Clinical Trials |
Current Studies |
Completed Studies
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)
- Enrollment Period: Stage 1- October 2006; Stage 2- January 2007
- SUMMARY: The emergence of the avian influenza virus strains in human populations outside of the U.S. has added urgency to ongoing efforts to develop plans for responding to potential world-wide outbreak. The purpose of this NIH-sponsored clinical trial is to compare the safety and immune response of varying doses of a Vero cell-culture derived A/H5N1 influenza vaccine, either alone or when combined with alum adjuvant. The experimental vaccine is manufactured by Baxter Bioscience. The Stanford-LPCH Vaccine Program enrolled 74 healthy adults between 18-40 years who were randomly assigned to receive one of five different vaccine dose combinations, or placebo. Four other universities are participating, with a total study enrollment of 215 volunteers. The trial will be completed in the fall of 2007 (enrollment is closed).
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)
- Enrollment Period: June - August 2006
- SUMMARY: The United States has faced a flu vaccine shortage for the last couple of years. The purpose of this NIH-sponsored clinical trial was to test the clinical consistency of different batches of vaccine in order to provide information needed to license the flu vaccine in the United States. The vaccine was manufactured by CSL Limited. The Stanford-LPCH Vaccine Program enrolled 133 healthy adults between 18-64 years, who were randomly assigned to receive one of four different lots of the same dose of flu vaccine, or placebo. Eight other universities participated, with a total study enrollment of 1,359 volunteers.
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)
- Enrollment Period: March 2006
- SUMMARY: The emergence of the avian influenza virus strains in human populations outside of the U.S. has added urgency to ongoing efforts to develop plans for responding to potential world-wide outbreak. The purpose of this NIH-sponsored study was to measure the immune responses to various A/H5N1 influenza antigen dose and adjuvant (none, alum or MF59) combinations to see which warrant further study. The experimental vaccine was manufactured by Chiron Corporation. The Stanford-LPCH Vaccine Program enrolled 81 healthy adults between the ages of 18-64 years who were randomly assigned to receive one of eight vaccine dose and adjuvant combinations, or placebo. Three other universities participated, with a total study enrollment of 393 volunteers.
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)
- Enrollment Period: September - October 2005
- SUMMARY: The purpose of this Phase II, NIH-sponsored clinical trial was to determine if administration of the flu vaccine into the skin and at lower doses would induce immune response and reactions comparable to the traditional method of injecting the vaccine into the muscle. The Stanford-LPCH Vaccine Program enrolled 75 adults between 18-64 years who were randomly assigned to one of four groups: two groups received the vaccine intradermally, one group under the skin, and one group in the arm muscle. Volunteers were also stratified by age. Nine other universities participated, with a total study enrollment of 1,597 volunteers.
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
- Enrollment Period: Fall 2003
- SUMMARY: This was the first in a series of studies to be conducted over the next five years. The Stanford-LPCH Vaccine Program randomized 86 subjects (16 children between 5-9 years of age and 70 adults 18-49 years of age) who were randomly assigned to receive either the inactivated flu vaccine (Fluzone), or the live, attenuated intranasal flu vaccine (FluMist).
- Enrollment Period: Fall 2004
- SUMMARY: This study provided follow-up of participants from Year 1 of the trial. The Stanford-LPCH Vaccine Program enrolled 44 adults who participated in Year 1 and who agreed to return for reimmunization in Year 2. Volunteers received the same vaccine dose assignment as in Year 1. Only adult participants were enrolled in Year 2. New protocols were developed to study children.
- Enrollment Period: September - October 2005
- SUMMARY: The Stanford-LPCH Vaccine Program enrolled 66 healthy adults between ages of 18-49 who were randomly assigned to receive either the inactivated flu vaccine (Fluzone), or the live, attenuated intranasal flu vaccine (FluMist).
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
- Enrollment Period: Fall 2004
- SUMMARY: The Stanford-LPCH Vaccine Program enrolled 31 children ages 6 mo.-5 years of age into this study. Volunteers received the inactivated flu vaccine (Fluzone) only.
Immune Response to Influenza in Young Children Immunized with Trivalent Inactivated Influenza Vaccine (TIV).
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
- Enrollment Period: Fall 2004
- SUMMARY: The Stanford-LPCH Vaccine Program enrolled 39 children in this study in Year 2. Volunteers were randomly assigned to receive either the inactivated flu vaccine (Fluzone), or the live, attenuated intranasal flu vaccine (FluMist).
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
- Enrollment Period: September - October 2005
- SUMMARY: The Stanford-LPCH Vaccine Program enrolled 42 young children between ages of 5-9 years. Volunteers were randomly assigned to receive either the inactivated flu vaccine (Fluzone), or the live, attenuated intranasal flu vaccine (FluMist).
A Phase I/II Clinical Trial Evaluating the Safety and Immunogencity of LC16m8, A Modified Vaccinia Vaccine, in Healthy Volunteers
- Enrollment Period: June 2005
- SUMMARY: Smallpox is an infectious disease, caused by a virus called variola. Smallpox used to be a major cause of death and sickness throughout the world, but was eliminated as a natural disease in 1977 by global vaccination against the disease. Up until 1972, everyone in the US was routinely vaccinated in childhood with Dryvax. Even though it no longer occurs naturally, smallpox has the potential to be used as a weapon of bioterrorism. Stanford-LPCH Vaccine Program enrolled 27 healthy adult between ages of 18-34 who have never been immunized against Smallpox. The goal of this study was to test a smallpox vaccine called LC16m8, which was licensed in Japan, and developed in the US by VaxGen, and compare it to the US smallpox vaccine called Dryvax, which is currently licensed by the FDA.
Immune Response to Influenza in Young Children Immunized with Trivalent Inactivated Influenza Vaccine (TIV).
- SUMMARY: In order to gain a better understanding of how a child's immune system responds as a result of being exposed to flu vaccine, the Stanford-LPCH Vaccine Program enrolled 21 healthy children between the ages of 3 and 9 in 2003, who had previously been immunized against the flu, and vaccinated them with the trivalent inactivated flu vaccine (Fluzone) during the summer then again just prior to immunization and 4 weeks after immunization during the fall.
Antiviral Immune Mechanisms in Early Childhood
- SUMMARY: The purpose of this study was to understand better how HCMV behaves when it infects healthy infants and how the body’s immune system controls the infection. 38 healthy HCMV-positive adults and 77 infants and children less than 24 months of age were enrolled and followed prospectively. Virus shedding was monitored as were as CD4, CD8 T-cell frequencies and dendritic cell antigen presentation studies.
Human Cytomegalovirus (HCMV) Infection and Immunity In Healthy Adults
- SUMMARY: The purpose of this study was to understand better how HCMV behaves when it infects healthy adults and how the body's immune system controls the infection. 55 HCMV-negative adults at risk for HCMV infection were enrolled into this study, and followed prospectively for HCMV infection.
A Multicenter, Double Blind, Randomized Dose-Response Study of Dryvax Vaccine Against Smallpox in Previously Vaccinated Adults
- SUMMARY: The Stanford-LPCH Vaccine Program vaccinated 90 healthy adults at least 32 years of age who had previously been vaccinated with smallpox vaccine. The purpose of this study was to determine whether the available smallpox vaccine can be diluted to provide an increased number of doses in the event of a release of smallpox into the environment. This study was sponsored by the NIH and was part of a national trial involving 7 clinical sites.
Radiologic Imaging Study of the Bowel in Young Children with Rotavirus Infection
- SUMMARY: Rotavirus is a common germ that causes vomiting, diarrhea and fever. It infects all children by about 4 years of age. Some children may have severe vomiting and diarrhea lasting up to one week but others who get rotavirus infection may not be very sick. In this country, about 1 in 75 children has to be treated in the hospital each year because of this infection. The purpose of this study was to understand better how the bowel changes during infection with rotavirus. 5 children with acute rotavirus infection were studied radiologically with real-time MRI & ultrasound. This study was sponsored by the NIH and conducted with Drs. Dorsey Bass and Christopher Cassady in Pediatric Gastroenterology and Pediatric Radiology, respectively.
