Reactogenicity

Presentations at IDWeek 2023 Highlight Potentially Differentiated Immunogenicity of Gritstone bio’s Next Generation COVID-19 Vaccine

Retrieved on: 
Wednesday, October 11, 2023
COVID-19, NIAID, National Institute of Allergy and Infectious Diseases, Vaccine, RNA, Immunity, Immunogenicity, Gritstone bio, Group A, Infection, PLWH, HIV, CORAL, Epitope, NAB, Reactogenicity, Messenger, Infectious Disease Clinics of North America, Pharmaceutical industry, Gritstone, Safety

EMERYVILLE, Calif., Oct. 11, 2023 (GLOBE NEWSWIRE) -- October 11, 2023 (GLOBE NEWSWIRE) – Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced the presentation of results from three ongoing Phase 1 studies evaluating its self-amplifying mRNA (samRNA) vaccine candidates against COVID-19 (part of the company’s CORAL program) at IDWeek 2023, occurring October 11-15, 2023, in Boston, MA.

Key Points: 
  • Gritstone will present further follow up data from the CORAL-CEPI and CORAL-BOOST studies (most recent prior presentation in April 2023, press release ).
  • CORAL-BOOST (NCT05148962) is a Phase 1 study evaluating a samRNA-based COVID-19 vaccine candidate containing spike plus other viral targets in older adults ≥60 years of age (N = 40).
  • Broad T cell responses induced against Spike and non-Spike T cell epitopes included in the vaccine.
  • To view Gritstone’s IDWeek 2023 poster presentations, visit ir.gritstonebio.com/investors/events .

Insights on the Antibiotics Global Market to 2027: by Action Mechanism, Drug Class, Spectrum of Activity, Route of Administration, End-user and Region - ResearchAndMarkets.com

Retrieved on: 
Friday, January 20, 2023
Health, Pharmaceutical, Capsule, Toxicity, Conjunctivitis, Infection, Acne, Protein, Tuberculosis, Pneumonia, Maharashtra University of Health Sciences, Food safety, HIV/AIDS, Patient, Skin, Risk, Parasitism, Reactogenicity, Growth, AIDS, Prevalence, COVID-19, Tablet, Malaria, Antibiotics, Pharmaceutical industry, Vaccine

These insights are included in the report as a major market contributor.

Key Points: 
  • These insights are included in the report as a major market contributor.
  • They are generally administered orally in the form of pills, liquids, tablets, and capsules.
  • Furthermore, antibiotics are finding extensive application in livestock farming to safeguard animal health and welfare and support food safety.
  • Our report has categorized the market based on action mechanism, drug class, spectrum of activity, route of administration and end user.

CEPI partners with Tiba Biotech to evaluate next-generation RNA vaccine platform technology to respond to 'Disease X'

Retrieved on: 
Thursday, January 12, 2023
Fever Dream, CEPI, Reactogenicity, Fever, COVID-19, RNA transfection, Yellow fever, G7, LNP, Vaccine, Coalition for Epidemic Preparedness Innovations, Equitable, Partnership, Disease, Refrigeration, RNA, Mortality, Flavivirus, Epidemic, Coalition, US, Venezuelan equine encephalitis virus, Policy, JEV, Control

OSLO Norway and CAMBRIDGE, Mass., Jan. 12, 2023 /PRNewswire/ -- The Coalition for Epidemic Preparedness Innovations (CEPI) and Tiba Biotech , a preclinical biopharmaceutical company, today announced a new partnership agreement to evaluate Tiba Biotech's next-generation RNA vaccine platform technology.

Key Points: 
  • OSLO Norway and CAMBRIDGE, Mass., Jan. 12, 2023 /PRNewswire/ -- The Coalition for Epidemic Preparedness Innovations (CEPI) and Tiba Biotech , a preclinical biopharmaceutical company, today announced a new partnership agreement to evaluate Tiba Biotech's next-generation RNA vaccine platform technology.
  • Tiba Biotech's innovative platform could offer substantial advantages over existing RNA vaccines when responding to future epidemic or pandemic diseases.
  • CEPI will provide US$2 million to advance Tiba Biotech's novel RNA nanoparticle delivery platform, RNABL™.
  • To deliver an RNA payload, Tiba Biotech uses organic molecules to form biodegradable nanoparticles that are less inflammatory than current lipid nanoparticle (LNP) formulations.

