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Girard M.P.,French National Academy of Medicine | Katz J.M.,Centers for Disease Control and Prevention | Pervikov Y.,Initiative for Vaccine Research | Hombach J.,Initiative for Vaccine Research | Tam J.S.,Initiative for Vaccine Research

On February 17-18, 2011, the World Health Organization convened the 7th meeting on " The Evaluation of Pandemic Influenza Vaccines in Clinical Trials" to review the progress made on pandemic A (H1N1) 2009 vaccines and the evaluation of their effectiveness in the field, especially in children less than 3 years of age and in pregnant women. Other topics to be addressed included a comparison of egg- and cell culture-based influenza vaccines, technical issues related to vaccine strain development and vaccine potency, and the status of development of prototype influenza vaccines using new technologies. Pandemic A (H1N1) vaccines were safe in young children, pregnant women and immunocompromized individuals. Overall effectiveness of inactivated A (H1N1) vaccines for all ages was found to vary between 72% and 100% in different countries and with different vaccine preparations. Effectiveness of pandemic A (H1N1) 2009 live attenuated vaccine was estimated to be approximately 80% in pediatric populations in the USA. A single dose of inactivated vaccine adjuvanted with AS03, MF59 or AF03 induced protective immunity in young children and pregnant women. However, unadjuvanted vaccines as well as low dose adjuvanted vaccines (1.9 μg HA) required two doses to elicit protective antibody levels in these populations. Clinical trials of influenza vaccines developed using new technologies showed they were well tolerated and induced antibody and/or T cell immune responses to viral proteins. Further studies are warranted to validate novel immunological criteria for evaluation and licensing of such new influenza vaccine concepts. On the regulatory side, work should be undertaken to harmonize the results of serological tests used to evaluate the immunogenicity of traditional influenza vaccines. © 2011. Source

Steele A.D.,Initiative for Vaccine Research | Steele A.D.,University of Limpopo | Madhi S.A.,University of Witwatersrand | Louw C.E.,Madibeng Center for Research | And 7 more authors.
Pediatric Infectious Disease Journal

Background: Rotavirus and human immunodeficiency virus (HIV) infections are a cause of great public health concern in developing countries. The current study evaluated the safety, reactogenicity, and immunogenicity of RIX4414 vaccine in asymptomatic or mildly symptomatic (clinical stages I and II according to WHO classification) HIV-infected South African infants. Methods: A total of 100 HIV-positive infants aged 6 to 10 weeks enrolled in this double-blind, 1:1 randomized, placebo-controlled study were allocated into 2 groups to receive 3 doses of RIX4414 vaccine/placebo according to a 0-, 1-, and 2-month schedule. Routine vaccines were concomitantly administered. Solicited and unsolicited symptoms were recorded for 15 and 31 days after each dose, respectively. Serious adverse events were recorded throughout the study period. Serum antirotavirus IgA concentrations (enzyme-linked immunosorbent assay, cut-off 20 U/mL) and the immunodeficiency status were determined at screening and 2 months post-Dose 3. Stool samples were analyzed for rotavirus using enzyme-linked immunosorbent assay at predetermined points and during diarrhea episodes. Results: All symptoms (solicited and unsolicited) occurred at a similar frequency in both groups. Six fatal serious adverse events in RIX4414 and 9 in placebo groups were reported. At 2 months post-Dose 3, the seroconversion rates were 57.1% (95% CI: 34-78.2) in RIX4414 and 18.2% (95% CI: 5.2-40.3) in the placebo group. The mean absolute CD4 cell count, CD4 percentage, and HIV-1 viral load were comparable in both groups at screening and 2 months post-Dose 3. Rotavirus shedding peaked at Day 7 after Dose 1 of RIX4414 with prolonged shedding was observed in 1 infant only. Conclusions: Three doses of RIX4414 vaccine was tolerated well by the South African HIV-positive infants. A satisfactory immune response was mounted without aggravating their immunologic or HIV condition. Copyright © 2011 by Lippincott Williams & Wilkins. Source

Tam J.S.,Initiative for Vaccine Research | Barbeschi M.,Health Security and Environment Cluster | Shapovalova N.,Health Security and Environment Cluster | Briand S.,Health Security and Environment Cluster | And 3 more authors.
The Lancet Infectious Diseases

Public health research is essential for the development of effective policies and planning to address health security and risks associated with mass gatherings (MGs). Crucial research topics related to MGs and their effects on global health security are discussed in this review. The research agenda for MGs consists of a framework of five major public health research directions that address issues related to reducing the risk of public health emergencies during MGs; restricting the occurrence of non-communicable and communicable diseases; minimisation of the effect of public health events associated with MGs; optimisation of the medical services and treatment of diseases during MGs; and development and application of modern public health measures. Implementation of the proposed research topics would be expected to provide benefits over the medium to long term in planning for MGs. © 2012 Elsevier Ltd. Source

