Lucanix greatly improves survival rates in patients with NSCLC
Novel HIV vaccines in early development
Peptide vaccine therapy: Immunological and clinical activity in children with gliomas
New oral rotavirus vaccine is developed for newborns
Allergy vaccine in phase 2 for rhinitis/rhinoconjunctivitis
New promising vaccine targets identified for HCV
Gardasil may also help women already infected with HPV
Positive phase 1 results for hand, foot and mouth disease vaccine
As a veterinary student I always felt misplaced. Not until I attended a course in immunology did I really feel the urge and drive to dive into the matter. Almost by coincidence, as a brand new candidate, I had the fortune to get a position in Tuberculosis vaccine research, and never since have I doubted that it was the right choice for me. Since then I have been driven by scientific curiosity and the prospects of generating results that can be used for products for which there is a real need.
Despite the success of infant vaccinations, periods of low vaccination coverage and the limited immunogenicity and duration of protection of certain vaccines have resulted in sporadic outbreaks, allowing some diseases to spread in communities. These challenges suggest that expanded vaccination coverage to younger infants and adolescents, and more immunogenic vaccines, may be needed in some instances.
This review focuses on the importance of infant immunization and explores the successes and challenges of current early childhood vaccination programs and how these lessons may be applied to other invasive diseases, such as meningococcal disease.
We evaluated the vaccine’s immunogenicity. Sixteen pediatricians received 15 μg hemagglutinin antigen subcutaneously. Antibody titer assays were conducted using hemagglutination-inhibition antibody assay on days 0 and 21 and at 5 mo after vaccination. Seroprotection rates, seroconversion rates, and geometric mean titer folds at 21 d were, respectively, 43.8%, 43.8% and 5.4 in all subjects, 70.0%, 70.0% and 8.0 in subjects aged 27–34 y, and 0.0%, 0.0% and 8.0 in subjects aged ≥ 35 y. None of the latter group met the European Medicines Agency criteria.
We hope to adopt intradermal routes and further the development of the influenza vaccine using new technology to improve immunogenicity in Japan.
To determine whether immunotherapy with HPV6 L1 virus like particles (VLPs) without adjuvant (VLP immunotherapy) reduces recurrence of genital warts following destructive therapy.Trial design
A randomized placebo controlled blinded study of treatment of recurrent genital warts amenable to destructive therapy, conducted independently in Australia and China.Methods
Patients received conventional destructive therapy of all evident warts together with intramuscular administration of 1, 5 or 25 µg of VLP immunotherapy, or of placebo immunotherapy (0.9% NaCl), as immunotherapy at week 0 and week 4. Primary outcome, assessed at week 8, was recurrence of visible warts.Results
Of 33 protocol compliant Brisbane recipients of placebo immunotherapy, 11 were disease free at two months, and a further 9 demonstrated reduction of > 50% in total wart area. Wart area reduction following destructive treatment correlated with prior duration of disease. Among 102 protocol compliant Brisbane recipients of VLP immunotherapy, disease reduction was significantly greater than among the placebo immunotherapy (50% ± s.e.m. 7%) recipients for subjects receiving 5 µg or 25 µg of VLP immunotherapy/dose (71% ± s.e.m.7%) but not for those receiving 1 µg VLP immunotherapy/dose (42% ± 7%). Of 52 protocol compliant placebo immunotherapy recipients in Wenzhou, 37 were disease free at two months, and a further 8 had > 50% disease reduction. Prior disease duration was much shorter in Wenzhou subject (8.1 ± 1.1 mo) than in Brisbane subjects (53.7 ± 5.5 mo). No significant reduction in mean wart area was observed for the 168 Wenzhou protocol compliant subjects who also received VLP immunotherapy.Conclusions
This study confirms the findings in a previous open label trial that administration of VLP immunotherapy may assist in clearance of recurrent genital warts in patients for whom destructive therapy is unsuccessful and that unsuccessful destructive therapy is more common with increasing prior disease duration.
Recently, more clinical trials are being conducted in Africa and Asia, therefore, background morbidity in the respective populations is of interest. Between 2000 and 2007, the International AIDS Vaccine Initiative sponsored 19 Phase 1 or 2A preventive HIV vaccine trials in the US, Europe, Sub-Saharan Africa and India, enrolling 900 healthy HIV-1 uninfected volunteers.Objective
To assess background morbidity as reflected by unsolicited adverse events (AEs), unrelated to study vaccine, reported in clinical trials from four continents.Methods
All but three clinical trials were double-blind, randomized and placebo-controlled. Study procedures and data collection methods were standardized. The frequency and severity of AEs reported during the first year of the trials were analyzed. To avoid confounding by vaccine-related events, solicited reactogenicity and other AEs occurring within 28 d after any vaccination were excluded.Results
In total, 2134 AEs were reported by 76% of all participants; 73% of all events were mild. The rate of AEs did not differ between placebo and vaccine recipients. Overall, the percentage of participants with any AE was higher in Africa (83%) compared with Europe (71%), US (74%) and India (65%), while the percentage of participants with AEs of moderate or greater severity was similar in all regions except India. In all regions, the most frequently reported AEs were infectious diseases, followed by gastrointestinal disorders.Conclusions
Despite some regional differences, in these healthy participants selected for low risk of HIV infection, background morbidity posed no obstacle to clinical trial conduct and interpretation. Data from controlled clinical trials of preventive interventions can offer valuable insights into the health of the eligible population.
The effectiveness of the 23-valent polysaccharide pneumococcal vaccine (PPV-23) is controversial, especially among people with high-risk conditions. This study assessed the clinical effectiveness of vaccination against pneumonia among patients with chronic pulmonary diseases.Methods
We conducted a population-based case-control study including 96 non-immunocompromised patients with clinical diagnosis of chronic pulmonary disease (chronic bronchitis, emphysema and/or asthma), aged 50 y or older, with radiographically confirmed pneumococcal pneumonia (19 bacteremic and 77 nonbacteremic cases) and 192 outpatient control subjects with similar chronic pulmonary diseases (matched by primary care center, age, sex and main comorbidity). Adjusted odds ratios (ORs) for vaccination were calculated using conditional logistic regression, controlling for by underlying conditions.Results
Pneumococcal vaccination did not alter significantly the risk of overall pneumococcal pneumonia [adjusted OR: 0.71; 95% confidence interval (CI): 0.37–1.39]. Point estimates of vaccine effectiveness was the maximum against bacteremic pneumococcal pneumonia due to vaccine-serotypes, although neither reached statistical significance (adjusted OR: 0.51; 95% CI: 0.03–8.19). Vaccination pointed to a smaller benefit against nonbacteremic pneumococcal pneumonia (adjusted OR: 0.66; 95% CI: 0.33–1.34). Pneumococcal vaccination was associated with a non-statistically significant reduction in the risk of all pneumococcal pneumonia among persons 75 y or older (adjusted OR: 0.45; 95% CI: 0.16–1.27), but no apparent protective effect emerged among people 50–74 y (adjusted OR: 1.48; 95% CI: 0.62–3.56).Conclusions
The effectiveness of the PPV-23 in preventing pneumonia among patients with chronic pulmonary disease is uncertain. Our results point to PPV-23 having little or null effect against pneumococcal pneumonia in such patients, but definitive conclusions cannot be established based on our data.
Adult and elderly subjects previously immunized with cell culture-derived (CCIV; Optaflu®) or egg-derived (TIV; Agrippal®) trivalent influenza vaccines were enrolled in two extension studies (E1 and E2) to evaluate safety and immunogenicity after revaccination with CCIV/TIV alone or in combination with concomitant pneumococcal vaccine (PV).Methods
Adults and elderly subjects (n = 2609) were randomized 1:1 in E1 and allocated 3:1 in E2 to receive CCIV/TIV. In E2, a subset of elderly subjects was randomized to receive CCIV/TIV, with or without PV. Adverse reactions were monitored for six months and immunogenicity was assessed by hemagglutination inhibition (HI) assay using CHMP criteria.Results
Overall, the safety profile of both vaccines was similar, no serious adverse events related to either vaccine occurred. Mild or moderate pain was the most commonly reported reaction. Reactogenicity was slightly higher in elderly subjects receiving CCIV/TIV concomitantly with PV [46% vs. 37%; p = non-significant (NS)]. Both vaccines met CHMP licensure criteria for adults and elderly subjects. With concomitant CCIV and PV, all three CHMP criteria were met for A/H1N1 and A/H3N2, whereas the B strain only met seroprotection and GMR criteria.Conclusions
Safety and immunogenicity of CCIV was not influenced by the type of vaccine received previously or by concomitant PV administration.
In this article, we present an immunotherapy case that shows how to overcome an obviousness rejection by showing an unexpected result. The new design using an anti-VEGF antibody-encoding sequence in vaccinia virus should significantly increase its therapeutic effect. Furthermore, the newly-designed virus would provide tumor-localized delivery of the antibody and enhance anti-tumor activity.