Sanaria initiates Phase 1 clinical trial of unique malaria vaccine candidate/MVI

Sanaria Inc. said that, with support from the PATH Malaria Vaccine Initiative (MVI), it has “initiated a Phase 1 clinical trial — the first tests in adult volunteers — of its unique malaria vaccine candidate. Unlike other malaria vaccine candidates, Sanaria’s approach deploys a weakened form of the whole malaria parasite harvested from irradiated mosquitoes instead of small portions of the parasite.” Sanaria’s vaccine candidate will be assessed in healthy US volunteers at two sites in Maryland — the US Naval Medical Research Center Clinical Trials Center in Bethesda and the Center for Vaccine Development at the University of Maryland School of Medicine in Baltimore. Recruitment has begun for the safety and efficacy study that will involve some 104 volunteers, with inoculation of the first groups expected to begin in mid-May.

Dr. Christian Loucq, Director of MVI, commented, “Initiation of this trial expands the spectrum of malaria vaccines in clinical development today. This trial marks a major achievement in a collaborative development effort that aims to determine whether Sanaria’s vaccine candidate is safe and effective.”

(PRNewswire, 23 April 2009)

IVI linceses new oral cholera vaccine to Shantha Biotechnics, India

The International Vaccine Institute (IVI) said a new oral cholera vaccine it developed has been licensed in India, “paving the way for the worldwide use of a low-cost cholera vaccine that is suitable for use in developing countries, where most cholera cases occur.”  Dr. John Clemens, Director-General of the IVI, said,”The licensure of the vaccine in India, where national regulatory authority is approved by the World Health Organization (WHO), paves the way for a wider use of the vaccine in cholera-endemic populations in Asia and elsewhere. We are delighted that the vaccine will be produced by Shantha Biotechnics, in Hyderabad, a company with a strong record of supplying high-quality vaccines to United Nations agencies, such as UNICEF.”

IVI said cholera remains an important public health problem in the developing world. In 2007, 177,963 cholera cases and 4,031 deaths were reported to WHO from 53 countries, with 94 percent of cases reported from Africa. The true figures are likely to be much higher, due to under-reporting, and as many as 120,000 deaths are estimated to occur each year from the disease. A recent outbreak in Zimbabwe has infected nearly 80,000 people, killing at least 4,000 since last August.

IVI noted that “despite recommendations from WHO for the use of new-generation oral cholera vaccines in 2001, no country has yet introduced cholera vaccines into its immunization program, with the exception of Vietnam, which has been using a locally produced oral cholera vaccine since 1997 following technology transfer from Swedish scientists. There is only one internationally licensed oral cholera vaccine that is currently available. But this vaccine, Dukoral produced by Crucell/SBL Vaccines, is too expensive ($30 in Scandinavia, $18 in Bangladesh) for developing country populations who need the vaccine most, and has been used mainly by travelers from developed countries.”

Adenovirus 14a: A New Epidemic Threat

Journal of Infectious Diseases
15 May 2009  Volume 199, Number 10

Human Adenovirus 14a: A New Epidemic Threat
Gregory C. Gray and Margaret L. Chorazy
Center for Emerging Infectious Diseases, Department of Epidemiology, College of Public Health, University of Iowa, Iowa City

Outbreak of Severe Respiratory Disease Associated with Emergent Human Adenovirus Serotype 14 at a US Air Force Training Facility in 2007
Jacqueline E. Tate,1; Michel L. Bunning,3; Lisa Lott,4; Xiaoyan Lu,1; John Su,2,6; David Metzgar,7; Lorie Brosch,3; Catherine A. Panozzo,1; Vincent C. Marconi,5; Dennis J. Faix,7; Mila Prill,1; Brian Johnson,1; Dean D. Erdman,1; Vincent Fonseca,6; Larry J. Anderson,1 and Marc-Alain Widdowson1

Background.In 2007, a US Air Force training facility reported a cluster of severe respiratory illnesses associated with a rare human adenovirus (Ad) serotype, Ad14. We investigated this outbreak to better understand its epidemiology, clinical spectrum, and associated risk factors.

Methods.Data were collected from ongoing febrile respiratory illness (FRI) surveillance and from a retrospective cohort investigation. Because an Ad7 vaccine is in development, Ad7 antibody titers in pretraining serum samples from trainees with mild and those with severe Ad14 illness were compared.

