Influenza, Human Clinical Trial
Official title:
A Phase I/II, Two-Staged, Single-Center, Randomized, Double-Blind, Antibody Titer Study to Assess Immunogenicity and Safety of FluMist® Intranasal Influenza Vaccine Administered With and Without a TLR-3 Agonist, Ampligen®.
The purpose of this study is to evaluate FluMist with and without Ampligen in healthy volunteers.
Influenza epidemics continue to represent a significant medical problem in the developed as well as the developing world. Even with existing vaccines, annual influenza epidemics typically results in 20-50 million cases, resulting in 30,000-40,000 deaths in the U.S. alone. A possible pandemic could have even more devastating consequences. Current vaccines have a number of disadvantages including slow and expensive manufacturing, and a relative lack of efficacy in elderly, children and immune-compromised populations. These disadvantages would be multiplied during a pandemic. Use of Ampligen® as an adjuvant combined with FluMist® has a number of potential advantages as compared to traditional inactivated vaccines: it is simpler to administer (intranasally), generation of a broader immunity at the natural site of entry of the influenza virus as well as systemic immunity (and hence should be more efficacious than traditional vaccines) and may stimulate cross-protection against pre-pandemic H5N1 and/or H7N9 avian influenza strains. As FluMist®, due to its intranasal administration, imitates the natural entry of the influenza virus, it will generate local 'first-line' immunity as well as the traditional systemic immunity; therefore, at least theoretically provide greater protection than injectable vaccines. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
| Completed |
NCT03275389 -
A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years
|
Phase 1 | |
| Completed |
NCT05981846 -
A Phase II Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19
|
Phase 2 | |
| Completed |
NCT05044195 -
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
|
Phase 3 | |
| Completed |
NCT02914275 -
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.
|
Phase 3 | |
| Completed |
NCT04590066 -
Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy
|
N/A | |
| Recruiting |
NCT03778203 -
Development of Childhood Anti-influenza Immunity
|
Phase 4 | |
| Completed |
NCT04527614 -
Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection
|
N/A | |
| Terminated |
NCT03658629 -
Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults
|
Phase 2 | |
| Completed |
NCT05269290 -
Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections
|
Phase 3 | |
| Completed |
NCT06385821 -
A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus
|
Phase 3 | |
| Completed |
NCT02998996 -
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU
|
Phase 1/Phase 2 | |
| Completed |
NCT02984280 -
Specific Respiratory Infections as Triggers of Acute Medical Events
|
N/A | |
| Completed |
NCT02867358 -
A Clinical Trial of KT07 Capsule in the U.S.A
|
Phase 2 | |
| Withdrawn |
NCT02883972 -
Childhood Influenza Immunisation Invitation Trial in Schools
|
N/A | |
| Completed |
NCT02545543 -
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
|
Phase 3 | |
| Completed |
NCT02621164 -
Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents
|
Phase 3 | |
| Completed |
NCT02212106 -
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
|
Phase 4 | |
| Completed |
NCT02243774 -
Mail Outreach To Increase Vaccination Acceptance Through Engagement
|
N/A | |
| Completed |
NCT02344134 -
Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects
|
Phase 3 |