Stanford-LPCH
Vaccine Program

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:

If eligible, you will receive:

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:

If eligible, you will receive:

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)

Flu

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:

If eligible, you will receive:

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:

If eligible, you will receive:

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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Malaria Map

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.

(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.)



 

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