A guide to vaccinology: from basic principles to new developments
This Clinical Trial Will Pay You To Help Prevent Malaria
Adobe Stock A malaria vaccine clinical trial is currently underway to test a promising new approach to prevent malaria, a serious and widespread disease. Researchers are looking for 22 healthy volunteers, aged 18 to 45, to participate in this important study. The trial focuses on evaluating the PfSPZ-LARC2 vaccine, an experimental vaccine designed to protect against malaria infection.
What is the malaria clinical trial?The PfSPZ-LARC2 vaccine, developed by Sanaria, a biotechnology company, uses a weakened form of the whole malaria parasite. The goal is to see if this vaccine can provide enhanced protection against malaria infection. Participants in the trial will be randomly assigned to receive either the experimental vaccine or a placebo, which is a saline solution. A key part of this research involves a controlled exposure to malaria after the vaccine or placebo is given. This allows researchers to see how well the vaccine prevents infection. Participants will be closely monitored throughout the study, and if malaria is detected, they will receive quick, effective treatment.
Taking part in the trial requires a major commitment. Volunteers will need to attend up to 38 in-person clinic visits over the course of a year. The study involves receiving three injections of the vaccine or placebo, keeping track of any symptoms or how they feel, and undergoing multiple blood draws for safety checks and to measure the immune response.
"Conducting this vaccine trial is an important step toward reducing the global burden of malaria and saving lives," said the trial's principal investigator Dr. Scott McClelland, professor of medicine at the UW School of Medicine and of epidemiology at the UW School of Public Health.
This research is supported by the Infectious Diseases Clinical Research Consortium. Participants will be compensated for their time.
What is malaria?Malaria is a life-threatening disease caused by Plasmodium parasites. It's transmitted to humans through the bite of infected female Anopheles mosquitoes. While most cases in the United States are reported in travelers returning from places like sub-Saharan Africa and South Asia, malaria poses a significant global health burden.
When an infected mosquito bites someone, the parasites enter the bloodstream and travel to the liver. After multiplying in the liver, they infect red blood cells, leading to symptoms like fever, chills, sweating, headache, muscle aches, and fatigue. Severe malaria can cause serious complications and can be life-threatening.
In 2021, the first vaccine to protect against malaria was endorsed by the World Health Organization (WHO) and helps prevent the deaths of tens of thousands of children a year.
Why we need new malaria prevention methodsMalaria is a major global health challenge. The fight against malaria has been ongoing for decades, relying on a combination of vector control measures (such as insecticide-treated bed nets and indoor residual spraying), prompt diagnosis, and effective treatment with antimalarial drugs. However, the emergence of drug-resistant parasites poses a significant challenge. This highlights the critical need for new interventions, and vaccines are a vital tool in the fight against malaria.
Drug-resistant malaria occurs when malaria parasites evolve and develop the ability to survive exposure to antimalarial medications. This phenomenon threatens to undermine the effectiveness of current treatments, making it more difficult to cure patients and control the disease.
Vaccines offer a promising approach to preventing malaria infection. A highly effective and long-lasting vaccine could provide sustained protection, reducing the incidence of the disease and ultimately saving lives.
This clinical trial and others like it are essential steps toward developing better ways to combat malaria and improve global health.
Are you interested? Fill out a short survey at the study's participant registry. You can also reach the virology research clinic team at the University of Wisconsin [email protected] or 206-520-4340 (phone/text). The team will contact you if you're eligible.
A New Era In Hope And Health Equity: Malaria Vaccinations
By Sophia Ononye-Onyia, PhD, MPH, MBA
I was born in Enugu, Nigeria. Malaria was a gruesome reality for all of us. In fact, a child dies from malaria every two minutes, according to the World Health Organization (WHO). So, I was obviously ecstatic when the WHO announced its recommendation for widespread use of the first malaria vaccine on October 6, 2021. This RTS,S/AS01 (RTS,S) malaria vaccine is approved for children from 5 months of age in sub-Saharan Africa and other regions with moderate to high transmission of the most lethal malarial pathogen, Plasmodium falciparum.
There are obvious questions that come to mind, including the simplest, why did it take so long for a vaccine to be developed for a disease that kills more than 250,000 African children yearly? Is it because we deprioritized infectious diseases prior to the COVID-19 pandemic? Is it a much larger issue that is related to the social determinants of health and health equity? In other words, are socioeconomically disadvantaged individuals at higher risk for virtually all diseases due to lower access and prioritization?
I remember suffering from malaria as a teenager -- the aches and pains, high fevers, chills, loss of appetite. Fortunately, I survived because my parents could afford the more effective Artemisinin-based combination (ACT) therapies versus the more affordable chloroquine, which many still rely on despite its proven ineffectiveness on the lethal P. Falciparum pathogen. Afterwards, I went ahead to obtain several advanced degrees in the United States, including a PhD in Medicinal Chemistry and a master's degree in Public Health (MPH) because I wanted to play a role in amplifying scientific innovation by becoming a leader in the life sciences. For me, the most unique aspect of the life science industry is its ability to bring hope and optimism to the masses through breakthrough science that range from preventative therapies such as vaccines to tertiary care that is
Yet, there are some days when I wonder how many lives would have been saved if the same synthetic pesticide, dichlorodiphenyltrichloroethane (DDT), which was used to essentially eradicate malaria in the United States and other Western countries was also used in sub-Saharan Africa and other WHO regions such as South-East Asia. There are many who still maintain that Rachel Carson's highly controversial 1962 book, Silent Spring, sparked a government investigation into the widespread use of pesticides that eventually led to the ban of DDT based on concerns about cancer and threats to birds. Of note, DDT was used in the second half of World War II to limit the spread of malaria and typhus among civilians and troops, and the Swiss Chemist Paul Hermann Müller was awarded the 1948 Nobel Prize in Physiology or Medicine "for his discovery of the high efficiency of DDT as a contact poison against several arthropods."
The 21st century has showcased the vast disparities between the "haves and have-nots" when it comes to the iron triangle of public health i.E. Access, cost and quality. As I shared in a business school presentation on financial risk management, emigrating from Nigeria to the United States essentially meant that I could potentially increase my life expectancy from an average of 53 years to 79 years -- a difference of more than 25 years. I am thrilled that this malaria vaccine can ultimately save millions of lives while also improving the life expectancy for future generations. There is no doubt that the global shared experience from the ongoing COVID-19 pandemic has highlighted the need for a renewed focus on infectious disease prevention. Technology is evolving to the point where we have casual space travel for the ultra-rich. Conversely, the poor, developing nations are still in dire need of basic life-saving vaccines and effective therapies against constantly evolving pathogens. While I applaud the approval of this malaria vaccine, there is still a lot more to do. We can no longer turn a blind eye to these infectious diseases because globalization and international travel are real phenomena. Investments in infectious disease might not be as financially rewarding as some chronic diseases like cancers. But the fact that a certain pervasive virus has essentially slowed down economies, global travel and many forms of socialization means that we need to have a deeper respect and weaponry for infectious diseases. We must continue to invest in novel solutions that can help to reduce the physiological and psychosocial disease burden.
Public-private partnerships are key to effective innovation. For example, the malaria vaccine is a result of 30 years of research and development by the British pharmaceutical company, GlaxoSmithKline (GSK) through a partnership with the global public health nonprofit, PATH, with support from a network of African research centers and 15 years of catalytic funding for late-stage development by the Bill & Melinda Gates Foundation. I must also point out that adults also suffer from malaria and contribute to the over 200 million global annual cases for this deadly disease. So naturally, the next wave of innovation in the malaria vaccine space is to also develop a vaccine for adults, particularly the immunocompromised, who may be at a higher risk of transmission and potentially death.
In closing, scientific innovation is ultimately a story about optimism—researchers who must remain resilient in advancing drug development and patients who can experience better quality of lives because of these transformative therapies. We must continue to do all we can to bridge the health equity gap by devising novel solutions for lethal pathogens.
Sophia Ononye-Onyia, PhD, MPH, MBA, is a Yale-trained molecular oncologist and founder of The Sophia Consulting Firm, a WBENC-certified, New York City life-sciences marketing and communications consultancy. She is also the host of her firm's Amplifying Scientific Innovation® Video Podcast.
This article is part of WebMD's contributor program, which lets people and organizations outside of WebMD submit articles for consideration on our site. Have an idea for a submission? Email us at [email protected].
Uganda Launches Largest Malaria Vaccine Introduction To Date
Apac District, Northern Uganda — Today, Uganda's Ministry of Health, with support from Gavi, the Vaccine Alliance (Gavi) and Alliance partners, UNICEF, the World Health Organization (WHO), PATH and CHAI rolled out a malaria vaccination campaign in Apac District, northern Uganda. This makes Uganda the 19th country in Africa to introduce the malaria vaccine into routine immunisation, and it is the largest malaria vaccine roll-out to date in terms of target districts and population.The R21/Matrix-M malaria vaccine, administered in four doses at 6, 7, 8 and 18 months, will initially target 1.1 million children aged under two years in 105 high- and moderate-transmission districts across Uganda, with plans to expand nationwide.
Apac District is reported to have the highest number of mosquito bites per person globally (over 1,500 bites per person annually).
Malaria is the leading cause of illness and death among young children in Uganda, responsible for up to 40% of all outpatient visits, 25% of hospital admissions and 14% of all hospital deaths, according to 2022 data from WHO. In 2023, Uganda was among the top five African countries with the highest malaria burden, alongside Nigeria, Democratic Republic of the Congo, Ethiopia and Mozambique.
The Minister of Health, Dr Jane Ruth Aceng Ocero, said: "The introduction of the vaccine marks a significant milestone in our fight against malaria. It is expected to prevent at least 800 cases of severe malaria among children every day and ease the financial burden on families, saving them approximately UGX 15,000 per case that would have been spent on treating severe malaria. I urge all parents and caregivers to ensure that children aged 6 to 18 months receive the malaria vaccine at the nearest health facility. For the best protection, it is essential that the children complete all four doses on schedule."
Gavi coordinates the global malaria vaccination programme, providing essential financial support for the procurement, transport and roll-out of doses. To date, Gavi has supported 19 African countries in integrating the malaria vaccine into routine immunisation programmes. By collaborating with countries and partners, Gavi ensures the delivery of malaria vaccines as part of a comprehensive malaria control strategy.
Gavi's model relies on co-financing, meaning that countries contribute to the cost of their own vaccines, paying progressively more as their income rises to the point where they fully pay for their own programmes. Future support for its global malaria programme is dependent on Gavi securing sufficient funds for its next five-year strategic period starting in 2026, however; and any shortfall in funding will result in programmes being cut back, leading to preventable deaths and a greater threat to global health security.
Commenting on the historic roll-out, Dr Sania Nishtar, CEO of Gavi, said: "With one of the highest malaria incidence rates globally, Uganda faces a relentless battle against this deadly disease that has devastated families and communities for far too long. The malaria vaccine, proven safe and effective, saves lives and prevents hospitalisations. However, without sustained financial support, these life-saving efforts could falter, leaving millions of children vulnerable and undermining the progress made so far. Continued funding is crucial to sustain and expand these efforts, ensuring that more children are protected, and more countries benefit from this vital tool."
UNICEF, responsible for the procurement and air freighting of the vaccines and raising awareness within the community to enhance demand for vaccines, reaffirmed its commitment to child health and immunisation efforts in Uganda.
"UNICEF is proud to support Uganda's historic roll-out of the malaria vaccine, which represents a significant milestone in our collective efforts to protect children from this deadly disease. This vaccine must be combined with existing preventive measures, and this combination of preventive measures will create a powerful shield against malaria. We urge all parents and caregivers to ensure their children receive all four doses of this life-saving vaccine as part of Uganda's routine immunization services," said Dr Robin Nandy, UNICEF Representative to Uganda.
In preparing for the roll-out of the malaria vaccination campaign, the Ministry of Health, supported by partners, has distributed 2.278 million doses of malaria vaccine to the 105 districts with high and moderate transmission across Uganda. The Ministry has also been conducting intensified community mobilisation and awareness campaigns, which include engaging Members of Parliament, cultural leaders and religious leaders at the community level, as well as conducting door-to-door campaigns. Other preparatory activities included developing vaccine implementation plans, conducting health worker training and ensuring sufficient cold chain capacity across districts.
WHO coordinated the pilot evaluation of the first malaria vaccine, RTS,S/AS01, which was co-funded by Gavi and other partners. Through a multiyear programme in Kenya, Ghana and Malawi, which protected millions of children, the pilot generated evidence that the introduction of the vaccine resulted in a 13% reduction in all-cause mortality among children. This led to WHO's recommendation and prequalification of the two safe and effective malaria vaccines available today. WHO continues to support countries by providing guidance, sharing experiences and offering technical assistance to ensure successful implementation.
"Today marks a historic turning point in Uganda's fight against malaria. By integrating the malaria vaccine into routine immunisation, Uganda is taking a bold step to protect its children, save lives and secure a healthier future. This vaccine is a game-changer, and together, we must ensure that every child receives it," said Dr Kasonde Mwinga, WHO Representative to Uganda.
Notes to Editors
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About Gavi, the Vaccine Alliance
Gavi, the Vaccine Alliance is a public-private partnership that helps vaccinate more than half the world's children against some of the world's deadliest diseases. The Vaccine Alliance brings together developing country and donor governments, the World Health Organization, UNICEF, the World Bank, the vaccine industry, technical agencies, civil society, the Gates Foundation and other private sector partners. View the full list of donor governments and other leading organisations that fund Gavi's work here.
Since its inception in 2000, Gavi has helped to immunise a whole generation - over 1.1 billion children - and prevented more than 18.8 million future deaths, helping to halve child mortality in 78 lower-income countries. Gavi also plays a key role in improving global health security by supporting health systems as well as funding global stockpiles for Ebola, cholera, meningococcal and yellow fever vaccines. After two decades of progress, Gavi is now focused on protecting the next generation, above all the zero-dose children who have not received even a single vaccine shot. The Vaccine Alliance employs innovative finance and the latest technology - from drones to biometrics - to save lives, prevent outbreaks before they can spread and help countries on the road to self-sufficiency. Learn more at www.Gavi.Org and connect with us on Facebook and X (Twitter).
About UNICEF
UNICEF promotes the rights and wellbeing of every child, in everything we do. Together with our partners, we work in 190 countries and territories to translate that commitment into practical action, focusing special effort on reaching the most vulnerable and excluded children, to the benefit of all children, everywhere.
For more information about UNICEF and its work for children, visit www.Unicef.Org/uganda
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