Redmond-based biotechnology company Inventprise recently announced a Phase 1/2 clinical study of its 25-valent pneumococcal conjugate vaccine (IVT PCV-25) has begun in Halifax, Canada.
This phase of the study is a step towards developing an affordable and expanded coverage pneumococcal conjugate vaccine (PCV). The vaccine is designed to prevent pneumococcal disease caused by serotypes, or varieties, that are not covered in current vaccines. Another goal of Inventprise is to provide protection to people globally, including those in low and middle income regions, where disease burden is the greatest.
“PCV’s are the world’s most complex vaccines and increasing the number of serotypes has challenged the vaccine development field for many years,” said Yves Leurquin, President and CEO of Inventprise.
PCV’s act as preventative tools and approved infant vaccines currently cover 10-15 pneumococcal serotypes, according to Inventprise, although some vaccines don’t yet include certain serotypes that remain threats.
Inventprise’s PCV could increase the number of serotypes included in vaccines to 25, which would expand the potential to prevent several deadly and emerging serotypes.
About Pneumococcal disease
Pneumococcal disease can include several different types of infections and symptoms depend on which part of the body is affected, according to the Centers for Disease Control and Prevention (CDC).
Types of infections include pneumonia, a lung infection which presents with fever and chills, cough, rapid breathing or difficulty breathing and chest pain. Meningitis is an infection of the lining of the brain and spinal cord, and symptoms include stiff neck, fever, headache, light sensitivity and confusion. About 1 in 12 children who get pneumococcal meningitis dies of the infection, and those who survive may have long-term issues such as hearing loss or developmental delays.
Sepsis is the body’s extreme response to an infection, with symptoms presenting as confusion or disorientation; shortness of breath; high heart rate; fever, shivering or feeling cold; extreme pain or discomfort; and clammy or sweaty skin. Complications of sepsis include kidney failure and damage to the brain, lungs or heart.
Pneumococcal bacteria commonly cause middle ear infections, which are usually mild and more common than severe forms of pneumococcal disease. Symptoms include ear pain, a red and swollen ear drum, fever and sleepiness.
The World Health Organization (WHO) estimates that pneumococcal disease kills over 300,000 children under five years old worldwide each year.
Pneumococcal bacteria is spread to others through direct contact with respiratory secretions such as saliva or mucus. According to the CDC, antibiotics are commonly used to treat pneumococcal disease, although some pneumococcal bacteria have become resistant to certain antibiotics used to treat infections.
Vaccines are the most effective way to prevent pneumococcal disease, according to the CDC. Two kinds of pneumococcal vaccines are available in the United States:
- Pneumococcal conjugate vaccines (PCV13, PCV15 or PCV20)
- Pneumococcal polysaccharide vaccine (PPSV23)
Phase 1/2 study
The Phase 1/2 study is evaluating the IVT PCV-25’s safety and ability to induce immune responses in adults, young children and infants. The Phase 1 portion of the study, which is now underway, will enroll healthy adult volunteers and use an authorized adult 20-valent PCV as a comparator.
Phase 2 of the study will be triggered by satisfactory Phase 1 results, and the second phase will evaluate IVT PCV-25 first in young children, and pending satisfactory data, in infants. Phase 2 will use an authorized infant 13-valent PCV as a comparator.
“This Phase 1/2 study is important to determine how IVT PCV-25 performs in people and will inform decisions around the vaccine’s progression into later-stage clinical development,” said Dr. Joanne Langley, the study’s principal investigator.
The study is conducted in collaboration with the international nonprofit, PATH, and the Canadian Immunization Research Network. Enrollment is taking place at Halifax’s Canadian Center for Vaccinology, with other sites enrolling over time. The vaccine development is also made possible through funding support from the Bill & Melinda Gates Foundation.
“If studies show that the vaccine can safely protect against more types of pneumococcal disease, it could be a meaningful tool in the fight against pneumonia–the long-reigning leading cause of child death due to infectious disease in the world,” said Langley.
For more information visit https://inventprise.com/