Wheat dextrin
Place in Therapy
Place in Therapy
As suggested by the literature reviewed, the clinical use of the killed whole cell Vibrio cholera and non-toxic recombinant cholera toxin B-subunit vaccine is dependent on the risk of travelers’ diarrhea occurrence based on the patient and should be weighed against the limitations of applying its limited efficacy, the cost of the vaccine, and the risks associated with taking and without taking the vaccine. There are three major efficacy trials that initially showed the benefits of the vaccine. A secondary analysis of a phase III clinical trial in Bangladesh initiated the potential for this WC-BS vaccine in protecting against ETEC, with the biggest benefit being against severe, life-threatening diarrhea; however, the patient population was locals in an endemic ETEC region and not in travelers. (1) This along with two other studies has shown that the vaccine has limited efficacy in preventing travelers’ diarrhea in general, and ETEC specifically. (1) The RCT appraised in this literature review was chosen to demonstrate the lack of all-around/overall benefit, though does demonstrate some potential in reducing severe diarrhea; that being said, the overall incidence of ETEC travelers’ diarrhea and the even-more reduced number of severe cases, suggests that the impact of this potential benefit may not be high. (2) As such, the place in therapy of this vaccine can be described as at the level of “Accept” though not necessarily recommended for the general public. With minimal adverse effects as described by the literature reviewed, patients who wish to or are able to afford the added cost can be safely counseled on its use at their own discretion. (3) Based on patient-specific factors or those traveling to high-risk areas with endemic levels (such as parts of Asia, Africa, Mexico, Central and South America), the vaccine can potentially be considered for use in high-risk individuals. (3) That being said, it should not be routinely recommended for travelers based on the evidence available, and can be seen as behind education on safe food and beverage ingestion, water purification, and chemoprophylaxis with non-antibiotic drugs or antibiotics in terms of preventative measures. (4)
References:
As suggested by the literature reviewed, the clinical use of the killed whole cell Vibrio cholera and non-toxic recombinant cholera toxin B-subunit vaccine is dependent on the risk of travelers’ diarrhea occurrence based on the patient and should be weighed against the limitations of applying its limited efficacy, the cost of the vaccine, and the risks associated with taking and without taking the vaccine. There are three major efficacy trials that initially showed the benefits of the vaccine. A secondary analysis of a phase III clinical trial in Bangladesh initiated the potential for this WC-BS vaccine in protecting against ETEC, with the biggest benefit being against severe, life-threatening diarrhea; however, the patient population was locals in an endemic ETEC region and not in travelers. (1) This along with two other studies has shown that the vaccine has limited efficacy in preventing travelers’ diarrhea in general, and ETEC specifically. (1) The RCT appraised in this literature review was chosen to demonstrate the lack of all-around/overall benefit, though does demonstrate some potential in reducing severe diarrhea; that being said, the overall incidence of ETEC travelers’ diarrhea and the even-more reduced number of severe cases, suggests that the impact of this potential benefit may not be high. (2) As such, the place in therapy of this vaccine can be described as at the level of “Accept” though not necessarily recommended for the general public. With minimal adverse effects as described by the literature reviewed, patients who wish to or are able to afford the added cost can be safely counseled on its use at their own discretion. (3) Based on patient-specific factors or those traveling to high-risk areas with endemic levels (such as parts of Asia, Africa, Mexico, Central and South America), the vaccine can potentially be considered for use in high-risk individuals. (3) That being said, it should not be routinely recommended for travelers based on the evidence available, and can be seen as behind education on safe food and beverage ingestion, water purification, and chemoprophylaxis with non-antibiotic drugs or antibiotics in terms of preventative measures. (4)
References:
- Hill DR, Ford L, Lalloo DG. Review – Oral cholera vaccines: use in clinical practice. Lancet Infect Dis. 2006:6;361-73
- Sack DA, Shimko J, Torres O, et al. Randomised, double-blind, safety and efficacy of a killed oral vaccine for enterotoxigenic E. coli diarrheoea of travellers to Guatemala and Mexico. Vaccine. 2007:25;4392-4400
- Wanke. CA, Calderwood SB, Bloom A. Travelers’ Diarrhea. Up to date. Accessed on March 10, 2014. http://www.uptodate.com/contents/travelers-diarrhea?source=machineLearning&search=travelers+diarrhea&selectedTitle=1~50§ionRank=1&anchor=H11#H11
- Committee to Advise on Tropical Medicine and Travel (CATMAT). An Advisory Committee Statement: Statement on New Oral Cholera and Travellers’ Diarrhea Vaccination. Can Comm Dis Rep. 2005:31;1-12.