Most Read Articles
08 Jul 2017
Entecavir and lamivudine demonstrate comparable effects on the mortality rate of patients with chronic hepatitis B virus (HBV)-related acute exacerbation with or without acute-on-chronic liver failure (ACLF), reports a study. In patients with ACLF, however, entecavir delivers a more favourable long-term outcome and is associated with greater clinical improvements.
Pearl Toh, 26 Sep 2019
The Singapore Health Sciences Authority (HSA) has recalled eight brands of ranitidine products containing trace amounts of the nitrosamine impurity NDMA*, which is a potential human carcinogen.
05 Oct 2019
The combination of sofosbuvir and velpatasvir is safe and effective for the treatment of hepatitis C virus (HCV) in patients with end-stage renal disease (ESRD) undergoing haemodialysis, a study has shown.
Rachel Soon, 24 Apr 2019

With recent recalls of losartan-containing products contaminated by potentially carcinogenic nitrosamines, MIMS speaks to the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for more details.

Bivalent C. difficile vaccine safe, well tolerated in older adults

01 Jul 2019

An investigational bivalent Clostridium difficile vaccine that contains equal dosages of genetically and chemically detoxified toxins A and B has a tolerable safety profile and is immunogenic in healthy older adults, according to the results of a phase II trial.

The trial randomized 855 healthy adults aged 65-85 years to receive vaccine (100 or 200 μg) or placebo at 0, 1 and 6 months (month regimen) or 1, 8 and 30 days (day regimen).

Researchers assessed the safety, tolerability and immunogenicity of the vaccine by measuring serum toxin A- and B-specific neutralizing antibodies. They also recorded participant-reported local reactions (LRs) and systemic events (SEs), adverse events (AEs), serious AEs, newly diagnosed chronic medical conditions, and immediate AEs.

Immune responses were higher in the 200- vs 100-µg dose group across regimens. Compared with the day regimen, the month regimen produced stronger and more persistent immune responses, which remained elevated 12 months after the third dose. Responses peaked at month 7 in the month-regimen group and at day 37 in the day-regimen group.

More patients in the vaccine groups than in the control groups reported LRs (primarily injection site pain), while SE incidence was similar across groups. AEs occurred with greater frequency in the day-regimen group than in the month-regimen group.

The findings demonstrate encouraging tolerability and immunogenicity of the C. difficile vaccine, supporting its continued development for C. difficile infection prevention in older adults, the researchers said, adding that the 200-μg dose vaccine was selected for development in ongoing phase III studies.

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Most Read Articles
08 Jul 2017
Entecavir and lamivudine demonstrate comparable effects on the mortality rate of patients with chronic hepatitis B virus (HBV)-related acute exacerbation with or without acute-on-chronic liver failure (ACLF), reports a study. In patients with ACLF, however, entecavir delivers a more favourable long-term outcome and is associated with greater clinical improvements.
Pearl Toh, 26 Sep 2019
The Singapore Health Sciences Authority (HSA) has recalled eight brands of ranitidine products containing trace amounts of the nitrosamine impurity NDMA*, which is a potential human carcinogen.
05 Oct 2019
The combination of sofosbuvir and velpatasvir is safe and effective for the treatment of hepatitis C virus (HCV) in patients with end-stage renal disease (ESRD) undergoing haemodialysis, a study has shown.
Rachel Soon, 24 Apr 2019

With recent recalls of losartan-containing products contaminated by potentially carcinogenic nitrosamines, MIMS speaks to the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for more details.