Month: July 2021

Categories : Diseases, Syndromes and Conditions Injury & TraumaTags :

New Biomarker for Soft Tissue Infections

On By ModernMedia
This illustration depicted a three-dimensional (3D), computer-generated image, of a group of Gram-positive, Streptococcus pneumoniae bacteria. The artistic recreation was based upon scanning electron microscopic (SEM) imagery. Photo by CDC on Unsplash
This illustration depicted a three-dimensional (3D), computer-generated image, of a group of Gram-positive, Streptococcus pneumoniae bacteria. The artistic recreation was based upon scanning electron microscopic (SEM) imagery. Image by CDC on Unsplash

Researchers have identified a new and very promising biomarker for bacterial soft tissue infections, which previously lacked one. 

In bacterial soft tissue infections, rapid diagnosis is crucial in reducing the risk of severe injury or amputation. Vague symptoms and a varied patient presentations increase the risk of misdiagnosis.The study, by  Researchers at Karolinska Institutet in Sweden  and other research institutions, and published in the Journal of Clinical Investigation, may have implications for both diagnosis and treatment.

Last author Anna Norrby-Teglund, Professor, Department of Medicine, Karolinska Institutet, said: “There are currently no tools for safe, rapid diagnosis in life-threatening soft tissue infections. Our findings are consequently very interesting as the biomarkers identified are possible candidates for improved diagnostics. The results are also relevant for individualised treatment in the future.”

Necrotising soft tissue infections (NSTI) are bacterial infections which are characterised by rapid tissue degradation. Such infections, often caused by streptococci, while relatively uncommon, are extremely serious. In most cases they necessitate intensive care and can quickly become life-threatening.

Extensive surgery, intravenous antibiotics are often required to prevent the infection from spreading, and amputation may be required in extreme situations. Many patients also develop sepsis, which further complicates the course of the condition.

Early, correct diagnosis is crucial to save lives and avoid amputation, but this is complicated by factors such as vague symptoms including vomiting, fever and severe pain, as well as the heterogeneous group of patients. Despite recommendations for surgical evaluation in suspected NSTI, there is a considerable risk of misdiagnosis.

Currently, various laboratory tests, including white blood cell counts, are used as diagnostic tools, but suffer from low sensitivity. NSTI-specific biomarkers are therefore needed. The condition is classified into four types depending on the infecting organism.

Researchers at Karolinska Institutet, Haukeland University Hospital, Norway, and Copenhagen University Hospital, Denmark, have now been able to identify biomarkers specific to different patient groups with soft tissue infections.

Using machine learning, the researchers analysed 36 soluble factors in blood plasma from the 311 NSTI patients included in the international INFECT study. Control groups included patients with suspected NSTI and sepsis, respectively.

The analyses showed a new biomarker that accurately identifies patients with tissue necrosis.

“The new biomarker, thrombomodulin, proved to be superior to the laboratory parameters used clinically today. The analyses also identified biomarkers for patients with soft tissue infection caused by different types of bacteria, as well as patients who developed septic shock,” said first author Laura Palma Medina, researcher at the Department of Medicine, Karolinska Institutet (Huddinge).

Source: Karolinska Institutet

Journal information: Palma Medina, L.M., et al. (2021) Discriminatory plasma biomarkers predict specific clinical phenotypes of necrotizing soft-tissue infections. Journal of Clinical Investigation. doi.org/10.1172/JCI149523.

Categories : VaccinesTags :

Vaccination Setbacks and Medical Supply Shortages from Riots

On By ModernMedia
Photo by Jilbert Ebrahimi on Unsplash
Photo by Jilbert Ebrahimi on Unsplash

Speaking to Bheksisa, deputy director-general at the health department Dr Nicholas Crisp described the vaccination programme’s setbacks and medical supply shortages resulting from the recent violence and looting.

The vaccination programme has been set back due to damage at vaccination sites such as pharmacies, and others such as clinics being unable to operate except for some in KwaZulu Natal’s outer rural regions. The programme is unlikely to reach its 250 000 vaccinations per day, he said, rather, 200 000 is a more likely goal. Currently, “going flat out”, the programme is vaccinating 140 000 people per day elsewhere in the country.

