Most Read Articles
Audrey Abella, 15 May 2020
In adults with atrial fibrillation (AF) after percutaneous coronary intervention (PCI), dual therapy (direct oral anticoagulant [DOAC] + P2Y12 inhibitor) reduces the risk of bleeding compared with triple therapy (vitamin K antagonist [VKA] + DAPT* [aspirin and P2Y12 inhibitor]), a meta-analysis has shown. However, its effects on the risks of mortality and ischaemic endpoints** remain unclear.
09 May 2020
Use of aspirin during the implantation window of the menstrual cycle appears to increase fecundability, reveals a recent study.
31 Mar 2020
When treating fibromyalgia patients with low-dose naltrexone, the 4.5-mg dose appears to be a good choice, according to a recent study.
Pearl Toh, 11 Jun 2019
The novel antibody-drug conjugate enfortumab vedotin showed promising clinical activity in patients with advanced and metastatic urothelial cancer for whom there is a high unmet need, according to the EV-201 study presented at the ASCO 2019 Meeting.

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
Audrey Abella, 15 May 2020
In adults with atrial fibrillation (AF) after percutaneous coronary intervention (PCI), dual therapy (direct oral anticoagulant [DOAC] + P2Y12 inhibitor) reduces the risk of bleeding compared with triple therapy (vitamin K antagonist [VKA] + DAPT* [aspirin and P2Y12 inhibitor]), a meta-analysis has shown. However, its effects on the risks of mortality and ischaemic endpoints** remain unclear.
09 May 2020
Use of aspirin during the implantation window of the menstrual cycle appears to increase fecundability, reveals a recent study.
31 Mar 2020
When treating fibromyalgia patients with low-dose naltrexone, the 4.5-mg dose appears to be a good choice, according to a recent study.
Pearl Toh, 11 Jun 2019
The novel antibody-drug conjugate enfortumab vedotin showed promising clinical activity in patients with advanced and metastatic urothelial cancer for whom there is a high unmet need, according to the EV-201 study presented at the ASCO 2019 Meeting.