A Randomised Controlled Trial to Assess the Immunogenicity, Safety & Reactogenicity of Standard Dose Versus Fractional Doses of COVID-19 Vaccines (Pfizer-BioNTech, AstraZeneca or Moderna) Given as a Booster Dose After Priming With Coronavac or AstraZeneca in Healthy Adults in Indonesia

This is a randomised controlled clinical trial to determine the reactogenicity and immunogenicity of booster doses of SARS-CoV-2 vaccines (Pfizer-BioNTech, AstraZeneca or Moderna) in adults who have previously received either AstraZeneca or Coronavac as their primary doses.
Both fractional and standard doses of Pfizer-BioNTech, AstraZeneca and Moderna will be tested.

Start Date01 Apr 2024

Sponsor / Collaborator

Murdoch Childrens Research Institute

[+4]

NCT06441955 / Active, not recruitingPhase 4IIT

Covid-19 Long Haul Syndrome: Undiagnosed Disorder Post Covid-19 Alternative Treatment Study.

We are conducting a study on alternative treatments for patients who have received an current or previous positive COVID-19 diagnosis with mild-serve symptoms or undiagnosable condition after testing positive for severe acute COVID-19 infection and are experiencing long-haul symptoms. The symptoms of long COVID can include extreme tiredness (fatigue), shortness of breath, memory and concentration issues (brain fog), heart palpitations, dizziness, joint pain, muscle aches, cough, headaches, anxiety, and depression.
It's important to note that there are various other symptoms that individuals can experience after a COVID-19 infection, such as loss of smell, chest pain or tightness, difficulty sleeping (insomnia), pins and needles, depression, anxiety, tinnitus, earaches, nausea, diarrhea, stomach aches, loss of appetite, cough, headaches, sore throat, and changes to the sense of smell or taste.
To be included in the study, participants must have had symptoms for more than 4 weeks. The goal of the study is to measure biomarkers, identify new ones through clinical trials, and individualize and optimize treatment plans, which may or may not include COVID-19 post-market antivirals, vaccines, and medical care.
It's essential to conduct thorough clinical trials to understand the long-term effects of COVID-19 and to develop personalized treatment plans for individuals experiencing long-haul symptoms.

Start Date01 Mar 2024

Sponsor / Collaborator-

PACTR202212801139469 / SuspendedPhase 2

A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled, Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Adolescents 12 to < 18 years of age

Start Date01 Aug 2023

Sponsor / Collaborator-

100 Clinical Results associated with Elasomeran

100 Translational Medicine associated with Elasomeran

100 Patents (Medical) associated with Elasomeran

4,721

Literatures (Medical) associated with Elasomeran

31 Dec 2024·Annals of medicine

SARS-CoV-2 vaccination in inflammatory bowel disease patients is not associated with flares: a retrospective single-centre Swiss study

Article

Author: Rossier, Laura N ; Staudenmann, Dominic A ; Décosterd, Natalie P ; Matter, Christoph B ; Seibold, Frank W ; Egger, Bernhard ; Moser, André

INTRODUCTION:

Vaccination hesitancy is an important barrier to vaccination among IBD patients. The development of adverse events is the main concern reported. The purpose of this monocentric study was to assess SARS-CoV-2 vaccination safety in IBD patients by evaluating the postvaccination flare risk and incidence of overall adverse events.

METHODS:

Surveys were handed out on three consecutive months to each patient presenting at the Crohn-Colitis Centre, where they documented their vaccination status and any side effects experienced after vaccination.Dates of flares occurring in 2021 were recorded from their electronic medical records. Baseline and IBD characteristics and flare incidence were compared between the vaccinated and unvaccinated patients, and among the vaccinated population before and after their vaccination doses. The characteristics of patients who developed side effects and of those who did not were compared.

RESULTS:

We enrolled 396 IBD patients, of whom 91% were vaccinated. The proportion of patients who experienced flares was statistically not different between the vaccinated and the unvaccinated population (1.8 vs 2.6 flares per 100 person-months (p = 0.28)). Among vaccinated patients, there was no difference across the prevaccination, 1 month post any vaccination, and more than 1 month after any vaccination periods, and between the Spikevax and Cominarty subgroups. Overall, 46% of patients reported vaccination side effects, mostly mild flu-like symptoms.

CONCLUSION:

SARS-CoV-2 vaccination with mRNA vaccines seems safe, with mostly mild side effects. The IBD flare risk is not increased in the month following any vaccination.

01 Mar 2024·Autoimmunity reviews

Autoimmune response after SARS-CoV-2 infection and SARS-CoV-2 vaccines

Review

Author: Tambuwala, Murtaza M ; Lundstrom, Kenneth ; Aljabali, Alaa A A ; Serrano-Aroca, Ángel ; Adilović, Muhamed ; Hromić-Jahjefendić, Altijana ; Uversky, Vladimir N

The complicated relationships between autoimmunity, COVID-19, and COVID-19 vaccinations are described, giving insight into their intricacies. Antinuclear antibodies (ANA), anti-Ro/SSA, rheumatoid factor, lupus anticoagulant, and antibodies against interferon (IFN)-I have all been consistently found in COVID-19 patients, indicating a high prevalence of autoimmune reactions following viral exposure. Furthermore, the discovery of human proteins with structural similarities to SARS-CoV-2 peptides as possible autoantigens highlights the complex interplay between the virus and the immune system in initiating autoimmunity. An updated summary of the current status of COVID-19 vaccines is presented. We present probable pathways underpinning the genesis of COVID-19 autoimmunity, such as bystander activation caused by hyperinflammatory conditions, viral persistence, and the creation of neutrophil extracellular traps. These pathways provide important insights into the development of autoimmune-related symptoms ranging from organ-specific to systemic autoimmune and inflammatory illnesses, demonstrating the wide influence of COVID-19 on the immune system.

01 Mar 2024·Advanced drug delivery reviews

mRNA delivery systems for cancer immunotherapy: Lipid nanoparticles and beyond

Review

Author: García Del Valle, Lucía ; Estapé Senti, Mariona ; Schiffelers, Raymond M

mRNA-based vaccines are emerging as a promising alternative to standard cancer treatments and the conventional vaccines. Moreover, the FDA-approval of three nucleic acid based therapeutics (Onpattro, BNT162b2 and mRNA-1273) has further increased the interest and trust on this type of therapeutics. In order to achieve a significant therapeutic efficacy, the mRNA needs from a drug delivery system. In the last years, several delivery platforms have been explored, being the lipid nanoparticles (LNPs) the most well characterized and studied. A better understanding on how mRNA-based therapeutics operate (both the mRNA itself and the drug delivery system) will help to further improve their efficacy and safety. In this review, we will provide an overview of what mRNA cancer vaccines are and their mode of action and we will highlight the advantages and challenges of the different delivery platforms that are under investigation.

214

News (Medical) associated with Elasomeran

26 Jun 2024

·firstwordpharma.com

Moderna reports waning efficacy for RSV jab as CDC committee backs shots for 75-and-up group

