Clinical Trials |
Completed Studies |
Current Studies
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.
Links to studies:
2009 Seasonal Flu Vaccine Study (B-Cell)
2009 Seasonal Flu Vaccine Study (T-Cell)
2009 Adult Flu Vaccine Study
2009 Novel H1N1 Flu Vaccine Study
NIH-Sponsored Malaria Vaccine Trial
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Seasonal Flu Vaccine Study (Enrollment Closed)
B-cell Immunity to Influenza and Measuring the Immunome: Genomic Approaches to B-cell Repertoire
SUMMARY The Stanford-LPCH Vaccine Program is seeking healthy children, teenagers and adults to take part in an influenza (commonly known as "the flu") vaccine study. In this study, we will be looking at immune response differences between age groups and between the two different vaccines given to identical twins. Immune responses will include the B-cell response to the trivalent inactivated influenza vaccine (TIV) given as a flu shot and live attenuated influenza vaccine (LAIV) given as intranasal spray. Both are licensed by the FDA and are not experimental vaccines. They are the same seasonal flu vaccines that will be used for the public during the fall flu season. The research will be conducted at Stanford University by Mark Davis, Ph.D. (Institute of Immunity, Transplantation and Infection) and Dr. Cornelia L. Dekker, M.D., Professor of Pediatrics at Stanford (Stanford-LPCH Vaccine Program).
We hope to compare the B-cell response to LAIV and TIV in the identical twin children given LAIV/TIV within the pair and the B-cell response of younger and older adults given TIV by analyses of immunoglobulin gene repertoire and functions of recombinant influenza-specific monoclonal antibodies. We will also analyze the T-cell receptor repertoire in the same study volunteers. Lastly, we will compare the reactivity and affinity of influenza-specific polyclonal antibodies induced the TIV between younger and older adults.
To qualify you should be:
- Healthy
- Group A: 8-17 years old identical twin pairs
- Group B: 18-30 years old non-twin adults
- Group C: 70-100 years old non-twin adults
- Able to attend 3 clinic visits at Stanford within a one month-period (September - December)
- Able to provide 3 blood samples
If eligible, you will receive:
- Group A: 2009-2010 either a flu shot or intranasal spray vaccine
- Group B and C: 2009-2010 flu shot vaccine
- $30 per clinic visit
- Parking vouchers
ELIGIBILITY:
To review the complete list of eligibility requirements and to learn more about the visit schedule for this study, please click this link: ** Eligibility Criteria and Visit Schedule **
For further information or to volunteer for other research studies:
Please contact the Stanford-LPCH Vaccine Program at (650) 498-7284 or email us at Vaccines_Program@stanford.edu
If you are a twin, and would like to join the Northern California Twin Registry (not affiliated with Stanford University), call 1-800-SRI-TWIN (1-800-774-8946). You may be eligible to participate in other research studies that could help scientists advance new treatments for diseases and explain the roles of genetics and the environment in health and behavior.
For general information about participant rights, contact 1-866-680-2906
Seasonal Flu Vaccine Study (Enrollment Closed)
T-cell and General Immune Responses to Influenza, Single-cell Phospho-protein Signaling Analysis of the Response to Influenza Vaccination and Measuring the Immunome: Genomic Approaches to B-cell Repertoire
SUMMARY The Stanford-LPCH Vaccine Program is seeking healthy children, teenagers and adults to take part in an influenza (commonly known as "the flu") vaccine study. This study will investigate markers and mechanisms and define general predictors for immunological health. This goal is analogous to what has been achieved in cardiovascular medicine where the levels of different forms of cholesterol have provided useful benchmarks for cardiovascular health. In this context, immunization with approved flu vaccines represents a safe and accessible opportunity to gauge the immune response in a particular individual as a function of age and genetics and then to try to find predictive biomarkers. The vaccines used are licensed by the FDA and are not experimental. They are the same seasonal flu vaccines that will be used for the public during the fall flu season. The research will be conducted at Stanford University by Mark Davis, Ph.D. (Institute of Immunity Transplantation and Infection) and Dr. Cornelia L. Dekker, M.D., Professor of Pediatrics at Stanford (Stanford-LPCH Vaccine Program).
We plan to compare lymphocyte and serology responses, evaluate changes in the cytokine profile in the immune response, evaluate any potential gene expression signatures associated with immune senescence, compare lymphocyte and monocyte reactivity with the lymphocyte and serology responses, identify age-specific biomarkers or clusters of markers, quantify the frequency of influenza-specific T-cells pre and post vaccination, and determine the effective breadth of T-cell repertoire to an influenza vaccine within an individual.
To qualify you should be:
- Healthy
- Group A: 8-17 years old identical twin pairs
- Group B: 18-30 years old identical twin pairs
- Group C: 18-30 years old fraternal twin pairs
- Group D: 40-49 years old identical twin pairs
- Group E: 40-49 years old fraternal twin pairs
- Group F: 70-100 years old adult twin pairs
- Group G: 70-100 years old adults
- Able to attend 3 clinic visits at Stanford within a one month-period (September - December)
- Able to provide 3 blood samples
If eligible, you will receive:
- Group A: 2009-2010 either a flu shot or intranasal spray flu vaccine
- Group B, C, D, and E: 2009-2010 intranasal spray flu vaccine
- Group F and G: 2009-2010 flu shot vaccine
- $30 per clinic visit
- Parking vouchers
ELIGIBILITY:
To review the complete list of eligibility requirements and to learn more about the visit schedule for this study, please click this link: ** Eligibility Criteria and Visit Schedule **
For further information or to volunteer:
Please contact the Stanford-LPCH Vaccine Program at (650) 498-7284 or email us at Vaccines_Program@stanford.edu
If you are a twin, and would like to join the Northern California Twin Registry (not affiliated with Stanford University), call 1-800-SRI-TWIN (1-800-774-8946). You may be eligible to participate in other research studies that could help scientists advance new treatments for diseases and explain the roles of genetics and the environment in health and behavior.
For general information about participant rights, contact 1-866-680-2906
2009 Adult Flu Vaccine Study (Enrollment Closed)

Immune Senescence in the Elderly: Comparison of Immune Reponses to Influenza Vaccine in Adults of Different Age Groups
SUMMARY The Stanford-LPCH Vaccine Program is seeking healthy adults to take part in an influenza vaccine study (commonly known as "the flu"). We hope to discover new biological markers that are associated with the age-related immune response to the seasonal flu vaccine. The research will be conducted at Stanford University by Cornelia L. Dekker, M.D., Professor of Pediatrics, and by Mark M. Davis, Ph.D., Professor of Microbiology and Immunology. The trial is sponsored by the Ellison Medical Foundation and the Bill and Melinda Gates Foundation.
The flu vaccine used in this study is licensed by the FDA and is not experimental.
To qualify you should be:
- Healthy
- 18-30 or 60-100 years old at time of initial enrollment
- Able to attend 3 clinic visits at Stanford
- Able to provide 3 blood samples
If eligible, you will receive:
- 2009-2010 licensed seasonal flu vaccine
- $30 per clinic visit attended
- Parking vouchers
ELIGIBILITY:
To review the complete list of eligibility requirements and to learn more about the visit schedule for this study, please click this link: ** Eligibility Criteria and Visit Schedule **
For further information or to volunteer:
Please contact the Stanford-LPCH Vaccine Program at (650) 498-7284
or email us at Vaccines_Program@stanford.edu
For general information about participant rights, contact 1-866-680-2906
2009 Novel H1N1 Flu Vaccine Study (Enrollment Closed)
A Phase II Study in Healthy Adult and Elderly Populations to Assess the Safety and Immunogenicity of a Sanofi Pasteur H1N1 Influenza Vaccine Administered at Different Dose Levels Given With and Without Glaxo SmithKline AS03 Adjuvant (DMID 09-0058)
SUMMARY The Stanford-LPCH Vaccine Program is seeking healthy adults to take part in a novel H1N1 flu vaccine study. The purpose of this trial is to study the immune responses to two doses of the novel H1N1 flu vaccine when given with or without an adjuvant. The research will be conducted at Stanford University by Cornelia L. Dekker, M.D., Professor of Pediatrics. This trial is sponsored by the National Institutes of Health (NIH).
To qualify you should be:
- Healthy
- Age 18 years or older
- Able to attend 7-8 clinic visits at Stanford and complete 4 brief follow-up phone calls
- Able to provide blood samples at each clinic visit
If eligible, you will receive:
- The novel H1N1 flu vaccine given with or without an adjuvant
- $30 for each regular clinic visit and each of two follow-up phone calls completed
- Parking vouchers
ELIGIBILITY:
To review the complete list of eligibility requirements and to learn more about the visit schedule for this study, please click this link: ** Eligibility Criteria and Visit Schedule **
For further information or to volunteer:
Please contact the Stanford-LPCH Vaccine Program at (650) 498-7284
or email us at Vaccines_Program@stanford.edu or Join Our Mailing List (see Link on left-side of web page).
For general information about participant rights, contact 1-866-680-2906
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NIH-Sponsored Malaria Vaccine Trial (Enrollment closed)
A Phase I, Randomized, Controlled, Dosage-Escalation Trial to Evaluate the Immungenicity, 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 Plasmodium parasite and is transmitted from person-to-person through the bite of a female Anopheles mosquito. 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 7 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.)



