Stanford-LPCH
Vaccine Program

Clinical Trials

Current Studies


Completed Studies






T-cellSeasonal Flu Vaccine Study for Twins (T-cell Responses Y5-2013-2014)
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 young twins, 1-8 years old, 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 vaccine that will be used for the public during the fall flu season.  The research will be conducted at Stanford University by Dr. Cornelia L. Dekker, M.D., Professor of Pediatrics at Stanford (Stanford-LPCH Vaccine Program) and Mark Davis, Ph.D. (Institute of Immunity Transplantation and Infection)


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)

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.

 



DNA_Vaccine 2012-2013 Experimental Seasonal Influenza DNA Vaccine Study (Enrollment Closed)
                 
An Open-Label, Randomized Phase 1b Study of the Safety and Immunogenicity of Investigational Seasonal Influenza DNA Vaccine (HA DNA), Followed by Trivalent Inactivated VAccine (TIV) Administered Intradermally (ID) or Intramuscularly (IM) in Healthy Adults Ages 18-70 Years (VRC703)

SUMMARY The Stanford-LPCH Vaccine Program is seeking healthy adults to take part in an experimental universal flu vaccine study.  The purpose of this trial is to study the the safety and effectiveness of three different  seasonal flu vaccines.  The other main purpose is to see which vaccination schedules result in the best immune responses.  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). Three different types of flu vaccines are being studied. Two are regular seasonal flu vaccine that is approved by the Food and Drug Administration (FDA) for use in the influenza season. The other vaccine is experimental and is not approved by the FDA.


B-Cell2013 Seasonal Flu Vaccine Study (B cell)

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, and young adults to take part in an influenza (commonly known as "the flu") vaccine study.  In this study, we will be looking at the B cell immune response differences between age groups to the flu vaccine. We would like to compare the B-cell response to flu vaccine in vaccine-naïve young children and in young adults who did not receive a seasonal influenza vaccination in 2012-2013.
 The vaccine used in the study is licensed by the FDA and is not experimental.  It’s the same seasonal flu vaccine that will be given to the public during the fall flu season.   



Bangladesh

Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh

(Enrollment Closed)


Oral vaccines are given to children around the world to prevent diseases that have serious, long-term or fatal consequences. Two such vaccines, the oral polio vaccine and oral rotavirus vaccine, aim to prevent children from getting sick with paralytic polio or rotavirus diarrhea: two potentially devastating illnesses.  However, these vaccines are generally not as effective at preventing disease in children living in developing countries, like Bangladesh, as they are in developed countries. The Stanford-LPCH Vaccine Program is seeking healthy infants to take part in a research study to look at immune response differences between healthy children living in the United States compared with children from India and Bangladesh. This will possibly lead to the development of more effective vaccines.

 

Varicella
Varicella Zoster Virus (VZV)

Study of Age-Related Immune Responses to VZV
T Cell Responses to Varicella Zoster Virus After Vaccination and Viral Escape





Summary:  The Stanford-LPCH Vaccine Program is seeking healthy adults to take part in a study of the immune system of individuals who have had chickenpox in the past in order to learn more about  the influence of age and inherited factors on VZV-specific T cell response in naturally-acquired VZV immunity and the response to VZV vaccination. This knowledge may lead to an improvement in vaccination strategies and identification of ways to improve vaccine responses in older individuals. 




Flu

Immune Senescence in the Elderly: Comparison of Immune Reponses to Influenza Vaccine in Adults of Different Age Groups

 




FluSeasonal Flu Vaccine Study: For 8-33 years old
Vaccination and infection: indicators of immunological health and responsiveness; Project 1: Plasmablast trafficking and antibody response in influenza vaccination. (SLVP021) - 2013

 


ILIImmune Responses to Influenza-like Illness








Flu
Seasonal Flu Vaccine Study: For 18-30 years old

(Fall 2012 HIPC IOF: The Human Mucosal Immune Responses to Influenza Virus: A Systems Biology Approach: CCHI DF: Innate Immune Responses to Influenza Virus in Single Human Nasal Epithelial Cells)

T-CellSeasonal Flu Vaccine Study (T-cell  Responses 2012-2013)
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




SHIMR

Seasonal Flu Vaccine Study: For 18-32 years old

Vaccination and infection: indicators of immunological health and responsiveness; Project 1: Plasmablast trafficking and antibody response in influenza vaccination - 2012 (Referrals from past studies only)

 


FluStanford Flu Vaccine Study: For 18-30 years old
Spring 2012 Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization




The research will be conducted at Stanford University by Dr. Cornelia L. Dekker, M.D., Professor of Pediatrics at Stanford (Stanford-LPCH Vaccine Program), Mark Davis, Ph.D. (Institute of Immunity Transplantation and Infection) and Dr. Stephen Quake, Professor of Bioengineering, Co-Chair, Department of Bioengineering.