All of the available vaccines will be used including those Johnson & Johnson vaccines left over from innoculating teachers and other critical workers.

Those receiving Pfizer vaccines needn’t be too concerned about missing their second dose appointment, as research shows that the immunity conferred is as strong or even stronger at 42 days as compared to the standard 21 days.

However, he said that “the biggest disaster with the looting of medicine isn’t vaccines; it’s the looting of chronic medicine. For close to half of patients in KwaZulu-Natal, it’s gone. So much of the insulin for diabetes patients, the morphine, the antiretroviral drugs for HIV patients, are gone.”

The other challenge, he said, is getting oxygen to COVID patients via blocked roads, and delivering food supplies to hospitals, warning that there are patients who are without food. 

Afrox has confirmed that its facilities in Durban have not been affected by rioting, and their deliveries of medical oxygen continue though often under police escort.

Source: Bheksisa

Categories : AddictionTags :

High-dose Buprenorphine in ED Could Improve Opioid Abuse Outcomes

On By ModernMedia
Photo by Mat Napo on Unsplash
Photo by Mat Napo on Unsplash

High-dose buprenorphine therapy, provided under emergency department care, is safe and well tolerated in people with opioid use disorder experiencing opioid withdrawal symptoms, according to a study supported by the National Institutes of Health’s National Institute on Drug Abuse (NIDA).

Lower doses of buprenorphine, a medication approved by the US Food and Drug Administration to treat opioid use disorder, are the current standard of care. Higher doses, however, could extend the period of withdrawal relief for people after being discharged from the emergency department that could help them better seek care. 

“Emergency departments are at the front lines of treating people with opioid use disorder and helping them overcome barriers to recovery such as withdrawal,” said Nora D Volkow, MD, director of NIDA. “Providing buprenorphine in emergency departments presents an opportunity to expand access to treatment, especially for underserved populations, by supplementing urgent care with a bridge to outpatient services that may ultimately improve long-term outcomes.”

Presently, some emergency departments already administer higher buprenorphine doses to treat withdrawal and opioid use disorder. They do this as a response to the growing potency in illicit opioid drug supplies and delays in access to follow-up care, but this practice has not been evaluated previously.

Researchers used a retrospective chart review to analyse data from electronic health records documenting 579 emergency department visits at the Alameda Health System Highland Hospital in California, made by 391 adults with opioid use disorder in 2018. Many patients were from vulnerable populations, with 23% experiencing homelessness and 41% having a psychiatric disorder.

In 63% of cases, clinicians administered more than the standard upper limit of 12 mg of sublingual buprenorphine during emergency department induction, and in 23% of cases, patients were given 28 mg or more. Higher doses of buprenorphine were seen to be safe and tolerable, and there were no reports of respiratory problems or drowsiness among those given the higher doses. The few serious adverse events that occurred were determined to be unrelated to high-dose buprenorphine therapy.

Studies have shown that initiating buprenorphine in emergency departments improves engagement in treatment and is cost effective, but barriers to the medication’s use in the US persist, with restrictions on what training is required, how much can be administered and for how long. Recent changes to prescribing guidelines by the US Department of Health and Human Services now let some clinicians treating up to 30 patients to prescribe buprenorphine without the previous training and services criteria.

“Once discharged, many people have difficulty linking to follow-up medical care,” explained study leader Andrew A Herring, MD, of Highland Hospital Department of Emergency Medicine. “Adjusting the timing and dosage of buprenorphine in the emergency department, along with resources and counseling aimed at facilitating the transition to outpatient services, may provide the momentum needed to access continuing care.”

“This study enhances the evidence we know about emergency-department buprenorphine induction, and could be a gamechanger, particularly for vulnerable populations who would likely benefit from a rapid induction at the time of the visit,” said study author Gail D’Onofrio, MD, of Yale University. Dr D’Onofrio published the original studies on emergency department-initiated buprenorphine, as well as recent consensus recommendations on the emergency department treatment of opioid use disorder.
The researchers noted that their findings need confirmation in other emergency departments. Nevertheless, this study suggests that with proper support and training, emergency medicine providers may safely and effectively initiate high-dose buprenorphine therapy.

Source: NIH

Journal information: JAMA Network Open (2021). DOI: 10.1001/jamanetworkopen.2021.17128

Categories : Injury & Trauma Mental Health PaediatricsTags :

Self-inflicted Firearm Injuries Among Rural Youth Three Times Urban Rates

On By ModernMedia
Photo by Annie Spratt on Unsplash
Photo by Annie Spratt on Unsplash

Emergency Department visits by youth for self-inflicted firearm injuries were three times more common in rural areas compared to urban ones, a national study has found.
The study, published in the Journal of Pediatrics found that Emergency Department (ED) visits by youth for self-harm were nearly 40 percent higher in rural areas compared to urban settings. Youth from rural areas presenting to the ED for suicidal ideation or self-harm also were more likely to need to be transferred to another hospital for care, which underscores the insufficient mental health resources in rural hospitals.

“Our study used pre-pandemic data, and we know that increased attention to youth mental health is even more pressing now everywhere, but especially in rural settings to prevent self-harm in youth,” said lead author Jennifer Hoffmann, MD, pediatric emergency medicine physician at Ann & Robert H. Lurie Children’s Hospital of Chicago and Assistant Professor of Pediatrics at Northwestern University Feinberg School of Medicine. “We need universal screening for suicidal ideation for all children and adolescents age 10 and up who present in the ED to identify youth at risk and intervene before tragedy occurs.”

The study drew on national data on suicidal ideation or self-harm in youth (ages 5-19 years) from a sample of EDs across the country, including those in general hospitals and children’s hospitals. The researchers extrapolated the results to arrive at national estimates.

Dr Hoffmann explained that a number of factors contribute to higher suicide rates and self-harm in rural youth. One of these is access to mental healthcare, which she said is a huge challenge. A lack of paediatric mental health professionals in rural areas is another factor, forcing patients to travel long distances for help. In addition, poor insurance coverage resulting from lower family income and unemployment. Small towns also have anonymity concerns, possibly delaying seeking care until a crisis brings the child to the ED. Firearm ownership is higher in rural firearms, so increased access to firearms may account for the high degree of disparity in self-inflicted firearm injuries.

“We need to improve mental health training for ED providers, allocate more resources and implement policies in rural hospitals on managing young patients who present with suicidal ideation or self-harm,” said Dr Hoffmann. “More widespread use of tele-psychiatry also might help prevent unnecessary transfers to other hospitals. But even more importantly, we need to train primary care providers to help diagnose and treat mental health issues earlier, so we can prevent self-inflicted injuries and death.”

Source: Ann & Robert H. Lurie Children’s Hospital of Chicago

Categories : Injury & TraumaTags :

A New Snake Venom ‘Super Glue’ For Wound Closures

On By ModernMedia
Photo by David Clode on Unsplash
Photo by David Clode on Unsplash

A novel snake venom ‘super glue’ has been developed, that can stop life-threatening bleeding in under a minute.

Over the past 20 years, bioengineer Kibret Mequanint, a professor at the University, has developed an array of biomaterials-based medical devices and therapeutic technologies – some of which are either now licensed to medical companies or are in the advanced stage of preclinical testing.

This latest work focuses on a blood clotting enzyme called reptilase or batroxobin, which is found in the venom of lancehead snakes (Bothrops atrox), which are amongst the most venomous snakes in South America.

Prof Mequanint and the international research team designed a body tissue adhesive that takes advantage of the clotting property of this enzyme, incorporating it into a modified gelatin that can be packaged into a small, handy tube for easy application.

“During trauma, injury and emergency bleeding, this ‘super glue’ can be applied by simply squeezing the tube and shining a visible light, such as a laser pointer, over it for a few seconds. Even a smartphone flashlight will do the job,” said Prof Mequanint.

Compared to the industry gold standard for clinical and field surgeons, clinical fibrin glue, the new tissue sealant has 10 times the adhesive strength to resist detachment or washout from bleeding. The blood clotting time is also much shorter, halving the 90 seconds for fibrin glue to 45 seconds for this new adhesive.

This novel biotechnology could reduce blood loss and save more lives. Tests were performed in models of major bleeding, such as deep skin cuts, ruptured aortae, and severely injured livers.

“We envision that this tissue ‘super glue’ will be used in saving lives on the battlefield, or other accidental traumas like car crashes,” said Prof Mequanint. “The applicator easily fits in first aid kits too.”

Besides its trauma application, the new snake venom ‘super glue’ can be used in surgical wound closures.

The study was published in the journal Science Advances..

“The next phase of study which is underway is to translate the tissue ‘super glue’ discovery to the clinic,” said Prof Mequanint.

Source: University of Western Ontario

Journal information: Guo, Y., et al. (2021) Snake extract–laden hemostatic bioadhesive gel cross-linked by visible light. Science Advances.doi.org/10.1126/sciadv.abf9635.

Categories : HospitalsTags :

Manufacturer Shuts Down its Robot Mid-surgery

On By ModernMedia
Photo by Piron Guillaume on Unsplash
Photo by Piron Guillaume on Unsplash

One of a series of lawsuits against the company that makes the da Vinci surgical robot alleges that the company shut down its robot mid-surgery, forcing the surgeons to switch to an open surgery.

Several hospitals have launched a legal battle against the company Intuitive Surgical, the manufacturer of the da Vinci surgical robot. They allege that the company’s monopoly position forces hospitals to buy its maintenance services and spare parts at inflated prices even though cheaper alternatives are available.

One hospital alleges that, after it said that it was considering a service contract with a third party, Intuitive Surgical remotely shut down its surgical robot “in the middle of a procedure”, forcing the surgeon “to convert the procedure to open surgery with the patient on the operating table”.

Separately, malfunctions of the instrument arms have been reported, requiring additional, sometimes larger, incisions in patients in order to complete the surgical procedure manually. Use of the robotic technology also requires longer operating and anesthesia times as well as several complications occurring from the use of the da Vinci Surgical System itself.

Intuitive Surgical sells its da Vinci surgical robot to hospitals for anywhere from $500,000 to $2.5 million each. However, a majority of Intuitive Surgical’s $4 billion of annual revenue comes from the parts and services that are required to keep the robots running. Its executives are among the most highly paid in the healthcare industry.
Franciscan Health, Valley Medical Center and Kaleida Health filed class-action lawsuits. These hospitals that claim Intuitive Surgical has a monopoly on minimally invasive surgical robots, giving the company a “near-stranglehold” on the parts and services market for the robots.

One lawsuit alleges hospitals cannot have their da Vinci robots serviced by third parties because Intuitive Surgical forces hospitals to sign “multi-year, exclusive servicing agreements” at rates that are much higher than other vendors’. Hospitals also allege they are coerced into buying new, expensive instruments and attachments for their robots (called EndoWrists) after 10 uses, even if the parts are in good working condition. A limited extension of these uses has been launched by the company. The lawsuit alleges that Intuitive Surgical engineers have threatened hospitals with turning the machines into “paperweights” should hospitals seek outside vendors for parts or repairs.

While Intuitive Surgical has faced antitrust lawsuits from third-party repair and service companies since 2019, these hospital class-action lawsuits are new.

In an email, an Intuitive Surgical spokesperson told MedPage Today that the medical robotics company “does not have the ability to remotely shut down a da Vinci system during a surgical procedure underway at hospital.”

“There is risk associated with deviating from the validated processes cleared by regulatory authorities,” the spokesperson stated. “Continued use beyond an instrument’s determined useful life may reduce safety, precision, and dexterity. Further, third parties may use incompatible or unvalidated parts or processes in servicing or repairing the systems, which could cause damage and put patient safety at risk.”

