BEAR Men B: Babies born Early Antibody Response to Men B Vaccination
In 2015 the UK became the first country in the world to introduce the meningococcal group B (Men B) vaccine into its routine schedule for infants. This vaccine provides protection against meningitis (infection of the lining of the brain) and septicaemia (blood poisoning) caused by a subgroup (group B) of the meningococcus germ. In the UK babies are offered this vaccination at 2, 4 and 12 months. We are working with Public Health England (PHE) to compare two schedules of the Men B vaccine in babies who were born prematurely. One group of babies will receive the Men B vaccine according to the current schedule and the other group will receive an additional dose at 3 months.
Hepatitis B usually affects adults, but children can be infected through close contact with carriers of the virus. Children with hepatitis B infection may not have symptoms for many years but may go on to develop liver failure, cirrhosis and cancer. At present, babies in the UK receive a 5-in-1 vaccine (Pediacel) which protects them against diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus influence type b (Hib). By replacing Pediacel with infanrix-Hexa, children could also be protected against hepatitis B. However, before this can happen we need to make sure that Infanrix-Hexa and the other vaccines in the UK infant schedule all continue to provide adequate protection when given together. We are inviting all babies who have not yet had their routine immunisations to take part in this study. By taking part in this study, your baby will be immunised against hepatitis B as well as being offered extra vaccination if he/she does not develop enough antibody levels against Hib or MenC.
Chickenpox is a highly contagious illness caused by the chickenpox (varicella) virus. Symptoms include a red, itchy rash, fever and headache. The disease is usually mild and lasts 5 to 10 days, but it sometimes causes serious problems, such as pneumonia or brain swelling (encephalitis). The blisters can become infected by bacteria which may cause skin infection (cellulitis) or occasionally spread to the blood stream.
The purpose of this study is to compare the Varilrix vaccine, which is already licensed in the UK, with another version of the same vaccine that is made in a different way in order to find out more about the safety and immune response of this new version of the vaccine.
Congenital Cytomegalovirus (CMV) infection is a common viral cause of hearing loss and/or developmental delay in the UK. Our long term aim is to try to bring this disease under control. Based on research in the USA, it is now recommended that all babies up to one month of age are given ganciclovir as part of routine clinical practice. We will find out if giving valganciclovir (the oral form of ganciclovir) to older children (between 31 days of age up through 47 months of age) can reduce hearing loss at a later age.
Respiratory Syncytial Virus (RSV)
RSV is a leading cause of chest disease and breathing difficulty in infants. It can cause some children to be very sick and can cause longer term chestiness in some infants who have been infected. Currently, there are no routinely used medications to treat RSV infection. We are currently researching two new study drugs in the hopes of being able to medicate against RSV:
RSV Study Drug Orally Administered
Up to 264 infants aged between 1 month and 12 months and hospitalised with RSV will be enrolled into this study at hospitals in Europe, Asia Pacific and Latin America. The study drug will be given by mouth as a liquid. Approximately 75% of infants will be randomly assigned to the study drug and approximately 25% of infants will receive a placebo drug. If an infant receives the study drug, there is a chance that it might improve their health by decreasing the severity of their RSV infection.
RSV Study Drug Administered Via Inhalation
This study is evaluating the safety of when a new study drug is given to infants (aged between 3 and 24) and looking to see how effective it is as a medication against RSV chest infections. The first infants to take part in this study will receive an inhaled dose of the study drug once per day for 3 days whilst in hospital. Those who take part in the second part of the study will receive either an inhaled dose of the study drug or an inactive placebo once per day for 3 days whilst in hospital. If an infant receives the study drug, there is a chance that it might improve their health by decreasing the severity of their RSV infection.
Chickenpox can be life-threatening for a child with cancer. If they have close contact with someone who is infectious for chickenpox, they are usually offered a medicine called post-exposure (PEP). There are two different types of PEP used in the UK, VZIG (an injection of chickenpox antibodies into the muscle) and aciclovir (an orally administered course of antiviral medicine). Medical opinion is divided over the two types of PEP, so research is needed to find out which one is the best. This study invites the participation of children who have been diagnosed with cancer or have recently completed treatment for cancer. We are interested in whether these two types of PEP have different costs to the health service and, crucially, finding what the effects are on a patients’ quality of life.
Since 2013, the UK government has begun to phase in the introduction of Fluenz, an influenza (‘flu) vaccine to all children aged 2-17 years. Fluenz is not an injection but is given as a nasal spray. Since 2003, it has been used routinely in the USA, and has been given to over a million children. Influenza (‘flu) vaccines contain traces of egg because their production uses hen’s eggs. Fluenz contains a similar amount of egg to the injected ‘flu vaccines that are used routinely in the UK. Over the last ten years injected ‘flu vaccines have been shown to be safe in children and adults with egg allergy, even severe allergy, so they are now routinely given in GP surgeries with no special precautions needed. Until last year, Fluenz had not been used in children with egg allergy before. In the SNIFFLE-1 Study, 282 egg-allergic children were given Fluenz, and no child experienced a significant allergic reaction as a result. By conducting the SNIFFLE-2 study, we plan to add to the safety data generated by the original SNIFFLE-1 study, so that in future years the intranasal Fluenz vaccine can be given to egg-allergic children and young people outside hospital. The study will run during the winter ‘flu vaccination season, which is from autumn 2014 to early 2015.