Moderna shares sank 11% on Wednesday after the biotech revealed 18-month efficacy data for its newly approved respiratory syncytial virus (RSV) vaccine mRESVIA (mRNA-1345). The results, presented before a panel of advisors to the US Centers for Disease Control and Prevention (CDC), showed that mRESVIA's effectiveness waned substantially compared to rival RSV vaccines from GSK and Pfizer.The CDC's Advisory Committee on Immunization Practices (ACIP) convened this week to vote on which patient groups should receive RSV, influenza, COVID-19 and other vaccines this fall.US regulators late last month approved mRESVIA – based on the same mRNA technology Moderna uses for its COVID-19 vaccine Spikevax – to protect adults 60 and older from lower respiratory tract disease (LRTD) caused by RSV infection. The shot is expected to be available in time for the start of this fall's RSV season.Efficacy dwindles to about 50%According to Moderna's ACIP presentation, mRESVIA demonstrated 50.3% efficacy at preventing RSV-related LRTD with two or more symptoms after 18 months, and 49.9% efficacy at preventing more serious infection involving at least three symptoms over the same time period. That stands in stark contrast to the vaccine's initial potency of 83.7% reported at 3.7 months in an earlier analysis.A spokesperson for Moderna offered some context, saying that "immunity from RSV is not lifelong, and as with all currently licensed RSV vaccines, mRESVIA demonstrates waning (effectiveness) over time." The biotech is banking on mRESVIA's convenience factor to differentiate it in the market, highlighting its availability in pre-filled syringes to make it easier to administer.Lagging behind rivalsStill, the longer-term data raise concerns about mRESVIA's ability to carve out its own niche in RSV while facing two competitors, both of which were approved by the FDA last year for people aged 60-plus.A single dose of GSK's Arexvy reduced symptomatic RSV LRTD by 82.6% during the first RSV season compared to placebo, and by 56.1% during the second RSV season. Meanwhile, Pfizer's Abrysvo was found to be 77.8% effective against RSV-associated LRTD with three or more symptoms through two seasons.Evercore ISI analysts suggested that "GSK's Arexvy still appears to have the most impressive VE (vaccine efficacy) of the group, which we believe will help it to maintain majority market share." Arexvy generated about $1.5 billion in sales last year, followed by Pfizer's Abrysvo at $890 million, although a recent tender win in the UK could see Pfizer's shot turn up the heat. For more, see – Spotlight On: Domestic setback for GSK's RSV vaccine could show Pfizer means business.Analysts have projected mRESVIA sales of $397 million this year, potentially reaching blockbuster status with $1.5 billion in sales by 2026.Pfizer's vaccine is also approved for maternal use to protect infants and the company is hoping to grow that to all at-risk adults aged 18 and older, while GSK's shot was recently greenlit for people ages 50 to 59 who are at high risk of severe RSV.ACIP votes to broaden RSV useMeanwhile, the CDC's ACIP panel unanimously recommended late Wednesday that RSV vaccines be given to all people ages 75 and older if they have not yet had one, as well as to those aged 60 to 74 at risk of severe disease because they have other health conditions. If the CDC director ultimately waves through the policy recommendation, that would be a step-up from previous guidance, which said that older adults may be offered a vaccine, but stopped short of saying they should be given a shot.

VaccineDrug ApprovalmRNAClinical ResultClinical Study

13 Jun 2024

·firstwordpharma.com

Moderna’s next-gen COVID-19 vaccine more effective than Spikevax in adults

Moderna’s next-generation COVID-19 vaccine mRNA-1283 was more effective in adults than its current jab Spikevax, building on positive immunogenicity data released in March. CEO Stéphane Bancel said the latest Phase III results show that the company’s “platform is consistently demonstrating its ability to address significant unmet needs."Earlier this week, Moderna announced that its combination vaccine against influenza and COVID-19 had met the primary endpoints of a late-stage study as well. The shot, dubbed mRNA-1083, combines mRNA-1283 with the company’s vaccine candidate for seasonal flu mRNA-1010.The study reported Thursday, called NextCOVE, enrolled approximately 11,400 participants aged 12 and older, with half administered a single dose of mRNA-1283 and the other half immunised with Spikevax. Earlier data showed that mRNA-1283 induced a stronger immune response against the Omicron BA.4/BA.5 subvariants and the original SARS-CoV-2 strain, particularly in adults over 65, compared to Spikevax.Moderna now says the trial met its primary efficacy endpoint, demonstrating non-inferior vaccine efficacy against COVID-19 compared to Spikevax. Meanwhile, it noted that higher efficacy versus Spikevax was observed in adults 18 years of age and older, with a "consistent trend" seen in the subset of people aged 65 and older. The company added that in the trial, mRNA-1283 was found to have a similar safety profile to Spikevax, with the most commonly solicited side effects being injection site pain, fatigue, headache and myalgia. Results will be presented at an upcoming medical meeting, while Moderna will also discuss next steps for the programme with regulatory agencies.

Clinical ResultPhase 3VaccinemRNA

13 Jun 2024

·www.biospace.com

Moderna Announces Positive Phase 3 Efficacy Data for mRNA-1283, the Company’s Next Generation COVID-19 Vaccine

mRNA-1283 met its primary vaccine efficacy endpoint in a Phase 3 trial, demonstrating non-inferior vaccine efficacy against COVID-19 compared to Spikevax® in participants 12 years of age and older Higher efficacy was observed in mRNA-1283 compared to Spikevax in adults 18 years of age and older CAMBRIDGE, MA / ACCESSWIRE / June 13, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that its Phase 3 trial of mRNA-1283, an investigational next-generation COVID-19 vaccine, has met its primary efficacy endpoint, demonstrating non-inferior vaccine efficacy against COVID-19 compared to Spikevax. The Company also announced that higher efficacy was observed in adults 18 years of age and older compared to Spikevax (mRNA-1273), with a consistent trend observed in the subset of adults age 65 and older. Positive interim immunogenicity results for mRNA-1283 in this study were previously reported in March 2024. "We are very pleased that mRNA-1283 has now met its primary vaccine efficacy endpoint in Phase 3, and showed higher efficacy in adults compared to Spikevax," said Stéphane Bancel, Chief Executive Officer of Moderna. "With five vaccine programs that have achieved positive Phase 3 results, Moderna's platform is consistently demonstrating its ability to address significant unmet needs in public health." The ongoing Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498) is a randomized, observer-blind, active-controlled study of approximately 11,400 individuals aged 12 years and older. Half of the participants received a 10 μg dose of mRNA-1283, while the other half received a 50 μg dose of mRNA-1273 (Spikevax). Today's vaccine efficacy data are consistent with the previously announced immunogenicity results from the study, which showed that mRNA-1283 had higher neutralizing antibody responses against both Omicron BA.4/5 and ancestral SARS-CoV-2 than mRNA-1273, with the highest geometric mean titer ratios observed in adults and in the subset of participants aged 65 years and older. In the trial, mRNA-1283 was found to have a similar safety pro Spikevax. The most commonly solicited side effects were injection site pain, fatigue, headache and myalgia. Moderna's combination vaccine candidate against influenza and COVID-19, mRNA-1083, includes mRNA-1283. That vaccine candidate recently announced positive results in its separate Phase 3 trial. Moderna plans to present the Phase 3 clinical data for mRNA-1283 at an upcoming conference as well as submit it for publication. The Company will also engage with regulators on the next steps for the program. About Moderna Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Spikevax® is a registered trademark of Moderna. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the safety and efficacy of mRNA-1283; and the relative effectiveness of mRNA-1283 compared to Spikevax. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at . Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. Moderna Contacts Media: Elise Meyer Sr. Director, Corporate Communications +1 617-852-7041 Elise.Meyer@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 Lavina.Talukdar@modernatx.com SOURCE: Moderna, Inc. View the original press release on accesswire.com

Clinical ResultPhase 3VaccinemRNA

100 Deals associated with Elasomeran

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07	DB15654

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
COVID-19 omicron variant infection	GB	Moderna, Inc.	15 Aug 2022
COVID-19	CA	Moderna, Inc.	23 Dec 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 2	US	ModernaTX, Inc.	13 May 2022
Respiratory Syncytial Virus Infections	Phase 1	US	ModernaTX, Inc.	14 Oct 2022
Respiratory Syncytial Virus Infections	Phase 1	AU	ModernaTX, Inc.	14 Oct 2022
Respiratory Syncytial Virus Infections	Phase 1	GB	ModernaTX, Inc.	14 Oct 2022
Severe Acute Respiratory Syndrome	Phase 1	US	ModernaTX, Inc.	14 Oct 2022
Severe Acute Respiratory Syndrome	Phase 1	AU	ModernaTX, Inc.	14 Oct 2022
Severe Acute Respiratory Syndrome	Phase 1	GB	ModernaTX, Inc.	14 Oct 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05047770 (Pubmed)	Phase 3	COVID-19 \| Influenza, Human	-	Seasonal quadrivalent influenza vaccine (QIV)	srwxvvarwe(kxpattsgst) = The most frequently reported adverse events in both groups were myalgia hzoeokpxdb (lyplmhwejh ) View more	Positive	31 Dec 2024
NCT04792567 (AMA-VACC, CTgov)	Phase 4	Multiple Sclerosis, Secondary Progressive	41	BAF312+BNT162+mRNA-1273 (Siponimod - Continuous)	qmvgqyzmbq(mqvwzaoqex) = vyndoteoeh uzqimxlmec (orxrqnoktr, qdxnuzzxzq - cqcuaorrys) View more	-	17 May 2024
				BAF312+BNT162+mRNA-1273 (Siponimod- Interrupted)	qmvgqyzmbq(mqvwzaoqex) = irdefrhsje uzqimxlmec (orxrqnoktr, rcqaztxmax - qoddofdsvc) View more
NCT05375838 (CTgov)	Phase 1/2	COVID-19 \| Influenza, Human	550	placebo+mRNA-1273 (mRNA-1273 + Placebo)	evhfuelael(ymnqcgbncv) = sqzrdnxlea dniuwewdsx (slltjckxeg, ginjynydpi - iqmquevyzb) View more	-	28 Feb 2024
				placebo+mRNA-1010 (mRNA-1010 + Placebo)	evhfuelael(ymnqcgbncv) = oepbntmwcc dniuwewdsx (slltjckxeg, azkkipcrpz - frgnzvgvva) View more
NCT05047770 (CTgov)	Phase 3	COVID-19 \| Herpes Zoster \| Influenza, Human	2,013	mRNA-1273+HZ/su (HZ/suSeq Group)	vodjxfitve(zwddielfqu) = wvuaayyykz lmalxjhmeb (dwuhhgdekh, eocqlqlfmz - ievrejpngk) View more	-	13 Nov 2023
				mRNA-1273+HZ/su (HZ/suCoAd Group)	vodjxfitve(zwddielfqu) = jbdrychofw lmalxjhmeb (dwuhhgdekh, cfogcfwgfe - atbqknnfkg) View more
EHA2023	Not Applicable	-	49	MRNA-1273 SARS-COV-2 VACCINE (Recently transplanted patients (RTP))	pqacicvolm(hxskbawxmb) = lkxpmxfvwd rsjzahfkpo (pfsdgogknx ) View more	-	08 Jun 2023
				MRNA-1273 SARS-COV-2 VACCINE (Long-term transplanted patients (LTTP))	pqacicvolm(hxskbawxmb) = vfatdiwgri rsjzahfkpo (pfsdgogknx ) View more
ARVO2023	Not Applicable	Retinal Vascular Occlusion	1,250	BNT162b2(Pfizer-BioNTech)	wfkdsmhuaz(olaadhmljy) = tcxlizwlxk wpbyicvhfy (ipkltcigeu )	Positive	01 Jun 2023
				SARS-CoV-2 vaccine	wfkdsmhuaz(olaadhmljy) = nybjkunkqs wpbyicvhfy (ipkltcigeu )
EULAR2023	Not Applicable	Inflammation specific IgG antibodies against the trimeric spike protein of SARS-Cov2	114	Patients treated with Rituximab	rxevsokwjn(ojfnmvonsh) = jztwpusnbv lumcagvsev (dpvwojnwwr )	Positive	31 May 2023
NCT04677660 (CTgov)	Phase 1/2	COVID-19	200	Placebo	jubnsxeotv(jolqjuwlrb) = ypxjsetibl lsuvlreoyr (ipgzekmrqq, huhdrnveth - iyxxzphpcc) View more	-	03 May 2023
P367 (EBMT2023)	Not Applicable	Hematopoietic stem cell transplantation	49	MRNA-1273 SARS-COV-2 VACCINE	axejyhibly(fwtgiytuxx) = rmvdanyndw ktyftvpeme (hxyehnnmzj ) View more	Negative	23 Apr 2023
				MRNA-1273 SARS-COV-2 VACCINE	axejyhibly(fwtgiytuxx) = etybjobnda ktyftvpeme (hxyehnnmzj ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis