Phase 4
N=12
Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response
Influenza A Subtype H5N1 Infection
Bottom Line
View on ClinicalTrials.gov: NCT03701061 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Number of Participants With a Four-fold Increase in Stem-specific Antibody Titers (H5, Hemagglutinin Antibody) Against H5N1 at Day 29 After Vaccination With the Seasonal Influenza Vaccine Among All the Participants in Both Arms — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Seasonal Influenza Vaccine (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Four-fold Increase in Stem-specific Antibody Titers (H5, Hemagglutinin Antibody) Against H5N1 at Day 29 After Vaccination With the Seasonal Influenza Vaccine Among All the Participants in Both Arms |
0; 0 | — |
| SECONDARY Number of Solicited (AE's) Grade 2 and Above at Day 8 After Vaccination With the Seasonal Influenza Vaccine Among the Participants in Both Arms |
1; 0 | — |
| SECONDARY Number of Unsolicited Adverse Events (AE's) Grade 2 and Above at Day 29 After Vaccination With the Seasonal Influenza Vaccine Among the Participants in Both Arms |
0; 0 | — |
| SECONDARY Number of Serious Adverse Events at Day 365 Among the Participants in Both Arms |
0; 0 | — |
Summary
The study is a prospective single site exploratory study to examine the impact of Food and Drug Administration (FDA) approved seasonal flu vaccine on the immune responses of H5N1 vaccine previously received with or without the AS03 adjuvant.
Eligibility Criteria
Inclusion Criteria
- Participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with and without AS03 Adjuvant study.
- Capable of informed consent and provision of written informed consent before any study procedures.
- Capable of attending all study visits according to the study schedule.
- Are in good health, as determined by medical history and targeted physical exam related to this history.
- Female subjects of childbearing age must have a negative urine pregnancy test before study vaccination, and must use at least one form of contraception to avoid pregnancy for 28 days before and 28 days after Fluarix Quadrivalent administration.
Exclusion Criteria
- Have an acute illness, including any fever (> 100.4 F [> 38 degrees C], regardless of the route) within 72 hours before vaccination.
- Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination.
- Alcohol or drug abuse and psychiatric conditions that, in the opinion of the investigator, would preclude compliance with the trial or interpretation of safety or endpoint data.
- Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination.
- Are pregnant or breastfeeding or plan to within one month of vaccination.
- Have taken oral or parenteral corticosteroids of any dose within 28 days before study vaccination.
- Have a known history of autoimmune disease.
- Have a history of Guillain-Barre Syndrome.
- Have a history of bleeding disorders.
- Have known hypersensitivity or allergy to any component of the vaccine, including egg and latex allergies, or history of anaphylaxis with influenza vaccine or vaccine component.
- Have received blood or blood products 3 months prior to study entry or expected to receive through 6 months after study entry.
- Have received any live virus vaccines within 4 weeks prior to study entry or expected receipt within 4 weeks after study entry.
- Have received any inactivated vaccine within 2 weeks or expected receipt within 2 weeks after study entry.
- Have received any experimental agents within 6 weeks prior to study or plan to through study duration.
- Have received the 2018-2019 influenza seasonal vaccine.
- Documented influenza infection during the 2018-2019 influenza season.
- Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.
Data sourced from ClinicalTrials.gov (NCT03701061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.