Jit M.,London School of Hygiene and Tropical Medicine | Jit M.,Public Health England | Brisson M.,Imperial College London | Brisson M.,Laval University | Hutubessy R.,Initiative for Vaccine Research
The Lancet Global Health

Background: Introduction of human papillomavirus (HPV) vaccination in settings with the highest burden of HPV is not universal, partly because of the absence of quantitative estimates of country-specific effects on health and economic costs. We aimed to develop and validate a simple generic model of such effects that could be used and understood in a range of settings with little external support. Methods: We developed the Papillomavirus Rapid Interface for Modelling and Economics (PRIME) model to assess cost-effectiveness and health effects of vaccination of girls against HPV before sexual debut in terms of burden of cervical cancer and mortality. PRIME models incidence according to proposed vaccine efficacy against HPV 16/18, vaccine coverage, cervical cancer incidence and mortality, and HPV type distribution. It assumes lifelong vaccine protection and no changes to other screening programmes or vaccine uptake. We validated PRIME against existing reports of HPV vaccination cost-effectiveness, projected outcomes for 179 countries (assuming full vaccination of 12-year-old girls), and outcomes for 71 phase 2 GAVI-eligible countries (using vaccine uptake data from the GAVI Alliance). We assessed differences between countries in terms of cost-effectiveness and health effects. Findings: In validation, PRIME reproduced cost-effectiveness conclusions for 24 of 26 countries from 17 published studies, and for all 72 countries in a published study of GAVI-eligible countries. Vaccination of a cohort of 58 million 12-year-old girls in 179 countries prevented 690 000 cases of cervical cancer and 420 000 deaths during their lifetime (mostly in low-income or middle-income countries), at a net cost of US$4 billion. HPV vaccination was very cost effective (with every disability-adjusted life-year averted costing less than the gross domestic product per head) in 156 (87%) of 179 countries. Introduction of the vaccine in countries without national HPV vaccination at present would prevent substantially more cases of cervical cancer than in countries with such programmes, although the disparity has narrowed since 2012. If 71 phase 2 GAVI-eligible countries adopt vaccination according to forecasts, then in 2070 GAVI Alliance-funded vaccination could prevent 200 000 cases of cervical cancer and 100 000 deaths in some of the highest-burden countries. Interpretation: Large between-country disparities exist for HPV vaccination, with countries with the most to gain yet to introduce national HPV vaccination. Support from the GAVI Alliance could help to reduce such disparities, but a substantial burden will remain even after presently projected vaccine introductions. Funding: WHO. © 2014 World Health Organization. Source

Steele A.D.,PATH | Steele A.D.,Initiative for Vaccine Research | Patel M.,Centers for Disease Control and Prevention | Cunliffe N.A.,University of Liverpool | And 3 more authors.

Rotavirus causes approximately 450,000 deaths annually among children less than 5 years of age worldwide, almost half of which occur in Africa. After the recent completion of successful trials of 2 new rotavirus vaccines, the World Health Organization has recommended these vaccines for all children worldwide. Because a previous rotavirus vaccine, Rotashield®, was associated with intussusception, a form of intestinal obstruction among infants, the current rotavirus vaccines were tested in large clinical trials and found to be safe. However, due to the past Rotashield® experience, post licensure monitoring of intussusception is considered to be crucial after the introduction of future oral rotavirus vaccines. Thus, in planning for future introductions of rotavirus vaccine in Africa, a workshop of experts working on intussusception was convened by the World Health Organization in May 2004 in association with the Pan-African Association of Paediatric Surgeons (PAPSA) in Malawi. In brief, delegates from ten countries presented data from retrospective record reviews of intussusception events from 1993 to 2003 at selected hospitals in their respective countries. This review showed that age of intussusception onset during infancy varies markedly with peak prevalence between 4 and 6 months of life. Diagnostic modality (e.g., contrast enema, ultrasound) was employed in <20% of the events; nearly 70% of the intussusception events were diagnosed at the time of surgery. Overall, case-fatality was high, ∼13%, in these African countries. The findings of this meeting highlight the challenges in implementing surveillance for intussusception after rotavirus vaccine introduction in Africa. The deliberations identified some concrete steps necessary to establish active surveillance at sentinel sites in African countries. This is becoming more urgent now that many countries are expressing interest in introducing rotavirus vaccines. © 2012. Source

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