Cadorna-Carlos J.B.,University of the East Ramon Magsaysay |
Nolan T.,University of Melbourne |
Borja-Tabora C.F.,Institute of Tropical Medicine |
Santos J.,Philippine Childrens Medical Center |
And 9 more authors.
Vaccine | Year: 2015
Background: Inactivated quadrivalent influenza vaccine (IIV4) containing two influenza A strains and one strain from each B lineage (Yamagata and Victoria) may offer broader protection against seasonal influenza than inactivated trivalent influenza vaccine (IIV3), containing a single B strain. This study examined the safety, immunogenicity, and lot consistency of an IIV4 candidate. Methods: This phase III, randomized, controlled, multicenter trial in children/adolescents (9 through 17 years) and adults (18 through 60 years) was conducted in Australia and in the Philippines in 2012. The study was double-blind for IIV4 lots and open-label for IIV4 vs IIV3. Children/adolescents were randomized 2:2:2:1 and adults 10:10:10:1 to receive one of three lots of IIV4 or licensed IIV3. Safety data were collected for up to 6 months post-vaccination. Hemagglutination inhibition and seroneutralization antibody titers were assessed pre-vaccination and 21 days post-vaccination. Results: 1648 adults and 329 children/adolescents received IIV4, and 56 adults and 55 children/adolescents received IIV3. Solicited reactions, unsolicited adverse events, and serious adverse events were similar for IIV3 and IIV4 recipients in both age groups. Injection-site pain, headache, malaise, and myalgia were the most frequently reported solicited reactions, most of which were mild and resolved within 3 days. No vaccine-related serious adverse events or deaths were reported. Post-vaccination antibody responses, seroconversion rates, and seroprotection rates for the 3 strains common to both vaccines were comparable for IIV3 and IIV4 in both age groups. Antibody responses to IIV4 were equivalent among vaccine lots and comparable between age groups for each of the 4 strains. IIV4 met all European Medicines Agency immunogenicity criteria for adults for all 4 strains. Conclusions: In both age groups, IIV4 was well tolerated and caused no safety concerns, induced robust antibody responses to all 4 influenza strains, and met all EMA immunogenicity criteria for adults. Clinical trial registry number: NCT01481454. © 2015 The Authors.
According to the findings, the extinction rate of the ancient marine plankton was largely influenced by global changes in climate, and the ocean's dramatic changes in temperature and circulation patterns. Professor James Crampton, from Victoria's School of Geography, Environment and Earth Sciences, along with Dr Roger Cooper, Emeritus Research Scientist at GNS Science, used computer-optimised analysis to examine the exact time of origination and extinction of graptolites—an extinct group of ancient marine animal that lived over 400 million years ago. "We found that extinction happens in short bursts or episodes, separated by longer settled spells, rather than gradually and continuously," says Professor Crampton. "When the world had a warm 'greenhouse' climate, there were low rates of extinction among the plankton. Then there was a sharp change to a cooler, fluctuating 'icehouse' climate like today, and several sharp peaks in the extinction rate, including one very severe peak where graptolites were almost wiped out." Professor Crampton and Dr Cooper worked alongside researchers in the United States to examine each of the 2041 species of the plankton through their 70 million year history. "Our analysis also shows that minor changes in the climate affected the newly evolved species of plankton—these new species were unable to compete and became extinct. It seems that nature was generating lots of new species, many of which could not survive," says Professor Crampton. "In contrast, the most abrupt, severe episodes of environmental change affected the old species more profoundly—in this situation, the old guard was disadvantaged. "So it is the severity of the change in the environment that determines if old or new species are prone to extinction. Overall the extinction changes were very rapid and the ecosystem was relatively unstable." The research group believes that the findings demonstrate the effect the current global climate may have on ocean habitats. "Our research suggests that the modern rate of environmental change could alter the balance of extinction risk, so that the old species will be at greatest risk," says Professor Crampton. The research was recently published in Proceedings of the National Academy of Sciences. Explore further: How the fossilized past can help predict our oceans' future
Gilpin D.,Brisbane Hand and Upper Limb Clinic |
Gilpin D.,Emeritus Research |
Gilpin D.,Caboolture Clinical Research Center |
Gilpin D.,Peninsula Clinical Research Center |
And 26 more authors.
Journal of Hand Surgery | Year: 2010
Purpose The Collagenase Option for the Reduction of Dupuytren's (CORD) II study investigated the efficacy and safety of injectable Xiaflex (collagenase clostridium histolyticum), in patients with Dupuytren's contracture. Methods This was a prospective, randomized, placebo-controlled trial with 90-day double-blind and 9-month open-label phases. We randomized patients with contractures affecting metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints 2 to 1 to collagenase (0.58 mg) or placebo. Cords received a maximum of 3 injections. Cord disruption was attempted the day after injection using a standardized finger extension procedure. Primary end point was reduction in contracture to 0° to 5° of normal 30 days after the last injection. Results We enrolled 66 patients; 45 cords (20 MCP to 25 PIP joints) received collagenase and 21 cords (11 MCP to 10 PIP joints) received placebo in the double-blind phase. Statistically significantly more cords injected with collagenase than placebo met the primary end point (44.4% vs 4.8%; p <. 001). The mean percentage decrease in degree of joint contracture from baseline to 30 days after last injection was 70.5% ± 29.2% in the collagenase group and 13.6% ± 26.1% in the placebo group (p < .001). The mean increase in range of motion was significantly greater in the collagenase (35.4° ± 17.8°) than in the placebo (7.6° ± 14.9°; p < .001) group. Efficacy after open-label treatment was similar to that after the double-blind phase: 50.7% of all joints achieved 0° to 5° of normal. More patients were satisfied with collagenase (p < .001). No joint had recurrence of contracture. One patient had a flexion pulley rupture and one patient underwent routine fasciectomy to address cord proliferation and sensory abnormality. No tendon ruptures or systemic allergic reactions were reported. Most adverse events were related to the injection or finger extension procedure. Conclusions Collagenase clostridium histolyticum is the first Food and Drug Administrationapproved, nonsurgical treatment option for adult Dupuytren's contracture patients with a palpable cord that is highly effective and well tolerated. Type of study/level of evidence Therapeutic I. © 2010 American Society for Surgery of the Hand.