Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral, cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine dose and compared with baseline values.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults

NCT01776541

Pandemic H5N1 Influenza

COMPLETED PHASE2

H5N1 Priming and Boosting Strategies

NCT00703053

Influenza

COMPLETED PHASE2

Single Group Study of the Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults

NCT00488046

Influenza Virus Diseases

COMPLETED PHASE1

Evaluating the Safety and Immune Response to an H5N1 Influenza Vaccine in People Who Have Previously Received an H5N1 or H7N3 Influenza Vaccine and in People Who Have Never Received a Live Attenuated Influenza Vaccine

NCT01443663

H5N1 Influenza

COMPLETED PHASE1

Safety and Immunogenicity of Live Attenuated Influenza H5N2

NCT01841918

Influenza Due to Influenza A Virus Subtype H5N2

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Autologous prime boost regimen 1

FluMist® live intranasal vaccine (LAIV) 0.2mL (0.1mL per nostril): 2 doses separated by 8 weeks (+/- 7 days)

Group Type ACTIVE_COMPARATOR

FluMist® live, attenuated, intranasal seasonal influenza vaccine

Intervention Type BIOLOGICAL

FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril)

Autologous prime boost regimen 2

Fluzone® inactivated seasonal influenza virus vaccine intramuscularly: 2 doses separated by 8 weeks (+7 days)

Group Type ACTIVE_COMPARATOR

Fluzone® inactivated influenza virus vaccine

Intervention Type BIOLOGICAL

Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly

Heterologous prime boost regimen 1

FluMist® live, intranasal vaccine single dose, followed by Fluzone® inactivated influenza virus vaccine 8 weeks (+/-7 days) later

Group Type EXPERIMENTAL

FluMist® live, attenuated, intranasal seasonal influenza vaccine

Intervention Type BIOLOGICAL

FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril)

Fluzone® inactivated influenza virus vaccine

Intervention Type BIOLOGICAL

Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly

Heterologous prime boost regimen 2

Fluzone® inactivated seasonal influenza virus vaccine single dose, followed by FluMist® live, intranasal seasonal influenza vaccine 0.2mL 8 weeks (+/- 7 days) later

Group Type EXPERIMENTAL

FluMist® live, attenuated, intranasal seasonal influenza vaccine

Intervention Type BIOLOGICAL

FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril)

Fluzone® inactivated influenza virus vaccine

Intervention Type BIOLOGICAL

Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FluMist® live, attenuated, intranasal seasonal influenza vaccine

FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril)

Intervention Type BIOLOGICAL

Fluzone® inactivated influenza virus vaccine

Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Aged 18-49 years.
2. Healthy as determined by the PI or designate
3. Willing to give informed consent.
4. Willing to attend follow-up appointments and undergo study procedures.
5. US passport holder residing in Bangkok
6. If military, have a letter of approval for participation from the chain of command (Unit Commander).

Exclusion Criteria

1. History of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine.
2. Severe or life-threatening reaction to any previous vaccine.
3. History of chronic respiratory illness, including asthma and sinusitis.
4. History of heart disease
5. History of kidney disease
6. Metabolic disease such as diabetes
7. Immunocompromised as determined by the PI, or a household contact of an immunocompromised individual.
8. History of Guillain-Barre syndrome.
9. Blood disease including sickle cell disease and/or bleeding tendency (by history or based on medical records).
10. Any influenza vaccination within the previous 6 months, or any other vaccine within 30 days of either dose of influenza vaccine.
11. Pregnant woman or nursing mother or unwilling to use reliable contraception during the study period until the final day of follow-up.
12. Blood donation within the preceding 3 months, or screening hemoglobin value of \<12.5 g/dl.
13. Receipt of blood products including immunoglobulins within the preceding 3 months.
14. Receiving any of the following therapies: aspirin, warfarin, theophylline, phenytoin, aminopyrine, immunosuppressive drugs,
15. Receipt of any antiviral agents within 48 hours of vaccine administration.
16. HIV positive on screening blood tests.
17. Any other condition that in the opinion of the study investigator warrants exclusion from the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes