One of GlaxoSmithKline’s big projects at its global vaccine R&D center in Rockville, MD is set to enter Phase III after passing early-stage tests with flying colors.
Eyeing the wide-open respiratory syncytial virus (RSV) space, GSK is pushing two different vaccine candidates: GSK3888550A is designed to confer protection to infants via maternal immunization, while GSK3844766A is meant for the elderly.
The pharma giant presented Phase I/II data for both at ID Week. Three different doses of the maternal candidate were tested among 502 healthy non-pregnant women and investigators reported “high levels” of protective neutralizing antibodies. For the older adults candidate, the 60-to-80-year-old vaccinated group had “a close to 10 times increase of protective antibodies” compared to placebo, coupled with CD4+ T cells boosted to similar levels observed in younger adults who were given the vaccine in the lead-in phase.
“We are delighted to see these positive results confirming our approach to develop dedicated vaccines building on the strategic use of our platform technologies for the populations most at risk from RSV infections – young infants and older adults,” Emmanuel Hanon, SVP and head of vaccines R&D, said in a statement.
A leading cause of respiratory infections and pneumonia for children and the elderly, RSV has been an elusive target for vaccine developers.
Before Novavax became a favorite to deliver a shot for Covid-19, RSV was a key focus in the pipeline. Despite multiple Phase III flops, the biotech insisted that they had a comeback plan for the Gates Foundation-backed program by highlighting prevention of serious consequences. And a host of biotechs, including Meissa and Codagenix, have bagged considerable venture cash to explore new ways of assembling a vaccine.
GSK’s approach involves administering a recombinant subunit pre-fusion RSV antigen to pregnant women and combining it with its adjuvant system, AS01, to boost the immune response among older adults. AS01 is also used in GSK’s new shingles vaccine, Shingrix.
Phase III studies for both candidates are on track to start in the coming months, according to the company. A third pediatric program, which targets both infants, is in Phase I/II for RSV-seronegative populations and Phase II for a RSV-seropositive group.
Joined up thinking needed for joined up data plans
Joined up data could transform the pharmaceutical industry and help create a healthier Europe for decades to come
The post Joined up thinking needed for…
Joined up data could transform the pharmaceutical industry and help create a healthier Europe for decades to come – but the route to change is far from smooth sailing.
Without careful consideration and full stakeholder input, the EU’s plans for a connected data system could end up being counterproductive.
That’s the view of the European Federation of Pharmaceutical Industries and Associations (EFPIA), which has published a list of recommendations aimed at helping the sector get the most of out of the data it holds.
“If the European Health Data Space (EHDS) and the rules surrounding access to the data are not carefully thought through, with the involvement of all stakeholders, there could be unintended consequences that limit the utility of the data for developing innovative medicines,” said the organisation.
The EFPIA Recommendations on a Connected Data System in Europe, published at the end of April, welcomes the proposals, which are part of the European Strategy for Data, to create common data spaces.
Said the authors: “A connected health data ecosystem has the potential to empower more effective and efficient research and development of new treatments and diagnostics. It would also ensure better planning and delivery of patient-centred care through personalised medicine.
“This, combined with value-based healthcare, can result in better allocation of resources and more sustainable healthcare systems.”
The value of this approach, which places real-world data in the hands of the right people at the right time, was demonstrated in abundance over the last few years, they went on.
It was, they explained, stakeholders from across the healthcare ecosystem coming together to share insights, whether from clinic, research, or genomics, that changed the course of the COVID-19 pandemic.
Applying the same ethos to healthcare in general, then, could give the drug development sector all the information it needs to contribute to a fitter, healthier Europe.
“For the research-based industry, access to data is critical at every step. From accelerating drug discovery to understanding patients’ behaviours and the outcome of treatment, the availability of data is essential to testing hypotheses, identifying trends and assessing proposed treatments,” they said, adding that improved access to, and transmission of, health data could “transform the pharmaceutical industry”.
While EHDS is a lofty ambition, bringing it to fruition will not be without its challenges, both practical and regulatory.
As the EFPIA paper points out, health data is currently held in a wide range of repositories, from clinical notes and electronic health records to insurance claims, patient registries, patient-reported outcomes records, and continuous patient monitoring data from apps and wearables.
Unlocking their value, then, requires a high level of interoperability between different IT systems, providers, data sources, and software, all based in different countries with different levels of infrastructure maturity.
“Healthcare system information must be better connected. This will allow stakeholders to use this data for optimising and improving health outcomes,” said the paper, adding that interoperability was a “critical enabler of the digital transformation of healthcare in Europe”.
Conflicting national laws could be another important barrier to data access and use. Varying interpretations of the General Data Protection Regulation (GDPR), for example, present challenges for clinical development of innovative medicines, said the authors.
“Conflicting interpretations of Article 9 of the GDPR, and the additional limitations on processing of health and genomic data that member states have enacted under this article, cause significant delays in study start-up and patient enrolment.
“Some member states take the position that the only lawful basis for processing health data is when individuals have given their consent for its collection and use. Others… take the position that processing this health data, when necessary for scientific research, is lawful.”
EU Data Protection Supervisors, the paper recommends, must reach a common understanding of key GDPR terms if citizens are to enjoy the same rights across the EU.
The EFPIA paper makes a number of recommendations on how the EU could embrace the full potential of the proposed EHDS.
First, it says that developing a shared understanding of the relevant requirements in digital health is essential, and calls for an EU-wide approach to how data is accessed, pooled, compared and used, while also protecting privacy.
In terms of possible solutions, it points to the use of Federated Data Networks (FDN), in which separate networks share mutual RWD resources.
“In an FDN, data is not moved from its host source, though hybrid models can exist with local and central data hosting. The research question or query moves to where the data is originally hosted, with results aggregated centrally or delivered to the researcher,” said the authors.
This, they went on, could unlock the power of data in primary or secondary care settings, in clinical care decision-making, and in research, whilst preserving the privacy of the RWD at a local level.
Common data models (CDM), which standardise the logical infrastructure of software systems to enable interoperability, are also required.
“CDM is essentially a construct, a means to an end to help organise RWD into a common structure, formats, and terminologies across diverse, heterogeneous, and multiple source datasets,” said the paper.
“It addresses a central need to be able to curate data for analysis on a contemporaneous and continuous basis (not on a per study basis) or for largescale, geographically diverse, network studies of multiple data sources.”
Joined up approach to joined up data
Ultimately, building a usable EU-wide health data system requires input from all stakeholders, and decisions on FDNs and CDMs should be taken internationally, as a sector.
Because, as the EFPIA says, we all have one goal: using the power of data to improve the health of the citizens of Europe.
- Read the full recommendations paper here
About the author
Amanda Barrell is a freelance health and medical education journalist, editor, and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, HCPs and the public.
The post Joined up thinking needed for joined up data plans appeared first on .treatment testing pandemic covid-19 transmission european europe eu
Large UK study suggests vaccination helps treat long COVID
An observational study in the UK has found evidence that COVID-19 vaccination can help alleviate the lingering symptoms
The post Large UK study suggests…
An observational study in the UK has found evidence that COVID-19 vaccination can help alleviate the lingering symptoms that afflict some people who contract the virus, often referred to as ‘long COVID’.
There have been persistent anecdotal reports that vaccines can help people with persistent symptoms get better, but the study published in the British Medical Journal is the first to explore the connection in large numbers of patients.
It is based on responses from more than 28,300 adults who are taking part in the UK’s COVID-19 Infection Survey, carried out by the Office for National Statistics, and focused on individuals who reported symptoms that lasted for 12 or more weeks after infection.
The likelihood of long COVID symptoms was found to decrease after COVID-19 vaccination, and evidence pointed to an even greater improvement after a second dose. However, the authors say more data is needed before vaccination can be considered a treatment for the condition.
The team, led by ONS’ Daniel Ayoubkhani, found that before vaccines were available, the chances of experiencing long COVID were fairly constant after infection, but fell around 13% after a first dose, and a further 9% after a second.
The trial completed before the third booster doses were rolled out, and researchers say there is no data yet on whether the improvements reported after vaccines will be sustained with further follow-up.
They speculate that vaccination may “reset” immunity in people with long COVID who are thought to develop dysregulation of the immune system, similar to an autoimmune condition.
“Although causality cannot be inferred from this observational evidence, vaccination may contribute to a reduction in the population health burden of long COVID,” says the paper.
Further research is needed to look at the long-term relationship between vaccines and long COVID, and to gauge the effect of boosters and reinfection with SAS-CoV-2, particularly with the now-dominant Omicron variant, which had not emerged when the data was collected, according to the researchers.
Commenting on the results, Prof Penny Ward, visiting professor in pharmaceutical medicine at King’s College London, said: “These data broadly support prescribers encouraging patients with ‘long COVID’ to be vaccinated, or to complete the course of vaccination if they have not already done so.”
Meanwhile, Dr Peter English, a retired consultant in communicable disease control, said it is likely that long COVID is, in fact, a collection of different conditions, only some of which may respond to vaccination.
“The large scale of this study means that we can be fairly confident about what has been observed; but it does not mean we can be sure what it means,” he cautioned.
Nevertheless, faced with the potentially very significant consequences the condition could have on the health of the population, “anything that can reduce the burden of disease from Long COVID at reasonable cost is…important and valuable”.
The post Large UK study suggests vaccination helps treat long COVID appeared first on .disease control covid-19 treatment uk
Moderna’s HIV vaccine prepped for trials in Africa
Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV
The post Moderna’s HIV vaccine prepped for…
Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt.
IAVI (the International AIDS Vaccine Initiative) has started screening subjects to be included in the study, called IAVI G003, at centres in Rwanda and South Africa, said the biotech.
Moderna’s vaccines deliver HIV-specific antigens discovered by researchers at IAVI and Scripps Research that have already been tested in a proof-of-concept study carried out last year using an adjuvant protein vaccine approach.
There are hopes that its mRNA approach, which proved so effective against COVID-19, could succeed where traditional vaccine technologies have failed in HIV.
One candidate – mRNA-1644 – has already shown its potential in an earlier phase 1 trial (IAVI G001) run in the US. It codes for an antigen called eOD-GT8 60mer and, in the study, stimulated a targeted B-cell immune response in 97% of vaccine recipients.
Moderna says that B-cell activation should lead to the induction of broadly neutralising antibodies (bnAbs), widely considered to be a goal of an efficacious HIV vaccine, but that immunising with eOD-GT8 60mer alone will almost certainly not be sufficient.
The biotech is looking at a combination regimen of vaccines targeting different HIV immunogens such as Core-g28v2 60mer to try to boost the immune response further against HIV and improve the protective efficacy.
Earlier this year, the first healthy volunteers were dosed with mRNA-1644 in a second phase 1 trial (IAVI G002), which is being funded in part by the Bill & Melinda Gates Foundation and is being carried out in US populations.
On HIV Vaccine Awareness Day, we want to acknowledge and thank the scientists, clinical trial participants, volunteers and so many others around the globe working together to advance the hope of a preventive #HIV #vaccine. #HVAD #HVAD2022 pic.twitter.com/KLrVRXtEAv
— Moderna (@moderna_tx) May 18, 2022
IAVI G003 will enrol 18 healthy HIV-negative adult volunteers who will receive two doses of the eOD-GT8 60mer mRNA shot. They will be followed for six months to gauge the safety and immunogenicity of the vaccine.
Moderna said the trial is a “first-in-Africa” study, evaluating an mRNA-delivered HIV immunogen in Africa with African researchers leading the project.
Despite more than 30 years of research, the tendency of the virus to mutate means that classical approaches to vaccine design have been ineffective, and at least four prior vaccine candidates have failed in clinical trials.
In February, one of the front-runner candidates in the decades-long quest to find an HIV vaccine – Johnson & Johnson – reported that its candidate failed a phase 2b trial.
The Ad26.Mos4.HIV vaccine – which uses the same adenoviral technology as J&J’s COVID-19 vaccine and targets four HIV antigens – showed that the shot was safe but unable to meet its target of reducing transmission of HIV by 50%.
And last year, the HVTN 702 study of two co-administered HIV candidate vaccines from Sanofi Pasteur and GlaxoSmithKline, combined with GSK’s adjuvant MF59, was also discontinued due to a lack of efficacy.
The post Moderna’s HIV vaccine prepped for trials in Africa appeared first on .vaccine clinical trials antibodies covid-19 transmission africa
Six Natural Gas Investments to Buy as Energy Prices Soar Amid War
“They Shut Us Down”: Michigan Businesses Sue Whitmer For Losses Due To COVID Lockdowns
VIRI: Enrollment Complete in FORTRESS Trial; Results Expected in September 2022…
FDA authorizes COVID-19 boosters for kids 5-11 as cases creep up
Strategies to Increase Diversity in Rare Genetic Disease Trials
Pfizer study: 110K more lives could have been lost if not for vaccine
Pfizer Jab In Young People Only 20% Effective After 60 Days, 0% After 5 Months
European outbreak of monkeypox: what you need to know
Type-I interferon stops immune system ‘going rogue’ during viral infections
Aging-US: Hallmarks of cancer and hallmarks of aging reviewed
Government11 hours ago
“They Shut Us Down”: Michigan Businesses Sue Whitmer For Losses Due To COVID Lockdowns
Economics15 hours ago
Utah’s Breaks Financial Transaction Value Record for Second Year in a Row, According to MountainWest Capital Network Report
Economics19 hours ago
“Natural Immunity” from Omicron is Weak and Limited, Study Finds
Spread & Containment13 hours ago
Diesel Costs Deliver Body Blow To Trucking Industry, Impacting Broader Economy
Government15 hours ago
Weaponizing The Pursuit Of Profit: Rubio Warns Of ‘Extraordinary’ Leverage Held By China Over American Companies
Spread & Containment22 hours ago
Global Supply Chain Pressure Index: May 2022 Update
Government20 hours ago
European outbreak of monkeypox: what you need to know
Economics14 hours ago
What Is the VIX Volatility Index? Why Is It Important?