Study finds that Ebola vaccine is safe and stimulates strong immune responses in adults in Mali and USA

Scanning electron micrograph of Ebola virus budding from the surface of a Vero cell (African green monkey kidney epithelial cell line). Credit: NIAID

Scanning electron micrograph of Ebola virus budding from the surface of a Vero cell (African green monkey kidney epithelial cell line). Credit: NIAID

A clinical trial of a new Ebola vaccine (ChAd3-EBO-Z) that resulted from an unprecedented global consortium assembled at the behest of the World Health Organization has found that it is well tolerated and stimulates strong immune responses in adults in Mali, West Africa and in the US, according to a study published today in the journal Lancet Infectious Disease. If the vaccine is ultimately found to be safe and effective, it could offer crucial protection for contacts (family members, neighbors, etc.) of patients with confirmed Ebola disease in future epidemics, thereby helping to interrupt transmission. Larger trials of the vaccine sponsored, by GSK Biologicals, have already begun.

The study, carried out in Mali, West Africa and Baltimore, included the first testing of this vaccine in adult health care workers and other at-risk persons in Africa. It identified the dose to be used in subsequent clinical trials and for large-scale manufacture of the vaccine. The researchers say that if larger trials (some already ongoing at CVD-Mali) corroborate the vaccine’s clinical acceptability and immunogenicity, and with evidence of protection from future field trials or from non-human primate challenge models, the vaccine could obtain regulatory approvals to become a tool to interrupt transmission in future outbreaks. This would be achieved by vaccinating all people who have come into contact with confirmed Ebola cases.

The investigators also found that the administration of a booster vaccination with another vector vaccine producing Ebola virus antigens led to further enhanced immune responses likely to be associated with long-lived protection. This “prime-boost” approach provides a way to vaccinate health care workers and other front-line workers who live in areas where Ebola poses a threat to re-emerge and who need prior enduring protection.

The trial was carried out by a group of faculty researchers within the Center for Vaccine Development (CVD) of the University of Maryland School of Medicine (UM SOM), led by Milagritos D. Tapia, MD and Kirsten Lyke, MD, collaborating closely with Professor Samba O. Sow, MD, MSc, Director General of the Center for Vaccine Development of Mali (CVD-Mali, an institution jointly maintained by the Ministry of Health of Mali and CVD-UM SOM).

Drs. Tapia and Lyke are also Associate Professors in the Department of Pediatrics and Medicine, respectively, at CVD-UM SOM., provided overall coordination of this study that evaluated the experimental Ebola vaccine (ChAd3-EBO-Z) developed by the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and GlaxoSmithKline (GSK). Other key partners in the study included the University of Oxford’s Jenner Institute and the World Health Organization.

The study was the result of a consortium of the World Health Organization (WHO), the VRC, the Jenner Institute at the University of Oxford, CVD-Mali, CVD-UM SOM, and GSK Biologicals (manufacturer of the vaccine).

The study also involved others at CVD-UM SOM, including Marcelo B. Sztein, MD, and, James D. Campbell, MD, MS, both of whom are Professors of Pediatrics at UM SOM, as well as Rezwanul Wahid, PhD, Assistant Professor of Pediatrics at UM SOM.

“This is a crucial step on the road to using this vaccine in humans,” said Dr. Levine. “This gives us essential information that the vaccine is not only well-tolerated but the high dose stimulates strong immune responses in adults in West Africa, the global region where the Ebola outbreak was rampant last year.”




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First real-life trial finds oral cholera vaccine protects against endemic disease and could speed up global control efforts



An oral cholera vaccine (Shanchol) given as part of routine health services is safe and protects against severe cholera in children and adults in urban Bangladesh where the disease is endemic, according to the first real-life trial of this vaccine published in The Lancet. The findings lend support to the use of the vaccine in routine mass vaccination programmes to help to control cholera in endemic countries.

The study shows that even with moderate vaccination coverage, cases of severe, life-threatening cholera were reduced by nearly 40% among the vaccinated, including children aged 5 years and under who are especially vulnerable to severe cholera. Surprisingly, a supplementary campaign to encourage hand-washing and to provide clean drinking water provided little additional protection.

Over 1 billion people are estimated to be at risk of cholera in more than 50 countries where it is endemic. Around 2.8 million cases and 91000 deaths occur every year in endemic regions. Cholera is an infectious disease that causes acute watery diarrhoea, which spreads from person to person through water or food contaminated by Vibrio cholerae bacteria. Up to 40% of people with cholera develop severe dehydration that, if untreated, can be fatal.

While oral cholera vaccines have been used to protect travellers from high-income countries for more than a decade, they have not been used for widespread control of the disease in endemic regions. Shanchol is one of two internationally licensed killed whole-cell oral cholera vaccines currently available. Although the vaccine is effective, easy to administer, and relatively inexpensive at US$ 1.85 per dose , its feasibility and effectiveness in a real-life setting was not known until now.

The ‘Introduction of Cholera Vaccine in Bangladesh’ feasibility study included almost 270000 residents aged 1 year and older from the urban slums of Mirpur in Dhaka who were at high risk of cholera infection due to overcrowding and poor sanitation. Residents were cluster-randomised by dwelling to receive either oral cholera vaccine (94675), oral cholera vaccine plus a behavioural change programme to improve hand-washing and to provide clean drinking water (92539), or no intervention (80056).

