LION MenB
Research type
Research Study
Full title
Early Protection against meningococcal disease B in infants
IRAS ID
265199
Contact name
Georgia Bullock
Contact email
Sponsor organisation
St George's, University of London
Eudract number
2021-001561-21
ISRCTN Number
ISRCTN52318758
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Summary of Research
In 2015, the United Kingdom became the first country in the world to introduce the meningococcal group B (Men B) vaccine into its routine schedule for infants. This vaccine has proved to be very effective in protecting 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 United Kingdom, babies are offered this vaccination at 2, 4, and 12 months.
We want to compare two different schedules of Men B vaccination, the standard schedule (at 2, 4, and 12 months) and the early schedule (at 2, 3, and 12 months). Receiving the first two doses of Men B vaccine by 3 months could provide infants earlier protection against Men B disease. This is what we are trying to find out through this study.We will recruit 220 babies. We will randomly (“toss of a coin”) assign these babies to one of the two study groups: one group will receive all recommended vaccines according to the standard UK schedule and the other will receive the second dose of Men B vaccine at 3 instead of 4 months and the first dose of PCV13 at 4 instead of 3 months. Both groups will receive an additional dose 'booster' dose at 12 months. We will obtain three blood tests over the study period to check the babies’ antibody levels against Meningococcus and Pneumococcus germs, and will ask caregivers to keep a record of any reactions that occur after their vaccinations.
Summary of Results
The LIONMenB study, early protection against meningococcal B disease in infants, is a clinical research study carried out by City St George’s University of London with a network of vaccine trial sites in the UK Paediatric Vaccine Group (UKPVG) and the UK Health Security Agency (UKHSA). The Chief Investigator was Professor Paul Heath and it was funded by GSK through an Investigator-initiated grant.
The meningococcal group B (Men B) vaccine has proved to be very effective in protecting against meningitis (infection of the lining of the brain) and septicaemia (blood poisoning) caused by the group B type of the meningococcus germ. In the United Kingdom, babies are offered this vaccination at 2, 4, and 12 months of age.
Since the introduction of the MenB vaccine in the UK there has been a reduction in the number of cases of MenB in infants and also a shift in the peak age of disease, to younger infants. This suggests that if the initial two doses of Men B vaccine could be completed earlier, by 3 months of age, then infants might have earlier protection against Men B disease and, overall, more disease could be prevented.
This study therefore aimed to compare two different schedules of MenB vaccination, the standard schedule (at 2, 4, and 12 months) and a reduced-interval schedule (at 2, 3, and 12 months). To allow for this change, the first dose of the vaccine against the pneumococcus germ (PCV13 vaccine) was moved from 3 months in the standard schedule group, to 4 months in the reduced-interval schedule group. This study aimed to compare the immune response in babies receiving these two different vaccine schedules, as well as assess any differences in safety.
221 babies joined the study from 6 hospitals in England. They were randomly (“toss of a coin”) assigned to one of the two study groups. The babies received all their other routine childhood vaccinations as usual and were followed up for a total of 13 months. Three blood tests were collected at set times over the study period to check the babies’ antibody levels against the meningococcus and pneumococcus germs. We also asked caregivers to keep a record of any reactions that occurred after their vaccinations.
The study found that the reduced-interval group, receiving MenB at 2, 3 and 12 months, had lower antibody levels to MenB than those in the standard schedule group at the first blood test timepoint, but not at the other timepoints. However, the immune response was still robust and almost all babies in the study achieved protective antibody levels against MenB, regardless of allocated group.
The results showed giving the 2nd MenB vaccine dose earlier did not negatively affect the immune protection the babies received.
Giving the PCV13 dose later at 4 months of age rather than 3 months gave better immune responses for most of the pneumococcus germ sub-types when it was measured at 12 months of age. Almost all babies in the study achieved sufficient immune protection against the pneumococcus disease covered by the vaccine, in both groups.
The results showed giving the PCV13 vaccine dose later did not negatively affect the immune protection the babies received.
The side-effects that babies in both schedules experienced were within the expected range. The most common were reduced feeding, reduced activity, diarrhoea, crying and irritability. Other symptoms reported were redness and pain at the injection site, and vomiting. Fever was also
reported in some infants. There were no serious events related to vaccination. Both study groups reported similar levels of post-vaccination symptoms but the standard schedule group reported more irritability and crying than the reduced-interval group.
The results showed giving the MenB doses earlier resulted in fewer post-vaccination symptoms in the babies in this study.
Overall, giving the MenB doses to UK infants at 2, 3 and 12 months with PCV13 at 4 and 12 months has the potential to provide earlier protection against vaccine-preventable MenB disease up to 13 months of age, better immune protection against vaccine-preventable pneumococcal disease up to 13 months of age and may result in fewer post-vaccination symptoms. Based on the results of this study, the UK will make these changes in the childhood immunisation schedule in July 2025.
Once the full research paper is published, it will be made available on the City St George’s, University of London Vaccine Institute website: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fvaccine.ac.uk%252Fresearch%252Flion-menb%252F%2FNBTI%2FHMq9AQ%2FAQ%2F4f62b34a-f54b-4056-8409-19aeb99a97b4%2F2%2FF93djW3sz7&data=05%7C02%7Cnewcastlenorthtyneside1.rec%40hra.nhs.uk%7C975884dcff4a46f12d1208dda3461b6c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638846243697231338%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=tIClxEaNgM6KbRMVrEXEpRH9bhYKX8zuqRUBQwFKJOU%3D&reserved=0
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
21/NE/0093
Date of REC Opinion
7 Jul 2021
REC opinion
Further Information Favourable Opinion