Javier Casellas MD PID PhD’s Post

A recent Phase I clinical trial evaluated the safety and immunogenicity of an optimized self-replicating RNA (srRNA) rabies vaccine in healthy volunteers. Unlike previous srRNA vaccines, this study demonstrated that the optimized srRNA platform is both safe and capable of inducing a robust immune response at lower doses or with a single dose. The srRNA technology offers significant advantages over traditional mRNA vaccines, including approximately tenfold dose-sparing and more durable immune responses. This optimized srRNA platform holds promise for developing effective vaccines that require lower doses or fewer administrations, potentially enhancing vaccine accessibility and compliance. #Vaccines #virology #rabies https://lnkd.in/edKpteWR

Antibody Therapeutics (indexed in ESCI, 2023 CiteScore: 8.7), the official journal of Chinese Antibody Society published by Oxford University Press would like to share a research article entitled “FcRider: a recombinant Fc nanoparticle with endogenous adjuvant activities for hybrid immunization”. The corresponding author is Wenda Gao from ANTAGEN PHARMACEUTICALS, INC.. Active immunization (vaccination) induces long-lasting immunity with memory, which takes weeks to months to develop. Passive immunization (transfer of neutralizing antibodies) provides immediate protection, yet with high cost and effects being comparatively short-lived. No currently approved adjuvants are compatible with formulations to combine active and passive immunizations, not to mention their huge disparities in administration routes and dosage. To solve this, researchers engineered the Fc fragment of human IgG1 into a hexamer nanoparticle and expressed its afucosylated form in Fut8−/− CHO cells, naming it “FcRider”, which is highly soluble with long-term stability, easily produced at high levels equivalent to those of therapeutic antibodies, and is amenable to conventional antibody purification schemes. Click the link for the free access of the full article https://lnkd.in/gwfFBkCa We are also welcoming therapeutic antibody related submission through https://lnkd.in/dMJjtiD #Antibody #Therapeutics

https://lnkd.in/dw3_hkAB SHIGELLA VACCINE. AN ELUSIVE TARGET BUT STUDIES ARE STILL ONGOING! What is new? A novel vaccine against Shigella was developed. This vaccine includes Shigella sonnei and three prevalent Shigella flexneri serotypes. In Stage 1 (phase I) of the study, healthy European adults received two vaccine injections given 3 or 6 months apart. It was found that: The vaccine was well tolerated, and no safety signals or concerns were identified. Regardless of the interval between injections, specific antibodies were elicited against all four Shigella serotypes, with highest levels against Shigella flexneri 2a and Shigella sonnei. Functional antibody levels peaked after the first injection, remaining higher than the baseline up to 6 months. A second injection did not boost responses but restored functional antibody levels to those after the first injection. What is the impact? The vaccine can now be tested in Stage 2 (phase II) of the study in Africa, a region highly affected by shigellosis.

Vaccine Adjuvants Market is projected to reach $6,035.04 million by 2034, Vaccine adjuvants are substances added to vaccines to enhance the immune system's reaction to the antigen. They function by activating the immune system, providing a more robust and enduring defense against illnesses. Typical adjuvants are aluminum salts and oil-in-water emulsions, which enhance vaccine effectiveness, particularly in at-risk groups such as children and older adults. Adjuvants play a vital role in enhancing vaccine efficacy and decreasing the number of doses needed for immunity. Polaris Market Research & Consulting, Inc.

GSK fully liquid Menveo meningococcal vaccine approved by European Commission  GSK plc has announced that the European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (Meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y. This single-vial presentation is now licenced for active immunisation of children from 2 years of age, adolescents and adults, offering healthcare providers an option that does not require reconstitution before its use. Philip Dormitzer, GSK Head of Global Vaccines Research & Development, said, “As a leader in meningococcal vaccines, GSK is dedicated to finding innovative solutions that simplify immunisation and support vaccine uptake. We remain committed to safeguarding individuals from bacterial meningitis, and we will persist in our efforts to prevent this devastating disease among at-risk populations in the European Union.” GSK’s submission to the EC was based on two positive Phase IIb trials. The primary and secondary outcomes of these trials, supported by post-hoc pooled analyses, show that the fully liquid formulation of this vaccine has comparable immunogenicity, tolerability and a comparable safety profile to the existing lyophilised/liquid formulation. IMD is an unpredictable but serious illness that can cause life-threatening complications. Despite treatment, among those who contract IMD up to one in six will die, sometimes in as little as 24 hours. One in five survivors may suffer long-term consequences such as neurological damage, amputations, hearing loss and nervous system problems. Although anyone can get IMD, babies, young children and those who are in their late teens and early adulthood are amongst the groups at higher risk. The original presentation of Menveo that requires reconstitution, and which was approved by the EMA in 2010, is unaffected by this marketing authorisation. #GSK #GSKnews #Menveo #MenACWYvaccine #meningococcaldisease

🔬One of the early questions vaccine developers must answer when selecting an adjuvant for their vaccine is the compatibility between the antigen and the adjuvant. Saponins have proven to be eminently flexible in the various formats of FDA/EMA/WHO approved vaccines, veterinary vaccines and prototypes including live attenuated (≥3 vaccines), inactivated (≥37 vaccines), toxoid (prototypes), protein (≥11 vaccines), DNA (prototypes), mRNA (prototypes), saccharide(≥3 vaccines), glycoconjugate (prototypes), and VLP (≥1 vaccine). This compatibility is crucial in formulating stable vaccines targeting diverse pathogens, from viral infections to parasitic diseases. Saponins are potent immunostimulatory adjuvants that significantly increase the humoral and cellular immune response with a T helper to Th1 response profile. Q-VANT Biosciences is exploring scientific collaborations with developers of vaccines adjuvanted with QS-21 INFINITY, QS-ORAL. #VaccineDesign #SaponinAdjuvants #AntigenCompatibility #Immunology

#molecularbiology #vaccination #vaccine The second #mRNA product received a marketing authorization date. After the successful experience of the Corona vaccine based on mRNA technology, Maderna received the license to use its second product. This product is actually the second product of its kind in the world of mRNA. The new product of Maderna company that was unveiled last night is called mRESVIA and it is against #respiratory #syncytial #virus or RSV. #RSV is a highly #contagious seasonal respiratory virus and a major cause of lower respiratory tract infections and pneumonia, causing a large burden of disease in infants and the elderly. In fact, for many years, the medical world was looking for a safe and effective vaccine against RSV, but due to technical reasons, it was not possible to develop it. Recently, the two companies GSK and Pfizer for their new #vaccines against RSV, but based on recombinant protein technology, received a license for adults from the US #FDA, but due to technical reasons, including the better efficiency of mRNA vaccines, especially in the induction of both humoral and cellular immunity, experts They have predicted that the sales of Maderna products based on mRNA technology will soon overtake GSK and #Pfizer. Maderna's success in delivering its second product bodes well for a bright future for the all-important mRNA technology. It should be noted that the researchers of Renap Group have been developing this strategic technology in Iran since about seven years ago. The first product of this company named COReNAPCIN against Corona vaccine and similar to Maderna and Pfizer vaccines was developed in Iran and has entered the clinical phase. found and it is hoped that this vaccine against circulating strains will be available to compatriots this year after the completion of the clinical trials. Also, Renap company is developing the ReSVoReNPCIN vaccine, which is similar to Maderna's vaccine against RSV, which has had very good results in animal studies so far and will be informed about its progress in the near future.

Increasing Vaccine Efficacy with Novel Adjuvants In this thought leader article WuXi Vaccines' Xinhao Y., and Hongbing Wu describe how vaccine adjuvants can help shape immunological responses.

https://lnkd.in/d45hFfbf Vaccines Beat MOSQUITO-BORNE mRNA VACCINES - NICE REVIEW! Current research and clinical trials have shown encouraging results regarding the safety and efficacy of these vaccines in both animal models and humans. Advances in mRNA design, including optimized CAPs, UTRs, and the use of LNPs, have significantly improved vaccine stability and immunogenicity. Multi-target design strategies have further enhanced the immune response, providing broad-spectrum protection against various mosquito-borne viruses such as DENV, ZKV, CHIKV, YFV and RVF.

PFIZER AND BioNTech Press release Pfizer and BioNTech Announce Update on mRNA-Based Combination Vaccine Program for Influenza and COVID-19 in Individuals Ages 18 to 64 August 16, 2024 Pfizer and BioNTech's flu-COVID-19 combination vaccine candidate met one of its two primary immunogenicity goals in a Phase 3 trial The study did not meet one of its primary immunogenicity objectives because it failed to demonstrate an equivalent immune response to influenza B compared to an approved influenza vaccine; although it achieved stronger immune responses to influenza A and comparable immune responses to COVID-19, which were also compared to the immune response to an approved vaccine The companies are currently reviewing adjustments to the candidate and will discuss next steps with health authorities Pfizer also provides an update on its separate Phase 2 trial of a second-generation trivalent mRNA-based influenza vaccine; this showed encouraging data compared to an approved influenza vaccine, indicating robust immunogenicity against all influenza strains. Source: Pfizer and BioNTech