with RRV-TV at all ages studied. © The Author 2010.

Gerberding J.L.,Merck Vaccines
South Dakota medicine : the journal of the South Dakota State Medical Association | Year: 2013

Vaccines are one of the greatest public health achievements and have had a tremendous impact on people's health and survival around the world. Nevertheless, highly prevalent infectious disease threats unresponsive to traditional immunization strategies, emerging and re-emerging threats, and non-communicable diseases amenable to immunization remain critical global health challenges. Scientific advances will reveal solutions, but it will take political, social and economic commitment from all stakeholders for these solutions to achieve their health protection benefit among the people who need them most.

Grabenstein J.D.,Merck Vaccines | Musey L.K.,Merck And Co.
Vaccine | Year: 2014

Background: Infections due to Streptococcus pneumoniae serotypes differ in clinical manifestations among adults, varying in propensity for severity, invasiveness, and lethality. To characterize differences in serious outcomes between pneumococcal serotypes, we systematically reviewed the literature. Methods: After distilling 676 hits to 28 relevant articles, statistically significant differences in individual serotypes associated with serious clinical outcomes were assessed. Serotypes associated with elevated risk of serious clinical outcomes were evaluated in terms of serotypes included in licensed adult pneumococcal vaccines (i.e., 23-valent pneumococcal polysaccharide vaccine (PPSV23) and 13-valent pneumococcal conjugate vaccine (PCV13)). Repeated findings were considered a measure of robustness. Results: Among adult studies evaluating serious clinical outcomes, the following serotypes were associated with elevated risk: Empyema (serotypes 1, 3, 5, 7F, 8, 19A), necrotizing pneumonia (serotype 3), septic shock (serotypes 3, 19A), meningitis (repeatedly serotypes 10A, 15B, 19F, 23F), reduced quality-adjusted life years (QALYs, serotypes 15B, 3, 10A, 9N, 19F, 11A, 31), and increased case-fatality rates (repeatedly serotypes 3, 6B, 9N, 11A, 16F, 19F, 19A). Conclusion: Both vaccine formulations include multiple pneumococcal serotypes associated with increased risk for serious clinical outcomes. Three studies found elevated risk from serotype 6A (unique to PCV13). Fourteen studies found elevated risk from nine serotypes unique to PPSV23 (repeatedly: case-fatality-11A & 9N, meningitis-10A & 15B). Seven studies found elevated risk from serotypes not represented in either vaccine formulation (notably 16F). The pneumococcal serotypes repeatedly associated with elevated risk of serious outcomes in adults are an important consideration for vaccine policy making. © 2014 Elsevier Ltd.

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