Table of Contents

Volume 7, Issue 7

  July 2011

  Pages 713 - 800

View covers archive

 Issue Catalogue (MARC XML)

EDITOR'S CORNER

Open Access Article

Letter from the Editor

Ronald W. Ellis and Eva M. Riedmann
Page 713
http://dx.doi.org/10.4161/hv.7.7.17073
PDF




NEWS, POLICY AND PROFILES

Open Access Article

News

Eva M. Riedmann
Pages 714 - 717
http://dx.doi.org/10.4161/hv.7.7.17072
Abstract | PDF

Personalized therapy increases disease-free survival for lymphoma patients
TRANSVAC: European Network of Vaccine Research and Development
Promising Phase III results for melanoma vaccine
Sanofi Pasteur’s intradermal influenza vaccine licensed in the US
Malaria vaccine clinical trial begins in Africa
Prevnar-13 effective in adults over 50
Inovio reports long-term immune responses for therapeutic HPV vaccine
New study supports HPV vaccine for men





MEETING REPORT

Open Access Article

Next generation vaccines

Eva M. Riedmann
Pages 718 - 722
http://dx.doi.org/10.4161/hv.7.7.16976
Abstract | PDF

In February this year, about 100 delegates gathered for three days in Vienna (Austria) for the Next Generation Vaccines conference. The meeting held in the Vienna Hilton Hotel from 23rd–25th February 2011 had a strong focus on biotech and industry. The conference organizer Jacob Fleming managed to put together a versatile program ranging from the future generation of vaccines to manufacturing, vaccine distribution and delivery, to regulatory and public health issues. Carefully selected top industry experts presented first-hand experience and shared solutions for overcoming the latest challenges in the field of vaccinology. The program also included several case study presentations on novel vaccine candidates in different stages of development. An interactive pre-conference workshop as well as interactive panel discussions during the meeting allowed all delegates to gain new knowledge and become involved in lively discussions on timely, interesting and sometimes controversial topics related to vaccines.




REVIEWS

Open Access Article

Informed consent in vaccination in India: Medicolegal aspects

Meena Rajput and Luv Sharma
Pages 723 - 727
http://dx.doi.org/10.4161/hv.7.7.15411
Abstract | PDF

The doctrine of informed consent forms an integral part of any doctor-patient relationship. It serves two-fold as it develops trust and confidence in the patient for the doctor after being told about the plan of action; conversely the doctor can carry out planned medical interventions in a more composed manner, being confident in the protection of this doctrine if anything untoward occurs. Informed consent gives a blanket shield against compensation and criminal negligence charges filed by patients if the doctor has not deviated from standard practices of treatment or intervention or if no evidence of mal intention is forthcoming. Informed consent is applicable in most of the treatment modalities in which any intervention/invasive procedure is to be done or if any risk of complication is well known or documented. Surprisingly, even when serious life threatening complications are not only reported but on a steady rise due to vaccines, informed consent in vaccination is neither in vogue nor practice. Even in the US, there is no federal requirement for informed consent before vaccination,¹ even though National Childhood Vaccine Injury Act and the Vaccine Compensation Amendments are in place.² This paper attempts to present an overall comment on the necessity of informed consent before any vaccination especially in the Indian context in the backdrop of the beginning of vaccine compensation claims and litigation against the complications of vaccination in India.

Open Access Article

Prevalence of influenza vaccination among nurses and ancillary workers in Italy: Systematic review and meta analysis

Giuseppe La Torre, Alice Mannocci, Paolo Ursillo, Claudio Bontempi, Alberto Firenze, Maria Grazia Panico, Antonella Sferrazza, Chiara Ronga, Adele D'Anna , Emanuele Amodio , Nino Romano and Antonio Boccia
Pages 728 - 733
http://dx.doi.org/10.4161/hv.7.7.15413
Abstract | PDF