Results.During 2007, an estimated 551 (48%) of 1147 trainees with FRI were infected with Ad14; 23 were hospitalized with pneumonia, 4 required admission to an intensive care unit, and 1 died. Among cohort members ( ), the Ad14 infection rate was high (50%). Of those infected, 40% experienced FRI. No cohort members were hospitalized. Male sex (risk ratio [RR], 4.7 [95% confidence interval {CI}, 2.2-10.1]) and an ill close contact (RR, 1.6 [95% CI, 1.2-2.2]) were associated with infection. Preexisting Ad7 neutralizing antibodies were found in 7 (37%) of 19 Ad14‐positive trainees with mild illness but in 0 of 16 trainees with Ad14 pneumonia ( ).

Conclusions.Emergence of Ad14, a rare Ad serotype, caused a protracted outbreak of respiratory illness among military recruits. Most infected recruits experienced FRI or milder illnesses. Some required hospitalization, and 1 died. Natural Ad7 infection may protect against severe Ad14 illness.

1Division of Viral Diseases and 2Office of Workforce and Career Development, Centers for Disease Control and Prevention, Atlanta, Georgia; 337th Medical Group, US Air Force, 4Epidemic Outbreak Surveillance, Modernization Directorate, Office of the Air Force Surgeon General, and 5Infectious Disease Service, Wilford Hall US Air Force Medical Center, Lackland Air Force Base, San Antonio, and 6Texas Department of State Health Services, Austin; 7Naval Health Research Center, San Diego, California

A CommunityBased Outbreak of Severe Respiratory Illness Caused by Human Adenovirus Serotype 14
Paul F. Lewis,1,a,b; Mark A. Schmidt,1,a; Xiaoyan Lu,3; Dean D. Erdman,3; Mary Campbell,2 ; Ann Thomas,1; Paul R. Cieslak,1; La Donna Grenz,1; Laura Tsaknardis,1; Curt Gleaves,2; Brian Kendall,2,b and David Gilbert2

Background.Human adenoviruses (Ads) typically cause mild illnesses in otherwise healthy hosts. We investigated a community‐based outbreak that had substantial morbidity caused primarily by Ad14, an uncommon serotype.

Methods.We retrospectively reviewed the medical records of all patients with confirmed cases of Ad infection from 1 November 2006 through 31 July 2007 in Oregon. Isolates were typed by sequencing. We analyzed clinical and laboratory variables to identify risk factors for severe Ad14 disease.

Results.Ad14 first emerged in Oregon in 2005. Of 67 cases of Ad infection detected during the study period, 40 (60%) involved Ad14. Most of the 38 Ad14‐infected patients who had medical records available for review presented with fever and cough; 29 (76%) required hospitalization, 23 (61%) required supplemental oxygen, 18 (47%) required critical care, 9 (24%) required vasopressors, and 7 (18%) died. Lobar infiltrates on chest radiographs suggestive of bacterial pneumonia were common among those needing hospitalization. Older age, chronic underlying condition, low absolute lymphocyte counts, and elevated creatinine levels were associated with severe illness. Except for 1 case of possible hospital transmission, we identified no epidemiological links among patients.

Conclusion.Ad14 emerged in Oregon in 2005 and became the predominant circulating type by 2007. Infection with this uncommon virus was primarily associated with a community‐acquired pneumonia syndrome and caused substantial morbidity and mortality.

1Oregon Public Health Division and 2Providence Portland Medical Center, Portland; 3Centers for Disease Control and Prevention, Atlanta, Georgia

Editorial: Resistance to the Affordable Medicines Facility for malaria?

The Lancet
Apr 25, 2009  Volume 373  Number 9673  Pages 1399 – 1494

Resistance to the Affordable Medicines Facility for malaria?
The Lancet

“Last week, an innovative financing mechanism, the Affordable Medicines Facility for malaria ( AMFm), was officially launched. The AMFm will make the most effective treatment for malaria, artemisinin combination therapies (ACTs), more affordable and so has the potential to save thousands of lives. The Global Fund to Fight AIDS, Tuberculosis and Malaria will manage the new scheme.”