The vaccine was given in two doses 14 days apart through routine government health services. The vaccination campaign was well accepted by the local community. Despite a highly mobile population, 65% of the vaccination only group and 66% of the vaccination and behavioural change group received two complete doses.

Vaccination with two doses reduced the overall incidence of severely dehydrating cholera by 37% after 2 years in the vaccination group and by 45% when used in combination with the hand washing and clean drinking water programme. Analysis of individual protection showed the vaccine gave 53% protection against cholera during the 2 year follow-up.

The vaccine was well tolerated with no serious adverse effects reported. The majority of adverse events were mild or moderate—the most common were acute watery diarrhoea, vomiting, abdominal pain, and fever.

Read more: First real-life trial finds oral cholera vaccine protects against endemic disease and could speed up global control efforts


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Bird Flu Vaccine to Be Rolled Out in 2013 After ‘Breakthrough’

Concerns about bird flu attacks surfaced following reports of deaths in Indonesia, Cambodia, China and Vietnam.

A vaccine that officials claim can prevent people contracting bird flu will be mass-produced by state pharmaceutical company Bio Farma by next year.

“I am grateful that we have made a breakthrough,” Research and Technology Minister Gusti Muhammad Hatta said on Thursday in Makassar.

“The bird flu spores have been found. We now only need to breed them and mass-produce them.”

Gusti told reporters that the spores would later be made into a vaccine, adding that the ministry had also started developing vaccines for infants and elementary school children.

“We know that every year we buy at least five to seven million vaccines for infants from overseas that drain our money in addition to more than 12 million vaccines for school-aged children. That’s why we will continue to conduct research so that we can produce them domestically,” Gusti said.

The vaccine is the result of 10 years of intensive research, the minister added. The ministry has plans to introduce a sample of the vaccine on Aug. 10 to coincide with the 17th National Technology Awakening Day.

The government has also formed a consortium and is looking to develop vaccines for Hepatitis B and C.

Gusti added that he also continued to encourage small and medium enterprises to develop vaccines.

Bird flu hit the country hardest in 2005, after which the attacks eased significantly. But the virus has re-emerged since last year, killing nine people in 2011.

Concerns about bird flu attacks surfaced following reports of deaths in Indonesia, Cambodia, China and Vietnam.

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Alzheimer’s Vaccine Trial a Success

Enzymes act on the APP (Amyloid precursor prot...

A tolerable treatment for patients with mild to moderate Alzheimer’s

A study led by Karolinska Institutet in Sweden reports for the first time the positive effects of an active vaccine against Alzheimer’s disease. The new vaccine, CAD106, can prove a breakthrough in the search for a cure for this seriously debilitating dementia disease. The study is published in the scientific journal Lancet Neurology.

Alzheimer’s disease is a complex neurological dementia disease that is the cause of much human suffering and a great cost to society. According to the World Health Organisation, dementia is the fastest growing global health epidemic of our age. The prevailing hypothesis about its cause involves APP (amyloid precursor protein), a protein that resides in the outer membrane of nerve cells and that, instead of being broken down, form a harmful substance called beta-amyloid, which accumulates as plaques and kills brain cells.

There is currently no cure for Alzheimer’s disease, and the medicines in use can only mitigate the symptoms. In the hunt for a cure, scientists are following several avenues of attack, of which vaccination is currently the most popular. The first human vaccination study, which was done almost a decade ago, revealed too many adverse reactions and was discontinued. The vaccine used in that study activated certain white blood cells (T cells), which started to attack the body’s own brain tissue.

The new treatment, which is presented in Lancet Neurology, involves active immunisation, using a type of vaccine designed to trigger the body’s immune defence against beta-amyloid. In this second clinical trial on humans, the vaccine was modified to affect only the harmful beta-amyloid. The researchers found that 80 per cent of the patients involved in the trials developed their own protective antibodies against beta-amyloid without suffering any side-effects over the three years of the study. The researchers believe that this suggests that the CAD106 vaccine is a tolerable treatment for patients with mild to moderate Alzheimer’s. Larger trials must now be conducted to confirm the CAD106 vaccine’s efficacy.

Read more . . .

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Hepatitis C breakthrough

Simplified diagram of the structure of Hepatit...

Simplified diagram of the structure of Hepatitis C virus (Photo credit: Wikipedia)

It will take at least five years before the vaccine can be put forwards for regulatory approval

After many years of research a group of Canadian scientists have announced a possible breakthrough for the development of a vaccine for hepatitis C.
Hepatitis C(or HCV) is a virus which can lead to serious illnesses and it is more virulent than HIV. Hepatitis C is an infectious disease affecting primarily the liver. HCV is spread primarily by blood-to-blood contact associated with intravenous drug use, poorly sterilized medical equipment and transfusions.

For many years scientists have thought that developing a hepatitis C vaccine was unlikely due to the complexities involved and resistance of the virus to most known compounds, the science website The Argosyreports. However, a research team based at the University of Alberta have posted research findings which indicate that a potential vaccine has been developed. The vaccine appears to be effective against all known strains of the hepatitis C virus.

According to a press release from the University of Alberta, the vaccine works by stimulating antibodies to fight the viral infection. If successful it could possibly be used to treat those who have the disease and can certainly be used by those most at risk from contracting it. However, it will take at least five years before the vaccine can be put forwards for regulatory approval from bodies like the US Food and Drug Administration (FDA).

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