Introduction: Italian Ministry of Health, recommends vaccination for seasonal influenza to all healthcare workers (HCW), particularly to nurses who have an important interaction with patients. The aim of this study is to conduct a systematic review in order to estimate the pooled prevalence of influenza vaccinations among nurses and ancillary workers in Italy and analyse the enhancing and hindering factors. Results: The review was performed using 15 articles, six containing the prevalence of vaccination for nurses and ancillary workers, while the others qualitative analysis. In all the selected articles the score calculation has been carried out by using a protocol for observational studies. The nurses and ancillary workers pooled proportion of influenza vaccination was respectively 13,47% (95%CI 9,58-17,90%) and 12,52% (95%CI 9,97-15,31%). Discussion: The Italian mean of influenza vaccination prevalence appear low if compared to other European countries, ranging from 15% to 29% in Countries such as UK, Germany, France. This situation of weakness should be seen as an opportunity to improve the vaccination rate for seasonal influenza significantly This should be done by intervening on the category which affirms caring less. In fact, this category has a priority to receive vaccination, due to their numbers and closer contact to patients. Methods: Research was conducted using medical database Scopus, PubMed, the search engine Google Scholar and ISI web of knowledge, and was concluded February 1st 2011.

Open Access Article

Summary of effectiveness and impact of rotavirus vaccination with the oral pentavalent rotavirus vaccine: A systematic review of the experience in industrialized countries

Carlo Giaquinto, Geraldine Dominiak-Felden, Pierre Van Damme, Tin Tin Htar Myint, Yvonne A. Maldonado, Vana Spoulou, T. Christopher Mast and Mary Allen Staat
Pages 734 - 748
http://dx.doi.org/10.4161/hv.7.7.15511
Abstract | PDF

The pentavalent rotavirus (RV) vaccine RotaTeq™ has been available in industrialized countries since 2006. Several studies have been conducted to evaluate the benefit of RV vaccination under routine conditions of use. A systematic review of all publicly available data from RotaTeq™ vaccine-effectiveness and vaccination-impact studies in the USA, Europe and Australia between 2006 and February 2010 was undertaken. Depending on the population studied, effectiveness of up to 100% (95% confidence interval 85–100%) associated with decreased hospitalizations for RV gastroenteritis (RVGE) was seen. Vaccination-impact studies demonstrated that the burden of RVGE has been reduced significantly since the introduction of RV vaccination. Evidence included reductions in healthcare utilization due to RVGE (hospitalizations and emergency-department visits reduced by up to 90%), reductions in the magnitude and duration of the RV season as assessed by laboratory testing for RV, and the possible induction of herd immunity.




SHORT REPORTS

Open Access Article

Economic evaluation of a vaccine for the prevention of herpes zoster and post-herpetic neuralgia in older adults in Switzerland

Thomas D. Szucs, Reto W. Kressig, Manto Papageorgiou, Werner Kempf, Jean-Pierre Michel, Anton Fendl and Xavier Bresse
Pages 749 - 756
http://dx.doi.org/10.4161/hv.7.7.15573
Abstract | PDF

Background: A life-attenuated vaccine aimed at preventing herpes zoster (HZ) and its main complication, post-herpetic neuralgia (PHN), will soon be available in Europe. The study’s objective was to assess the clinical and economic impact of a vaccination program for adults aged 70-79 years in Switzerland. Results: A vaccination strategy compared to a no-vaccination resulted in lifetime incremental cost-effectiveness ratios (ICERs) of 25,538 CHF (23,646 USD) per QALY gained, 6,625 CHF (6,134 USD) per HZ case avoided, and 15,487 CHF (14,340 USD) per PHN3 case avoided under the third-party payer perspective. Sensitivity analyses showed that the model was most sensitive to the discount rates, HZ epidemiological data and vaccine price used. Methods: A Markov model, simulating the natural history of HZ and PHN and the lifetime effects of vaccination, previously developed for the UK was adapted to the Swiss context. The model includes several health states including good health, HZ, PHN, and death. HZ and PHN states reflected pain severity. Conclusion: The model predicts clinical and economic benefits of vaccination in the form of fewer HZ and PHN cases and reductions in healthcare resource use. ICERs were within the commonly accepted thresholds in Switzerland, indicating that a HZ vaccination program would be considered a cost-effective strategy in the Swiss setting.