Incubation periods of acute respiratory viral infections: a systematic review

The Lancet Infectious Disease
May 2009   Volume 9  Number 5  Pages 265 – 330

Incubation periods of acute respiratory viral infections: a systematic review
Original Text
Justin Lessler PhD, Nicholas G Reich BA, Prof Ron Brookmeyer PhD, Prof Trish M Perl MD, Prof Kenrad E Nelson MD, Derek AT Cummings PhD

Knowledge of the incubation period is essential in the investigation and control of infectious disease, but statements of incubation period are often poorly referenced, inconsistent, or based on limited data. In a systematic review of the literature on nine respiratory viral infections of public-health importance, we identified 436 articles with statements of incubation period and 38 with data for pooled analysis. We fitted a log-normal distribution to pooled data and found the median incubation period to be 5·6 days (95% CI 4·8-6·3) for adenovirus, 3·2 days (95% CI 2·8-3·7) for human coronavirus, 4·0 days (95% CI 3·6-4·4) for severe acute respiratory syndrome coronavirus, 1·4 days (95% CI 1·3-1·5) for influenza A, 0·6 days (95% CI 0·5-0·6) for influenza B, 12·5 days (95% CI 11·8-13·3) for measles, 2·6 days (95% CI 2·1-3·1) for parainfluenza, 4·4 days (95% CI 3·9-4·9) for respiratory syncytial virus, and 1·9 days (95% CI 1·4-2·4) for rhinovirus. When using the incubation period, it is important to consider its full distribution: the right tail for quarantine policy, the central regions for likely times and sources of infection, and the full distribution for models used in pandemic planning. Our estimates combine published data to give the detail necessary for these and other applications.

H5N1 influenza vaccination policy in Japan

The Lancet Infectious Disease
May 2009   Volume 9  Number 5  Pages 265 – 330

H5N1 influenza vaccination policy in Japan Michiaki Masuda, Shigeo Sugita, Kazumichi Kuroda, Hidekazu Nishimura Vaccine preparedness and the timely use of stockpiled vaccines are important issues for tackling pandemic influenza.1 In Japan, based on the government’s Pandemic Influenza Preparedness Action Plan (PIPAP),2 the National Institute of Infectious Diseases, affiliated with the Ministry of Health, Labour and Welfare (MHLW), took the initiative to develop H5N1 vaccines in collaboration with domestic manufacturers. Consequently, production of H5N1 inactivated whole-virion vaccine containing aluminium hydroxide gel adjuvant was approved in October, 2007, for two Japanese manufacturers.

Infection control in the management of highly pathogenic infectious diseases: European Network of Infectious Disease

The Lancet Infectious Disease
May 2009   Volume 9  Number 5  Pages 265 – 330

Infection control in the management of highly pathogenic infectious diseases: consensus of the European Network of Infectious Disease
Original Text
Philippe Brouqui MD a Corresponding AuthorEmail Address, Vincenzo Puro MD b, Francesco M Fusco MD b, Barbara Bannister MSc c, Stephan Schilling MD d, Per Follin MD e, René Gottschalk MD f, Robert Hemmer MD g, Helena C Maltezou MD h, Kristi Ott MD i, Renaat Peleman MD j, Christian Perronne MD k, Gerard Sheehan MD l, Heli Siikamäki MD m, Peter Skinhoj MD n, Giuseppe Ippolito MD b, for the EUNID Working Group

The European Network for Infectious Diseases (EUNID) is a network of clinicians, public health epidemiologists, microbiologists, infection control, and critical-care doctors from the European member states, who are experienced in the management of patients with highly infectious diseases. We aim to develop a consensus recommendation for infection control during clinical management and invasive procedures in such patients. After an extensive literature review, draft recommendations were amended jointly by 27 partners from 15 European countries. Recommendations include repetitive training of staff to ascertain infection control, systematic use of cough and respiratory etiquette at admission to the emergency department, fluid sampling in the isolation room, and analyses in biosafety level 3/4 laboratories, and preference for point-of-care bedside laboratory tests. Children should be cared for by paediatricians and intensive-care patients should be cared for by critical-care doctors in high-level isolation units (HLIU). Invasive procedures should be avoided if unnecessary or done in the HLIU, as should chest radiography, ultrasonography, and renal dialysis. Procedures that require transport of patients out of the HLIU should be done during designated sessions or hours in secure transport. Picture archiving and communication systems should be used. Post-mortem examination should be avoided; biopsy or blood collection is preferred.