This fall, the Julius Center for Health Sciences and Primary Care – part of University Medical Center (UMC) Utrecht – will start the largest vaccination study ever conducted in the Netherlands. This will be done in collaboration with 750 general practitioners (GPs), the Spaarne Hospital in Hoofddorp, and the Netherlands Vaccine Institute (NVI). The effectiveness of a new vaccine against the pneumococcal bacterium will be tested in a group of 85,000 people 65 years of age and above. One in every hundred people over the age of 65 will suffer from a severe infection caused by this bacterium, such as pneumonia, meningitis, or blood poisoning. The death rate among people in this age group who became sick as a result of an infection is 30 to 50 percent among the elderly and high-risk patients.
The vaccine to be studied is what is known as 13-valent pneumococcal conjugate vaccine. This is a more comprehensive version of the 7-valent pneumococcal conjugate vaccine, which was included in the Dutch government’s vaccination program for children in 2006.
The study is being carried out under the name CAPITA (Community-Acquired Pneumonia Immunization Trial) and will go on for two years. It is a double-blind, placebo-controlled trial. Half of the participants will be given a placebo that contains no active ingredients, and the other half will be given the trial’s vaccine. If the vaccine turns out to be effective, the other group will be vaccinated as well.
To give significant (reliable) results, 85,000 older people (age 65 and above) from five regions will have to participate in the study. The participants are being carefully selected in cooperation with their GPs. They will be given either the pneumococcal vaccine or the placebo along with their flu shot at their local vaccination center during the months of October and November. A substudy will be conducted together with Spaarne Hospital in Hoofddorp. The 2,000 participants in this substudy will be visited in their homes in order to study pneumococcal bacteria antibodies in the blood. The CAPITA trial is being funded and made possible in part by the pharmaceutical company Wyeth.
The international body WHO (World Health Organization) has issued a positive recommendation with regard to giving the pneumococcal vaccine to older people. Most European countries have already implemented this recommendation. In 2003, the Health Council of the Netherlands advised the minister to conduct further research in this country.