Schistosoma vaccine to enter phase Ib clinical trial

January 18, 2018, George Washington University

Researchers at Baylor College of Medicine, in collaboration with a team of researchers at the George Washington University and the Rene Rachou Institute, have received funding from the National Institutes of Health for a Phase Ib clinical trial for a Schistosomiasis vaccine in an endemic area of Brazil. The same group also led the initial Phase I study performed at Baylor.

The vaccine was developed by a consortium of partners of the product development partnership led by Texas Children's Hospital Center for Vaccine Development.

"It's exciting to see this vaccine advance through clinical development," said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. "Schistosomiasis ranks among the most devastating poverty related neglected diseases - and a schistosomiasis vaccine would be a game changer both for global public health and poverty reduction."

Hotez and Dr. Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor, serve as co-directors of the product development partnership.

Schistosomiasis is the second most deadly parasitic infection in humans, following malaria. The chronic, often debilitating, infection afflicts more than 200 million people worldwide. Its toll on society is measured in terms of disability-adjusted life years lost, including losses due to premature death and losses of healthy life and productivity caused by poor health and disability. The disease most often occurs in sub-Saharan Africa and Latin America.

The vaccine target in this study is the intestinal/liver schistosomiasis caused by Schistosoma mansoni, one of two species that accounts for approximately one-third of the total number of schistosomiasis cases and almost one-half of deaths worldwide, including all of the cases occurring in the Americas.

The Sm-TSP-2 antigen was selected as the lead candidate to target the disease caused by S. mansoni. The first study to examine the vaccine's safety and immunogenicity was conducted at the Baylor College of Medicine Vaccine Treatment and Evaluation Unit in 2015 in persons who had not lived in an area where the disease is endemic. The current trial will be conducted in Brazil, where S. mansoni is endemic. Investigators from the George Washington University will enroll subjects at a clinical site they have developed in Americaninhas, Brazil with Brazilian colleagues from the René Rachou Institute that is part of the Oswaldo Cruz Foundation (FIOCRUZ) of the federal Brazilian government.

The study will recruit up to 60 healthy males and non-pregnant females for a clinical trial of a vaccine to protect against schistosomiasis caused by infection with S. mansoni. Two formulations of the vaccine will be tested using a double-blind, randomized and controlled study design.

"The main purpose of the study is to assess the in a group of healthy adults who may have previously been exposed to schistosomiasis," said Dr. Robert Atmar, professor of infectious diseases at Baylor and co-principal investigator of the trial. "The investigative team will also evaluate the ability of different doses of the vaccine with or without adjuvant to induce antibody and cellular immune responses to the vaccine agent."

Samples collected during the study will be analyzed at the George Washington University.

"Right now, people are treated for schistosomiasis only to be rapidly reinfected. Creating a vaccine is critical to stopping this cycle," said Dr. David Diemert, principal investigator of the study and associate professor of microbiology, immunology, and at the George Washington University School of Medicine and Health Sciences.

"We are excited to be collaborating with the research teams from Baylor College of Medicine and FIOCRUZ on this important trial," stated Dr. Jeffrey Bethony, professor of microbiology, immunology, and tropical at the George Washington University School of Medicine and Health Sciences, who will lead the laboratory evaluations of the immune response to the .

Explore further: Clinical trial of human hookworm vaccine begins at Children's National Medical Center

Related Stories

Clinical trial of human hookworm vaccine begins at Children's National Medical Center

June 13, 2012
Today, the Sabin Vaccine Institute, in partnership with the George Washington University and the Children's National Medical Center, began vaccinating participants for a Phase 1 clinical trial of a novel human hookworm vaccine. ...

New process may lead to vaccine for schistosomiasis

June 12, 2017
Cornell and Ludwig Institute for Cancer Research scientists have developed a way to produce a protein antigen that may be useful as vaccine for schistosomiasis – a parasitic disease that infects millions of people, mostly ...

Tuberculosis vaccine safe for teens with Schistosoma parasite

May 4, 2017
Of the millions of people at risk for contracting tuberculosis each year, many are already infected with helminths, parasitic worms including Schistosoma flatworms. In some cases, parasite infections can impair the ability ...

International Chagas Day draws attention to serious infection

April 17, 2017
April 14 marks International Chagas Day, which signifies an important awareness day for those living with or concerned about Chagas disease, a chronic disease that is caused a parasitic microorganism, Trypanosoma cruzi, and ...

Chikungunya vaccine trial underway

June 6, 2017
The National Institutes of Health-funded Vaccine and Treatment Evaluation Unit at Baylor College of Medicine will be one of the sites for a clinical trial testing the safety and immune responses to a vaccine against chikungunya ...

Brazil claims successful test of parasite vaccine

June 13, 2012
Brazilian researchers say they have successfully tested a vaccine against schistosomiasis, a disease caused by parasitic worms that afflicts more than 200 million people worldwide.

Recommended for you

Marker may help target treatments for Crohn's patients

October 16, 2018
Crohn's disease (CD), a chronic inflammatory condition of the intestinal tract, has emerged as a global disease, with rates steadily increasing over the last 50 years. Experts have long suspected that CD likely represents ...

Polio: Environmental monitoring will be key as world reaches global eradication

October 15, 2018
Robust environmental monitoring should be used as the world approaches global eradication of polio, say University of Michigan researchers who recently studied the epidemiology of the 2013 silent polio outbreak in Rahat, ...

Study traces hospital-acquired bloodstream infections to patients' own bodies

October 15, 2018
The most common source of a bloodstream infection acquired during a hospital stay is not a nurse's or doctor's dirty hands, or another patient's sneeze or visitor's cough, but the patient's own gut, Stanford University School ...

Researchers make essential imaging tests safer for people at risk of acute kidney injury

October 15, 2018
Every year, millions of people undergo medical tests and procedures, such as coronary angiography, which use intravascular contrast dyes. "For the majority of patients, these are safe and necessary procedures. However, about ...

Do not give decongestants to young children for common cold symptoms, say experts

October 11, 2018
Decongestants should not be given to children under 6—and given with caution in children under 12—as there is no evidence that they alleviate symptoms such as a blocked or runny nose, and their safety is unclear, say ...

New techniques can detect Lyme disease weeks before current tests

October 11, 2018
Researchers have developed techniques to detect Lyme disease bacteria weeks sooner than current tests, allowing patients to start treatment earlier.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.