Developing a vaccine to prevent RSV, a cause of serious respiratory infections in infants (children)

Respiratory syncytial virus (RSV) is a highly infectious respiratory virus that infects the lungs and breathing passages. In children RSV infection typically occurs at least once a year and in adults every 3-5 years during the winter season. RSV is considered to be one of the most important causes of serious acute respiratory illness in infants and children under 5 years of age. Children usually experience mild to moderate cold-like symptoms and recover in a few days to a week. However, some infants require hospital admission and sometimes need a ventilator to help with breathing. In a small number of these cases, RSV can result in death. RSV disease is also associated with persistent coughing and recurrent wheeze. Despite the high disease burden, no licensed vaccine is available for RSV.

We are looking for healthy children aged 12 to 24 months to take part. If you are interested in having your child take part, click on the link below.

What is this study about?

In this study, we are interested in learning more about an investigational vaccine designed to protect against RSV disease. Investigational means that the study vaccine is not yet licensed for use in the UK or elsewhere.

What is the purpose of this study?

We are interested in studying a new vaccine, Ad26.RSV.preF. The main purpose of this study is to see if the study vaccine is safe (if it causes any side effects) and how people feel after the vaccine (‘tolerability’). We would also measure your child’s immune response to the study vaccine. In this study, some participants (adults and toddlers) will receive placebo instead of the study vaccine. Placebo given in this study will consist of sterile saline for injection, with no vaccine in it.

What is involved?

We aim to enrol a total of 12 adults and 48 children.

We want to recruit children who:

  • Are 12-24 months of age who were not born premature (before 37 weeks gestation) or below 2.5kg
  • Have received their routine vaccinations
  • Are in good health without any significant medical illness
  • Have previously had an RSV infection (e.g. a cough, cold or bronchiolitis). This will be most children aged 12 to 24 months, but will be confirmed by a finger prick blood sample checking whether your child is RSV ‘seropositive’.

The study consists of:

  • Vaccination with 2 doses of Ad26.RSV.preF or placebo 1 month apart
  • Blood tests and nose swabs
  • Completion of a symptom diary for 7 days following vaccination
  • 7-9 visits in clinic/at home over a 30-week period, and regular phone calls
  • We will also ask your permission to access information about the mother’s vaccination through medical notes.

All participants would receive the vaccines or placebo as an injection into the muscle of the thigh.

If you would like to read more information, please click on the link to the information booklet below:

Study Information Booklet

Confidentiality

All information about you and your involvement in the study would be kept strictly confidential.

If you are interested in taking part, please click the link below.

What happens if I’m interested in taking part?

Thank you for considering taking part in this study. You do not need to make a final decision straight away. If you are interested in having your child take part, you will need to read the information booklet (see links below).  Please note that entering your details and obtaining a copy of the Study Information Booklet does not commit your child to participating in the study.

Study Information Booklet

What do I do next?

If you would like to arrange a screening appointment, please answer the questions below to see if you may be eligible. It is important for you to know that all answers are anonymous and kept completely confidential.

17 + 0 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.