Randomized, Observer-Blind, Active-Controlled, Clinical Trial to Assess the Immunogenicity of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults

To evaluate immune responses of an Investigational mRNA-1273.815 vaccine against the Omicron subvariant strain (XBB.1.5) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Start Date08 Apr 2024

Sponsor / Collaborator

ModernaTX, Inc.

NCT05387317 / WithdrawnPhase 3IIT

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

National Institute of Health

100 Clinical Results associated with Elasomeran

100 Translational Medicine associated with Elasomeran

100 Patents (Medical) associated with Elasomeran

4,725

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: Staudenmann, Dominic A ; Rossier, Laura N ; 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 ; Aljabali, Alaa A A ; Lundstrom, Kenneth ; 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.

213

News (Medical) associated with Elasomeran

22 Aug 2024

·www.prnewswire.com

FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants

SILVER SPRING, Md., Aug. 22, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. Today's actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc. In early June, the FDA advised manufacturers of licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 formula) should be monovalent JN.1 vaccines. Based on the further evolution of SARS-CoV-2 and a rise in cases of COVID-19, the agency subsequently determined and advised manufacturers that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 formula) is the KP.2 strain, if feasible. "Vaccination continues to be the cornerstone of COVID-19 prevention," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "These updated vaccines meet the agency's rigorous, scientific standards for safety, effectiveness, and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants." The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals 12 years of age and older, and the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, both of which are authorized for emergency use for individuals 6 months through 11 years of age. What You Need to Know Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated, authorized Moderna COVID-19 Vaccine. Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines (timing and number of doses to administer depends on the previous COVID-19 vaccine received). Individuals 5 years through 11 years of age regardless of previous vaccination are eligible to receive a single dose of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines; if previously vaccinated, the dose is administered at least 2 months after the last dose of any COVID-19 vaccine. Individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty or the updated, approved Spikevax; if previously vaccinated, the dose is administered at least 2 months since the last dose of any COVID-19 vaccine. Additional doses are authorized for certain immunocompromised individuals ages 6 months through 11 years of age as described in the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine fact sheets. Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines and as described in the respective prescribing information or fact sheets. The updated vaccines are expected to provide protection against COVID-19 caused by the currently circulating variants. Barring the emergence of a markedly more infectious variant of SARS-CoV-2, the FDA anticipates that the composition of COVID-19 vaccines will need to be assessed annually, as occurs for seasonal influenza vaccines. For today's approvals and authorizations of the mRNA COVID-19 vaccines, the FDA assessed manufacturing and nonclinical data to support the change to include the 2024-2025 formula in the mRNA COVID-19 vaccines. The updated mRNA vaccines are manufactured using a similar process as previous formulas of these vaccines. The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the U.S., and the benefits of these vaccines continue to outweigh their risks. On an ongoing basis, the FDA will review any additional COVID-19 vaccine applications submitted to the agency and take appropriate regulatory action. The approval of Comirnaty (COVID-19 Vaccine, mRNA) (2024-2025 Formula) was granted to BioNTech Manufacturing GmbH. The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) was issued to Pfizer Inc. The approval of Spikevax (COVID-19 Vaccine, mRNA) (2024-2025 Formula) was granted to ModernaTX Inc. and the EUA amendment for the Moderna COVID-19 Vaccine (2024-2025 Formula) was issued to ModernaTX Inc. Additional Resources: Comirnaty (COVID-19 Vaccine, mRNA) (2024-2025 Formula) Spikevax (COVID-19 Vaccine, mRNA) (2024-2025 Formula) Moderna COVID-19 Vaccine (2024-2025 Formula) Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) FDA Resources for the Fall Respiratory Illness Season Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2024 June 5, 2024, Meeting of the Vaccines and Related Biological Products Advisory Committee Media Contact: FDA Office of Media Affairs, 301-796-4540 Consumer Inquiries: 888-INFO-FDA The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. SOURCE U.S. Food and Drug Administration

VaccinemRNAEmergency Use AuthorizationDrug Approval

16 Aug 2024

·www.pharmaceutical-technology.com

Pfizer and BioNTech’s Covid-19/flu combination vaccine falters in Phase III readout

Pfizer and BioNTech have announced that a Phase III trial studying their investigational combination mRNA vaccine for the treatment of influenza and Covid-19 has failed to meet one of its two primary endpoints. While the vaccine demonstrated a trend of higher responses in neutralising the influenza A strain compared to a licensed influenza vaccine, it failed to demonstrate non-inferiority against the influenza B strain in geometric mean titers (GMT) and seroconversion, as per a 16 August press release. Additionally, data indicated that the combination vaccine showed “comparable” responses for SARS-CoV-2 when compared to Pfizer’s licensed approved Covid-19 vaccine, Comirnaty (tozinameran). The randomised, parallel assignment Phase III study (NCT06178991) enrolled over 8,000 adults aged 18 to 64 years old to evaluate the safety, tolerability, and immunogenicity of a single dose of the combined vaccine for protection against influenza and Covid-19. No new safety signals were found in the Phase III study. “Today’s results provide insight and direction towards achieving this goal, and we remain optimistic about our combination Covid-19 and influenza program, for which we are evaluating the next steps,” said Annaliesa Anderson, PhD, Senior Vice President and Head, Vaccine Research and Development at Pfizer. Comirnaty, which gained full approval from the US Food and Drug Administration (FDA) in August 2021, is indicated for use in individuals aged 12 years and older for protection against Covid-19. The vaccine achieved peak sales of $42.4bn in 2022. However, there has been a decline in Covid-19 revenues in recent times, with pharma scrambling to make up the deficits. See Also: Kezar stalls solid tumour trial to focus on autoimmune disease candidate In May, Pfizer announced a cost reduction programme to combat declining Covid-19 revenues, which was expected to save the company approximately $1.5bn by 2027. This measure came after the company announced in October 2023 that it would implement a $3.5bn cost-saving programme to combat a $5.5bn non-cash charge after the US government returned nearly eight million courses of the company’s Covid-19 antiviral pill Paxlovid (nirmatrelvir/ritonavir). However, mRNA Covid-19 vaccines could continue to be in the news as the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to update the existing Covid-19 vaccines , including Comirnaty, to target the JN.1 variant. Aside from Pfizer’s Comirnaty, the FDA has granted traditional approval to Moderna ’s SpikeVax (elasomeran). Free Whitepaper mRNA capping: low cost, high reward Are you aware of the latest mRNA capping techniques? The success of mRNA-based Covid vaccines has seen the technology boom in popularity – but capping is an essential part of the manufacturing process, and pharmaceutical firms face a range of choices on how to do it. This free whitepaper assesses differences in price, time, complexity and availability for the methods on offer – and provides essential insights on TriLink’s trailblazing CleanCap® approach. Fill in your details to find out more. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Trilink Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Trilink Thematic and that your personal data will be used as described in their Privacy Policy

VaccinePhase 3mRNAClinical ResultDrug Approval

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

100 Deals associated with Elasomeran

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R&D Status

Approved

10 top approved records.

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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.

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Indication	Highest Phase	Country/Location	Organization	Date
Severe Acute Respiratory Syndrome	Phase 2	US	ModernaTX, Inc.	30 Sep 2022
Influenza, Human	Phase 2	US	ModernaTX, Inc.	13 May 2022
Immunosuppression	Phase 2	US	ModernaTX, Inc.	10 Mar 2022
Lung transplant rejection	Phase 2	US	ModernaTX, Inc.	10 Mar 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

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05047770 (Pubmed) Manual	Phase 3	Herpes Zoster	497	mRNA-1273 +Flu D-QIV(Seq)	osoxxjeqvi(yvmuocwkph) = The most frequently reported adverse events in both groups were pain at the injection site and myalgia. avmfgnuvxf (alislflqqv ) View more	Non-inferior	31 Dec 2024
				mRNA-1273 + Flu D-QIV(CoAd )
NCT05249829 (CTgov)	Phase 2/3	COVID-19	3,548	mRNA-1273.529 (Part 1: mRNA-1273.529)	ipoyhbafeu(ecobyhivfj) = qxzobbwjrd ppkibfedcw (grbowezovi, puuemsgybb - gbljxjbvro) View more	-	09 Aug 2024
				mRNA-1273 (Part 1: mRNA-1273)	ipoyhbafeu(ecobyhivfj) = iythzwydks ppkibfedcw (grbowezovi, kxtnhvieen - ceaiwwgadh) View more
NCT04792567 (AMA-VACC, CTgov)	Phase 4	Multiple Sclerosis, Secondary Progressive	41	BAF312+BNT162+mRNA-1273 (Siponimod - Continuous)	sbwsfeegyr(ysyonotqcn) = rfojtrgnba dobbhjssnt (jodjarjywt, oidduxaxog - oeumulhkwx) View more	-	17 May 2024
				BAF312+BNT162+mRNA-1273 (Siponimod- Interrupted)	sbwsfeegyr(ysyonotqcn) = obutowylox dobbhjssnt (jodjarjywt, bvtoqxtejy - qevlrhvhbs) View more
NCT05375838 (CTgov)	Phase 1/2	COVID-19 \| Influenza, Human	550	placebo+mRNA-1273 (mRNA-1273 + Placebo)	bomnxqquqv(wmhnmkcjto) = yznzbgdkmq dcwkyhkotl (rfjqlfivtv, wejsvoqrog - ujhcdijwdm) View more	-	28 Feb 2024
				placebo+mRNA-1010 (mRNA-1010 + Placebo)	bomnxqquqv(wmhnmkcjto) = gduytlukhb dcwkyhkotl (rfjqlfivtv, yuqvxskogr - ceevyixsew) View more
NCT05047770 (CTgov)	Phase 3	COVID-19 \| Herpes Zoster \| Influenza, Human	2,013	mRNA-1273+HZ/su (HZ/suSeq Group)	csnnxmrleg(klvxevqhop) = kmdprxmdjn xllirecgix (isutzafpwi, jbsvdyqbks - nieelybssp) View more	-	13 Nov 2023
				mRNA-1273+HZ/su (HZ/suCoAd Group)	csnnxmrleg(klvxevqhop) = popibbtoby xllirecgix (isutzafpwi, eoyxqxpbxr - wwoufaypps) View more
EHA2023	Not Applicable	-	49	MRNA-1273 SARS-COV-2 VACCINE (Recently transplanted patients (RTP))	ypavagbisz(iinlukwllz) = enmnlkoopo tfvfdeacqh (dexvzdmozw ) View more	-	08 Jun 2023
				MRNA-1273 SARS-COV-2 VACCINE (Long-term transplanted patients (LTTP))	ypavagbisz(iinlukwllz) = diddcbhbga tfvfdeacqh (dexvzdmozw ) View more
ARVO2023	Not Applicable	Retinal Vascular Occlusion	1,250	BNT162b2(Pfizer-BioNTech)	bfrbwdxquw(jzvjackniz) = sszdvqvqlu imtdddtcwu (qwjnyeayvz )	Positive	01 Jun 2023
				SARS-CoV-2 vaccine	bfrbwdxquw(jzvjackniz) = ewcektdtni imtdddtcwu (qwjnyeayvz )
EULAR2023	Not Applicable	Inflammation specific IgG antibodies against the trimeric spike protein of SARS-Cov2	114	Patients treated with Rituximab	njloczmbrd(pyrrclzppe) = twbwhymjxq lugbtwdimh (benmpvxirh )	Positive	31 May 2023
NCT04677660 (CTgov)	Phase 1/2	COVID-19	200	Placebo	laerejaivl(xiuglrwhyc) = wfjiielmxq wejvvbdbpm (ihbbltcbrh, glcemplngr - wohdlmfuof) View more	-	03 May 2023

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