What is the purpose of this clinical research study?
We are asking for volunteers join this study 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 by a nasal spray, so no shot is required.
BPZE1 has been studied in 4 adult trials (over 350 adults have received this product) and this is the first study in school-age children. In these adult trials the vaccine has been well tolerated, without any serious side effects, and induced the antibodies against the germ as expected. The potential to protect against getting an infection and infecting others could provide additional benefit to current pertussis vaccines used in your country.
What does the trial involve?
We aim to recruit 600 students, who are expected to remain in the trial for a total of 6 months.
These 600 students will be assigned to one of 3 groups:
- BPZE1 + Boostrix
There will be 4 scheduled visits and at each visit students will be asked about their general state of health and blood and nasal secretion samples will be taken each time.
What are the potential risks and discomforts?
To date, no serious side effects considered related to the study treatment have been reported. Of research participants in a prior BPZE1 study, the most common reported symptoms following vaccination were:
- Runny or stuffy nose
Most of these symptoms were mild or moderate and lasted only a few days.
The side effects of Boostrix are well studied and the most common side effects include the following:
- Pain, redness, and swelling at the injection site
- Feeling tired or sleepy
- Loss of appetite
Syncope (fainting) can occur in association with administration of injectable vaccines (e.g. Boostrix).
Side effects of the tests during the study are minor – samples from nasal secretions and blood. Participants will be provided with a patient information sheet with full details of procedures and potential risks.
Risks that are not known:
The vaccine used in this study (BPZE1) is experimental. There may be risks that are unknown. Study staff will update participants in a timely way on any new information that may affect their health, welfare, or decision to stay in the study.
Are there any possible benefits of being in the study?
Taking part in this study may or may not help to protect against whooping cough (pertussis). However, the data we get from participants during this study may help doctors learn more about the study vaccine and the disease, and this may help people who may receive such vaccines in the future. If volunteers receive Boostrix in this study, it has a known benefit to stop severe pertussis infections. Participants have a 66% chance of receiving Boostrix.
What will happen if I don’t want to carry on with the trial?
If, at any time, after enrolment, you change your mind about being involved with this trial you are free to withdraw without giving a reason. If you choose to withdraw from the trial, your standard medical care will not be affected.