University of Massachusetts Medical School
Worcester, Massachusetts, 01605, United States
NCT Number: NCT00902278
The goal of this research is to find out how the body's immune system responds to different manufacturer's "flu" vaccines.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Worcester, Massachusetts, 01605, United States
There are currently five licensed inactivated influenza vaccines approved for use in the United States by the Food and Drug Administration.Current influenza virus vaccines consist of 3 components: the HA protein from an H1N1 virus, an H3N2 and an influenza B virus.Influenza vaccines are evaluated and approved by the FDA on the basis of HA and NA content. However, different manufacturing processes are involved in the preparation of these commercial vaccines and evidence suggests that each of these vaccines contain similar patterns of HA protein but different patterns of influenza influenza internal proteins such as NP and M1. The presence of these additional internal proteins of influenza virus which are targets of T cell responses suggest not only the potential for additional protection derived from influenza vaccines other than antibody mediated protection but also differential levels of T cell mediated protection between different manufacturers of commercial influenza vaccines.Each subject will have four blood samples taken- prevaccination and at Days 7, 14,30 and 3-5 months post vaccination. These samples will be tested for T and B cell responses and the results compared between different manufacturers.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
one 0.5-mL dose via intramuscular injection
one 0.5-mL dose via intramuscular injection
one 0.5-mL dose via intramuscular injection
one 0.5-mL dose via intramuscular injection
one 0.5-mL dose via intramuscular injection
Time frame: Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination
Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups
Time frame: Prevaccination and approximately 1 month post vaccination
Geometric mean fold rise in antibody titer between day 0 ( baseline) and approximately 1 month post vaccination within each vaccine group
University of Massachusetts, Worcester
Other
Immune Response Induced by Different Manufacturers of Influenza Vaccines
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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