Source: Axios

Categories : Implants and ProsthesesTags :

Liquid Metal Sensors Recreate a Sense of Touch

On By ModernMedia
Photo by ThisisEngineering RAEng on Unsplash
Photo by ThisisEngineering RAEng on Unsplash

To recreate a sense of ‘touch’, researchers have incorporated stretchable tactile sensors using liquid metal on the fingertips of a prosthetic hand. 

When manipulating an object, humans are heavily reliant on sensation in their fingertips, each of which has over 3000 pressure-sensitive touch receptors. While there are many high-tech, dexterous prosthetics available today, they all lack the sensation of ‘touch‘, resulting in objects inadvertently being dropped or crushed by a prosthetic hand.
To make a prosthetic hand interface that feels more natural and intuitive, researchers from Florida Atlantic University’s College of Engineering and Computer Science and collaborators incorporated stretchable tactile sensors using liquid metal on a prosthetic hand’s fingertips. Encapsulated within silicone-based elastomers, this technology provides key advantages over traditional sensors, including high conductivity, compliance, flexibility and stretchability.

For the study, published in the journal Sensors, researchers used individual fingertips on the prosthesis to distinguish between different speeds of a sliding motion along different textured surfaces. The four different textures had one variation: the distance between the ridges. To detect the textures and speeds, researchers trained four machine learning algorithms. For each of the ten surfaces, 20 trials were performed to test the ability of the machine learning algorithms to distinguish between the different textured surfaces.

Results showed that integrating tactile information from the fingertip sensors simultaneously distinguished between complex, multi-textured surfaces – demonstrating a new form of hierarchical intelligence. The algorithms could accurately distinguish between the fingertip speeds. This new technology could improve prosthetic hand control and provide haptic feedback for amputees to restore a sense of touch.

“Significant research has been done on tactile sensors for artificial hands, but there is still a need for advances in lightweight, low-cost, robust multimodal tactile sensors,” said senior author Erik Engeberg, PhD, an associate professor in the Department of Ocean and Mechanical Engineering. “The tactile information from all the individual fingertips in our study provided the foundation for a higher hand-level of perception enabling the distinction between ten complex, multi-textured surfaces that would not have been possible using purely local information from an individual fingertip. We believe that these tactile details could be useful in the future to afford a more realistic experience for prosthetic hand users through an advanced haptic display, which could enrich the amputee-prosthesis interface and prevent amputees from abandoning their prosthetic hand.”

Researchers compared four different machine learning algorithms for their successful classification capabilities. The time-frequency features of the liquid metal sensors were extracted to train and test the machine learning algorithms. Of these, a neural network algorithm generally performed the best at the speed and texture detection with a single finger and had a 99.2 percent accuracy to distinguish between ten different multi-textured surfaces using four liquid metal sensors from four fingers simultaneously.

“The loss of an upper limb can be a daunting challenge for an individual who is trying to seamlessly engage in regular activities,” said Stella Batalama, Ph.D., dean, College of Engineering and Computer Science. “Although advances in prosthetic limbs have been beneficial and allow amputees to better perform their daily duties, they do not provide them with sensory information such as touch. They also don’t enable them to control the prosthetic limb naturally with their minds. With this latest technology from our research team, we are one step closer to providing people all over the world with a more natural prosthetic device that can ‘feel’ and respond to its environment.”

Source: Florida Atlantic University

Journal information: Abd, M.A., et al. (2021) Hierarchical Tactile Sensation Integration from Prosthetic Fingertips Enables Multi-Texture Surface Recognition. Sensors. doi.org/10.3390/s21134324.

Categories : Diseases, Syndromes and ConditionsTags :

New Insights into Gum Disease and Inflammatory Response

On By ModernMedia
Photo by Caroline LM on Unsplash
Photo by Caroline LM on Unsplash

A team of researchers has identified how different people respond to the accumulation of dental plaque, helping us understand the vulnerability of some to serious conditions that lead to tooth loss and other problems. 

The study was led by University of Washington researchers and recently published in the journal Proceedings of the National Academy of Sciences (PNAS). 

Buildup of plaque, the sticky biofilm covering teeth and gums, can induce gingivitis, or gum inflammation if left unchecked. Gingivitis, in turn, can lead to periodontitis, a serious infection that can damage and destroy the gum and bones supporting teeth. As well as causing tooth loss, this chronic inflammation can also trigger heart disease, diabetes, cancer, arthritis, and bowel diseases.

The researchers also discovered a range of inflammatory responses to oral bacterial accumulation. When bacteria build up on tooth surfaces, it generates inflammation as the body responds. Two known major oral inflammation phenotypes were known: a high or strong clinical  response and a low clinical response. The team identified a third phenotype, which they dubbed ‘slow’: a delayed strong inflammatory response in the wake of the bacterial buildup.

The study also found that subjects with low clinical response also showed a low inflammatory response for a variety of inflammation signals.  “Indeed, this study has revealed a heterogeneity in the inflammatory response to bacterial accumulation that has not been described previously,” said Dr Richard Darveau of the UW School of Dentistry, one of the study’s authors.

Study co-author Dr Jeffrey McLean said, “We found a particular group of people that have a slower development of plaque as well as a distinct microbial community makeup prior to the start of the study.” The authors wrote that understanding the variations in gum inflammation could help screen for higher periodontitis risk. In addition, it is possible that this variation in the inflammatory response among the human population may be related to the susceptibility to other chronic bacterial-associated inflammatory conditions such as inflammatory bowel disease.

Additionally, the researchers found a novel protective response by the body, triggered by plaque accumulation, that can save tissue and bone during inflammation. This mechanism, which was apparent among all three phenotypes, utilises white blood cells known as neutrophils. In the mouth, they act something like cops on the beat, patrolling and regulating the bacterial population to maintain a stable condition known as healthy homeostasis.

In this instance, plaque is not a villain. To the contrary, the researchers said that the proper amount and makeup of plaque supports normal tissue function. Studies in mice have also shown that plaque also provides a pathway for neutrophils to migrate from the bloodstream through the gum tissue and into the crevice between the teeth and gums.

When healthy homeostasis exists and everything is working right, the neutrophils promote colonization resistance, a low-level protective inflammatory response that helps the mouth fend off an excess of unhealthy bacteria and resist infection. At the same time, the neutrophils help ensure the proper microbial composition for normal periodontal bone and tissue function.

The researchers’ findings underscore why dentists preach the virtues of regular brushing and flossing, which prevent too much plaque buildup. “The idea of oral hygiene is to in fact recolonise the tooth surface with appropriate bacteria that participate with the host inflammatory response to keep unwanted bacteria out,” Dr Darveau explained. The bacteria start repopulating the mouth’s surfaces spontaneously and almost immediately afterward, Dr Darveau said.

Source: University of Washington School of Dentistry

Journal information: Bamashmous, S., et al. (2021) Human variation in gingival inflammation. PNAS. doi.org/10.1073/pnas.2012578118.

Categories : Antibiotics Obstetrics & Gynaecology PaediatricsTags :

In Utero or Neonatal Antibiotic Exposure Could Lead to Brain Disorders

On By ModernMedia
Image by Ahmad Ardity from Pixabay
Image by Ahmad Ardity from Pixabay

According to a new study, antibiotic exposure early in life could alter human brain development in areas responsible for cognitive and emotional functions.

The study suggests that penicillin alters the body’s microbiome as well as gene expression, which allows cells to respond to its changing environment, in key areas of the developing brain. The findings, published in the journal iScience, suggest reducing widespread antibiotic use or using alternatives when possible to prevent neurodevelopment problems.
Penicillin and related medicines, such as ampicillin and amoxicillin, are the most widely used antibiotics in children worldwide. In the United States, the average child receives nearly three courses of antibiotics before age 2, and similar or greater exposure rates occur elsewhere.

“Our previous work has shown that exposing young animals to antibiotics changes their metabolism and immunity. The third important development in early life involves the brain. This study is preliminary but shows a correlation between altering the microbiome and  changes in the brain that should be further explored,” said lead author Martin Blaser, director of the Center for Advanced Biotechnology and Medicine at Rutgers.

