Safety and immunogenicity of the live-attenuated chikungunya virus vaccine candidate VLA1553

A recent study suggests that VLA1553 batches are both safe and immunogenic. This study’s findings were published in the Journal of travel medicine.

This was a phase 3, randomized, double-blinded, and focused on lot-to-lot consistency trial that included 408 healthy adults (aged 18-45 years). The primary endpoint of the study was to compare the geometric mean titre (GMT) ratios of chikungunya virus (CHIKV)-specific neutralizing antibodies between three different batches of VLA1553, 28 days after the administration of the vaccine. Additionally, secondary endpoints included assessing the immunogenicity and safety of the vaccine over a period of 6 months post-vaccination.

GMTs were similar among the batches that met the criteria for equivalence. The average GMT (measured by fifty percentage CHIKV micro plaque neutralization test; μPRNT50) reached 2643 at 28 days post-vaccination and dropped to 709 at 6 months post-vaccination. At 28 days post-vaccination, a high seroresponse rate (μPRNT50 titre ≥ 150 considered protective) was seen in 97.8% of participants, maintained at 96% at 6 months post vaccination. Following the administration of VLA1553 immunization, adverse events (AEs) were reported by 72.5% of the participants with no significant variations observed between the different batches. Generally, AEs were mild or moderate and resolved without any sequela, typically within 3 days.

Thus, it can be concluded that all three batches of VLA1553 were found to be safe and immunogenic. These findings emphasize the potential of VLA1553 as a vaccine for effectively preventing CHIKV disease in individuals residing in or visiting areas where the disease is prevalent.

Safety and efficacy of linaclotide in treating functional constipation in paediatric patients

According to a recent study, linaclotide has proven to be an effective and well-tolerated remedy for functional constipation in pediatric patients. This study’s findings were published in the journal, Lancet. Gastroenterology & hepatology.

In this double-blind, randomised,  placebo-controlled, phase 3 study, patients aged 6-17 years were randomly assigned to receive either oral linaclotide 72 μg [n=166] or placebo [n=164] once daily for 12 weeks. The study's primary efficacy endpoint was the change from baseline (CFB) in the frequency rate of spontaneous bowel movements (SBM) per week over a twelve-week period. The change from baseline in stool consistency during the treatment period was the secondary efficacy endpoint. Efficacy and safety were analyzed in all patients who received at least one dose of the study intervention.

The mean frequency rate for SBMs was 1·28 SBMs per week (SD 0·87) with placebo and 1·16 SBMs per week (0·83) with linaclotide at baseline. This rate increased to 2·29 SBMs per week (1·99) with placebo and 3·41 SBMs per week (2·76) with linaclotide during the intervention. Patients treated with linaclotide demonstrated a significant increase in SBM frequency [least-squares mean (LSM) CFB 2·22 SBMs per week (SE 0·19)] compared to those on placebo [LSM CFB 1·05 SBMs per week (0·19)]. Additionally, linaclotide demonstrated a notable improvement in stool consistency compared to the placebo group [LSM CFB 1.11 (SE 0.08) versus 0.69 (0.08)]. Based on the above results, it can be concluded that linaclotide is an efficacious and well-tolerated treatment for functional constipation in paediatric patients.

3 L split-dose PEG regimen superior to 2 L PEG regimen for colonoscopic bowel preparation

A recent study demonstrated that 3 L split-dose polyethylene glycol (PEG) is superior to 2 L polyethylene glycol for colonoscopic bowel preparation in individuals with relatively high BMI. This study was published in the journal, BMC Gastroenterology.

This was a multicenter randomized controlled trial that included 710 individuals with high BMIs (≥ 24 kg/m2), who were scheduled to undergo colonoscopy. The participants were randomly assigned into the 3 L split-dose polyethylene glycol (PEG) group (n=353) and the 2 L PEG group (n=357).  The primary outcome of the study was the rate of adequate bowel preparation, and the secondary outcomes included the Boston Bowel Preparation Scale (BBPS) score, polyp detection rate, cecal intubation rate, and adverse reactions during bowel preparation. Additionally, the study had exploratory subgroup analyses for adequate bowel preparation.

After enrollment, 15 participants did not undergo colonoscopy, only 345 participants received 3 L split-dose PEG regimen, and 350 participants received 2 L PEG regimen for colonoscopic bowel preparation. It was shown that the rate of adequate bowel preparation was superior in the 3 L split-dose PEG regimen (81.2%) compared to the 2 L PEG regimen (74.9%). Additionally, it was found that the BBPS score (6.71±1.15 vs. 6.37±1.31) and the rate of polyp detection (62.0% vs. 52.9%) were better with the 3 L split-dose PEG regimen compared to the 2 L PEG regimen. In the subgroup analysis, the 3 L split-dose PEG regimen performed better than the 2 L PEG regimen in the overweight individuals (BMI 25-29.9 kg/m2).

These findings suggest that a 3 L split-dose PEG regimen is superior to a 2 L PEG regimen for colonoscopic bowel preparation in individuals with high BMI (25-29.9 kg/m2).

Antibiotic prophylaxis results in lower risk of infectious complications before ERCP in patients with biliary obstruction

A recent study suggests that incidence of postendoscopic retrograde cholangiopancreatography (ERCP) infections was significantly lower with antibiotic prophylaxis in patients with biliary obstruction. The study's findings were published in The American Journal of Gastroenterology.

This double-blind, placebo-controlled, randomized trial included 378 patients who were randomly assigned in a 1:1 ratio to receive either a single dose of 1 g intravenous cefoxitin (n=189) or normal saline (n=189; placebo), 30 minutes before undergoing ERCP. The incidence of infectious complications after ERCP comprised the primary outcome of this trial.

At the end of the study, it was found that the risk of infectious complications after ERCP was 2.8% and 9.8% in the antibiotic prophylaxis group and placebo group, respectively. The incidence rates of bacteremia in the antibiotic prophylaxis and placebo groups were 2.3% and 6.4%, respectively. Finally, the incidence rate of cholangitis was 1.7% in the antibiotic prophylaxis group and 6.4% in the placebo group.

Based on the above results, it can be concluded that before ERCP, antibiotic prophylaxis resulted in a significantly lower risk of infectious complications, especially cholangitis, in patients with biliary obstruction.