Phase 1/2 Study of 25-Valent Pneumococcal Conjugate Vaccine in Healthy PCV-Naïve Adults

Participants needed: Ages 18-40

Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Inventprise’s 25-Valent Pneumococcal Conjugate Vaccine in Healthy PCV-Naïve Adults

What is the purpose of the study?

Pneumonia is the #1 cause of child deaths due to infectious disease worldwide. It’s responsible for 14% of all deaths before age five each year, most of which are in low- and middle-income parts of the world. The most common cause of childhood pneumonia that can lead to death is pneumococcus, a bacteria which is also linked to other serious infections like sepsis and meningitis, as well as debilitating middle ear infections. Pneumococcal conjugate vaccines (PCVs) are lifesaving tools for children and cover 10, 13 or 20 varieties (or serotypes) of pneumococcus, but don’t yet cover some important serotypes that remain threats.

This early-stage Phase 1/2 clinical study will evaluate safety and immunogenicity (ability to produce an immune response) of a new PCV developed by Inventprise. The study vaccine is designed to cover 25 serotypes of pneumococcus posing greatest risk to children globally, but particularly in low- and middle-income regions where the pneumococcal disease burden is highest. We will compare the PCV candidate’s safety and ability to induce an immune response with a licensed 20-valent PCV among adults and a licensed 13-valent PCV among young children and infants.

 

Am I eligible?

To participate in this study, you must be 18-40 years old, healthy, and have not received a PCV vaccine.

What would I be expected to do?

Participation in the adult portion of this study will last about 6 months. You will receive a health screening to ensure you are eligible. Then, you will receive either the study vaccine or a Health Canada-approved PCV vaccine that covers 20 serotypes of pneumococcus.

After vaccination, you will be monitored by healthcare staff for 30 minutes to ensure there are no adverse reactions to the vaccine.

Each adult participant will undergo a total of 4 clinic visits, including at least one screening visit, a vaccination visit, and 2 follow-up clinic visits post-vaccination.

Study staff are on-call 24 hours a day and periodically follow up with participants over the course of the study to monitor for reactions.

What are the next steps of this study?

The first portion of this study will evaluate the vaccine in adults in Canada. After the adult portion is completed and if the vaccine safety and immunogenicity is satisfactory, it will be evaluated in young children in Canada. Once this stage is complete and if the safety and immunogenicity continues to meet requirements, the last step of the study will be to evaluate the vaccine in infants. The infant portion will also include locations outside of Canada.

Results from this phase of the study will inform decisions for moving into late-stage clinical evaluation to assess performance in key infant populations living in both high- and low-income contexts.

About the study partners:

Inventprise is a biopharmaceutical company leveraging its innovative platform technology to develop vaccines against infectious diseases with an initial focus on invasive pneumococcal disease. Inventprise platform technologies are designed to enable high valent vaccines to induce broad, robust, and durable protection against pathogenic strains of infectious diseases. Inventprise has a robust pipeline of investigational vaccines including candidates to prevent group B streptococcus (GBS), Haemophilus influenzae type A (Hia), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Inventprise was founded by Subhash Kapre, PhD in 2012 to advance novel, affordable and highly impactful vaccines using proprietary technology, with the initial goal of providing lifesaving interventions globally, including to low and middle-income countries. Inventprise maintains facilities in Redmond and Woodinville, Washington.www.inventprise.com

PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships, and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing health challenges. PATH’s Center for Vaccine Innovation and Access accelerates the development and delivery of lifesaving vaccines for the most vulnerable children and communities around the world. We focus on deadly and disabling diseases that pose the greatest threats to long-term health and development. www.path.org.

Technical Resources International, Inc. (TRI) is a full-service Contract Research Organization Plus (CRO+). TRI’s areas of expertise include clinical operations, communications, data analytics & visualization, data management & biostatistics, trial management, event planning & management, information technology, medical writing, next generation sequencing, regulatory affairs, safety & pharmacovigilance, and quality assurance. For more than 42 years, TRI has provided support to government agencies, the private sector, and nonprofit organizations.  www.tech-res.com