Health
Coordination of COVID-19 Vaccine Clinical Trials Produces a ‘Treasure Trove’ of Data and a Model for the Future
Harmonized approach and vast database of trial participants could bolster future research well beyond SARS-CoV-2
Newswise — SEATTLE – The federally funded COVID-19 Prevention Network (CoVPN), headquartered at Fred Hutchinson Cancer Center in Seattle, was instrumental in the rapid development of safe, effective and lifesaving COVID-19 vaccines during earlier phases of the pandemic.
Its vital work to expedite Phase 3 COVID-19 vaccine clinical trials also resulted in a highly collaborative and harmonized approach that can serve as a national and even international model for major research initiatives while also guiding responses to future public health emergencies.
That’s the overarching theme from a new study published Monday, Jan. 23, in JAMA Network Open.
“Our success, which depended entirely on the investments into HIV vaccine research, can be replicated for other important research initiatives and highlights the importance of investments that boost pandemic preparedness for years to come,” explained James G. Kublin, MD, MPH, executive director of CoVPN and senior and corresponding author of the study.
Additionally, he and his colleagues, including Alfredo Mena Lora, MD, assistant professor of medicine at the University of Illinois at Chicago, and co-first author Jessica Long, PhD, MPH, a postdoctoral fellow at the University of Washington Department of Medicine in Seattle, noted that the COVID-19 clinical trials produced a vast database of critical information that could help researchers answer pressing questions about this novel virus moving forward.
“The harmonization of data across trials is a new strategy that will set the standard for collaboration in future clinical trials,” said Mena Lora.
The authors detail how CoVPN was able to help secure authorized vaccines in less than a year by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health as part of Operation Warp Speed. Its mission was, and continues to be, to support the rapid development of vaccines for the U.S. and global populations by coordinating and implementing Phase 3 trials for COVID-19 vaccine candidates.
CoVPN officials were able to leverage existing resources, including clinical and laboratory infrastructure, community partnerships and research expertise, to get clinical sites to quickly pivot to conduct the vaccine trials as soon as investigational products were ready for Phase 3 testing.
“The CoVPN approach drew on years of experience and infrastructure from partnering networks and institutions, which not only allowed for rapid rollout of the trials, but also contributed to broader representation of trial participants,” said Long.
Overall, CoVPN deployed five Phase 3 clinical trials involving more than 136,000 participants to test the safety and effectiveness of COVID-19 vaccines. While doing so, it implemented several innovative procedures that were essential to its ultimate success. These included:
- Harmonized study designs that were similar in relative size, number of endpoints and time to analysis.
- A model that accelerated vaccine development by allowing phases to occur in parallel rather than sequentially. For example, vaccine manufacturing and scale-up were greenlighted while the trials were ongoing in anticipation of meeting efficacy targets.
- Establishment of a single Data Safety Monitoring Board for review and oversight of all vaccine studies.
- Targeted outreach and enrollment efforts supported by an online screening registry to ensure broad and diverse representation among study participants. Extensive engagement was conducted with communities and community leaders to build and enhance trust in the science to help enroll more Black, Indigenous and people of color (BIPOC) volunteers who are historically underrepresented in clinical trials.
- A cross-platform approach that led to harmonization of data collection across trials and the ability to analyze data from all studies.
“This unique, cross-platform concept allowed for sharing of data from all of the studies and helped bridge gaps in understanding so we could better answer key research questions and guide policy decisions,” explained Kublin, who’s also a principal staff scientist at Fred Hutch.
Larry Corey, MD, an internationally renowned expert in vaccine development, and principal co-investigator of CoVPN, believes the success of COVID-19 clinical trials should be thought of as an important model for developing vaccines for significant infectious diseases globally.
“Harmonizing study design, enrollment, clinical endpoints and methods for follow-up could very well become best practices that shape the future landscape of major research initiatives and pandemic responses,” he said.
Kublin and colleagues regard the vast database from more than 130,000 trial participants, including over 2,500 with documented COVID-19 cases, as a “treasure trove” of data that could help unlock mysteries about the virus. For example, they noted that the pooled data from five trials can help address specific questions such as:
- How effective are vaccines for at-risk groups?
- Can vaccines have an impact on long COVID?
- Are safety, immunogenicity and vaccine efficacy different in special populations, such as people living with HIV?
- What impact do chronic health conditions have on vaccine efficacy or protection duration?
- What are the impacts of variants on both the population at large and within special communities?
Additional CoVPN publications planned for the months ahead will address many of these topics. Researchers who have ideas for further investigation and want to collaborate with CoVPN can find more information here.
Source: Covid-19 Prevention Network (CoVPN)
5 strategies to combat stressful triggers
(Family Features) Stress, the physical or mental response to external causes like overwhelming work assignments or difficult life moments, can add unnecessary pressure to your day to day. While everyone feels stress from time to time, when left untreated or unrecognized, it can begin to wreak havoc in the form of anxiety.
In honor of National Stress Awareness Month, consider these strategies to combat stress from the National Institutes of Mental Health.
Learn Your Triggers
Different events and situations cause stress for different people. Knowing what triggers your stress to kick in – mounds of office paperwork, important financial decisions or hectic mornings, for example – can help you plan and prepare for stress-inducing moments.
Exercise and Eat Right
Maintaining physical health can be beneficial for mental health, too. Find time to do exercises you enjoy like walking, jogging, yoga or playing a sport. Identifying activities that bring you joy can make it easier to fit 30-60-minute workouts into your schedule without adding even more stress. Complement your workout routine with nutritional meals that help you stay on track with your fitness goals.
Practice Relaxation
Whether you find inner peace through journaling, breathing exercises, reading or some other form of slowing down, find what works for you and prioritize fitting it into your daily schedule. Relaxing activities help you slow down the pace of life, providing a chance to reset by doing something you enjoy.
Get Enough Sleep
A lack of quality sleep can add to stress. Creating a bedtime routine can increase your sleep habits and help you achieve the expert-recommended 7-9 hours per night. Put away electronics, which can interfere with your ability to calm your mind, and find an activity that puts you at ease like reading a book or listening to relaxing music. Ensure your bedroom is optimized for comfort by making it cool, dark and quiet.
Create a Network of Support
Everyone experiences stress. Reach out to family members and close friends you can lean on in stressful and frustrating moments. Share your feelings and encourage others to do the same, which can increase trust and help everyone in your circle cope in a positive way.
Find more ways to combat stress and care for your mental health at eLivingtoday.com.
Photo courtesy of Unsplash
SOURCE:
eLivingtoday.com
(Family Features) For those with asthma, understanding what can trigger symptoms is a part of getting the condition under control. Some of the same things that cause allergies can worsen symptoms, but not every allergen is a trigger for everyone with asthma. The places where you live, learn, work and play can expose you to common asthma triggers like pet dander, dust mites, pests like rodents and cockroaches, mold, cigarette smoke, pollen, air pollution and more. Managing triggers is just one part of controlling asthma, however. Work with your health care provider to make an asthma action plan and keep track of your symptoms and where you are when they occur. Learn more at nhlbi.nih.gov/BreatheBetter.
Food and Beverage
The 10 Best Healthiest Seafood Options: Nutrient-Rich and Sustainable Choices
“From sardines to salmon, discover the top 10 healthiest and sustainable seafood options for a nutrient-rich diet. 🐟🌱 #Seafood”
Seafood is a treasure trove of essential nutrients and beneficial compounds that can significantly contribute to a healthy diet. From the omega-3 fatty acids that promote heart health to the abundance of vitamins and minerals, incorporating seafood into your meals can have a positive impact on your overall well-being. In this blog post, we will delve into the ten best healthiest seafood options, considering their nutritional content, sustainability, and potential contaminants.
- Sardines:
These small fish are incredibly nutritious, packed with omega-3 fatty acids, vitamin B12, vitamin D, and calcium. Sardines are also low in contaminants and are considered one of the most sustainable seafood options available. - Salmon:
Salmon is well-known for its impressive omega-3 content. It also provides high-quality protein, vitamin D, vitamin B12, and selenium. Opt for wild-caught Alaskan salmon for the best nutritional benefits and sustainability. - Oysters:
Oysters are a true nutritional powerhouse, rich in vitamins B12, D, and zinc. They are a sustainable choice and an excellent source of lean protein. Including oysters in your diet not only benefits your health but also supports local marine ecosystems due to their ability to filter water. - Mackerel:
Mackerel is another fish that boasts high levels of omega-3 fatty acids, along with vitamin D, vitamin B12, and selenium. This flavorful fish is considered a sustainable choice and offers numerous health benefits. - Rainbow Trout:
Rainbow trout is a deliciously mild-flavored fish that is packed with omega-3 fatty acids, protein, vitamin B12, and iron. It is a sustainable choice, particularly when sourced from responsible fish farms. - Clams:
Clams are an excellent source of protein, vitamin B12, iron, and selenium. They are sustainable, low in contaminants, and make a versatile addition to dishes like pasta, chowders, and stir-fries. - Herring:
Herring is an oily fish that delivers a healthy dose of omega-3 fatty acids, vitamin D, and vitamin B12. It is an eco-friendly choice and can be enjoyed smoked, pickled, or grilled. - Cod:
Cod is a lean white fish that provides protein, vitamin B12, selenium, and phosphorus. It is known for its mild flavor and versatility in cooking methods. - Shrimp:
Shrimp is low in calories and rich in protein, vitamin D, and selenium. Choose sustainably sourced shrimp to minimize environmental impact and ensure a healthier choice. - Anchovies:
Anchovies may be small in size, but they are big in nutritional value. These tiny fish deliver omega-3 fatty acids, calcium, and vitamins D and E. They are also a sustainable choice when sourced responsibly.
When it comes to the healthiest seafood options, there is an abundance of choices that offer an array of essential nutrients while also being environmentally responsible. Sardines, salmon, oysters, mackerel, rainbow trout, clams, herring, cod, shrimp, and anchovies are all fantastic choices to boost your overall health while supporting sustainable fishing practices. Incorporate these nutrient powerhouses into your diet and savor the benefits they provide for your well-being and the planet.
What are the Risks of Eating Seafood?
Although seafood is a nutritious option to fulfill dietary nutrient gaps, there are some environmental and health concerns related to its consumption.
Seafood may contain toxins, viruses, parasites, and bacteria that can be harmful if consumed. To avoid getting sick, it is essential to cook fish and shellfish thoroughly. As per the USDA guidelines, most seafood should be cooked to an internal temperature of 145 degrees Fahrenheit.
Contaminants, including Mercury and Others
Overconsumption of certain seafood varieties can have negative health effects due to the presence of contaminants. For instance, specific fish species contain high levels of mercury, a heavy metal that can be easily absorbed by the body. Mercury accumulation is more common in larger fish, as they consume smaller fish that have ingested mercury-rich plankton. Consequently, larger and older fish are typically the most mercury-contaminated.
Regularly consuming foods high in mercury can result in mercury accumulation in the body, leading to health problems like high blood pressure, heart attack, and developmental delay in offspring. Mercury is toxic and can have detrimental effects on the body.
Mercury can have a greater impact on certain groups, such as pregnant and breastfeeding women, as well as children, who are more susceptible to its effects.
To reduce the amount of mercury in your diet, avoid consuming seafood like shark, certain types of tuna, swordfish, tilefish, and king mackerel as they have high mercury levels. Instead, opt for low-mercury options such as trout, cod, oysters, clams, herring, salmon, and sardines.
Recommendations for Incorporating Seafood into Your Eating Plan
Eating seafood can boost the quality of your diet and support and protect your health. However, it’s important to consider the nutrition and environmental impact of seafood when narrowing down options to add to your diet.
Adding seafood to your diet can boost its nutritional quality and promote your overall health. However, it is essential to consider the nutritional composition and environmental impact of various seafood options before including them in your meals.
Read the article in Health titled Healthiest Seafood Options, Ranked for further insight into the topic. https://www.health.com/healthiest-seafood-8630471
https://stmdailynews.com/category/food-and-beverage/
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