Meningitis Vaccine Studies

Meningococcal bacteria (Neisseria meningitidis types A, B, C, Y, and W135) are responsible for most meningococcal diseases worldwide.  Groups B and C are the most important groups in Australia. 

Meningococcal infection can cause several serious diseases, including meningitis (infection of the membranes covering the brain), septicaemia (infection of the bloodstream), infection of the joints, infection around the heart, and pneumonia.

Meningococcal disease can occur in people of all ages. The symptoms of meningococcal disease are similar to other diseases. Symptoms include fever, aches chills and headaches. Infection can result in hospitalisation and even death in children and adults.  Despite  treatment, there is a 7-19% death rate with any type of meningococcal disease. 

For more information about meningococcal disease click here. 

Thanks to our volunteers, progress is being made in the search for effective vaccines to protect children and adults from the types of meningococcus bacteria that cause meningococcal disease.
  
Meningoccocal B Study for Adolescents Aged 11 - 17 years
 

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Healthy adolescents aged between 11 – 17 years were invited to take part in an investigational Meningococcal B (Men B) vaccine study.
This study is being done to:
Compare 2 batches of vaccine manufactured at two different sites;  
To see if the Men B vaccines in this study are safe to give to adolescents and;
To see if these vaccinated adolescents make antibodies to the disease.


STUDY STATUS: Recruitment closed - Study Ongoing
 

The Meningococcal B Vaccine Study for Children and Teenagers  11-18 Years of Age (2009)

77 young people aged 11-18 years volunteered for the study at VTG. Stage 1 of the study evaluated the immune response to the vaccine, and the safety of the vaccine. Volunteers received 3 doses of a placebo or 3 doses of 60mcg, 120mcg or 200mcg Meningococcal B Vaccine. 

Stage 2 began in March 2010 with 33 participants. Those in the 120mcg and 200mcg groups were invited to remain in the study to assess the effectiveness of these dose strengths over the longer term. To do this, blood samples are taken every 6 - 12 months. This stage of the study will take 31/2 years.

STUDY STATUS: Recruitment closed - Study Ongoing 

 

The Meningococcal B Vaccine Study for Adults 18-40 Years of Age (2008 to 2009) 

Vaccine Trials Group conducted 3 early phase studies in healthy adults, adolescents and toddlers to assess the safety and effectiveness of a Meningococcal vaccine  made by Wyeth. The vaccine was based on a recombinant (artificially produced) protein of the bacteria. Three different dose levels were given:  20, 60 and 200ug.

The Meningococcal B Vaccine Study for adults aged 18-40 Years of Age (2008 to 2009) used a medium dose level (120ug) which was chosen based on previous results. Some of the levels of the non-active ingredients were also changed in this vaccine to make it easier to manufacture and increase its stability. The main aims of this study were:  
  • Collection of  large volumes of blood from healthy vaccinated adults, to use in tests that will assist in the development of the vaccine.
  • Continued assessment of the safety and effectiveness of the vaccine.
STUDY STATUS: Completed

The Combined Meningitis Vaccine Study for Toddlers Aged 12-18 Months

The purpose of this study was to reduce the number of injections toddlers receive while still protecting them against the germs that cause meningitis. The study also assessed how long protection would last.

The current Australian Immunisation Schedule for babies aged 12 months recommends 3 separate injections:  Meningoccocal C (MenC), Haemophillus Influenzae type b (Hib) and measles, mumps and rubella (MMR).

This study investigated whether the combined vaccine (HibMenC) is as effective as giving each vaccine separately. The MMR vaccine was also given.

The combined HibMenC vaccine is already licensed and being used for babies in the United Kingdom.

STUDY STATUS: Completed

The Toddler Four in One  (ACW-135) Meningitis Vaccine Study for Toddlers Aged 10-12 months

This study looked at a vaccine called TetraMen-T, which is designed to protect young children under the age of 2 years against meningococcal groups A, C, Y, and W-135.  Immunity to all 4 of these groups will offer wider protection than is currently available.
The study aimed to test how well the vaccine works and also how well tolerated it was.
STUDY STATUS: Completed 

The Meningococcal B Vaccine study for adults 18-25 years of age (2006 to 2007)

This study was a phase 1 trial (meaning the first time the vaccine has been used in humans) of a new vaccine made by Wyeth, to protect against meningococcal B disease. Participants received three doses of vaccine or placebo.

The aim of this study was to determine how well-tolerated and effective the vaccine was in adults aged between 18 and 25 years. This is a high-risk age group for the disease. 

STUDY STATUS: Completed

 

The Meningococcal B Vaccine study for Adolescents and Toddlers (2007)

These 2 studies commenced in 2007 following the Meningococcal B vaccine study for adults.

STUDY STATUS: Completed

 

The Combined Meningitis (HibMenCY) Vaccine Study for infants aged 6-12 weeks (2005 to 2007)

This study was run at three sites within Australia with 1100 babies. Perth recruited the target number of 200 babies by February 2006.

The study combined the Meningococcal C vaccine and the Meningococcal Y strain vaccine, with the Haemophilus influenza type B (Hib) vaccine that is normally given at two, four and six months of age.

The aim of this study was to see how well the new combined Hib-MenCY vaccine worked when given to babies during their primary vaccination course. It is hoped that in the future, the use of combined vaccines will protect babies against more diseases at an earlier age with less actual injections.

STUDY STATUS: Completed

Last updated 14 November 2011