Nasal Spray Whooping Cough Vaccine in Healthy Children

What is the purpose of this clinical research study?

We are asking for volunteers join this phase 2b clinical trial to find out if a new nasal spray vaccine called BPZE1 can help prevent people from getting whooping cough (pertussis) or spreading it to others.

Approximately 600 school-age children and teenagers will take part in this study. This study will be done in approximately 15 locations in the United Kingdom and other European/Commonwealth countries.

What is the drug that is being tested?

Bordetella pertussis is a bacteria (germ) that causes infection in the upper airway and the lungs, often known as “whooping cough”. This is a serious infection that is easily passed to others (it’s very contagious). The effects of this infection can last up to 100 days. Germs are tiny organisms that cause disease.

Vaccines work by making your body fight germs by producing antibodies (this is called immunity). By getting a vaccine your body can fight germs to protect you without having to get ill or have a disease. Not only do vaccines stop you from getting sick, they also help stop you from spreading these germs to babies, others in your family or friends at school. So, they protect you and those around you.

Although whooping cough is most dangerous in very young babies, it is now known that this germ is carried and transmitted by primary school age children, teenagers and young adults. Although we have vaccines against whooping cough, they are not as effective as we would like in stopping infection and in spreading the germ to others.

The current vaccine being used in the national immunisation program is called Boostrix, and it works to protect people from severe disease but not from getting infected or passing the germ to others. Pertussis vaccines are given starting in infancy and then periodically during childhood, pregnancy and in adulthood. Boostrix is one of the vaccines used in this study and it is given in the arm (a shot).

BPZE1 is an experimental vaccine, which means health authorities have not approved it to be used except in a clinical trial setting. This vaccine belongs to a group of vaccines known as live attenuated vaccines. Live attenuated vaccines use a weakened form of the

germ (bacteria) that cannot cause the disease but can provide protection because they make antibodies against the germ. BPZE1 is given may a nasal spray, so no shot is required.