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submitted by Allison Clifford
08/14/2013 at 11:26

As part of my work for PATH, I recently had the pleasure of visiting the Kasturba Hospital in Sewagram, India. My colleague and I were given a tour of the facility by a young doctor on staff there, Dr. Abhishek, and his enthusiasm for the hospital and its practices was, dare I say it, infectious. Aside from the open-air aspect of the main floor of the facility and the huge number of motorbikes in the parking lot, the hospital seemed to have many of the same things that we would find at most major medical centers in the US – an emergency room, X-ray and MRI machines, blood bank, pharmacy, etc. However, I was intrigued by what I learned regarding their common practices for women who come to the hospital to give birth.

Among the interesting facts Dr. Abhishek shared with us was that this hospital has been promoting breastfeeding within the first half-hour of birth for decades. Given breastfeeding’s proven impact on reducing infant illnesses, including diarrhea and pneumonia, this seemingly progressive approach to initiating early breastfeeding has surely saved countless young lives in this central Indian district. I couldn’t help but draw comparisons with my own experiences in giving birth at a hospital in Washington, DC. It wasn’t until well over an hour after I gave birth that the nurses finally suggested that I try breastfeeding my son. From my work in child health, I knew that it would have been ideal to do it sooner. But, being a first-time mom and feeling completely unsure about everything, I found myself relying entirely on what the doctors and nurses in the hospital told me to do, and I was hesitant to speak up and suggest something different. It was great to hear that the women giving birth at Kasturba Hospital aren’t faced with this situation, and instead are encouraged to begin breastfeeding right away.

In addition, no matter how natural and normal the delivery is, Kasturba Hospital always keeps mothers and babies as patients there for three full days after birth. Dr. Abhishek said that if a baby survives the first day of life, he is three times more likely to survive his first year. For that reason, they have a strong focus on the first 28 days of life, when most child deaths occur, and they have found that keeping a close eye on mother and baby for those first three days is critical to keeping them healthy in the longer term. In the US, women who have given birth naturally seem to be practically pushed out the door of the hospital just 24 hours after giving birth, so this seemed like a really different approach.

I’m honored to have had the chance to visit this hospital and learn about how it serves its local community so well, particularly its new mothers and their babies. It’s easy to see why Dr. Abhishek enjoys giving these tours to visitors so much. They know what works best for their community and, most importantly, what keeps new babies healthy and thriving, and they have put that into practice in the best possible way.

 

-- Allison Clifford, Communications Officer for Vaccine Development program at PATH

 

Photo credit: PATH

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submitted by Sushmita Malaviya
08/07/2013 at 10:34

For the affable Dr. Tushar Tewari, PATH Team Leader of a rotavirus vaccine project, Eastern and Southern India have been his home as a medical student.  As a professional it has been Western and Northern India, thus, literally covering the breadth of the country. He has worked on clinical studies ranging from vaccines, oncology, and infectious diseases to ophthalmology, pulmonology, and neurology and now brings his expertise to the efficacy trial of a rotavirus vaccine in India. PATH is currently collaborating with the Serum Institute of India in developing a bovine-human reassortant pentavalent vaccine (BRV-PV) to prevent rotavirus infections, which will soon be in a Phase 3 clinical trial in India. Rotavirus diarrhea is a leading cause of morbidity and mortality in children under 5 years of age in developing world.

 

You are the Team Leader for PATH’s BRV-PV project in India. Tell us, what does that mean?

I am responsible for planning and execution and medical supervision of the study. This includes writing critical study documents like the protocol and the consent documents. Once the study starts, I will be keeping an oversight on operational execution and safety issues of the vaccine. This is to preempt any untoward incident. The medical team is the champion of the protocol and the point of contact for anybody who was a protocol related query.  

As an MD, what brought you to clinical trials? You have been associated with research for the past 10 years. What fascinates you?

The journey of a drug from the laboratory to the clinic has always fascinated me and I wanted to be a part of such an endeavor. Being a medical doctor I thought I can contribute to this journey by bringing in my expertise to plan and design clinical studies, so it has been worthwhile.

What do you find most exciting in your job profile in PATH?

This is a great team, where each supports the other in its possibilities and there is opportunity to work with global stalwarts who are now fantastic colleagues. There are exciting and challenging assignments which impart a great deal of all-around learning and appreciation for a good job done.

Do you face any challenges?

Well, for this study we have sites from across the country – East, South, Central, and Western India. Every State has a different culture and social habits. Also there are multiple stakeholders and it will be important to communicate firmly and effectively so that everybody is aboard to work to consensus. As we progress, there will be new challenges.

You have hiked to the Himalayas – any similarities in your work life?

I have been a keen hiker and the Himalayas have been a preferred destination for me and my group of friends. Trekking has parallels with my work now – it is a journey, there are peaks and valleys. There are challenges every day and as we overcome these, we scale new heights. Getting a rotavirus vaccine for the developing world is going to be a great new high!

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submitted by Dr. Thomas Brewer
07/31/2013 at 15:53

Over the course of my career I’ve spent over thirty years working in various developing countries trying to better understand and fight infectious diseases. One of the things that alarmed me most was that in many places, parents and caretakers didn’t even have a word for diarrhea. Sadly, this wasn’t because diarrhea was rare. On the contrary, diarrhea was so common that it was seen as a normal part of early childhood, and thus didn’t need a name. 

There were of course exceptions, particularly during major diarrhea outbreaks. I remember a visit to Beira, Mozambique, where the International Vaccine Institute was carrying out a vaccination campaign to control a rainy season cholera outbreak. Everyone was relieved when “the cholera” was finally gone, but with it disappeared recognition of diarrhea as a continuing health problem.  Cholera was the only form of diarrhea with a name. Unfortunately, the vast majority of cases in Beira were not caused by cholera, and the problem was not limited to just the rainy season.

In Beira and elsewhere, a lack of any local epidemiological evidence about what actually causes diarrheal diseases and the impact they have on young children limited the ability of public health officials, researchers, caretakers and parents to protect children from this devastating scourge.  

Fortunately, we now have a better understanding thanks to the Global Enteric Multicenter Study (GEMS), which published data on the impact and leading causes of moderate-to-severe diarrhea in The Lancet last month. 

GEMS was conducted at sites in seven countries across Africa and Asia, ranging from a rural village to an urban slum, to account for the various contexts where diarrhea occurs. We were surprised, and encouraged, to learn that of the nearly 40 possible causes GEMS tested for, just four pathogens – rotavirus, Cryptosporidium, Shigella and ST-ETEC – were responsible for the majority of diarrheal disease cases across all sites. More troubling, GEMS found that a single diarrheal disease episode stunted children’s growth and increased their risk of death over a two month period. What concerns us the most is that the majority of these deaths occurred after children returned home from a healthcare facility.

To fully appreciate the importance of the GEMS data, however, we must look at the impact it can have in individual study countries.

In Mali, like Biera and other regions, local data on the causes of diarrheal diseases was utterly nonexistent prior to GEMS. My friend Dr. Samba Sow, principal investigator of the GEMS trial site in Mali, tells a story about a child who arrived at the hospital a few years ago with severe diarrhea. Ten doctors worked to save his life in the intensive care unit, but could not. When lab results later confirmed the boy died of rotavirus, the nurses and parents all asked: “What is rotavirus?”

Thanks to GEMS, healthcare providers, researchers and policymakers in Mali will know which causes of diarrheal diseases they need to target. Fortunately, Mali is preparing to introduce rotavirus vaccines later this year or early next. GEMS also helped us to identify other steps that need to be taken to combat diarrheal diseases. For instance, when children survive the initial diarrheal episode, doctors and nurses should continue to monitor them to make sure they do not die at home.   

In contrast to Mali, we knew comparatively more about what caused diarrhea in India. But, in a country where the population and burden of diarrheal diseases is so high, a clear understanding of what interventions would have the greatest impact is essential. By establishing a baseline measurement on diarrheal disease, we will be able to track the impact of introducing new interventions, such as vaccines, and adjust our strategy accordingly to focus on the most effective interventions.

Fittingly, the same day that the GEMS study results were published, an Indian company, Bharat Biotech, announced promising results from the first Phase III trials of its rotavirus vaccine, ROTAVAC. It is my hope that with a clear understanding of the need, and with a vaccine almost in hand, India will strengthen its commitment to delivering rotavirus vaccines to children who urgently need them.    

Regardless of context – whether in a country where the causes of diarrhea are a relative mystery or one in the final stages of developing its own rotavirus vaccine – fully understanding the problem is what enables us to act in the most effective way possible. By building on the GEMS findings, we can accelerate progress toward our goal of a world where children are no longer dying of diarrheal diseases

To learn more about how you can get involved in combating diarrheal disease, visit the DefeatDD campaign.

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submitted by Deborah Kidd
07/24/2013 at 12:59

You are a new parent. Your infant daughter is nine weeks old today. She has just begun to coo, and she smiles in recognition when you greet her each morning.

Your little one is a healthy eater, hungry and eager. The antibodies in her mother’s milk go a long way in protecting her growing belly, but strong as they are, they don’t quite match many threats looming near her still-sensitive system.

You live in a rural village of a poor country. Some days, you gather water from a distant, deep well tapped into a fresh spring, but more often than not, you rely on the muddy river closer to home. Washing your hands with this brackish brew—and without soap—seems an exercise in futility, but you have learned it is an important example to set for your children. Your family does not have a toilet, rather a rudimentary pit latrine dug years ago, never emptied, never cleaned. This is your baby’s world, too; where she learns by sounds, scents… also touch and taste. Her tiny tummy barely stands a chance.

Though the nearest health center is a 3-mile walk, you have diligently brought your little girl in for each recommended vaccination, including the new rotavirus vaccine, which nurses have assured you will help protect her from the most dangerous diarrhea infections. But the vaccine is not a magic bullet. It will not remove all threats in your daughter’s daily environment. And with the challenges of ever-present bacteria, viruses, and persistent malnutrition, her tiny system may be too vulnerable to fully reap the vaccine’s protective benefits.

Rotavirus vaccines have already saved thousands of lives, even in places where environmental factors and existing gastrointestinal vulnerabilities limit their potential. They are an essential element of strategies to control deadly diarrhea around the world. But the current vaccines often face an uphill battle in poor, less developed settings. They are administered orally, sent right to the gut, and can struggle to impart their lifesaving benefits to children whose stomachs and systems are weakened by malnutrition or constantly fighting other belly bugs.

Could an injected rotavirus vaccine be the next step? PATH is investigating non-replicating rotavirus vaccines (NRRV) to find out. Because they are not administered orally, NRRVs would not pass through the digestive tract, thus avoiding gastrointestinal factors that may be the culprit of reduced efficacy of live, oral vaccines in low-income settings. This novel approach is in early stages, with clinical studies of one candidate ongoing, and others planned for the near future.

NRRVs also are projected to be easier to manufacture and could cost less than the current vaccines. Also, if they are administered via the same route as current routine vaccines, they could theoretically be combined, further reducing costs and helping ensure uptake. Of course, this could only follow pivotal studies to ensure the NRRV addition would not affect the performance of other vaccines. But the studies underway are an important first step to realizing these potential extra benefits.  

In the meantime, research on the current oral rotavirus vaccines is helping pin down the reasons for their reduced performance in developing countries. These vaccines are powerful tools that are making dramatic impact, but we want to know if and how they can save even more lives in the communities where children are most vulnerable. We’re also working with developing country manufacturers on additional live, oral rotavirus vaccines to address strains of the disease most common in Asia and Africa, as well as to help keep pace with the global market by increasing available supply and driving down cost through competition.

All parents deserve the chance to give their children a healthy start. PATH and our partners are helping them get there through research into novel ways to protect from deadly diarrhea, alongside investigation into improving today’s tools, added to partnerships that ensure rotavirus vaccines reach all children.

 

For more information:

-- PHOTOS: Vaccines are foundational to child health.

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submitted by Eileen Quinn
07/17/2013 at 11:51

This is what caregivers in Kenya and India told researchers is most important to them when choosing treatment for their child. Now, you may be wondering ‘did we need a research study to learn that?’ Yes, because of this paradox: the highly effective treatment for diarrhea, oral rehydration solution (ORS), doesn’t really “stop the diarrhea.” What it does is help the child ride out the episode and recover more quickly.

The impetus for this research was to better understand why coverage of and demand for ORS remains low in many countries, despites its tremendous therapeutic benefits. Similarly, the team looked at perceptions and use of zinc, another cornerstone treatment to reduce the length and severity of diarrhea episodes.

The results, recently published in the Journal of Global Health, will help inform how we can do a better job of providing and promoting these treatments. On zinc, the data suggest that “treatment regimens remain unwieldy and unrealistic, perhaps unnecessarily.” Regarding ORS, the researchers learned that “Caregivers feel that the recommended dosing of ORS is impractical and overly ambitious, and they are giving less” and suggest that it would be useful to come up with a more practical yet effective dose.

The caregivers’ concern that the ORS liquid is too much for a child to take really resonated with me. I remember how challenging it was to keep pushing liquids when my infant son was very sick with diarrhea. I was grateful that I could make a call to a nurse whose guidance helped me. Would that parents and other caregivers everywhere can easily access the support and reassurance they need. Absent that, factoring their real-world concerns and needs into the dosing regimens is a great start.

 

Photo credit: PATH

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