Ocugen Announces Publication of Positive Results of COVID-19 Vaccine Trial for Children 2-18 in The Lancet Infectious Diseases

Retrieved on: 
Tuesday, June 21, 2022
Security (finance), Immunization, COVID-19, Hope, Safety, Science, World, Private Securities Litigation Reform Act, Observation, Vaccine, Vero, Death, Clinical Trials Registry – India, CEO, U.S. Securities and Exchange Commission, Risk, The Lancet, American Market, Research, LinkedIn, Hospital, BBV152, College of Arts and Sciences, Disease, Ageing, Master of Science, Medical research, Health, NASDAQ, Intention, SEC, World Health Organization, Bharat Biotech, Twitter, Reactogenicity, Patient, Myocarditis, Â, Pericarditis, Pediatrics, GLOBE, National Institute of Virology, RNA transfection, Pharmaceutical industry, Virology, Lancet

MALVERN, Pa., June 21, 2022 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologicals, and vaccines, today announced the publication of positive pediatric Phase 2/3 study results in children aged 2–18 years for the COVID-19 vaccine COVAXIN™ (BBV152) in The Lancet Infectious Diseases (“The Lancet”). COVAXIN™ is developed and manufactured by Ocugen’s partner Bharat Biotech International Limited (“Bharat Biotech”), a global leader in vaccine innovation based in Hyderabad, India, and is under clinical investigation by Ocugen in the United States for use in adults aged 18 years and older.

Key Points: 
  • Ocugen is continuing its effort to bring this vaccine to the North American Market.
  • We congratulate Bharat Biotech on the publication of the COVAXINpediatric data in this prestigious peer-reviewed medical journal, said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen.
  • Safety of the vaccine is critical for children, and we are glad to share that COVAXINhas proven data for safety and immunogenicity in children.
  • COVAXINis formulated uniquely such that the same dosage can be administered to adults and children alike, making it truly a universal vaccine.

Medicago and GSK Announce Positive Interim Phase 2 Results for Adjuvanted COVID-19 Vaccine Candidate

Retrieved on: 
Tuesday, May 18, 2021
Health, Infectious diseases, Clinical trials, General Health, Pharmaceutical, Biotechnology, Vaccination, Medical specialties, Medicine, Drug Safety, Food and Drug Administration, Reactogenicity, Vaccine, Neutralizing antibody, Health care

These results are part of the ongoing Phase 2/3 study and reiterate the promising profile observed during Phase 1 testing.

Key Points: 
  • These results are part of the ongoing Phase 2/3 study and reiterate the promising profile observed during Phase 1 testing.
  • No related severe adverse events were reported and reactogenicity was generally mild to moderate and short in duration.\n\xe2\x80\x9cWe are very excited to see such positive results from the Phase 2 data.
  • After two doses, the adjuvanted vaccine candidate induced robust neutralizing antibody and cellular immune responses in all subjects, irrespectively of age,\xe2\x80\x9d said Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago.
  • \xe2\x80\x9cThese results give us confidence as we continue to move forward with our Phase 3 clinical trial.

Medicago and GSK announce positive interim Phase 2 results for adjuvanted COVID-19 vaccine candidate

Retrieved on: 
Tuesday, May 18, 2021
Vaccination, Medical specialties, Medicine, Health, Clinical trials, Drug Safety, Food and Drug Administration, Reactogenicity, COVID-19 vaccines, Vaccine, Neutralizing antibody

These results are part of the ongoing Phase 2/3 study and reiterate the promising profile observed during Phase 1 testing.

Key Points: 
  • These results are part of the ongoing Phase 2/3 study and reiterate the promising profile observed during Phase 1 testing.
  • No related severe adverse events were reported and reactogenicity was generally mild to moderate and short in duration.\n"We are very excited to see such positive results from the Phase 2 data.
  • After two doses, the adjuvanted vaccine candidate induced robust neutralizing antibody and cellular immune responses in all subjects, irrespectively of age," said Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago.
  • "These results give us confidence as we continue to move forward with our Phase 3 clinical trial.

OSE Immunotherapeutics Receives Authorization for Phase 1 Clinical Trial of its Multi-Target Multi-Variant COVID-19 Vaccine

Retrieved on: 
Thursday, April 1, 2021
Medical specialties, Medicine, Clinical medicine, Immunology, Vaccination, Biotechnology, Virology, Vaccines, Monoclonal antibody, Immunogenicity, Reactogenicity, Vaccine

CoVepiT is based on the identification of multiple immuno-dominant epitopes that generate a T memory lymphocyte response and combining them in the vaccine.

Key Points: 
  • CoVepiT is based on the identification of multiple immuno-dominant epitopes that generate a T memory lymphocyte response and combining them in the vaccine.
  • The objective of the clinical development for our next-generation vaccine CoVepiT is to evaluate its safety and benefit, particularly for people at risk, i.e., vulnerable populations.
  • This Phase 1 clinical trial will evaluate the safety, reactogenicity and immunogenicity of CoVepiT in healthy adult volunteers.
  • FR104 (anti-CD28 monoclonal antibody): positive Phase 1 results; ongoing Phase 1/2 in renal transplant, Phase 2-ready asset in a niche indication in autoimmune diseases.

COVAXX’s COVID-19 Vaccine, UB-612, Induced Neutralizing Antibodies in 100% of Participants During Phase 1 Clinical Trial

Retrieved on: 
Monday, February 8, 2021
Health, Infectious diseases, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Drug Safety, Food and Drug Administration, Reactogenicity, Vaccination, Advanced Encryption Standard, Health, Medicine

Minimal local or systemic AEs were observed after dose 1 and 2, with no increase in reactogenicity after the second dose.

Key Points: 
  • Minimal local or systemic AEs were observed after dose 1 and 2, with no increase in reactogenicity after the second dose.
  • Almost all AEs were mild (Grade 1) and of
  • The trial is ongoing and all participants are being followed up to day 196.
  • All subjects developed neutralizing antibodies after two doses of the vaccine.

Moderna Announces First Participants Dosed in Phase 2/3 Study of COVID-19 Vaccine Candidate in Adolescents

Retrieved on: 
Thursday, December 10, 2020
Health, Infectious diseases, Clinical trials, General Health, Pharmaceutical, Biotechnology, Vaccination, Medicine, Medical specialties, Health sciences, Vaccines, Medical research, Drug Safety, Food and Drug Administration, Reactogenicity, Vaccine, COVID-19 vaccine, H5N1 clinical trials

We hope we will be able to provide a safe vaccine to provide protection to adolescents so they can return to school in a normal setting.

Key Points: 
  • We hope we will be able to provide a safe vaccine to provide protection to adolescents so they can return to school in a normal setting.
  • This randomized, controlled Phase 2/3 study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.
  • The Company intends to enroll 3,000 adolescent participants in the U.S. ages 12 to less than 18 years.
  • The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing.

Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates

Retrieved on: 
Friday, December 4, 2020
FDA, Health, Infectious diseases, Clinical trials, Pharmaceutical, Biotechnology, Medical specialties, Health sciences, Vaccination, Medicine, Medical research, Vaccines, Virology, COVID-19 vaccine, Reactogenicity, Adjuvant, Vaccine, H5N1 clinical trials, COVID-19 S-Trimer Vaccine, Trimer-Tag© Technology, Clover Biopharmaceuticals, GSK, Dynavax, CEPI

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels.

Key Points: 
  • The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels.
  • Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant.
  • Thus, the ability of Clovers COVID-19 vaccine candidates to be stored in standard refrigeration temperatures makes them suitable for broad global distribution based on current results.
  • Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines.