Influenza Clinical Trial
Official title:
Bacterial Composition and Immune Responses in the Nose and Oropharynx During Influenza Infection
This study will serve to determine how influenza infection alters the bacterial colonization
patterns in the nasal and oropharyngeal compartments, and whether the immune response
correlate with these alterations. The investigators will be determining bacterial
composition and immune responses in the nose and oropharynx during influenza infection.
Specific Aims
Therefore, the overall aims of this study are as follows:
1. To identify baseline composition and kinetic changes in the nasal and oropharyngeal
microflora and immune responses after administering intranasal live attenuated
influenza virus (i.e., FluMist® vaccine) or saline mist to healthy subjects;
2. To identify nasal and oropharyngeal microbial composition and local immune responses
during influenza infections and after resolution of infection, and correlate these
changes with clinical outcomes.
Randomization and Post-Randomization Visits After undergoing the nasal swabs and
nasopharyngeal washes, and nasal epithelial brushing, healthy volunteers will be randomly
assigned to receive either saline nasal spray (placebo) or FluMist® nasal influenza vaccine
(live attenuated influenza vaccine, or LAIV). They will return 1-2 weeks and 4-6 weeks later
to repeat the nasal swabs and nasopharyngeal washes, and nasal epithelial brushings done at
the Enrollment Visit.
Samples will be processed to isolate 16s bacterial RNA and host RNA. 16s rRNA will be
analyzed by 16S sequencing for to determine the composition of the bacterial microbiome pre
and post LAIV or saline (placebo) administration. Host immune responses will be assessed
based upon microarray analysis of host RNA pre and post LAIV or saline administration.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
| Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
| Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
| Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
| Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
| Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
| Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
| Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
| Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
| Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
| Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
| Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
| Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
| Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
| Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
| Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
| Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
| Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
| Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
| Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |