Search API | Vax-Before-Travel

ASP3772 Pneumococcal Vaccine

Affinivax ASP3772 vaccine candidate offers cell (antibody) and T-cell immune protection against Streptococcus pneumoniae. ASP3772 includes 24 pneumococcal polysaccharides and two conserved pneumococcal proteins. ASP3772 utilizes the Multiple Antigen Presenting System (MAPS) platform, Affinivax’s proprietary, next-generation vaccine technology. The MAPS tech ology platform uses proprietary chemistry that capitalizes on the highly specific, durable, non-covalent affinity binding between biotin and rhizavidin, a biotin-binding protein.

The highly stable MAPS complex creates affinity binding and creates tributes to a simple, modular, and efficient approach to developing novel vaccines and immunotherapies. Conventional vaccine conjugation technology seeks to optimize the generation of protective antibody responses mainly to polysaccharide antigens, using the protein antigen as a carrier. In stark contrast, a MAPS vaccine can present both the polysaccharide and the protein antigens to the host immune system to induce bot- and T-cell immune response.

On July 13, 2021, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for ASP3772 to prevent pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes included in ASP3772 in adults aged 50 years and older. The results formed the FDA's decision regarding the Phase 2 data. The design is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.

In May 2022, GlaxoSmithKline plc (GSK) pledged $2.1 billion and up to $1.2 billion in development milestone payments to take over Affinivax Inc. For more information, visit www.affinivax.com. Affinivax Hea quarters is located at 301 Binney St., Suite 302, Cambridge, MA 02142.

ASP3772 Pneumococcal Vaccine Indication

ASP3772 is a vaccine candidate that offers the potential to provide broader protection against pneumococcal disease. Streptococcus pneumoniae is a bacterium frequently found in the upper respiratory tract of healthy children and adults and can cause serious infections ranging from pneumonia, meningitis, and sepsis, representing a major global health problem.

ASP3772 Pneumococcal Vaccine Dosage

Study participants received a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels.

ASP3772 Pneumococcal Vaccine Development News

July 13, 2021—Affinivax, Inc. and Astellas Pharma Inc. announced results from the Phase 2 clinical trial of ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae. The results demonstrated that ASP3772 was well tolerated. ASP3772 also exhibited an antibody response to each of the 24 polysaccharides and an additional antibody response to the conserved pneumococcal proteins.

April 23, 2020: Affinivax Announces $120 Million Series B Financing to Advance Pipeline of Novel MAPS Vaccines and Immunotherapies.

February 13, 2019: The first subject was dosed with ASP3772, a novel MAPS vaccine targeting Streptococcus pneumoniae (pneumococcal). This followed the successful submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration in December 2018.

February 28, 2017: Affinivax, Inc. and Astellas Pharma Inc. announced they have entered into an exclusive worldwide license agreement to develop and commercialize a vaccine targeting Streptococcus pneumoniae (pneumococcus).

ASP3772 Pneumococcal Vaccine Clinical Trials

The ASP3772 clinical development program includes indications for protection against Streptococcus pneumoniae infections in boults and infants. The clinical trials can be found here.

0 min read

Manufacturer:

Affinivax

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Natasha Gildersleeve PharmD

Vaccine:

ASP3772 Pneumococcal Vaccine

Generic:

ASP3772

Drug Class:

Vaccine

Clinical Trial Phase I:

A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of

Clinical Trial Phase II:

Single Ascending Dose-Finding Study (Phase 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine

Condition:

Pneumococcal

Last Reviewed:

Tuesday, June 25, 2024 - 05:25

Status:

Candidate

Manufacturer Country ID:

Side Effects:

Phase 2

Afluria Influenza Vaccine

Afluria® Influenza Vaccines

CSL Seqirus's Afluria® Quadrivalent is an inactivated egg-based influenza vaccine designed to protect against four flu viruses, including two influenza A viruses and two influenza B viruses. Afluria Quadrivalent is an influenza vaccine for people six months and older. For intramuscular injection only, by needle and syringe (6 months and older) or by PharmaJet® Stratis® Needle-Free Injection System (18 through 64 years); Afluria Quadrivalent is supplied in 3 product presentations: as a package of ten 0.5-mL prefilled needleless syringes or as a 5-mL multidose vial; Administer Afluria Quadrivalent as a 0.25-mL dose for patients 6-35 months of age and as a 0.5-ml dose for patients 36 months of age and older; Both the multidose vial and prefilled syringe presentations are not made with natural rubber latex; The prefilled syringe presentation is preservative-free.

On October 10, 2022, Pediatrics published the results of a clinical trial demonstrating the safety and Immunogenicity of Aflura compared to an egg-based influenza vaccine. The study results concluded that Afluria was well-tolerated and immune responses were similar to a US-licensed QIV.

The U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee announced on March 7, 2023, the influenza vaccine strains for the 2023-2024 flu season in the Northern Hemisphere. On June 30, 2023, the FDA issued BL 125254/838. On July 3, 2023, the FDA published BL 125254, Afluria Quadrivalent, and Afluria Quadrivalent Southern Hemisphere. On February 8, 2024, Seqirus announced it intends to remove the B/Yamagata influenza virus strain from all influenza vaccines distributed in the United States.

New Jersey-based CSL Seqirus US is a leader in the fight against influenza with an innovative portfolio of influenza products. As part of the CSL Group (ASX: CSL; USOTC: CSLLY), Seqirus draws on over a century of experience in influenza vaccines. From 1916 to today, CSL has been driven by the promise to save lives using the latest technologies.

Afluria Quadrivalent Vaccine Price

Seqirus USA, Inc. provides a coding and billing guide for healthcare providers. The CDC vaccine price list indicates this flu shot will range from $18.52 to $20.03. The U.S. CDC confirmed that the Vaccines For Children program is federally funded and provides vaccines and medicines to children at no cost.

Afluria Quadrivalent Vaccine Indication

Afluria Quadrivalent is indicated in people six months of age and older for active immunization against influenza disease caused by influenza A subtype vid type B viruses contained in the vaccine.

Afluria Quadrivalent Vaccine Dosage

Afluria is administered as an intramuscular injection by needle and syringe (6 months+) or by PharmaJet®Stratis® Needle-Free Injection System (18 through 64 years). Store AFLURIA QUADRIVALENT refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Discard if the vaccine has been frozen. Please, do not use it after the expiration date. Afluria Quadrivalent Side Effects

Afluria Quadrivalent is generally well-tolerated; however, if you or your loved one has an adverse reaction to the vaccine, that information should be reported to VAERS, a U.S. passive reporting system, meaning it relies on individuals to send in reports of their experiences to a vaccine. Anyone can submit a report to VAERS, including parents and patients. Furthermore, healthcare providers are required by law to report to VAERS.

Afluria Quadrivalent Vaccine News

September 12, 2023 - Physicians can choose from up to nine different influenza vaccines for the 2023-2024 flu season now that the CDC has published a report and summary of recommendations from the ACIP for preventing and controlling seasonal influenza.

July 17, 2023 - Dave Ross, Vice President, North America Commercial Operations, CSL Seqirus, said in a press release, "Influenza vaccination is critical in reducing flu-related hospitalizations and overall disease burden.17 At CSL Seqirus, we're committed to working with our public health partners to do what we can to help drive vaccination rates at least back up to pre-pandemic levels."

October 10, 2022 - The journal Pediatrics reported on a clinical trial comparing Afluria with an egg-based flu vaccine. The trial results confirmed that the QIVc vaccine was just as effective and safe as the QIV vaccine for young children.

July 11, 2022 - CSL Seqirus announced they have begun shipping 55 million doses of their influenza offerings to the U.S.

August 18, 2021 - The U.S. FDA confirmed that it has released Afluria Quadrivalent flu vaccine lots, which are available for distribution by the manufacturers.

September 16, 2020 - The American Academy of Pediatrics recommends routine influenza immunization of all children without medical contraindications, starting at six months of age.