Open Access Article

Effectiveness of rotavirus vaccination in Spain

Federico Martinón-Torres, Marta Bouzón Alejandro, Lorenzo Redondo Collazo, Juan Manuel Sánchez Lastres, Sonia Pértega Díaz, Mª Teresa Seoane Pillado and José María Martinón Sánchez
Pages 757 - 761
http://dx.doi.org/10.4161/hv.7.7.15576
Abstract | PDF

With the aim of determining rotavirus vaccine effectiveness (RVVE) in Spain, from Oct-2008/Jun-2009, 467 consecutive children below 2 years old with acute gastroenteritis (AGE) were recruited using a pediatric research network (ReGALIP-www.regalip.org) that includes primary, emergency and hospital care settings. Of 467 enrolled children, 32.3% were rotavirus positive and 35.0% had received at least one dose of any rotavirus vaccine. RRVE to prevent any episode of rotavirus AGE was 91.5% (95% CI: 83.7%–95.6%). RVVE to prevent hospitalization by rotavirus AGE was 95.6% (85.6–98.6%). No differences in RVVE were found regarding the vaccine used. Rotavirus vaccines have showed an outstanding effectiveness in Spain.




RESEARCH PAPERS

Open Access Article

Pre-deployment vaccinations and perception of risk among US military personnel

Suzanne Polak, Mark S. Riddle, David R. Tribble, Adam W. Armstrong, Manal Mostafa and Chad K. Porter
Pages 762 - 767
http://dx.doi.org/10.4161/hv.7.7.15574
Abstract | PDF




Background: Vaccination programs have significantly reduced the incidence of numerous infectious diseases; however, public attitudes toward immunization oftentimes remain contentious. Concerns over vaccine safety and effectiveness, compounded with reduced perceived risk of disease, influence decision making and frequently override public health recommendations. Although vaccinations are compulsory for US military personnel, their concerns mirror the general population, resulting in sub-optimal coverage.

 

Results: Demographics of the 1,757 respondents: 83.3% male, 71.1% Army, 87.5% enlisted, mean age of 29.2 years (standard deviation: 8.3). The majority (89.3%) reported receiving all pre-deployment vaccines; 17.1% stated they would decline if given the opportunity. Factors associated with an increased likelihood of declining vaccines included a perception that the vaccines were not safe (odds ratio [OR]: 3.7; p <0.001) and rarely/never believing information from the military command (OR: 2.2; p <0.001). Those with a perceived risk for the diseases targeted by the vaccines were less likely to decline (OR: 0.6; p <0.001).

 

Discussion: In US military personnel, negative perceptions of pre-deployment vaccines exist. These attitudes appear to be associated with negative perceptions of vaccine safety and low perceived disease risk. Targeted interventions, focusing on the drivers of negative perceptions toward vaccines, and accounting for the source of the educational material, may influence attitudes and improve vaccination perceptions.

 

Methods: A self-administered questionnaire was completed by a convenience sample of US military personnel deployed to Iraq, Afghanistan and surrounding regions. Questions solicited demographic information and assessed agreement with statements in an attempt to identify factors associated with declining pre-deployment vaccines.

Open Access Article

Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults

Edson D. Moreira, Joel M. Palefsky, Anna R. Giuliano, Stephen Goldstone, Carlos Aranda, Heiko Jessen, Richard J. Hillman, Daron Ferris, Francois Coutlee, Eftyhia Vardas, J. Brooke Marshall, Scott Vuocolo, Richard M. Haupt, Dalya Guris and Elizabeth I.O. Garner
Pages 768 - 775
http://dx.doi.org/10.4161/hv.7.7.15579
Abstract | PDF

Prophylactic vaccination with a quadrivalent HPV (types 6, 11, 16, 18) vaccine (qHPV) has been shown to prevent infection with HPV 6/11/16/18 and associated disease in women and more recently, in men. Here we report on the safety and reactogenicity of the qHPV vaccine in males. A total of 4,065 healthy males aged 16-26 years were enrolled into a randomized, placebo-controlled, double-blind trial. Subjects were randomized 1:1 to receive qHPV vaccine or placebo at day 1, month 2, and month 6. Safety and tolerability were assessed via the collection of reported adverse experiences (AEs). All serious AEs (vaccine- or procedure-related or not) and all deaths occurring during the study were recorded. Safety analyses were conducted in all subjects who received at least one dose of vaccine or placebo. The proportion of subjects who reported at least one injection-site AE was higher in the qHPV vaccine group versus the placebo group (60.1% vs 53.7%, respectively), however most of these AEs were mild/moderate in intensity. The incidence of at least one systemic AE was comparable between the vaccine and placebo groups (31.7% vs 31.4%, respectively). There were no vaccine-related serious AEs or deaths. The occurrence of AEs did not increase with each successive injection, and among trial participants who were seropositive for at least one vaccine HPV type at enrollment, the profile of adverse events was similar to that of the entire study cohort. The qHPV vaccine was generally well tolerated in males aged 16-26 years and had a favorable safety profile.

Open Access Article

Estimating potential demand and supply of dengue vaccine in Brazil

Ananda Amarasinghe and Richard T. Mahoney
Pages 776 - 780
http://dx.doi.org/10.4161/hv.7.7.16255
Abstract | PDF

Dengue is endemic in Brazil. Several dengue vaccine candidates, including one at the Butantan Institute in Sao Paulo, are being evaluated in clinical trials and may be licensed in several years. This study estimates the potential doses of dengue vaccine needed in Brazil under different scenarios in the first 5 years after vaccine introduction. Estimates were based on 2015-2022 country population projections. An estimated country population of 200-209 million with an annual 3.3-3.5 million cohort in the 12 to 23 month age group was included in the analysis. Computations were made for vaccines requiring one, two and three doses. A total of 7.8-62.9 million doses would be needed for only routine vaccination of 12-23 months cohort in first five years with different vaccination schedules. A combination of country-wide routine 12-23 month-old vaccination plus catch-up vaccination of individuals up to 40 years age is an appropriate strategy to control dengue. For this combination strategy, 129-425 million doses would be needed in the first five years after introduction. If vaccination is not provided to areas with low incidence of dengue, an estimated 108-360 million doses would be needed. This study provides a range of vaccine uptake estimates under different scenarios based on disease epidemiology. Actual demand and uptake will depend on the country vaccine introduction policy and strategies, vaccine supply capacity, cost, and vaccine profile. We consider one option based on the availability of vaccine from different sources. A more advanced vaccine uptake model based on estimates of vaccine impact under various scenarios should be developed.

Open Access Article

Early clinical experience with a candidate meningococcal B recombinant vaccine (rMenB) in healthy adults

Daniela Toneatto, Philipp Oster, A Corine W deBoer, Amy Emerson, George F Santos, Ellen Ypma, Lisa DeTora, Mariagrazia Pizza, Alan Kimura and Peter Dull
Pages 781 - 791
http://dx.doi.org/10.4161/hv.7.7.15997
Abstract | PDF

Background: The development of a broadly protective vaccine against meningococcal serogroup B is a well-recognized public health need. Whole-genome sequencing was used to identify meningococcal surface proteins that are conserved across strains. These proteins were incorporated into two investigational vaccines.
Methods: Three randomized studies were performed to evaluate a three-component recombinant meningococcal serogroup B vaccine (rMenB) and rMenB plus outer membrane vesicles from the Norwegian outbreak strain 44/76 (rMenB+OMVNW). Participants were randomized to receive 3 or 4 doses of rMenB or rMenB+OMVNW or control vaccines and provided sera for exploratory immunogenicity testing against a panel of meningococcal serogroup B strains. A booster dose was administered 12 months after the initial primary series in one of the studies. The control cohort received a licensed quadrivalent meningococcal polysaccharide vaccine against serogroups A, C, W-135 and Y as well as hepatitis B vaccine as safety comparators. Solicited reactions within 7 days of any vaccination and adverse events throughout the studies were recorded.
Results: One hundred four participants enrolled into the clinical trials. Both rMenB and rMenB+OMVNW induced immune responses to multiple serogroup B strains in the majority of participants. Compared with rMenB, rMenB+OMVNW appeared somewhat more immunogenic and reactogenic; the study was not adequately powered for statistical assessment of these small differences. Both investigational vaccines were more reactogenic than the licensed vaccines. Few vaccinees discontinued any study due to reactogenicity to any study vaccine administered.
Conclusion: Based on the immunogenicity and reactogenicity results in these participants, both rMenB and rMenB+OMVNW were promising candidates for further investigation.




COMMENTARIES

Open Access Article

Intra-dermal administration of rabies vaccines in developing countries: At an affordable cost

Ramesh Verma, Pardeep Khanna, Shankar Prinja and Meena Rajput
Pages 792 - 794
http://dx.doi.org/10.4161/hv.7.7.15410
Abstract | PDF

Rabies is a virtually 100% fatal acute viral encephalitis. Rabies occurs in more than 150 countries and territories. Globally there are 17.4 million animal bite cases and more than 55,000 deaths annually. India’s 20,000 deaths accounts for 36% of global and 65% of the Asian (31,000) deaths. The Intradermal Rabies Vaccine (IDRV) was first started in Thailand in 1984. In 1992, World Health Organization approved it for use in developing countries which face a shortage of rabies vaccine due to paucity of funds. Vaccines like Purified Vero cell vaccine (PVRV), Purified chick embryo cell vaccine (PCECV) and Human diploid cell vaccine (HDCV) that can be injected by the intradermal route for Post Exposure Prophylaxis as approved by WHO. The regimen approved by the WHO/DCGI India is the Updated Thai Red Cross Regimen, which involves injection of 0.1 mL of reconstituted vaccine per ID site and on two such ID site per visit on Days 0, 3, 7 and 28 (2-2-2-0-2). All reconstituted vaccine unused at the end of 6–8 h must be discarded. The ID route is ideal in terms of economic benefits, safety and efficacy. This reduces the cost of vaccination by about 68%, which is clearly an attractive option for resource-starved countries like India.

Open Access Article

Beyond epitopes: Future and application of computational vaccinology

Johannes Söllner
Pages 795 - 797
http://dx.doi.org/10.4161/hv.7.7.15412
Abstract | PDF

Vaccine research has significantly changed face within the last decade. Newly developed vaccines usually comprise defined subunits and often next generation adjuvants. On the downside, as in many areas ultimately of interest to clinical development, basic research does only slowly translate to bedside therapy. Part of the reason can be found in regulatory processes. On the other hand new technologies such as NGS (Next Generation Sequencing), Systems Biology, recently unimagined computing and storage power and suitable information technologies allow new perspectives and approaches to the field, enlarging the gap between possible and approved even more. Computational vaccinology is an aid to vaccine developers to help bridge this gap, but naturally only if it is accepted as tool and made use of. The aim of this commentary is to point out recent developments and trends and show how this can invigorate vaccine development. It is felt necessary to make a case for rational vaccine design augmented by computational vaccinology for the community to harness the full potential of emerging and already burgeoning technologies and concepts such as Next Generation Sequencing and Systems Biology.

Open Access Article

Circovirus and impact of temporary withdrawal of rotavirus vaccines in Spain

Marta Bouzón Alejandro, Javier Diez Domingo and Federico Martinón-Torres
Pages 798 - 799
http://dx.doi.org/10.4161/hv.7.7.15683
Abstract | PDF

At the beginning of 2010 DNA fragments of a porcine circovirus 1 (PCV-1) were detected in the monovalent rotavirus vaccine, Rotarix® (GlaxoSmithKline), and later also of PCV-1 and PCV-2 in the RotaTeq® (MSD) vaccine. These viruses are frequently found in meat and other products for normal human consumption and have not been shown to cause disease in humans. Although the World Health Organization (WHO) and the European Medicines Agency (EMA) did not recommended discontinuation of vaccination against rotavirus because of its positive risk- benefit ratio, the Spanish Medicines and Health Products Agency (AEMPS) did not authorize the release of new batches of Rotarix® and RotaTeq® vaccines onto the Spanish market since March 29 and June 10, 2010, respectively, due to problems of good manufacturing practice (GMP), until research on this issue was complete.¹ On November 4, 2010, AEMPS again allowed the release of batches of the RotaTeq® vaccine having checked that it only had fragments of the DNA of the porcine virus (and thereby met the GMP standards), so that currently there are only restrictions on the marketing of the Rotarix® vaccine.¹ Until March 2010, the average vaccination coverage against rotavirus in Spain in terms of dose distribution data (BMI and census data) had reached 40%. Furthermore, the first data reported on the effectiveness of the vaccine in Spain were consistent with this coverage and with the data reported for other countries.^2,3




LETTER

Open Access Article

Bivalent live poliovirus vaccine: A blessing or a curse

Subhash C. Arya and Nirmala Agarwal
Page 800
http://dx.doi.org/10.4161/hv.7.7.15646
Abstract | PDF