We are looking for healthy adults age 18 to 45 to help test an investigational vaccine for malaria. You do not need to be a Kaiser Permanente member to participate in this research, which is called the PfSPZ-CVac Malaria Vaccine Study.
Lisa Jackson, MD, MPH, senior investigator at Kaiser Permanente Washington Health Research Institute, is the lead researcher for the study, which is funded by the U.S. National Institutes of Health.
Malaria is a significant global health problem that infects 200 million people causing about 584,000 deaths worldwide each year. The vast majority of cases and deaths are in children less than 5 years old in sub-Saharan Africa. Malaria is caused by a parasite, which is transmitted by mosquito bites. Although there have been efforts to develop an effective malaria vaccine for many years, there is currently no licensed vaccine available.
The vaccine that is farthest along in development globally is the RTS,S vaccine, also known as Mosquirix™. This vaccine contains parts, or “subunits”, of the malaria parasite. It was first tested in adults in malaria-free regions. Adults who were given the vaccine were then exposed to malaria to see if the vaccine could prevent infection. Promising results from those trials led to the start of a large study involving 15,000 young children in Africa. The vaccine was modestly effective, reducing malaria cases by about one-third over a four-year period, but the protective effect lessened over time. Research continues on Mosquirix, which is considered to be a first generation vaccine that represents an important advance, but more highly effective vaccines are needed to achieve the goal of totally wiping out malaria.
This study will evaluate how well a newer investigational vaccine prevents malaria infection in adults. Rather than just the parasite subunits, this vaccine contains whole, live malaria sporozoites and can cause malaria infection. A sporozoite is the form of the parasite transmitted from the mosquito salivary glands into humans when the mosquito bites.
During the vaccination period, participants will also take weekly doses of an anti-malarial pill (chloroquine). This is done to allow the parasites in the vaccine to live in the body long enough to trigger a protective immune response, but not long enough to cause a malaria bloodstream infection.
This vaccination approach has been previously tested in clinical trials. The purpose of this study is to evaluate a more compressed vaccination schedule, giving the vaccine doses one week apart instead of several weeks apart to see if this could lead to immunity more quickly. The study will also evaluate how effective higher doses of the vaccine are when given on the compressed schedule.
We are enrolling healthy adults age 18 to 45. People who have medical conditions that affect the immune system or are taking medications that affect the immune system may not be in the study. There are other conditions that may make you ineligible for this study.
If you think you might want to be part of this study and would like more information, please email us at KPWA.firstname.lastname@example.org. Include your full name, phone number, and the best time to call, and we’ll get back to you soon.