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)
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(Family Features) Some women may be unaware they’re living with risks for heart disease, kidney disease and metabolic conditions like diabetes, which drive risk for cardiovascular disease.
The interplay among these conditions is called cardiovascular-kidney-metabolic (CKM) syndrome, according to the scientific experts at the American Heart Association. Consider these facts women should know about CKM syndrome.
Cardiovascular Disease is the No. 1 Killer of Women
Cardiovascular disease (CVD), which includes heart disease and stroke, affects nearly 45% of women ages 20 and older, and 1 in 3 women will die from it, according to the association.
“Despite heart disease being the leading cause of death for women, most women are not aware of their risk for heart disease,” said Sadiya S. Khan, M.D., M.Sc., FAHA, American Heart Association volunteer and a member of the science advisory group for the association’s CKM Health Initiative, supported by founding sponsors Novo Nordisk and Boehringer Ingelheim and champion sponsor DaVita.
Women may develop heart disease differently than men and experience symptoms uncommon in men. Women are more likely to have blockage in smaller blood vessels around the heart and, while chest pain is the most common heart attack symptom, women are more likely than men to experience pain in the arms, jaw and neck, too.
Early Action is Key
According to a study presented at an American Heart Association scientific conference, women with either Type 2 diabetes or chronic kidney disease are predicted to reach elevated risk for CVD 8-9 years earlier than women with neither condition while women with both conditions may reach high risk 26 years earlier.
Risk Factors are Connected
The health factors that comprise CKM syndrome are connected. They include high blood pressure, abnormal cholesterol, excess weight, high blood glucose sugar and low kidney function. If something goes wrong in one area, it affects others.
“Knowing your health numbers is critical to optimize your CKM health and prioritize prevention of heart, kidney and metabolic disease,” said Khan, who is also the Magerstadt professor of cardiovascular epidemiology and an associate professor of cardiology and preventive medicine at Northwestern School of Medicine.
Since high blood pressure and early stages of kidney disease and diabetes often don’t have symptoms, regular screening is necessary to be aware of your risk.
Pregnancy and Menopause Affect Women’s CKM Health
Each pregnancy is a window into later heart and kidney health, according to Janani Rangaswami, M.D., FAHA, professor of medicine at the George Washington University School of Medicine and Health Sciences and co-chair of the scientific advisory group for the American Heart Association’s presidential advisory that defined CKM syndrome.
Pregnancy complications such as pre-eclampsia, gestational diabetes and gestational hypertension are risk factors for future chronic kidney disease and cardiovascular disease, Rangaswami said.
Changes during menopause also influence long-term heart and metabolic health. This includes declining estrogen levels, increased body fat around the organs, increased cholesterol levels and stiffening or weakening of blood vessels, per the American Heart Association. Early menopause (before age 45) is linked to a higher risk for kidney disease, Type 2 diabetes and CVD.
“Women can mitigate those risks by getting appropriate treatment for their menopause symptoms,” Rangaswami said.
Social Factors Affect Women’s Health
Negative economic, environmental and psychosocial factors are associated with lower levels of preventive health behaviors like physical activity and healthy eating and higher levels of conditions like obesity and diabetes. Some factors affect women differently than men. For example, marriage is associated with worse health for women, and women are more likely than men to delay medical care because of costs, according to an American Heart Association scientific statement. Women are also more likely to have their health concerns dismissed, Khan said.
Women should know their risk and self-advocacy is critical. They should request thorough screenings that assess heart, kidney and metabolic health at visits with their health care providers. Visit heart.org/myCKMhealth to learn more.
Photos courtesy of Shutterstock
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(Family Features) These days, wellness information is practically everywhere you turn. Do this; don’t do that. Eat more of this; eat less of that. This is good for you; that is bad.
It can be hard to cut through all the noise, but the reality is, when it comes to something as serious as your heart health and LDL cholesterol – the “bad” cholesterol – ignoring it can be downright dangerous for your health.
According to the American Heart Association, about every 40 seconds, someone in the United States has a heart attack, and strokes occur at about the same frequency.
High LDL cholesterol, often called “bad” cholesterol, significantly increases your risk of heart disease.
A poll conducted by The Harris Poll for the American Heart Association revealed 75% of heart attack and stroke survivors reported having high cholesterol. Yet nearly half (47%) of heart attack and stroke survivors are unaware of their LDL cholesterol number. This lack of awareness shows more knowledge is needed to help survivors proactively manage their health.
In fact, knowledge is key to reducing your risk of heart disease. Understanding the impact of LDL cholesterol and knowing your LDL number can help you make informed decisions.
Cholesterol: The Good and The Bad
Cholesterol is a waxy, fat-like substance your body needs to build cells and produce hormones. However, not all cholesterol is created equal:
- LDL (low-density lipoprotein) Cholesterol: This is the “bad” cholesterol. When too much LDL cholesterol circulates in the blood, it can build up in the inner walls of the arteries that feed the heart and brain, forming plaque that can narrow and eventually block these arteries, leading to heart attack or stroke.
- HDL (high-density lipoprotein) Cholesterol: Known as the “good” cholesterol, HDL helps remove the “bad” cholesterol from the arteries, protecting against heart attack and stroke.
A Silent Threat
Many people think high cholesterol has obvious signs, but that’s not always the case. In fact, about half of U.S. adults and 42% of heart attack and stroke survivors mistakenly believe high cholesterol has clear symptoms. However, high LDL cholesterol typically doesn’t show any signs, which is why it’s known as a silent threat to your heart.
People who have had a heart attack or stroke are at higher risk of future cardiovascular problems, which is why it’s important to monitor your cholesterol regularly to help prevent future events.
It’s also important to know high LDL cholesterol can be genetic, meaning someone who eats a healthy diet and exercises regularly can still have high cholesterol. Additionally, the risk of high LDL cholesterol increases with age.
That’s why the American Heart Association’s “Lower Your LDL Cholesterol Now” initiative, nationally sponsored by Amgen, emphasizes the importance of regular cholesterol checks regardless of your weight, diet and physical activity levels. Knowing your LDL cholesterol number – and understanding the target levels based on your health history – gives you the opportunity to manage your health proactively. This enables you to make informed decisions to prevent future heart issues.
Know Your Number
You can reduce your risk of a heart attack or stroke by knowing and addressing your LDL cholesterol number.
Working closely with your doctor allows you to actively manage high LDL cholesterol – often a key risk factor you can help control – and together, you can develop a personalized treatment plan. Ask your doctor or health care provider for a cholesterol test to know your LDL number. Understanding your cholesterol number is the first step toward managing it effectively. If necessary, appropriate management of your LDL cholesterol can help reduce your risk of a heart attack or stroke.
Your doctor may also talk with you about your personal and family medical history; previous heart-related medical events such as a heart attack or stroke; lifestyle habits such as tobacco use, obesity, unhealthy living or aging; racial and ethnic backgrounds; and reproductive health.
Lower is Better
When it comes to your cholesterol, guidelines from the American Heart Association and the American College of Cardiology recommend “lower is better” to reduce your risk. Studies show that an LDL number or below 100 mg/dL is ideal for healthy adults.
If you have a history of heart attack or stroke and are already on a cholesterol-lowering medication, your doctor may aim for your LDL to be 70 mg/dL or lower.
Talk to your doctor about the right treatment plan for you. Positive lifestyle habits, such as exercising and eating a healthy diet, may also help.
However, if you’ve had a heart attack or stroke before, lifestyle changes alone may not be enough to lower your risk of another event. Your doctor may recommend cholesterol-lowering medications to protect your heart health.
Learn more about LDL (bad) cholesterol by visiting heart.org/LDL.
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(Family Features) Throughout history, humans’ ability to rely on one another has been crucial to survival. Despite modern developments that help individuals live with minimal human engagement, the human need to connect remains.
However, in many parts of America, a trend toward isolation is emerging. Over the past two decades, people are spending more time alone and less time engaging with others in person, according to data from the Office of the U.S. Surgeon General. One segment of Americans at particular risk of social isolation, loneliness and their negative impacts are select populations who live in rural areas.
“There is an urgent need to take action and improve mental health in rural America,” said Jeff Winton, dairy farmer and founder and chairman of Rural Minds, a nonprofit mental health advocacy organization that partnered with Pfizer to raise awareness about the physical and mental risks of social isolation. “Challenges to mental health can be inherent in a rural lifestyle, including a belief in self-reliance as a virtue, fear of judgment and difficulty getting an appointment with a limited number of mental health professionals, among others.”
Many Americans are increasingly spending more time alone according to the American Time Use Survey. They are increasingly more likely to take meetings, shop, eat and enjoy entertainment at home, making it easier for them to stay within their own four walls and avoid social interactions.
Authentic human connection is a basic but often unacknowledged necessity for health, “as essential to survival as food, water and shelter,” according to the U.S. Surgeon General’s Advisory on the Health Effects of Social Connection and Community.
Understanding Social Isolation
According to the Centers for Disease Control and Prevention (CDC), about one-third of U.S. adults reported feeling lonely and about one-fourth said they don’t have social and emotional support (the basis of social isolation).
The concepts of social isolation and loneliness can go hand-in-hand, but the two are actually quite different.
Social isolation is defined by an absence of relationships or contact with others. Someone experiencing loneliness may or may not have social connections, but lacks feelings of closeness, support or belonging. Despite the distinction, both can have a negative impact on a person’s mental and even physical health.
Several factors can influence a person’s risk for social isolation and loneliness.
“Social connection is a dynamic that changes over time,” said Nikki Shaffer, senior director, occupational health and wellness, Pfizer. “Transient feelings of loneliness or solitude may be beneficial because they can serve as motivation to reconnect. However, chronic loneliness (even if someone is not isolated) and isolation (even if someone is not lonely) can represent significant health concerns.”
Isolation in Rural America
Compared to people who live in urban areas, many rural Americans experience higher rates of depression and suicide but are less likely to access mental health care services, according to the “Health Disparities in Rural America: Current Challenges and Future Solutions” study published in “Clinical Advisor.” What’s more, CDC data shows suicide rates among people living in rural areas can be 64-68% higher than those in large urban areas.
Rural areas have 20% fewer primary care providers compared to urban areas, according to a report in JAMA, and the Health Resources and Services Administration reports more than 25 million rural Americans, more than half of rural residents, live in mental health professional shortage areas.
Among rural counties, 65% lack a psychiatrist. Nearly 30% of rural Americans don’t have internet access in their homes, which complicates the option for telehealth. These figures from Rural Minds exemplify the challenges facing rural America.
“Some people in rural communities still don’t understand or accept that mental illness is a disease,” said Winton, who grew up on a rural farm. “Rather, a mental illness can often be viewed as a personal weakness or character flaw. A lot of the stigma around mental illness results in unwarranted shame, which adds to the burden for someone already suffering from mental illness.”
Health Impacts of Social Isolation
Loneliness is far more than just a bad feeling; it harms both individual and societal health. In fact, loneliness and social isolation can increase the risk for premature death by 26% and 29%, respectively.
Lacking social connection can increase the risk for premature death as much as smoking up to 15 cigarettes a day or drinking six alcoholic drinks daily.
In addition, poor or insufficient social connection is associated with increased risk of disease, including a 29% increased risk of heart disease and a 32% increased risk of stroke.
Social isolation is also associated with increased risk for anxiety, depression and dementia. Additionally, a lack of social connection may increase susceptibility to viruses and respiratory illness.
Learn more about the impact of social isolation, especially on residents of rural areas, and the steps you can take to reduce isolation and loneliness by visiting ruralminds.org.
Boost Your Social Connections
Take a proactive approach to combatting social isolation and loneliness with these everyday actions that can promote stronger social ties.- Invest time in nurturing your relationships through consistent, frequent and high-quality engagement with others. Take time each day to reach out to a friend or family member.
- Minimize distractions during conversation to increase the quality of the time you spend with others. For instance, don’t check your phone during meals with friends, important conversations and family time.
- Seek out opportunities to serve and support others, either by helping your family, co-workers, friends or people in your community or by participating in community service.
- Be responsive, supportive and practice gratitude. As you practice these behaviors, others are more likely to reciprocate, strengthening social bonds, improving relationship satisfaction and building social capital.
- Participate in social and community groups such as religious, hobby, fitness, professional and community service organizations to help foster a sense of belonging, meaning and purpose.
- Seek help during times of struggle with loneliness or isolation by reaching out to a family member, friend, counselor, health care provider or the 988 crisis line.
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