An investigational UTI vaccine administered to both men and women with recurrent UTIs showed efficacy and a favorable safety profile. According to the investigators, 54% of study participants remained UTI-free for 9 years after the vaccine regimen.
The vaccine, MV140, developed for recurrent UTIs was administered with 2 sprays of a pineapple-flavored suspension under the tongue every day for 3 months. While investigators have previously studied MV140s short-term safety and effectiveness, this is the first long-term follow-up study.
Before having the vaccine, all our participants suffered with recurrent UTIs, and for many women, these can be difficult to treat. Nine years after first receiving this new UTI vaccine, around half of participants remained infection free, Bob Yang, MBBS, FRCS, consultant urologist at the Royal Berkshire NHS Foundation Trust, who co-led the research, said in a statement. Overall, this vaccine is safe in the long term and our participants reported having fewer UTIs that were less severe. Many of those who did get a UTI told us that simply drinking plenty of water was enough to treat it.
In terms of the scope of the health issue, UTIs are experienced by half of all women and 1 in 5 men and can be painful and uncomfortable. Recurrent infections, needing short-term antibiotic treatment, develop in between 20% to 30% of cases. With multidrug resistant UTIs now on the rise, novel modalities preventing and treating these infections are needed.
The investigational UTI vaccine, MV140, showed remarkable long-term efficacy in over half of the recipients.
The vaccine demonstrated a favorable safety profile in the long term. Participants reported fewer UTIs that were less severe, and many found that simple measures like drinking plenty of water were sufficient to manage the infection.
UTIs are a common health issue affecting half of all women and 1 in 5 men, with recurrent infections necessitating short-term antibiotic treatment in a significant portion of cases.
What the Data Showed In their original trial, participants were initially followed-up for 12 months and data from the women in the cohort was published in BJU International in 2017. For their 9-year follow-up study, the researchers reviewed data from the electronic health records of their original cohort. They interviewed participants about their experience of UTIs since receiving the vaccine and asked them about side effects.
Forty-eight participants remained infection free during the 9-year follow-up. The average infection-free period across the cohort was 54.7 months (4 1/2 years); 56.7 months for women and 44.3 months for men. Forty percent of participants reported having repeat doses of the vaccine after 1 or 2 years.
Participants in the trial were 18 years of age and older and were UTI-free when they were initially offered the vaccine. None of the participants had other urinary abnormalities such as catheters, tumors, or stones. The follow-up study included 72 women and 17 men and outcomes were self-reported.
MV140 was developed by the pharmaceutical company Immunotek, which is based in Spain, and contains 4 bacterial species in a suspension with water. It is available off-license in 26 countries. These results were presented at the at the ongoing European Association of Urology (EAU) Congress in Paris.
Reference Oral Vaccine for UTI is Potential Alternative to Antibiotics, Finds 9-Year Study. European Association of Urology Press release. April 6, 2024. Accessed April 7, 2024. https://www.eurekalert.org/news-releases/1039942?
Tokyo, April 8, 2024 - NEC Corporation (NEC; TSE: 6701) has released a white paper, "Towards the realization of AI drug development: Comprehensive process workflow for the commercial use of personalized cancer vaccines". This white paper introduces (1) a comprehensive process workflow that can be applied to a wide range of processes, starting from tumor sample collection to vaccine design, manufacturing, supply, and administration, (2) important perspectives for consideration in the workflow, and (3) advanced technologies that will contribute to the realization of the workflow.
NEC is committed to taking on the challenge of realizing new cancer treatments by aiming to establish an accurate, reliable, and comprehensive process workflow that utilizes AI and security technologies.
New Delhi: Urinary Tract Infection (UTI) is a common bacterial infection said to be experienced by half of all women and one in five men. However, a study has shown that more than 50 per cent of people remained UTI-free for up to nine years who received the oral spray-based vaccine 'MV140'.
