Meningitis Vaccine Studies

Meningococcus (Neisseria meningitidis) is a bacterium (a type of germ) that can cause several serious diseases, including meningitis (infection of the membranes covering the brain), meningococcemia (infection of the blood), 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, with fever, aches, chills, and headache.  The disease progresses rapidly, so even with proper treatment, the death rate is about 7% to 19% in patients with any type of meningococcal disease, and is as high as 53% in patients with meningococcemia.  About 20% of patients who survive meningococcal meningitis are left with serious neurological (brain or nerve) damage.There are at least 13 different types of meningococcus bacteria.  The five types   that are responsible for causing the most disease are called A, B, C, Y, and W-135 The Vaccine Trials Group, Telethon Institute for Chid Health Research are conducting several   vaccine studies that may protect children and adults against  the types of meninococcus bacteria that cause meningococcal disease.
 

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The Meningococcal B Vaccine study for children and teenagers  11-18 years of age (2009)

The purpose of this study is to collect information about how safe the Meningococcal B vaccine is in healthy adolescents aged 11-18 years of age. This Meningococcal B vaccine is new but has been given to over 100 adults, 127 adolescents and children and 99 toddlers. Since these studies have occurred some of the ingredients in the vaccine have changed so that the vaccine can be made more easily. In stage 1 of the study participants will be randomly placed into one of two groups by computer program to either receive the Men B vaccine or a placebo vaccine. A placebo vaccine looks like the study vaccine but only contains salty water. Participants will not be able to choose which group they are in, and will not know which group they are in until the study is completed.  Involvement in this part of the study is for 12 months.

Stage 2 is a follow up study which is optional (only if participants would like to be involved). At the end of this study  participants may be invited to take part. This phase of this study takes 3.5 years.

What does the study involve?
  • attend 6 study visits at The Princess Margaret Hospital over 12 months.
  • have 1 follow up visit over the phone at the end of the study
  • have a health assessment and a physical exam if  needed
  • receive a vaccine (an injection into the arm) at three different times.
  • have temperature, blood pressure and pulse recorded

  • females will need to have a  urine pregnancy test before receiving each dose of the vaccine
  • 4 blood  samples (about 2 tablespoons each time). An anaesthetic cream can be used to numb the skin beforehand.
  • be asked to record information in an electronic diary about how you feel after each injection.

STUDY STATUS: Recruitment closed - Study Ongoing 

The Meningococcal B Vaccine study for adults 18-40 years of age (2008 to 2009) 

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

This year  we are conducting another vaccine study in healthy adults, using a medium dose level (120ug) which was chosen based on the previous results. This vaccine has also had some of the levels of the non-active ingredients changed to make it easier to manufacture and increase its stability. The main aim of this study is to collect large volumes of blood from healthy vaccinated adults, to use in tests that will assist the development of the vaccine. Additionally we also aim to continue assessing the safety and effectiveness of the vaccine.
STUDY STATUS: Recruitment Closed - Study Ongoing

The Combined Meningitis Vaccine Study for toddlers aged 12-18 months

The purpose of this study is to try to reduce the number of injections that toddlers receive while still protecting them against the germs that causes meningitis. The current Australian Immunisation Schedule for babies aged 12 months is Meningoccocal C (MenC), Haemophillus Influenzae type b (Hib) and measles, mumps and rubella (MMR) given as three different injections. This study will look at whether the combined vaccine (HibMenC) is as effective as when given separately. The MMR vaccine will also be given. The study will also assess how long the protection lasts for. The combined HibMenC vaccine is already licensed and being used for babies in the United Kingdom. We are looking for 100 healthy toddlers aged between 12 and 18 months who have not yet had their 12-month vaccinations.

STUDY STATUS: Recruitment Closed - Study Ongoing

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

This study is looking at a vaccine called TetraMen-T, which is designed to protect young children under the age of 2 against the meningococcal groups A, C, Y, and W-135.  It is hoped that it will help young children develop immunity against all 4 of these groups, and thus offer wider protection than is currently available.  The study aims to test how well the vaccine works and also how well it is tolerated by young children.

STUDY STATUS:  Study is completed - results pending 


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

Sponsored by Wyeth, this study is a phase 1 trial (meaning the first time the vaccine has been used in humans) of a new vaccine that is hoped will provide protection against meningococcal B disease. A vaccine for this disease has been elusive for many years however it is vital because the B strain is the most common type of Meningococcal disease in Western Australia, accounting for about 80% of cases. The aim of this study is to determine how well-tolerated and effective the vaccine is in adult participants aged between 18 and 25 years, a high-risk age group for the disease. Participants received three doses of vaccine or placebo over 8 months. This part of the study has now been completed and participants have volunteered to return for a follow up study.

STUDY STATUS: Study is 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. Recruitment has closed and we are currently completing study appointments and preliminary results should be available at the end of the year. Further studies for infants may commence in 2008.

STUDY STATUS:  Study is 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 involved. The recruitment for Perth began in April 2005 and the target of 200 babies was reached in February 2006. The study combines 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 is to see how well the new combined Hib-MenCY vaccine works 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. The study completed in June 2007 and data is now in the process of being analysed. We hope to receive results from this study by the end of this year.

STUDY STATUS: Study completed - results pending.

Last updated 16 July 2009