Featured Research

from universities, journals, and other organizations

Oral vaccine against diarrhea promising

Date:
May 22, 2013
Source:
University of Gothenburg
Summary:
Medical researchers have announced promising results in a placebo controlled phase I study of an oral, inactivated Escherichia coli diarrhea vaccine.

Successful results in developing oral vaccine against diarrhea.
Credit: The University of Gothenburg

The University of Gothenburg Vaccine Research Institute (GUVAX) announces successful results in a placebo controlled phase I study of an oral, inactivated Escherichia coli diarrhea vaccine.

Enterotoxigenic Escherichia coli (ETEC) bacteria are the primary cause of diarrhea in children living in low and middle income countries result in 400 million diarrheal episodes and approximately 300,000 deaths among children per year.

ETEC is also the leading cause of illness among international travelers to developing countries. Among the 65 million people travelling from industrialized countries to ETEC high-risk areas in the developing world, 30-50 % (ca 30 million people) experience at least one TD episode during their journey. Today there is no ETEC vaccine available on the market for use in either children or travelers in ETEC high-risk areas.

A novel oral ETEC vaccine has been developed in Sweden and a clinical phase I-study of this vaccine has now been successfully completed. All predefined primary endpoints for the study were achieved showing that the vaccine is safe, with only few and mild adverse reactions observed, and strongly immunogenic, stimulating immune responses to all vaccine components.

The vaccine, consisting of four inactivated E. coli bacterial strains and the ETEC-based B subunit protein LCTBA, was studied for safety and immunogenicity in a total of 129 healthy volunteers. The study was designed as a four-armed, double-blinded, placebo-controlled trial. Study participants were randomized to receive two oral doses two weeks apart of either the vaccine alone, vaccine co-administered with an oral adjuvant in a low or a higher dose, or an inactive placebo preparation (a buffer solution).

In addition to safety parameters, antibody responses against various vaccine components in fecal samples, or antibodies produced by intestine-derived peripheral blood lymphocytes were measured at different time intervals.

The vaccine was well tolerated by the study participants. Adverse events were few and generally mild with no difference observed in subjects receiving vaccine or a placebo preparation. In total, 75% of all vaccine recipients responded to all 5 of the primary vaccine components, a result that well exceeds the primary immunological endpoint for the study (at least 50 percent of the subjects responding to at least 4 of the primary vaccine antigens).

Furthermore, 85 % of subjects receiving the vaccine co-administered with low dose adjuvant showed significant immune responses to all vaccine components. In addition to showing excellent safety and immunogenicity of the five-component vaccine, the results also confirm previous preclinical results as well as clinical results obtained with a prototype version of this vaccine.

This study was conducted at the Sahlgrenska Academy of University of Gothenburg as a collaborative effort between University of Gothenburg Vaccine Research Institute, Scandinavian Biopharma, Stockholm and the non-profit organization PATH, Washington D.C. The results will be presented at the Mucosal Vaccines, Adjuvants and Delivery Conference in Copenhagen, September 25-27 2013 and the 7th International Conference on Vaccines for Enteric Diseases, 6-8 November 2013 in Bangkok, Thailand.

Based on these very encouraging results, additional clinical studies are planned to document protective efficacy in travelers, and to study the safety and immunogenicity of the vaccine when given to children living in areas endemic for ETEC.


Story Source:

The above story is based on materials provided by University of Gothenburg. The original article was written by Krister Svahn. Note: Materials may be edited for content and length.


Cite This Page:

University of Gothenburg. "Oral vaccine against diarrhea promising." ScienceDaily. ScienceDaily, 22 May 2013. <www.sciencedaily.com/releases/2013/05/130522085215.htm>.
University of Gothenburg. (2013, May 22). Oral vaccine against diarrhea promising. ScienceDaily. Retrieved October 22, 2014 from www.sciencedaily.com/releases/2013/05/130522085215.htm
University of Gothenburg. "Oral vaccine against diarrhea promising." ScienceDaily. www.sciencedaily.com/releases/2013/05/130522085215.htm (accessed October 22, 2014).

Share This



More Health & Medicine News

Wednesday, October 22, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Orthodontist Mom Jennifer Salzer on the Best Time for Braces

Orthodontist Mom Jennifer Salzer on the Best Time for Braces

Working Mother (Oct. 22, 2014) Is your child ready? Video provided by Working Mother
Powered by NewsLook.com
U.S. Issues Ebola Travel Restrictions, Are Visa Bans Next?

U.S. Issues Ebola Travel Restrictions, Are Visa Bans Next?

Newsy (Oct. 22, 2014) Now that the U.S. is restricting travel from West Africa, some are dropping questions about a travel ban and instead asking about visa bans. Video provided by Newsy
Powered by NewsLook.com
US to Track Everyone Coming from Ebola Nations

US to Track Everyone Coming from Ebola Nations

AP (Oct. 22, 2014) Stepping up their vigilance against Ebola, federal authorities said Wednesday that everyone traveling into the US from Ebola-stricken nations will be monitored for symptoms for 21 days. (Oct. 22) Video provided by AP
Powered by NewsLook.com
Doctors Help Paralysed Man Walk Again, Patient in Disbelief

Doctors Help Paralysed Man Walk Again, Patient in Disbelief

AFP (Oct. 22, 2014) Polish doctors describe how they helped a paralysed man walk again, with the patient in disbelief at the return of sensation to his legs. Duration: 1:04 Video provided by AFP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins