Scandinavian Biopharma, May 2013
Results from a clinical Phase I study of a novel vaccine against diarrhea...
Five years ago, when Mitesh Gupta was born in Badohi (Uttar Pradesh), his mother Malti says, he was just fine. Five months down, the boy began to have severe episodes of diarrhea. Seeing no respite in the boy’s condition, she opted to bring him to Mumbai, where her husband was working. The mother of four still recalls vividly her struggle. Today as Mitesh plays in the congested lanes around his 10 X 10 feet house in, Zakir Hussain Colony in Mumbai, where he lives with his parents and three other siblings, Malti knows that he has been lucky.
Malti may not have the global statistics in hand, but diarrhea remains the second leading cause of death in children - 800,000 under the age of 5 globally. Rotavirus is the most severe and fatal cause of diarrhea and it claims around 450,000 children globally and more than 20 per cent of those who succumb to rotavirus worldwide are children in India.
In the same area, Zarina is troubled by her daughter Shabana’s episodes of diarrhea. The mother of three says, “Shabana has been having this problem ever since she was six. We have got a sonography done. Every time she has an episode, there is a visit to the doctor which costs us anything between Rs 500 ($9) and Rs 1,000 ($18).” For Zarina whose husband works as a small time tailor in Zakir Nagar, the diarrhea episodes are something that she is beginning to live with.
This settlement on the fringes of the Deonar garbage dump in Mumbai is a maze of narrow lanes with drinking water pipes crossing through, making it tricky to negotiate. In most places, the pipes run through the open gutters. Mitesh and Shabana’s families are but a reflection of many others, who live in these crowded and almost always dark alleys where the specter of a diarrhea outbreak looms large.
According to Dr. Asish Malekar, program manager, technical for the Strengthening Immunization in Mumbai Slums (SIMS), “In places where the drinking water pipes have rusted, there is a chance for contamination. Also since the water supply is intermittent, the empty pipes tend to pull in the water from the gutters. In the lower lying areas water tends to accumulate and during the warm seasons there are flies as there is garbage all over the place.”
Given the population in such health posts were a challenge to reach out to and children were missing their vaccination, over the past 18 months, the SIMS project aimed at the timely completion of antigen wise vaccination in all 0-2 year old children and pregnant women residing in five health posts in the project areas. The project developed a vaccination registry and its use for automated customized Short Text Messaging (SMS) services as mode of reminding and motivating respective families to get timely vaccination. The SMS is currently being sent out in Hindi and each SMS is directed to the family reminding them exactly which vaccination that particular beneficiary is due for. Typically the SMS will ‘speak’ to the family urging them “‘on 24/10/2012, Krishna has to be given her MMR, DPT B,and Polio B. Go immediately to your nearest health post and get the vaccination done.”
The baseline survey carried out prior to the pilot project revealed that only 34.3 per cent children were vaccinated in the four urban health posts. Today that figure stands at 59 per cent. The most striking impact of the SIMS project has been in Appapada, where the percentage of fully immunized children shot up from 12 per cent to 60 per cent.
The improvement in immunization coverage will provide a strong foundation for rapid update of rotavirus vaccines when they through the public health system.
-- Sushmita Malaviya is Communications Officer for Vaccine Development in PATH's India office.
For more information:
-- In India, PATH's Sure Start program has reached 25 million people, leading to substantial increases in safe practices for pregnancy and infant care.
-- Rota-what? Learn more about rotavirus, the most deadly form of severe diarrhea.
Photo credit: Lesley Reed/PATHRead more
“Oh, Stephanie, NO. Not while we’re eating our dinner!”
This is how the conversation usually goes when my parents make the mistake of asking me how my job is going over a family meal. I have become so used to discussing this subject, I forget that for most people it is perhaps more of an unrefined issue - certainly not a suitable topic of conversation during a meal at least.
But it IS a subject that we need to talk about – in fact, we need to ensure lots of people talk about it. Rather than being embarrassed to discuss this over dinner we need to be embarrassed that in the twenty-first century, diarrhoea is allowed to prevail as one of the top child killers in the world.
In fact, we should be horrified. Horrified that each year hundreds of thousands of children die from diarrhoea when we know how to prevent it and we know how to treat it. In 2009, UNICEF and WHO laid this out in a 7-point plan that brings together both the treatment (rehydration solution, zinc) and prevention (water, sanitation, hygiene, vaccines and exclusive breastfeeding).
As straightforward as it sounds to prevent people from getting it and give treatment once they have it, the development and implementation of policies is often challenging. Countries need to coordinate effectively between and within government departments responsible for water, sanitation, hygiene, and health. Dialogue, and, most importantly, action, is needed to overcome this.
This is why Tearfund and PATH gave their new report the title Diarrhoea Dialogues: from policies to progress.
The report examines how three high-burden countries are addressing diarrhoea –Mali, Ethiopia, and Zambia. It analyses both the opportunities and challenges in diarrhoea control. It concludes with recommendations that the international community need to shout about this issue and catalyse political will to give this issue the priority it deserves. Countries also need to review their policies and improve coordination. When UNICEF and WHO re-launch their 7-point plan in April 2013, we need to ensure that it doesn’t simply get lost or put on a shelf, but that it turns into action.
If we want to see lives saved and this avoidable suffering stopped we need to make a noise about this issue… even if it does make for an uncomfortable dinner time conversation.
-- Stephanie Gill, Public Policy Officer, TearfundRead more
As health leaders from around the globe gather for the Child Survival Call to Action, it is heartening to see India take a leadership role as co-convener of the Summit. Ghulam Nabi Azad, Minister of Health and Family Welfare for India, will help facilitate the two days of dialogue on how we can focus attention on protecting children from the leading killers of those below age five: diarrhea and pneumonia.
As director of PATH’s India program, I am proud of our team’s contribution to this goal. Our program is working to prevent disease through vaccines and immunization and improve the health of mothers and children. We are particularly excited about the results of our Sure Start program which reached almost 25 million people, leading to substantial increases in safe practices for pregnancy and infant care.
At the same time, we in India know that our country has one of the world’s highest burdens of diarrhea and pneumonia, and that we all – government, civil society, private sector, and communities – have to rededicate ourselves to accelerating progress.
Who can argue with the Summit’s organizing principle – that every child deserves a 5th birthday? This Call to Action is an opportunity for us to determine what steps we each can take to end preventable childhood deaths. That is why PATH is pleased to endorse the Declaration on Scaling Up Treatment of Diarrhea and Pneumonia, and commit our involvement in a “concerted global effort to end preventable child deaths from diarrhea and pneumonia in high-burden countries within a generation.”
The Declaration – and the UNICEF report last week – Pneumonia and diarrhoea: Tackling the deadliest diseases for the world’s poorest children underscore that we have the know-how and the solutions to save almost 2 million children’s lives by 2015. By delivering an integrated package of services that includes vaccines, treatment, water and sanitation, and nutrition, we can help children stay healthy to become the learners and earners that will help them, their families, and their communities thrive.
-- Tarun Vij is PATH’s country program leader for India.Read more
The Great, the Good and the Glamorous are gathering in Washington DC this week to talk about some really big issues affecting the world’s poorest and most vulnerable children and adults.
Anyone who is anyone in Global Health and Development is in town.
Nobel prize winner President Ellen Johnson Sirleaf of Liberia and Malawi’s President Joyce Banda top the bill at the Frontiers in Development Conference from 11-13 June and Hillary Clinton will kick things off at the Child Survival Call to Action from 14-15 June.
Mandy Moore, Christy Turlington Burns and Ben Affleck will add a little glamour but also a ton of heartfelt commitment. And, only slightly less exciting if you are a “development insider”, members of the GAVI Alliance Board will meet at the Capitol Hilton from 12-13 June to review progress since the historic GAVI Pledging Conference one year ago when generous donors made unprecedented commitments to childhood immunisation.
Of course, everyone is wondering if President Obama might even make an appearance? Now that would really help focus attention on important subjects like child and maternal mortality in the world’s poorest countries.
To raise awareness about the huge number of children who die before they reach the age of five (7.6 million in 2010) (and because they are good sports), many of these global health advocates have sent photographs of themselves taken when they were five to USAID’s excellent new website.
Even the media are getting in on the act with the likes of Judy Woodruff and Ray Suarez from PBS, Femi Oke of WNYC and CNN’s Kaj Larsen bringing professional TV-style moderation in order to keep the debates focussed and strategic.
And as they sit in their various sessions at the Hilton and Georgetown University, The Great, the Good and the Glamorous will no doubt all be discussing and wondering “What does success really look like?”
It’s a big question. But fortunately I know where they can find one answer at least.
It’s in this short film produced for GAVI with help from PATH’s communication expert Doune Porter about Ghana’s ambitious and unprecedented introduction of two vaccines at once – vaccines that have the power to help protect against the two diseases (pneumonia and diarrhea) that kill more of the world’s children before they reach their fifth birthday than any others.
So if, like so many people, you occasionally feel overwhelmed by the problems facing children and parents in the world’s poorest countries, I encourage you to watch this film. It’s guaranteed to vaccinate you against despair and give you some hope.
-- Dan Thomas is the Head of Media & Communication at the GAVI Alliance, a public-private global health partnership which aims to save children’s lives and protect people’s health by increasing access to immunisation in developing countries.
For more information:
-- Keep tabs on the Call to Action event on Twitter and join the conversation at #5thBDay and #promise4children.
-- Show your support for child health with a snazzy Facebook banner photo.Read more
The leading bacterial causes of diarrhea are enterotoxigenic Escherichia coli (ETEC) and Shigella, and vaccines against these pathogens could save the lives of up to a half-million children each year. PATH’s enteric vaccine project is working to accelerate the development of several promising vaccine candidates. We are also looking at innovative ways to make these vaccines as effective, practical, and affordable as possible so they can be easily implemented in the developing world.
Adjuvants, ingredients that may enhance the effectiveness of some vaccines, are one important area of focus. PATH is currently involved in research on a highly promising new adjuvant, the double-mutant heat-labile toxin (dmLT), which could open more doors to achieving immunity in the intestine. The dmLT is actually an ETEC antigen (a substance that causes the immune system to produce antibodies against it), so it may offer protection against both diarrhea and intestinal infection when used in conjunction with vaccines that are targeted to mucosal surfaces like the intestine. We aren’t exactly sure why, but children in resource-poor countries often have a lower response rate to mucosal vaccines. A wide range of factors may contribute to this issue, such as the influence of breastfeeding and maternal antibodies, poor nutrition, or increased exposure to intestinal pathogens. An adjuvant like the dmLT may help to bridge this gap in effectiveness.
Right now, we’re working with the National Institutes of Health’s (NIH) Division of Microbiology and Infectious Diseases on a Phase 1 clinical trial using oral doses of dmLT (not in conjunction with a vaccine) in healthy adults. We will have complete results later this year, but the preliminary data are quite promising. Meanwhile, we are about to launch our first Phase 1 trial of the dmLT combined with one of our oral ETEC vaccine candidates.
In addition, we plan to start another Phase 1 trial to test the dmLT intradermally (through the skin), and we would also like to study its use sublingually (under the tongue), to see if these alternative delivery routes can achieve an immune response in the intestine. If preclinical studies accurately predict what will be seen in humans, delivering dmLT in these ways could open up a whole range of possibilities for developing more effective and practical vaccines.
This type of innovative research is critical to moving forward the field of vaccines to address diarrheal disease, and support from the NIH and other partners is critical to this effort. As the dmLT and other promising vaccine technologies progress in their development, we know we are getting ever closer to expanding and improving the arsenal of tools to use in the fight against this major killer of children.
-- Dick Walker, director of the Enteric Vaccine Initative at PATH's Vaccine Development Program
For more information:
-- Escherichia coli (ETEC) and Shigella are major culprits of bacterial diarrheal disease. Learn how PATH is working with public and private sector partners to bring affordable vaccines to the children who need them most.Read more