Experience and Challenges from Clinical Trials with Malaria Vaccines in Africa.

Malaria vaccines are considered amongst the most important modalities for potential elimination of malaria disease and transmission. Research and development in this field has been an area of intense effort by many groups over the last few decades. Despite this, there is currently no licensed malaria vaccine. Researchers, clinical trialists and vaccine developers have been working on many approached to make malaria vaccine available.African research institutions have developed and demonstrated a great capacity to undertake clinical trials in accordance to the International Conference on Harmonization-Good Clinical Practice (ICH-GCP) standards in the last decade; particularly in the field of malaria vaccines and anti-malarial drugs. This capacity is a result of networking among African scientists in collaboration with other partners; this has traversed both clinical trials and malaria control programmes as part of the Global Malaria Action Plan (GMAP). GMAP outlined and support global strategies toward the elimination and eradication of malaria in many areas, translating in reduction in public health burden, especially for African children. In the sub-Saharan region the capacity to undertake more clinical trials remains small in comparison to the actual need.However, sustainability of the already developed capacity is essential and crucial for the evaluation of different interventions and diagnostic tools/strategies for other diseases like TB, HIV, neglected tropical diseases and non-communicable diseases. There is urgent need for innovative mechanisms for the sustainability and expansion of the capacity in clinical trials in sub-Saharan Africa as the catalyst for health improvement and maintained

Pharmacy Participation in Non-Prescription Syringe Sales in Los Angeles and San Francisco Counties, 2007

Increasing sterile syringe access for injection drug users (IDUs) is one way to prevent HIV and hepatitis C virus (HCV) transmission in this population. In 2005, California Senate Bill 1159 allowed counties to adopt the Disease Prevention Demonstration Project (DPDP). Where enacted, the DPDP allows pharmacies that register with the county to sell up to ten syringes to adults without a prescription. In the current study, we describe pharmacy participation in nonprescription syringe sales (NPSS) in two counties in California and examine factors associated with NPSS. Telephone and in-person interviews were conducted in Los Angeles (LA) and San Francisco (SF) with 238 pharmacies in 2007 (n = 67 in SF; n = 171 in LA). Quantitative survey items captured pharmacy registration with the county, pharmacy policies/practices, episodes and conditions of NPSS and refusals to sell, potential negative consequences of NPSS, and staff attitudes regarding HIV and HCV prevention for IDUs. Overall, 42% of pharmacies reported NPSS (28% in LA and 81% in SF), although only 34% had registered with the county (17% in LA and 76% in SF). Many pharmacies required proof of a medical condition (80% in LA and 30% in SF) and refused NPSS if the customer was a suspected IDU (74% in LA, 33% in SF). Few negative consequences of NPSS were reported. In multivariate logistic regression analysis, we found that the odds of NPSS were significantly higher among pharmacists who thought syringe access was important for preventing HIV among IDUs [adjusted odds ratio (AOR) = 2.95; 95% confidence interval (CI) = 1.10–7.92], were chain pharmacies (AOR = 12.5; 95% CI = 4.55–33.33), and were located in SF (AOR = 4.88; 95% CI = 1.94–12.28). These results suggest that NPSS were influenced by pharmacists’ perception. NPSS might be increased through greater educational efforts directed at pharmacists, particularly those in non-chain pharmacies

Genomewide linkage survey of nicotine dependence phenotypes

A comprehensive understanding of the etiology and neurobiology of nicotine dependence is not available. We sought to identify genomic regions that might contain etiologically-relevant loci using genomewide univariate and bivariate linkage analyses

Three Years after Legalization of Nonprescription Pharmacy Syringe Sales in California: Where Are We Now?

In January 2005, passage of California Senate Bill 1159 enabled California’s county or city governments to establish disease prevention demonstration projects (DPDPs) through which pharmacies could subsequently register to legally sell up to 10 syringes to adults without a prescription. California’s 61 local health jurisdictions (LHJs) were surveyed annually in 2005–2007 to monitor the progress of DPDP implementation and assess program coverage, facilitators, and barriers. Completed surveys were returned by mail, fax, e-mail, phone, or internet. We analyzed 2007 survey data to describe current DPDP status; data from all years were analyzed for trends in approval and implementation status. By 2007, 17 (27.9%) LHJs approved DPDPs, of which 14 (82.4%) had registered 532 (17.8%) of the 2,987 pharmacies in these 14 LHJs. Although only three LHJs added DPDPs since 2006, the number of registered pharmacies increased 102% from 263 previously reported. Among the LHJs without approved DPDPs in 2007, one (2.3%) was in the approval process, seven (16.3%) planned to seek approval, and 35 (81.4%) reported no plans to seek approval. Of 35 LHJs not planning to seek approval, the top four reasons were: limited health department time (40%) or interest (34%), pharmacy disinterest (31%), and law enforcement opposition (26%). Among eight LHJs pursuing approval, the main barriers were “time management” (13%), educating stakeholders (13%), and enlisting pharmacy participation (13%). The17 LHJs with DPDP represent 52% of California’s residents; they included 62% of persons living with HIV and 59% of IDU-related HIV cases, suggesting that many LHJs with significant numbers of HIV cases have approved DPDPs. Outcome studies are needed to determine whether SB 1159 had the desired impact on increasing syringe access and reducing blood-borne viral infection risk among California IDUs

Selected static foot assessments do not predict medial longitudinal arch motion during running

Background: Static assessments of the foot are commonly advocated within the running community to classify the foot with a view to recommending the appropriate type of running shoe. The aim of this work was to determine whether selected static foot assessment could predict medial longitudinal arch (MLA) motion during running. Methods: Fifteen physically active males (27 ± 5 years, 1.77 ± 0.04m, 80 ± 10kg) participated in the study. Foot Posture Index (FPI-6), MLA angle and rearfoot angle were measured in a relaxed standing position. MLA motion was calculated using the position of retro-reflective markers tracked by a VICON motion analysis system, while participants ran barefoot on a treadmill at a self-selected pace (2.8 ± 0.5m.s-1). Bivariate linear regression was used to determine whether the static measures predicted MLA deformation and MLA angles at initial contact, midsupport and toe off. Results: All three foot classification measures were significant predictors of MLA angle at initial contact, midsupport and toe off (p < .05) explaining 41-90% of the variance. None of the static foot classification measures were significant predictors of MLA deformation during the stance phase of running. Conclusion: Selected static foot measures did not predict dynamic MLA deformation during running. Given that MLA deformation has theoretically been linked to running injuries, the clinical relevance of predicting MLA angle at discrete time points during the stance phase of running is questioned. These findings also question the validity of the selected static foot classification measures when looking to characterise the foot during running. This indicates that alternative means of assessing the foot to inform footwear selection are required

The effect of different skin-ankle brace application pressures on quiet single-limb balance and electromyographic activation onset of lower limb muscles

<p>Abstract</p> <p>Background</p> <p>Several studies have been carried out in order to investigate the effect of ankle bracing on ankle joint function and performance. However, no study so far has examined the role of skin-brace interface pressure in neuromuscular control. The aim of this study was to investigate the effect of different skin-ankle brace interface pressures on quiet single limb balance and the electromyographic (EMG) activation sequence of four lower limb muscles.</p> <p>Methods</p> <p>Thirty three male physical education students who volunteered to take part in the study were measured under three ankle brace conditions: i) without brace, ii) with brace and 30 kPa application pressure and iii) with brace and 60 kPa application pressure. Single limb balance (anteroposterior and mediolateral parameter) was assessed on the dominant lower limb, with open and closed eyes, on a force platform, simultaneously with the EMG recording of four lower lower limb muscles' (gastrocnemius, peroneus longus, rectus femoris and biceps femoris) activation onset.</p> <p>Results</p> <p>The results showed that overall balance (total stability parameter) was not significantly affected in any of the three ankle brace conditions. However, the anteroposterior centre of pressure excursion and centre of pressure excursion velocity were significantly increased with the application of ankle brace, both with 30 and 60 kPa application pressures. Furthermore, it was found that single limb balance was significantly worse with closed eyes compared to open eyes. EMG measurements showed that the sequence of lower limb activation onset was not affected in any of the three ankle brace application conditions. The results of this study showed that the application of an ankle brace with two different skin-brace interface pressures had no effect on overall single limb balance and the sequence of lower limb muscle activation.</p> <p>Conclusion</p> <p>These findings suggest that peripheral joint receptors are either not adequately stimulated by the brace application and therefore are not able to alter the balance control strategy of the CNS, or that they play a less important role in the control of single limb balance. Further research is needed in this area with more dynamic and functional measurements, before the safe use of ankle bracing can be widely recommended.</p

Sharing Detailed Research Data Is Associated with Increased Citation Rate

BACKGROUND: Sharing research data provides benefit to the general scientific community, but the benefit is less obvious for the investigator who makes his or her data available. PRINCIPAL FINDINGS: We examined the citation history of 85 cancer microarray clinical trial publications with respect to the availability of their data. The 48% of trials with publicly available microarray data received 85% of the aggregate citations. Publicly available data was significantly (p = 0.006) associated with a 69% increase in citations, independently of journal impact factor, date of publication, and author country of origin using linear regression. SIGNIFICANCE: This correlation between publicly available data and increased literature impact may further motivate investigators to share their detailed research data

Are the pneumococcal polysaccharide vaccines effective? Meta-analysis of the prospective trials

The objective was to review the evidence of effectiveness of the polyvalent polysaccharide pneumococcal vaccine from prospective properly randomised controlled trials comparing pneumococcal vaccines with placebo in subjects who are immunocompetent and those likely to have an impaired immune system. Databases searched included the Cochrane Library, (issue 2, 2000), MEDLINE (1966-August 2000), PubMed (to August 2000) and EMBASE ( to August 2000). Reference lists of reports and reviews were also searched. To be included in the analysis, a study had to have been a prospective randomised comparison of a polysaccharide pneumococcal vaccine (any valency) and to have a placebo or no treatment comparison group. Papers had to report important clinical outcomes, such as rates of pneumonia, pneumococcal pneumonia, lower respiratory tract infections, pneumonia deaths or bacteraemia. Serological outcomes were not sought. Thirteen randomised comparisons with over 45,000 subjects were identified in an extensive literature review. Eight studies had a quality score of 3 or more on a scale of 1 to 5. In three comparisons with 21,152 immunocompetent subjects (South African gold miners, New Guinea highlanders) pneumococcal vaccination was effective in reducing the incidence of all-cause pneumonia (relative risk 0.56, 95% confidence interval 0.47 to 0.66), pneumococcal pneumonia (0.16; 0.11 to 0.23), pneumonia deaths (0.70; 0.50 to 0.96) and bacteraemia (0.18; 0.09 to 0.34). In ten comparisons in over 24,000 people who were elderly or likely to have impaired immune systems, pneumococcal vaccination was without effect for any outcome. Present guidelines recommend pneumococcal vaccination for "high-risk" groups. There is no evidence from randomised trials that this is of any benefit

Estimating Infection Attack Rates and Severity in Real Time during an Influenza Pandemic: Analysis of Serial Cross-Sectional Serologic Surveillance Data

This study reports that using serological data coupled with clinical surveillance data can provide real-time estimates of the infection attack rates and severity in an emerging influenza pandemic