Evaluation of long-term efficacy and safety of a tetravalent dengue vaccine (TAK-003) against all four DENV serotypes

According to a recent study, it was found that TAK-003, a tetravalent dengue vaccine showed long-term efficacy and safety against all four DENV serotypes in previously exposed individuals as well as against DENV-1 and DENV-2 in dengue-naïve individuals. The findings of this study were published in the journal The Lancet. Global Health.

This was a phase 3, randomized, double-blind, placebo-controlled trial that included healthy participants aged 4-16 years. They were randomly assigned in a 2:1 ratio to receive either two subcutaneous doses of TAK-003 (n=13,401) or placebo (n= 6,698) 3 months apart. RT-PCR testing of febrile illness episodes and active febrile illness surveillance were performed for identifying virologically confirmed dengue. Efficacy outcomes were measured in the safety analysis set and the per protocol set, comprising all randomly assigned participants who received ≥1 dose and all participants who had no major protocol violations, respectively. The efficacy outcomes also included cumulative vaccine efficacy from first vaccination to approximately 4·5 years after the second vaccination. SAEs (serious adverse events) were monitored throughout the study.

At the end of the study, it was observed that 1,007 (placebo: 560; TAK-003: 447) participants out of 27,684 febrile illnesses reported were virologically confirmed dengue cases, out of which 188 (placebo: 142; TAK-003: 46) required hospitalization. The cumulative efficacy of the vaccine was determined to be 61.2% against virologically confirmed cases of dengue and 84.1% against hospitalised virologically confirmed cases of dengue; corresponding efficacies were 53.5% and 79.3% in baseline seronegative participants belonging to the safety net. Vaccine efficacy was exhibited against all four serotypes in baseline seropositive participants as found out in an exploratory analysis. Reported SAEs were not considered related to the study vaccine. Thus, it can be concluded that TAK-003 vaccine may demonstrate long-term efficacy and safety against all four DENV serotypes.

Novel biobased polyester cast provides matching stability to conventional fiberglass cast and improves patient satisfaction

According to a recent study, novel biobased polyester cast provides clinical outcomes similar to the conventional fiberglass casts and improves overall patient satisfaction in an eco-friendlier and safer way. This study was published in the journal, BMC Musculoskeletal Disorders.

This was a single-center, prospective, randomized trial that included 100 children with cast-immobilized stable upper limb fractures. They were randomly divided into either biobased polyester or synthetic fiberglass groups. All the patients were followed up till the cast removal which was done at approximately 3-4 weeks after immobilizing. Subjective patient questionnaire and objective clinical findings for the study were collected and analyzed.

Both the groups did not show any loss of reduction, based on the radiographs taken on the day of cast removal. Occurrence of skin problems was 3.4 times higher in the synthetic fiberglass group than in the biobased polyester group. The biobased polyester cast was preferred in every sub-item in the subjective questionnaire.

Based on the above results, it can be concluded that the novel biobased polyester cast may provide an improved patient satisfaction and matching stability to conventional fiberglass casts in an eco-friendlier and safer way.

Efficacy of CoolSense in reducing the pain of intravenous cannulation

A recent study found that CoolSense demonstrated greater efficacy in minimizing the pain associated with intravenous cannulation compared to the EMLA cream. This study’s findings were published in the Indian journal of pediatrics.

In this randomized, controlled trial, a total of 140 children aged 6-12 years, classified by the American Society of Anesthesiologist I/II, who needed intravenous cannulation before anesthesia induction, were divided into two groups of 70 each. Group I received CoolSense pretreatment, while Group II was given EMLA cream pretreatment prior to intravenous cannulation. The primary outcome was to assess the effectiveness of CoolSense and EMLA cream in reducing pain during intravenous cannulation. The secondary outcomes included measuring the anxiety levels of children, the success rate of the first cannulation attempt, any technical challenges encountered, adverse reactions, and the satisfaction score of parents.

During intravenous cannulation, the CoolSense group demonstrated a significant decrease in pain scores compared to the EMLA cream group (mean pain score was 7.14 ± 4.322 vs. 29.32 ± 8.95). The CoolSense group experienced a decrease in anxiety levels before and after the procedure when compared to the EMLA group. Additionally, the application duration of CoolSense was significantly shorter than that of EMLA cream.

To summarize, CoolSense demonstrated superior effectiveness in reducing the pain associated with intravenous cannulation compared to the EMLA cream. Within the pediatric population, CoolSense presents itself as a simple and rapid method for delivering sufficient pain relief during venous cannulation.

Atropine combined with ortho-k treatment can improve the efficacy of myopia control

A recent study found that atropine combined with orthokeratology (ortho-k) can significantly improve the efficacy of myopia control in children compared with monotherapy. This study’s findings were published in the British Journal of Ophthalmology.

This was an age-stratified randomised controlled trial, including 164 children aged 8-12 years with spherical equivalent refraction of -1.00 to -6.00 D. The participants were stratified into two age subgroups and randomly assigned to receive placebo drops+spectacles (control), 0.01% atropine+spectacles (atropine), ortho-k+placebo (ortho-k) or combined treatment. Measurements of the axial length were taken at the baseline and visits at 6, 12, 18, and 24-months. The primary analysis of this study was done following the criteria of intention to treat, which included all randomised subjects.

After 2-year follow-up, it was demonstrated that axial elongation was significantly reduced in combined treatment than in monotherapies. In the ortho-k group, a significant age-dependent effect was evident when compared to the control group. Similarly, a significant age-dependent effect was observed in the ortho-k group when compared to the atropine group. Based on the findings of the study, it can be concluded that a combination of atropine and ortho-k treatment improves the efficacy of myopia control compared with monotherapy in children aged 8-12 years. Additionally, younger children may experience greater benefits from ortho-k treatment