Immunogenicity of H5N1 Vaccine Following H5N2

NCT ID: NCT02153671

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-09-30

Brief Summary

This study is designed to assess whether a live attenuated Influenza vaccine (LAIV) can induce a long-lasting immune memory by comparing the immunologic response to two doses of the OrniFlu® inactivated vaccine given to subjects previously primed with LAIV and subjects who did not received LAIV.

Detailed Description

This study evaluated immunogenicity of an adjuvanted A(H5N1) inactivated influenza vaccine (IIV) in healthy adult subjects who received A(H5N2) live attenuated influenza vaccine (LAIV) 1.5 years earlier (September/October 2012) and compared this with a group of naive subjects that did not participate in the previous study. Inclusion/exclusion criteria for the additional group of naive volunteers mirrored those utilized in the initial study.

Conditions

Influenza Vaccine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Primed with H5N2

Subjects who received A(H5N1) inactivated influenza vaccine as well as primed with H5N2 live attenuated influenza vaccine approximately 1.5 years before

Group Type: EXPERIMENTAL

A(H5N1) inactivated influenza vaccine (IIV)

Intervention Type: BIOLOGICAL

Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.

A(H5N2) live attenuated influenza vaccine (LAIV)

Intervention Type: BIOLOGICAL

Two doses of A(H5N2) live attenuated influenza vaccine (LAIV) administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV

Did not receive A(H5N2)

Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.

Group Type: ACTIVE_COMPARATOR

A(H5N1) inactivated influenza vaccine (IIV)

Intervention Type: BIOLOGICAL

Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.

Interventions

A(H5N1) inactivated influenza vaccine (IIV)

Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.

Intervention Type: BIOLOGICAL

A(H5N2) live attenuated influenza vaccine (LAIV)

Two doses of A(H5N2) live attenuated influenza vaccine (LAIV) administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV

Intervention Type: BIOLOGICAL

Other Intervention Names

Orniflu

Eligibility Criteria

Inclusion Criteria

• Legal male or female adult 18 through 51 years of age at the enrollment visit
• Literate and willing to provide written informed consent
• A signed informed consent
• Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination
• Capable and willing to complete a memory aid and willing to return for all follow-up visits
• For females, willing to take reliable birth control measures through Day 56

Exclusion Criteria

• Participation in another clinical trial involving any investigational agent within the previous three months or planned enrollment in such a trial during the period of this study
• Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt
• Participation in any other clinical trials involving any H5-matched influenza vaccines except that in Protocol LAIV-H5N2-01
• Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever
• Other acute illness at the time of study enrollment
• Receipt of immunoglobulin or other blood products within three months prior to study enrollment or planned receipt during study period
• Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants and/or immune-modulating therapy within six months prior to study enrollment
• History of bronchial asthma
• Hypersensitivity after previous administration of any (not only influenza) vaccines.
• Other adverse event (AE) following immunization at least possibly related to previous receipt of any (not only influenza) vaccine
• Suspected or known hypersensitivity to any of the study vaccine components, including protein of chicken eggs
• Seasonal (autumnal) hypersensitivity to the natural environment
• Acute or chronic clinically significant abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives. Subjects with physical examination findings or clinical laboratory screening results which would be graded 2 or higher on the AE severity grading scale will be excluded from entry into the study
• History of leukemia or any other blood diseases or solid organ cancer
• History of thrombocytopenic purpura or known bleeding disorder
• History of seizures
• Known or suspected immunosuppressive or immunodeficient condition of any kind, including HIV infection
• Known chronic hepatitis B virus (HBV) or hepatitis C (HCV) infection
• Known tuberculosis infection or evidence of previous tuberculosis exposure
• History of chronic alcohol abuse and/or illegal drug use
• Pregnancy or lactation.

• Systemic connective tissue disorders
• Adrenal gland diseases
• Hereditary, degenerative and progredient diseases of the nervous system
• Any condition that, in the opinion of the investigator, would increase the health risk to the subject if he/she participates in the study or would interfere with the evaluation of the study objectives
• Allergic, including anaphylactic, reactions to any (not only influenza) vaccines

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Experimental Medicine, Russia

OTHER

Sponsor Role: collaborator

Research Institute of Influenza, Russia

OTHER

Sponsor Role: collaborator

PATH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oleg I Kiselev, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Research Institute of Influenza

Locations

Research Institute of Influenza

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

LAIV-H5N2-02

Identifier Type: -

Identifier Source: org_study_id