Currently Enrolling for a Chicken Pox Vaccine Study
Ohio Pediatric Research Association is currently enrolling babies who are 12-15 months of age who have not had:
Chickenpox or vaccine against chickenpox.
Measles, mumps or rubella (MMR) or vaccination against MMR.
Your child may be able to take part if they:
Have not been vaccinated against Hepatitis A.
Are not taking part in another clinical research study.
Vaccine is free to all participants. Compensation is provided for time and travel.
What is chickenpox?
Chickenpox, also known as varicella, is a highly contagious viral infection caused by the varicella-zoster virus. It presents with an itchy rash, blisters, fever, and discomfort.
The virus spreads through direct contact with an infected person, or through the air when an infected person coughs or sneezes. Up to 90% of people who are not immune and close to someone with chickenpox will get infected.
For most people, getting chickenpox once provides immunity for life. A person can get chickenpox more than once, but it is uncommon.
While most people recover from chickenpox without complications, the infection can be severe in some cases, especially in infants, adults, and people with weakened immune systems.
Complications of chickenpox can include infections of the lungs (pneumonia) and swelling of the brain (encephalitis), which can sometimes be life-threatening.
Fortunately, chickenpox is preventable. The chickenpox vaccine is a safe and effective way to protect children from chickenpox and its complications.
More Information
Do You Have Concerns About Standard Of Care?
This is an investigational vaccine, but it’s important to understand its relationship to the current standard of care. The vaccine candidate contains the same strain of the varicella virus as all varicella-containing vaccines, the Oka strain. The difference is that it is passaged differently. Passaging a virus involves repeatedly growing the virus in cell cultures to gradually weaken it. Passaging creates a version of the virus that is weaker compared to the original but still triggers an immune response. GSK’s vaccine candidate is a different passage of the same Oka strain, which was developed in the 1970s and has been administered to children in the US since 1995.
GSK has been making varicella-containing vaccines since 1984. GSK’s varicella vaccine Varilrix, also a passage of the Oka strain, was the first registered varicella vaccine in the world and continues to be used throughout the world with decades of supporting safety data. It is not currently licensed in the US. his new vaccine candidate is intended to correspond to the CDC’s recommended vaccination schedule.
Do You Have Concerns About Infants and Pediatric Research?
The FDA puts additional safeguards in place for pediatrics, including enhanced safety monitoring, specialized ethics review, a staged development approach, and a specialized regulatory framework.
This is a Phase 3 trial – each stage can only proceed after safety data from the previous stage is thoroughly reviewed and approved.
Clinical trials involving infants use the lowest possible doses and only start after safety is established.
Pediatric vaccines are developed for an infant’s size and developing immune system.
We offer clinical trial participation to the parents of our infants to ensure that trials are done in the right populations..