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H7N9 vaccine progresses through Phase I trials...

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Back in August I wrote about Novavax entering Phase I clinical trials with its virus-like particle vaccine (VLP) to prevent influenza A(H7N9) virus disease. It is based on the A/Anhui/1/2013 strain.

Novavax, A United States company, has now reported in the New England Journal of Medicine that 80% of people may be protected by the generation of anti-H7N9 antibodies in response to 2x 5�g injections in the presence of 60 units of CSL's Iscomatrix adjuvant (see more on adjuvants in my August piece). 284 people were enrolled in a trial in Australia to determine these "very preliminary" results. Increased reactions were seen among the immunized at the injection site, but few were severe.

The move away from the egg-based vaccine manufacturing system is likely to allow vaccines to be produced in much shorter periods; 12-weeks after an outbreak starts, with 50,000,000 doses potentially available in 4-months.

You may ask, why then is it precisely 9-months after the 1st H7N9 case was retrospectively identified, and Novavax is still only at Phase I trials? I think, and I'm no expert in this area, that the process will increase in speed once the 'backbone' (the VLPs being used here which are based on a baculovirus, all produced in insect cells) in combination with this adjuvant etc, have been through the entire clinical trial process the first time. A successful backbone can be leveraged for other vaccines too.

You can see a little more of the process of making the VLPs, in this case for respiratory syncytial virus, here.

So, big changes lie not-too-far ahead for influenza vaccines....assuming the course through clicnial trials is smooth sailing of course!

For those hypersensitive to hyperlinks...
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EMERGENCY NEEDS ASSESSMENT IN WESTERN KENYA

After the first few weeks performing a needs assessment in and around Kisumu, Kenya, I'm getting the handle on the survey. I've managed to adopt a bit of an accent in order for the practitioners to understand me. And if I speak slowly enough, a true challenge for me, the language barrier is minimal. All the providers have been very helpful. At first, most seem a little skeptical and resistant to sit down with me for a full hour of interviewing. Eventually, they are able to find some time for our team and have a good conversation about their emergency care capabilities. Unfortunately, sometimes the conversation can run over sometimes, but that usually means we were laughing to much trying to get to know each other.


Dave Young, MD
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MERS-CoV tally....

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Click on image to enlarge.
The global MERS-CoV map as of 18-11-2013.
Kuwait is currently depicted as having imported, 
rather than locally transmitted or acquired cases.
The WHO tally for Middle East respiratory syndrome coronavirus (MERS-CoV) lab-confirmed cases now stands at 157, of which 66 have died. 

The 2 latest cases, with lots of relevant WHO details are from Kuwait but are reportedly not contacts.

  • FT#158. 47-year old male, ill on 30-Oct, hospitalized 7-Nov. He is critically ill. Travel outside of Kuwait, within a time-frame that might suggest MERS-CoV acquisition, has not been noted so far so I am marking this in red on the map to indicate a local acquisition for now.
  • FT#159. 52-year old male, ill on 7-Nov, hospitalized 10-Nov. He recently travelled overseas and there is possible exposure to camels (WHO tweet without specific detail, 16-Nov). Also critically ill.

My tally lists another case, that of the case imported into Spain (61-year old female). However, that case has not yet been confirmed to WHO standards which may require a change to the map if the case, like the 2 from Italy in September, are classified as "probable" rather than confirmed cases. 
Thus the proportion of fatal cases stands at 42%.
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RSV retreated, flu fading, parainfluenza picking up: Queensland respiratory virus numbers up to Week 45, 2013

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If you like to keep track of influenza cases in Queensland, Australia, then the Queensland Government's Queensland Health (QH) influenza data website is for you.

It's a great place to drop by and check out the comings and goings of influenza viruses and many of the other traditional respiratory viruses including adenoviruses (AdVs), parainfluenzaviruses (PIVs) 1, 2 and 3, human metapneumovirus (MPV) and respiratory syncytial virus (RSV) - the "Big8". Testing is not routinely conducted for the rhinoviruses (RVs).

The snippet below is from data that are publicly reported on the QH website. These images cover to the week beginning 3rd of November (up to Sunday, Nov 10th, 2013).

The charts highlight that the 2013 flu season is winding down in Australia, also reflected by the WHO global updates. This year flu followed on from what seemed to have been a large RSV season. Unfortunately I couldn't find data for this same time period last year to compare RSV prevalence.

In the wake of influenzavirus season, the parainfluenzaviruses are now on the rise in the lead up to summer. I expect the RVs (and enteroviruses) are also climbing, but in greater numbers.

Click to enlarge. 
A snippet from the Queensland Health Statewide Weekly Influenza Surveillance Report for 01.01.2013-10.11.2013
My thanks to the team at the Communicable Diseases Unit, Queensland Health.

The source of these data  can be read in full..
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Antenatal Ultrasound Training in Resource-Limited Regions of Western Kenya

 

Maternal mortality continues to be a significant public health problem throughout the developing world.  Sub-Saharan Africa accounts for approximately 50% of all maternal deaths globally.  World Health Organization data suggests that the majority of these deaths could be prevented if emergency obstetric care were available at every birth. However, since almost half of all births in developing countries take place at home without a skilled birth attendant, life-saving obstetrical interventions are often delayed.  This results in unnecessary maternal and fetal morbidity and mortality.

 

A new generation of affordable, hand-held ultrasound machines has opened the possibility for antenatal ultrasound screening programs in resource-limited settings, such as rural Kenya.  However, given the general paucity of radiologists in Kenya, the training of non-radiologist clinicians in point-of-care ultrasound is essential.  I had the pleasure of working with the Division of Global Health and Human Rights and Kisumu Medical Education Trust, our in country partner, to train midwives in point-of-care maternal ultrasound in Western Kenya.

 

Working with an ultrasound-trained Emergency Room physician from California and three Kenyan midwives with subspecialty training in ultrasound, we provided one week of refresher training in antenatal ultrasound to 16 nurse midwives from all over Western Kenya.  The midwives participating in the refresher course had received initial antenatal ultrasound training through our program nearly 1 year prior.  In the mean time they had integrated limited antenatal ultrasound services into their rural obstetrical practices.

 

 

It was great to reunite with the midwives whom I had worked with before and to meet and hear the stories of those midwives whom I was meeting for the first time.  These dedicated health care providers shared powerful stories of how ultrasound had impacted their patients in positive ways.  By identifying high-risk conditions early (i.e., placenta previa, twin gestation, and abnormal presentation), providers could arrange hospital delivery for these patients.  In the absence of these ultrasound-based diagnoses, these patients may have delivered at home, potentially resulting in untreated complications of delivery.

 

 

Overall, I feel blessed to have had the opportunity to participate in the amazing ultrasound work happening in Western Kenya.  Recently, the Kenyan Ministry of Health decided to provide free hospital-based labor and delivery care to any woman in Kenya who desired it � effectively eliminating another barrier to safe perinatal care for Kenyan women.  I look forward to continuing my participation in this important mission and thank the Partners Center of Expertise in Global and Humanitarian Health for helping to make it possible.

 

H. Benjamin Harvey, MD, JD

Resident

Department of Radiology

Massachusetts General Hospital

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