According to the study published in the journal European Association of Urology, the MV140 vaccine is a potential alternative to antibiotic treatments. About 54 per cent of study participants remained UTI-free for nine years after the vaccine, with no notable side effects reported.
"Recurrent infections, needing short-term antibiotic treatment, develop in between 20 to 30 per cent of cases," the study mentioned. This study, conducted by specialists at the UK's Royal Berkshire Hospital, examined the safety and efficacy of the MV140 vaccine in 89 patients.
"Nine years after first receiving this new UTI vaccine, around half of participants remained infection-free. Overall, this vaccine is safe in the long term and our participants reported having fewer UTIs that were less severe," said Dr Bob Yang, Consultant Urologist at the Royal Berkshire NHS Foundation Trust, who co-led the study.
MV140 vaccine was administered with two sprays of a pineapple-flavoured suspension under the tongue every day for three months in patients.
Developed by the Spain-based pharmaceutical company Immunotek, MV140 contains four bacterial species in a suspension with water. It is available off-license in 26 countries. In the research, 48 participants remained entirely infection-free during the nine-year follow-up.
The average infection-free period across the cohort was 54.7 months (four and a half years) - 56.7 months for women and 44.3 months, one year less, for men. 40 per cent of participants reported having repeat doses of the vaccine after one or two years, the study noted.
"This follow-up study reveals encouraging data about the long-term safety and effectiveness of the MV140 vaccine," said Gernot Bonkat, Professor at the Alta Uro Medical Centre for Urology in Switzerland. (With inputs from IANS)
A potential alternative to antibiotics for treatment of recurrent urinary tract infections has been shown to prevent UTIs for up to 9 years in 54% of people given the oral spray-based vaccine.
The initial results from the first long-term follow-up study on the safety and effectiveness of the MV140 vaccine are being presented this weekend at the European Association of Urology (EAU) Congress in Paris.
Before having the vaccine, all our participants suffered from recurrent UTIs, and for many women, these can be difficult to treat, says one of the research leaders, Dr Bob Yang, a Consultant Urologist at the Royal Berkshire NHS Foundation Trust.
Nine years after first receiving this new UTI vaccine, [about] half of the participants remained infection-free.
Overall, this vaccine is safe in the long term and our participants reported having fewer UTIs that were less severe. Many of those who did get a UTI told us that simply drinking plenty of water was enough to treat it.
The MV140 vaccine contains inactivated whole bacteria of the four major species known to cause recurrent UTIs: Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, and Proteus vulgaris.
The bacteria are administered in two sprays of a pineapple-flavoured liquid under the tongue every day for 3 months.In the original trial 89 patients (72 women and 17 men) received the vaccine at The Urology Partnership Reading in the UK, and interim results were published in the British Journal of Urology in 2017.
The latest results indicate that the average infection-free period across the cohort was 54.7 months (4.5 years) 56.7 months for women and 44.3 months for men.
This is a very easy vaccine to administer and could be given by GPs as a 3-month course. Many of our participants told us that having the vaccine restored their quality of life, says Yang.
While were yet to look at the effect of this vaccine in different patient groups, this follow-up data suggests it could be a game changer for UTI prevention if its offered widely, reducing the need for antibiotic treatments.
Gernot Bonkat, Professor of Urology at the Alta Uro Medical Centre for Urology in Switzerland and Chairman of the EAU Guidelines on Urological Infections, says the findings are promising.
Recurrent UTIs are a substantial economic burden and the overuse of antibiotic treatments can lead to antibiotic-resistant infections, says Bonkat.
This follow-up study reveals encouraging data about the long-term safety and effectiveness of the MV140 vaccine. Further research into more complex UTIs is needed, as well as research looking at different groups of patients, so we can better optimise how to use this vaccine.
Texas Biomedical Researchers study potential Bird Flu treatments and vaccines
by SBG San Antonio Staff Reports
Texas Biomed has broadened the scope of its vaccine research to include Avian Influenza amid recent concerns. (Getty Images){p}{/p}
SAN ANTONIO - Texas Biomedical Research Institute (Texas Biomed) has announced its researching potential vaccines and antivirals that could combat Avian Influenza, also known as H5N1 or Bird Flu.
These will be intended to combat strains that mirror those found in cows and chickens, and now one person in Texas.
This is only the second case of Bird Flu found in Humans in the United States, which officials say was contracted through contact with Dairy Cows.
Thankfully, the risk of the current H5N1 case becoming widespread among people remains low, says Larry Schlesinger, M.D., Texas Biomed President and CEO. But viruses adapt and evolve especially influenza viruses which is why it is so critical to be studying them and developing vaccines and treatments well before they are needed.
Researchers at Texas Biomed are using techniques learned from years of vaccine development for both Seasonal Influenza as well as the recent developments made as a result of the COVID-19 pandemic.
The new initiative, hosted by Professor Luis Martinez-Sobrido, Ph.D.s laboratory, will see the scope of research increased to include Avian Influenza, testing if current vaccines and antivirals would have any effect on stopping the spread or mitigating the virus impact.
The genetic sequencing analysis from the CDC indicates that the H5N1 strain found in the patient does not have any mutations associated with resistance to current antiviral drugs, says Prof. Martinez-Sobrido. However, it is important to continue developing an array of countermeasures in case existing ones lose effectiveness.
Fewer than 900 cases of bird flu infecting humans have been reported globally since 1996, however, infection has a fatality rate of about 50%.
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New research examining the characteristics of physicians with the largest share of patients unvaccinated against SARS-CoV-2 may help increase vaccination rates going forward. The study, published in CMAJ (Canadian Medical Association Journal) https://www.cmaj.ca/lookup/doi/10.1503/cmaj.230816, found that family physicians in Ontario with the largest percentage of unvaccinated patients generally served patients living in marginalized neighbourhoods and had less support in their practices.
Researchers analyzed linked data on 9060 family physicians with more than 10 million enrolled patients and calculated the percentage of patients unvaccinated against SARS-CoV-2 per physician. They compared family physicians (n = 906) caring for the largest proportion of unvaccinated patients (top 10%) with the rest of the comprehensive-care family physicians in Ontario. They found the group with the largest proportion of unvaccinated patients were more likely to be male, to have trained outside Canada, to be older (mean age of 56 v. 49 years), and to work in a fee-for-service model than the remaining 90% of physicians.
"The family physicians with the most unvaccinated patients were also more likely to be solo practitioners and less likely to practise in team-based models, meaning they may have fewer support staff in their clinics," says Dr. Jennifer Shuldiner, lead author and scientist, Women's College Hospital, Toronto, Ontario. "This illustrates the ongoing inverse relationship between the need for care, and its accessibility and utilization. In other words, the practices with the highest need receive the fewest resources."
As many of the physicians with the largest percentage of unvaccinated patients served people living in marginalized neighbourhoods, awareness of cultural differences in perspectives on vaccination should be considered.
"Many marginalized communities have a history of neglect from government (municipal, provincial, federal) and health care, and this may lead to mistrust in public health initiatives," the study authors write. "Interventions to support these communities should include meaningful community engagement and consideration for age-, language-, and culturally appropriate communication tools to assist primary care in boosting vaccine uptake."
Although the majority of SARS-CoV-2 vaccines were not administered by family physicians, clinicians have an important role to play in educating patients about the benefits of vaccination.
"We know that relationships with trusted family physicians can positively influence patients' decisions," explains Dr. Noah Ivers, senior author and clinician scientist, Women's College Hospital. "Our study highlights the need to create equitable systems and processes that create opportunities for primary care teams to play a crucial role in influencing both general and SARS-CoV-2-specific vaccine-related decision-making."
Expanding primary care teams in marginalized neighbourhoods and using hotspot strategies to focus public health resources in under-vaccinated communities could help support public health initiatives like vaccination.
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The same class of artificial intelligence that made headlines coding software and passing the bar exam has learned to read a different kind of textthe genetic code.
That code contains instructions for all of life's functions and follows rules not unlike those that govern human languages. Each sequence in a genome adheres to an intricate grammar and syntax, the structures that give rise to meaning. Just as changing a few words can radically alter the impact of a sentence, small variations in a biological sequence can make a huge difference in the forms that sequence encodes.
Now Princeton University researchers led by machine learning expert Mengdi Wang are using language models to home in on partial genome sequences and optimize those sequences to study biology and improve medicine. And they are already underway.
In a paper published April 5 in the journal Nature Machine Intelligence, the authors detail a language model that used its powers of semantic representation to design a more effective mRNA vaccine such as those used to protect against COVID-19.
Scientists have a simple way to summarize the flow of genetic information. They call it the central dogma of biology. Information moves from DNA to RNA to proteins. Proteins create the structures and functions of living cells.
Messenger RNA, or mRNA, converts the information into proteins in that final step, called translation. But mRNA is interesting. Only part of it holds the code for the protein. The rest is not translated but controls vital aspects of the translation process.
Governing the efficiency of protein production is a key mechanism by which mRNA vaccines work. The researchers focused their language model there, on the untranslated region, to see how they could optimize efficiency and improve vaccines.
After training the model on a small variety of species, the researchers generated hundreds of new optimized sequences and validated those results through lab experiments. The best sequences outperformed several leading benchmarks for vaccine development, including a 33% increase in the overall efficiency of protein production.
Increasing protein production efficiency by even a small amount provides a major boost for emerging therapeutics, according to the researchers. Beyond COVID-19, mRNA vaccines promise to protect against many infectious diseases and cancers.
Wang, a professor of electrical and computer engineering and the principal investigator in this study, said the model's success also pointed to a more fundamental possibility. Trained on mRNA from a handful of species, it was able to decode nucleotide sequences and reveal something new about gene regulation. Scientists believe gene regulation, one of life's most basic functions, holds the key to unlocking the origins of disease and disorder. Language models like this one could provide a new way to probe.
Wang's collaborators include researchers from the biotech firm RVAC Medicines as well as the Stanford University School of Medicine.
The new model differs in degree, not kind, from the large language models that power today's AI chat bots. Instead of being trained on billions of pages of text from the internet, their model was trained on a few hundred thousand sequences. The model also was trained to incorporate additional knowledge about the production of proteins, including structural and energy-related information.
The research team used the trained model to create a library of 211 new sequences. Each was optimized for a desired function, primarily an increase in the efficiency of translation. Those proteins, like the spike protein targeted by COVID-19 vaccines, drive the immune response to infectious disease.
Previous studies have created language models to decode various biological sequences, including proteins and DNA, but this was the first language model to focus on the untranslated region of mRNA. In addition to a boost in overall efficiency, it was also able to predict how well a sequence would perform at a variety of related tasks.
Wang said the real challenge in creating this language model was in understanding the full context of the available data. Training a model requires not only the raw data with all its features but also the downstream consequences of those features. If a program is designed to filter spam from email, each email it trains on would be labeled "spam" or "not spam." Along the way, the model develops semantic representations that allow it to determine what sequences of words indicate a "spam" label. Therein lies the meaning.
Wang said looking at one narrow dataset and developing a model around it was not enough to be useful for life scientists. She needed to do something new. Because this model was working at the leading edge of biological understanding, the data she found was all over the place.
"Part of my dataset comes from a study where there are measures for efficiency," Wang said. "Another part of my dataset comes from another study [that] measured expression levels. We also collected unannotated data from multiple resources." Organizing those parts into one coherent and robust wholea multifaceted dataset that she could use to train a sophisticated language modelwas a massive challenge.
"Training a model is not only about putting together all those sequences, but also putting together sequences with the labels that have been collected so far. This had never been done before."
The paper, "A 5' UTR Language Model for Decoding Untranslated Regions of mRNA and Function Predictions," was published in Nature Machine Intelligence. Additional authors include Dan Yu, Yupeng Li, Yue Shen and Jason Zhang, from RVAC Medicines; Le Cong from Stanford; and Yanyi Chu and Kaixuan Huang from Princeton.
More information: Yanyi Chu et al, A 5 UTR language model for decoding untranslated regions of mRNA and function predictions, Nature Machine Intelligence (2024). DOI: 10.1038/s42256-024-00823-9
Journal information: Nature Machine Intelligence
Patients suffering from Urinary Tract Infections (UTI) often struggle due to pain. However, a new oral spray vaccine can prevent recurring infections for up to years.
Known as MV140, the pineapple-flavoured oral spray can even be an alternative to antibiotics which are conventionally-used to treat the infection. According to the researchers, the antibiotics that often prescribed to treat UTIs have become less effective over time.
The study was conducted by the Royal Berkshire NHS Foundation Trust among 89 participants with recurrent UTIs and they were given MV140. The findings of the study were presented at the European Association of Urology Congress in Paris and it revealed that 54 percent of participants have not had a UTI since they took the vaccine.
The researchers also revealed that those volunteers who developed a UTI suffered from only minor symptoms.
According to report by Daily Mail, the vaccine contains four types of inactivated bacteria including E. Coli, the most common cause of a UTI.
Many of those who did get a UTI told us that simply drinking plenty of water was enough to treat it. [The vaccine] could be a game-changer for UTI prevention if it is offered widely, reducing the need for antibiotic treatments, Bob Yang, a consultant urologist at the Trust, said, as quoted by Daily Mail.
An infection in any part of the urinary system is called Urinary Tract Infection (UTI). According to Mayo Clinic, most infections involve the lower urinary tract the bladder and the urethra.
It is noteworthy that women are at more risk of developing a UTI than men. When a UTI occurs in the bladder, it leads to extreme pain and discomfort. However, if the infection spreads to the kidney, it can lead to serious health issues.
According to Mayo Clinic, UTIs dont always cause symptoms. When they do, they may include:
Usually, UTIs occur when bacteria enter the urinary tract through the urethra and begin to spread in the bladder. The most common UTIs occur mainly in women and affect the bladder and urethra.
These measures can help in lowering the risk of UTIs:
When youre pregnant, you know that youre in for a host of prenatal visits to make sure youre healthy and the fetus is developing appropriately.
And during those appointments, you can expect to have urine tests, blood tests, ultrasounds and other tests that will make sure your pregnancy is progressing healthily.
Your prenatal care may also include getting some vaccinations during your pregnancy.
Some vaccines are encouraged during pregnancy. Others should wait until after your baby is born.
"Most vaccines that contain live viruses shouldnt be administered during pregnancy because they might be harmful to the fetus. But others are very safe during pregnancy. Theyre important to your health and help to encourage healthy fetal development, says Ob/Gyn Oluwatosin Goje, MD.
Confused as to which vaccines you should get and which you should avoid during pregnancy? Dr. Goje walks us through it.
Vaccines strengthen your immune system so your body can fight off serious infectious diseases that can pose a risk to you and the fetus. They also benefit society by preventing the spread of communicable diseases.
If youre not up-to-date on certain vaccines, you may be more susceptible to diseases that can harm you or the developing fetus.
Not sure if youve had the proper vaccines? Youre not alone.
A lot of people dont have immediate access to their vaccination records, particularly from their childhood vaccinations, Dr. Goje states. If youve moved a lot or visited multiple healthcare systems throughout your life, piecing that information together can be tough.
Fortunately, your healthcare provider, such as a primary care physician, midwife or Ob/Gyn, can run a simple antibody test to check your blood for signs of immunity against diseases that can be harmful during pregnancy. From there, you and your provider can discuss what vaccines would be beneficial to you during pregnancy and which they would encourage you to wait to get after giving birth.
Some vaccines should be avoided during pregnancy because they can be harmful to the fetus. But others are safe during pregnancy and theyre important for keeping you both safe.
All vaccines are tested for safety under the supervision of the U.S. Food and Drug Administration (FDA). The vaccines are checked for purity, potency and safety. And the FDA and the U.S. Centers for Disease Control and Prevention (CDC) monitor the safety of each vaccine for as long as its in use.
The CDC also has guidelines regarding which vaccines should be given during pregnancy. Those are based on research studies about the potential benefits and risks of vaccines to both the pregnant person and the fetus.
If youre allergic to an ingredient in a vaccine, such as eggs in the influenza vaccine, talk with your healthcare provider before getting vaccinated.
Theres good reason your healthcare provider will recommend certain vaccines during your pregnancy: Theyre proven to be safe and to protect you and the fetus from serious complications.
Getting vaccines during pregnancy can protect you from certain illnesses, and that immunity can transfer to the fetus, Dr. Goje explains. That can help keep the baby protected during the first few months of their life until they can get vaccinated themselves.
But remember, even when you get vaccinated during your pregnancy, its important to keep up with babys own vaccination schedule, too. Thats because immunity from vaccines will decrease over time. So2, your baby will still need to be vaccinated on schedule to keep them safe from disease.
Heres a look at some common vaccines and whether they should be given during pregnancy:
The COVID-19 vaccine is recommended for everyone over the age of 6 months. The CDC says that during pregnancy, you may be at a higher risk for becoming severely ill if youre infected with COVID-19. That means a higher likelihood that if you catch COVID-19, you could need to be hospitalized and have complications that can severely affect fetal development.
The COVID-19 vaccine provides the best protection against developing severe cases of COVID-19 infection.
What weve found in a growing number of research studies is that the benefits of COVID-19 vaccination during pregnancy far outweigh any potential risks, Dr. Goje reassures.
Recommendations regarding how often you need a COVID-19 vaccine to be fully protected depend on several factors. Like when your last COVID-19 vaccine was given, which vaccine you got and if youre living with a condition that compromises your immune system. Talk with your pregnancy provider or a primary care provider about whether youre due for a COVID-19 vaccination.
The flu shot is safe and effective for every trimester of pregnancy. And an annual flu vaccine is the best way to protect yourself from the flu. Avoiding the flu is especially important when youre pregnant. Because research suggests that getting the flu during pregnancy can be associated with serious complications.
Pregnancy can make you more susceptible to becoming more seriously ill if you get the flu, Dr. Goje notes. And flu infection in a pregnant person is associated with increased risks, like preterm birth, low birth weight and even pregnancy loss.
The flu vaccine comes in a few different forms, including a live virus thats given as a nasal spray and an inactivated injection (flu shot). If youre pregnant during flu season, you should plan to get the inactive flu shot. The live vaccine should be avoided during pregnancy.
The RSV vaccine is a relative newcomer. And its a game-changer.
RSV (respiratory syncytial virus) is a respiratory illness that usually doesnt have severe effects on healthy adults. But it can be dangerous even life-threatening for older adults and babies under 6 months old.
Babies can be immunized for RSV as they enter their first respiratory illness season (typically, around September in the Northern Hemisphere).
But if you get the RSV vaccine during pregnancy, your baby will be protected from RSV from the get-go. And they wont need to get immunized later.
The RSV vaccine is administered during the third trimester (between 32 and 36 weeks of pregnancy) during the RSV season.
Pregnant people should plan to get the Tdap vaccine starting in the 27th week of pregnancy.
Tdap protects you and your baby from tetanus, diphtheria and pertussis (whooping cough).