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).





Immune Responses to the Influenza Vaccine in Persons with Mitochondrial Disease (MELAS)

SUMMARY The Stanford-LPCH Vaccine Program is seeking healthy adolescents and adults to participate in an influenza (commonly known as "the flu") vaccine research study to better understand effects of immunizations for people with MELAS syndrome.  We will enroll 15 healthy male and female adult participants (18-65 years old) along with 15 otherwise healthy adolescents and adults (12-60 years old) who have one of the genetic changes associated with a metabolic disorder called MELAS syndrome.




ILI

Flu Study 2012, Immune Responses to Influenza-like Illness




B-Cell2011 Seasonal Flu Vaccine Study (B-cell)

B-cell Immunity to Influenza and Measuring the Immunome: Genomic Approaches to B-cell Repertoire






T-CellSeasonal Flu Vaccine Study (T-cell  Responses 2011-2012)
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


SHIMR

Seasonal Flu Vaccine Study: For 18-49 years old

Vaccination and infection: indicators of immunological health and responsiveness; Project 1: Plasmablast trafficking and antibody responses in influenza vaccination




T-CellSeasonal Flu Vaccine Study
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


2008 Flu Vaccine Study for Toddlers


lady bug3

Kinetics of B-Cell Reponses to Live Attenuated Influenza Vaccine (LAIV) in Young Children Two Years of Age


Vero Cell-Culture Derived Avian Flu Vaccine Study

Official Title:  A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Clinical Trial of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Immunization With Inactivated, Vero Cell-Culture Derived Influenza A/H5N1 Vaccine Given Alone or With Aluminum Hydroxide to Healthy Young Adults (DMID 06-0052)
Southern Hemisphere Seasonal Flu Vaccine Study
Official Title: A Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Immunogenicity, Safety, and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults ≥18 to <65 Years of Age (DMID 06-0016)
Avian Flu Vaccine Study With Adjuvants
Official Title: A Randomized, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine with Different Adjuvants in Healthy Adults (DMID 04-062)
Intramuscular vs. Intradermal Seasonal Flu Vaccine

Official Title: Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route Compared to an Intramuscular Vaccination With Fluzone in Healthy Adults (DMID 05-0075)
TIV vs. LAIV- Adults
Official Title:  Influenza Immunity: Protective Mechanisms Against a Pandemic Respiratory Virus (SLVP 007)-Adults
Influenza causes natural pandemics, which can incapacitate a large fraction of the population.  The purpose of these Phase IV, NIH-sponsored clinical trials is to provide a better understanding the natural and adaptive immune response to the flu virus so that more effective vaccines can be developed.  Volunteers received one of two licensed influenza vaccines, either inactivated vaccine given IM or live, attenuated vaccine given intranasally.  Detailed studies of antibody, CD4 & CD8 T-cell and NK cell studies are performed as part of this large Program Project. A series of studies will be conducted over a five-year period.

Year 1

Year 2
Year 3
TIV vs. LAIV- Children
The purpose of these Phase IV, NIH-sponsored clinical trials is to provide valuable information about how children develop immunity to influenza following flu immunization.  Studies of CD4, CD8 T-cells, B-cells and antibody responses to influenza vaccine strains are performed.  These studies are associated with the TIV vs. LAIV adult studies titled Influenza Immunity: Protective Mechanisms Against a Pandemic Respiratory Virus.

Year 2
Official Title: Open-label Study of the Immunogenicity of an Inactivated Influenza Vaccine Given to Previously Unimmunized Children Between 6 Months and 5 Years of Age. Subset Follow-up for Nasal Swabs for Influenza PCR (SLVP010): Year 2 Year 2
Official Title: A Randomized Comparison of the Immune Response to Either Inactivated or Live, Attenuated Influenza Vaccine in Children 5-9 Years of Age. Subset Follow-up for NP Samples for Influenza PCR (SLVP011): Year 2   Year 3
Official Title:  A Randomized Comparison of the Immune Response to Either Inactivated or Live, Attenuated Influenza Vaccine in Children 5-9 Years of Age (SLVP-011): Year 3
A Phase I/II Clinical Trial Evaluating the Safety and Immunogencity of LC16m8, A Modified Vaccinia Vaccine, in Healthy Volunteers
Immune Response to Influenza in Young Children Immunized with Trivalent Inactivated Influenza Vaccine (TIV).
Antiviral Immune Mechanisms in Early Childhood
Human Cytomegalovirus (HCMV) Infection and Immunity In Healthy Adults
A Multicenter, Double Blind, Randomized Dose-Response Study of Dryvax Vaccine Against Smallpox in Previously Vaccinated Adults
Radiologic Imaging Study of the Bowel in Young Children with Rotavirus Infection

 

 

Stanford Medicine Resources:

Footer Links: