The following are ongoing vaccine clinical trials conducted by the Stanford-LPCH Vaccine Program. For more information about clinical trials and a nationwide database of clinical trials, please go to ClinicalTrials.gov.
NIH-Sponsored Malaria Vaccine Trial A Phase I, Randomized, Controlled, Dosage-Escalation Trial to Evaluate the Immungenicity, Double-Blind, Safety, Reactogenicity of an Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Healthy Adults 18 to 45 Years of Age. (DMID 05-0050)
Thank you for visiting the Stanford-LPCH Vaccine Program website to learn more about the NIH-sponsored Malaria Vaccine Clinical Trial.
SUMMARY: Malaria is caused by the Plasmodiumparasite and is transmitted from person-to-person through the bite of a female Anophelesmosquito. The disease currently represents one of the most prevalent infections in tropical and subtropical areas causing severe illness in 300 to 500 million individuals worldwide and causing up to three million deaths every year. Most of these deaths occur among children and pregnant women in the developing world, especially in sub-Saharan Africa. Although most people affected with malaria are from the developing world, the disease also affects travelers.
Enrolling in this study may help us develop a possible vaccine for this devastating disease by comparing the safety and immune response of varying doses of a malaria vaccine. The vaccine will be administered to healthy adults by intramuscular injection into the upper arm.
Dr. Cornelia L. Dekker, Professor of Pediatrics, will serve as the Principal Investigator for the Stanford-LPCH portion of the trial. The trial is sponsored by the National Institutes of Health and is taking place at Vanderbilt and Stanford Universities.
This study requires a firm commitment from the volunteers, so we recommend that you read carefully through this description of the study and review the eligibility criteria to determine if you would like to participate.
If you decide to help us, you will make 17 clinic visits at Stanford Hospital over a 12 month period. You will also receive 4 brief phone contacts. You will receive three doses of either a malaria vaccine (5 out of 6 chance) or a placebo injection that contains no vaccine (1 out of 6 chance). A blood sample will be taken at 11 of the clinic visits. After the 17 clinic visits are completed participants may be contacted by study staff once a year by telephone for an additional four years. Participants will receive $30.00 reimbursement for each regularly scheduled non-vaccination clinic visit and $60.00 for each vaccination visit that they complete. There will be no costs for participating in the study and parking vouchers will be given. If this sounds like a study you might be interested in we strongly encourage you to review the eligibility criteria on our website to see if you can qualify. Thank you for taking the time to learn more about our study. We look forward to the possibility of working with you, please feel free to contact us if you have any questions.
ELIGIBILITY: We are enrolling healthy adults who are 18 to 45 years of age. To see if you meet the eligibility requirements and to learn more about the visit schedule for this study, please click this link: Eligibility Criteria and Visit Schedule
FOR MORE INFORMATION: Please contact the Stanford-LPCH Vaccine Program at (650) 498-7284, or email us at Vaccines_Program@stanford.edu
(For further information regarding your rights as a participant, please call 1-866-680-2906 or write the Administrative Panel on Human Subjects in Medical Research, Administrative Panels Office, Stanford University, Stanford, CA 94305-5401.)
Health Impact of Congenital Cytomegalovirus Infection (Enrollment Closed)
SUMMARY: Human Cytomegalovirus (HCMV) is a common virus that infects most people at some time in their lives. It is not a well-known virus because it does not cause symptoms in most people. The purpose of this study is to determine the prevalence of congenital HCMV infection in Northern California newborn infants and what problems HCMV infection can cause. Improved knowledge about HCMV infection is needed because HCMV can cause serious damage to a fetus before birth if the mother becomes infected during pregnancy. This happens in about one pregnancy out of every 100. When it does, about 10% of infants born with congenital HCMV infection can have serious problems after birth with long-lasting problems including hearing loss, mental retardation, seizures and eye problems. In this study, we plan to screen 20,000 newborn infants in 3 local hospitals to see if they have the infection by swabbing the inside of their mouths to obtain a sample of saliva. Babies who have congenital HCMV infection will be offered enrollment into a companion study that will provide free hearing screening and medical visits to check the baby at 4, 8, 12, 24 and 36 months of age. We also will study the babies' immune response to the infection. There is no screening test available for congenital HCMV infection outside of a research study. We hope that by testing the babies and obtaining some information from their mothers, we can learn who is at risk for this infection and what problems may develop as a result. This study is sponsored by the National Institutes of Health.
ELIGIBILITY: We finished enrolling 20,000 infants less than 2 weeks old at Lucile Packard Children's Hospital, Stanford, CA, El Camino Hospital, Mountain view, CA and Santa Clara Valley Medical Center, San Jose, CA. We are still open for already-confirmed CMV-positive babies to be referred into our study for follow-up.
FOR MORE INFORMATION: Please contact Raquel Fleishmann at (650) 724-9224.
