MenPF-1 - A New Vaccine Against Meningococcal Disease (NCT01640652) | Clinical Trial Compass
CompletedPhase 1
MenPF-1 - A New Vaccine Against Meningococcal Disease
United Kingdom52 participantsStarted 2012-08
Plain-language summary
In this study the investigators are testing a new vaccine against Neisseria meningitidis, the leading infective cause of childhood death in the UK. This bug (also known as meningococcus) can infect the lining of the brain (meningitis) or the blood stream (septicaemia) and can affect all ages, but especially children, adolescents and young adults.
The bug is classified into different groups based on its outer capsule (or shell), and this study will test a new vaccine to protect against group B meningococcus (MenB) disease, which is the most common type in the UK.
Vaccines are given to prepare the immune system to fight an infection. Vaccines work by stimulating the immune system to produce specialised proteins (called antibodies) and white blood cells designed to kill the bug later in life if needed.
Vaccines against other types of meningococcus have been developed and saved many lives. However MenB is different because its outer capsule does not stimulate the immune system very effectively. There is therefore no broadly effective vaccine against MenB disease.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Willing and able to give informed consent for participation in the study
* Aged between 18 and 50 years
* In good health as determined by medical history, physical examination and clinical judgment of the investigators
* (Females) Willing to use effective contraception (such as the oral contraceptive pill, contraceptive implant or barrier methods) from one month prior and for the duration of the study
* Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of diary cards
* Willing to allow his or her General Practitioner and/or Consultant, if appropriate, to be notified of participation in the study
* Confirmation from GP that they are aware of the inclusion and exclusion criteria and are satisfied from their knowledge of the volunteer that they are suitable to enrol
Exclusion Criteria:
* History of significant organ/system disease that could interfere with trial conduct or completion
* Have any known or suspected impairment or alteration of immune function
* Study significant abnormalities on screening investigations at the discretion of an Investigator
* Receipt of a live vaccine within 4 weeks prior to vaccination or a killed vaccine within 7 days prior to vaccination
* Plan to receive any vaccine other than the study vaccine within 4 weeks following vaccination
* Scheduled procedures requiring general anaesthesia during the study
* Participant who is terminally ill
* Receipt of imm…
What they're measuring
1
To investigate safety and tolerability of 25 µg or 50 µg of the serogroup B meningococcal protein vaccine MenPF-1