In the study, mice were exposed to low-dose penicillin in utero or immediately after birth. Researchers found that, compared to the unexposed controls, mice given penicillin had large changes in their intestinal microbiota, with altered gene expression in the frontal cortex and amygdala. These two key brain areas are responsible for the development of memory as well as fear and stress responses.

Increasing evidence links conditions in the intestine to the brain in the ‘gut-brain axis‘. If this pathway is disturbed, it can lead to permanent altering of the brain’s structure and function and possibly lead to neuropsychiatric or neurodegenerative disorders in later childhood or adulthood.

“Early life is a critical period for neurodevelopment,” Blaser said. “In recent decades, there has been a rise in the incidence of childhood neurodevelopmental disorders, including autism spectrum disorder, attention deficit/hyperactivity disorder and learning disabilities. Although increased awareness and diagnosis are likely contributing factors, disruptions in cerebral gene expression early in development also could be responsible.”

Whether it is antibiotics directly affecting brain development or if molecules from the microbiome travelling to the brain, disturbing gene activity and causing cognitive deficits needs to be determined by future studies.

Source: Rutgers University-New Brunswick

Categories : COVID VaccinesTags :

ImmunityBio COVID Booster Gets Go-ahead for South African Trials

On By ModernMedia
Photo by Mufid Majnun on Unsplash
Photo by Mufid Majnun on Unsplash

Immunotherapy company ImmunityBio has been authorised by the South Africa Health Products Regulatory Authority (SAHPRA) to proceed with the South Africa Sisonke T-Cell Universal Boost trial. 

The Phase 1/2/3 study, starting in the second third quarter of 2021, is designed to evaluate hAd5 Spike + Nucleocapsid (S+N) as a boost for South African healthcare workers previously vaccinated with an S (Spike)-only vaccine.

“With the virus continuing to spread, moving forward with this boost trial is crucial,” said Leonard Sender, MD, Chief Operating Officer of ImmunityBio. “We are encouraged by the preliminary safety findings in our ongoing Phase 1 studies in both the U.S. and South Africa. In addition, our U.S. data show that just a single prime subcutaneous vaccination with our COVID-19 vaccine candidate induces a 10-fold increase in T cell response—equivalent to T cell responses from patients previously infected with SARS-CoV-2. We have also shown that the T-cell responses are maintained against variants, which is critical to providing protection against this ever-changing virus.”

In the trial, the effect of combining vaccination by subcutaneous (SC) and sublingual (SL) routes will be assessed. This combination has the potential to deliver protection from the virus with a single injection followed by droplets placed under the tongue. Methods that do not require injection such as SL, intranasal, and oral capsule offer potential advantages depending on the participant’s needs or situation. Sublingual administration offers the most rapid absorption, while nasal spray or oral capsule delivery have the potential to provide mucosal immunity, which could reduce both the chance of infection and potential spread of the virus via the respiratory tract. The three non-injection formulations do not need a trained healthcare worker to administer them and are easier to transport and store. The SL and nasal routes of administration are also currently being tested in a separate Phase 1 trial in South Africa.

“The number of new cases in South Africa is frightening, particularly when you consider recent data suggesting currently available COVID-19 vaccines may not provide the immune memory needed to fend off infection from future variants. This highlights an urgent need for a boost dose that confers long-term protection by activating both antibodies and T cells, ” said Patrick Soon-Shiong, MD, Founder and Executive Chairman of ImmunityBio.

“Several peer-reviewed studies demonstrate that patients who have recovered from SARS-CoV in the 2003 outbreak possess long lasting memory T cells reactive to the nucleocapsid protein of SARS-CoV 17 years after infection. While antibodies block infection when present, T cells are vital for long-term immune memory. We are excited to begin this controlled, randomized trial of boosting a previously administered DNA-based viral vector vaccine with our own Ad5 dual-antigen S plus N vaccine to see if it can augment protection in participants who have received the S-based vaccine alone,” added Dr Soon-Shiong.

Source: BusinessWire