The best advice is to get a Tdap vaccine during every pregnancy, regardless of whether youve had one in the past, Dr. Goje advises. Protection from these infections wanes over time. Getting the vaccine will make sure you pass along antibodies to help protect the baby from the day theyre born.
And early protection matters. Babies cant get their first dose of the Tdap vaccine until their two-month visit. That leaves a critical window of time where they can be infected with whooping cough during their first weeks of life. Whooping cough is highly contagious and can be life-threatening to infants.
For that reason, Tdap vaccines are recommended not just for pregnant people, but also for any adults wholl care for the baby. Talk with your provider if you have older children in the home who may also be candidates for Tdap boosters to help protect your new baby.
Vaccines typically are created in one of two ways.
Some use tiny amounts of live viruses that introduce germs to your immune system. Because theyre introduced at a very low dose, they typically wont make you sick. But they train your immune system to defend you against that virus. That means that the next time youre exposed to the virus, your body has the tools it needs to fight it off.
Other vaccines use deactivated viruses. Thats to say, viruses that arent alive and cant replicate in your body. But theyre still recognized by your immune system as invaders. Your body fights off deactivated viruses like theyre the real thing, so if youre infected later, your immune system is ready to mount a defense.
Deactivated vaccines like vaccines for COVID-19, RSV, whooping cough and flu shots have been proven to be safe and effective for pregnancy.
Live vaccines arent recommended for pregnancy. Thats because scientists believe theres a chance that live viruses in those vaccines could (at least in theory) cross the placenta and infect the fetus.
Live vaccines that arent recommended during pregnancy include MMR (which protects you from measles, mumps and rubella) and the varicella (chickenpox) vaccine. Babies typically get their first chickenpox and MMR vaccines around their first birthday.
The HPV vaccine is also not recommended during pregnancy. But unlike the MMR and chickenpox vaccines, HPV isnt a live vaccine. Its not given during pregnancy, though, because it hasnt yet been thoroughly tested to be proven safe during pregnancy.
If youre concerned about your vaccination status and its effect on fetal development, talk with your healthcare provider. They can help you understand the benefits of vaccines during pregnancy and advise you on which vaccines are best for you during pregnancy.
(Precision Vaccinations News)
As influenza vaccine producers prepare for the 2024 - 2025 flu season, innovative vaccine candidates are progressing in clinical research, focused on enhancing efficacy and safety.
CureVacN.V. today announced interim data from an ongoing Phase 2 study, which is part of the combined Phase 1/2 study of its seasonal influenza vaccine candidate.
The purpose of this clinical trial (NCT05823974)is to find and confirm the dose and asses the reactogenicity, safety, and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A) candidates administered in healthy younger and older adults.
Results from the planned interim analysis showed that the multivalent vaccine candidate using CureVac's proprietary second-generation mRNA backbone boosted antibody titers against all encoded flu strains and across all age groups and tested dose levels, including the lowest tested dose.
"The Phase 2 interim data show that CureVac's highly effective and flexible mRNA technology platform puts us on the right track to advance our joint seasonal influenza vaccine program," said Dr. Myriam Mendila, Chief Development Officer of CureVac, in a press release on April 4, 2024.
"Results regarding influenza A strains were strong. Immunogenicity for B strains was also in line with our expectations in view of other initial mRNA-based clinical flu development programs."
"We are confident that planned optimizations will improve performance against these historically challenging influenza strains."
The multivalent candidate was selected from a comprehensive Phase 1 part, which tested vaccine candidates with up to eight separate mRNA constructs per candidate.
It was designed for broad antigen coverage, encoding antigens that matched all World Health Organization (WHO) recommended flu strains.
The WHO says flu shot campaigns should be timed according to local conditions.
Countries are encouraged to analyze local surveillance information to assess their seasonality pattern at both national and subnational levels, as appropriate, to make evidence-based decisions on the timing of vaccination campaigns.
