What is the purpose of this clinical research study?

We are asking volunteers to join this study to find out how a new nasal spray vaccine called BPZE1 can best protect people against pertussis (more commonly known as whooping cough).

Pertussis is a highly contagious infection of the lungs and airways, caused by bacteria (small organisms which can reproduce and cause illness) called Bordetella pertussis (B. pertussis).

The results of this study will help researchers find out if the BPZE1 vaccine can protect people from being infected (or colonised) with the B. pertussis bacteria that causes pertussis.

What is the drug that is being tested?

BPZE1 is a new vaccine which will be delivered through the nose using an atomiser which is similar to a nasal spray.

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, but they also help stop you from spreading these germs to babies, others in your family or friends. Vaccines protect you and those around you.

Although we have vaccines against whooping cough, they are not as effective as we would like in stopping infection and the spread of the germ to others.

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 has been studied in 4 adult trials (over 350 adults have received this product). 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?

The study will take place at the Oxford University and University Hospital Southampton in the United Kingdom. Across the whole study, approximately 44 people aged 18 to 50 years old will be enrolled in the study for up to 8 months. This includes the following:

• A screening phase of up to 30 days prior to enrolment
• A vaccination phase lasting up to 120 days after the vaccination
• A challenge phase during which nasal drops containing non-weakened B. pertussis will be given on the first day of a 17-day/16-night stay at a study hotel Sample room photos and sample food menu available for review during the screening visit.
  • Each participant will be assigned to their own room with queen sized bed or larger, and private, full-size bathroom
  • Meals provided by the study hotel catering
• A safety follow-up phase lasting until either 180 days post-vaccination or 90 days after the challenge phase (whichever is longer).

Participants will be assigned to one of the 2 study treatment groups:

• BPZE1
• Placebo

What are the potential risks and discomforts?

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.

To date, no serious side effects considered related to the study vaccine BPZE1 have been reported. The most common reported symptoms by research participants in prior BPZE1 studies following vaccination were:

• Sneezing
• Tiredness
• Headache
• Runny or stuffy nose
• Cough

Most of these symptoms were mild or moderate and lasted only a few days. It is highly unlikely that anyone vaccinated with BPZE1 will spread the weakened bacteria to other people.

There is a possibility that participants may develop pertussis because of the nasal drops containing non-weakened B. pertussis. The main symptoms are:

• Runny nose
• Sneezing
• “Flu-like” symptoms
• Hoarseness
• Sinus pain
• Headaches
• Persistent cough

Fainting can occur in association with administration of injectable vaccines.

Side effects of the tests during the study are minor – samples from nasal secretions and blood. You will be provided with a patient information sheet with full details of procedures and potential risks.

Are there any possible benefits of being in the study?

Information collected during the study will increase knowledge about BPZE1 and may be useful for prevention of pertussis in the future. There is no guarantee that participants will receive any benefits from this study. Taking part in this study may or may not provide some degree of immunity to pertussis.

What will happen if I don’t want to carry on with the trial?

If at any time 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.