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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
43
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.
Two doses of A(H5N2) live attenuated influenza vaccine (LAIV) administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
Research Institute of Influenza
Saint Petersburg, Russia
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional World Health Organization (WHO)-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells. A four-fold or greater antibody rise in titer was considered to be a seroconversion.
Time frame: 56 days
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells. A four-fold or greater antibody rise in titer was considered to be a seroconversion.
Time frame: 56 days
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells. A four-fold or greater antibody rise in titer was considered to be a seroconversion.
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Time frame: 56 days
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/Turkey/Turkey/5/05(H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells. A four-fold or greater antibody rise in titer was considered to be a seroconversion.
Time frame: 56 days
Geometric Mean Titer of Microneutralization Antibody Response to A/17/Turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Serum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50).
Time frame: 56 days
Geometric Mean Titer of Microneutralization Antibody Response to A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Serum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50).
Time frame: 56 days
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
A four-fold or greater antibody rise in titer was considered to be a seroconversion. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Time frame: 56 days
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
A four-fold or greater antibody rise in titer was considered to be a seroconversion. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Time frame: 56 days
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
A four-fold or greater antibody rise in titer was considered to be a seroconversion. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Time frame: 56 days
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
A four-fold or greater antibody rise in titer was considered to be a seroconversion. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Time frame: 56 days
Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Serum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50). A four-fold or greater antibody rise in titer was considered to be a seroconversion.
Time frame: 56 days
Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Serum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50). A four-fold or greater antibody rise in titer was considered to be a seroconversion.
Time frame: 56 days
Number and Percentage of Subjects With Seroprotective Titers for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Seroprotection was defined as ≥1:40 antibody titer. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Time frame: 56 days
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Seroprotection was defined as ≥1:40 antibody titer. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Time frame: 56 days
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Seroprotection was defined as ≥1:40 antibody titer. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Time frame: 56 days
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Seroprotection was defined as ≥1:40 antibody titer. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Time frame: 56 days
Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Serum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50). Seroprotection was defined as ≥1:40 antibody titer.
Time frame: 56 days
Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Serum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50). Seroprotection was defined as ≥1:40 antibody titer.
Time frame: 56 days
Geometric Mean Titer of Serum Immunoglobulin A (IgA) Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Time frame: 56 days
Geometric Mean Titer of Serum Immunoglobulin A (IgA) Response to A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Time frame: 56 days
Geometric Mean Titer of Serum Immunoglobulin G (IgG) Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Time frame: 56 days
Geometric Mean Titer of Serum Immunoglobulin G (IgG) Response to A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Time frame: 56 days
Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
A four-fold or greater antibody rise in titer was considered to be a seroconversion. Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Time frame: 56 days
Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
A four-fold or greater antibody rise in titer was considered to be a seroconversion. Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Time frame: 56 days
Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
A four-fold or greater antibody rise in titer was considered to be a seroconversion. Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Time frame: 56 days
Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
A four-fold or greater antibody rise in titer was considered to be a seroconversion. Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Time frame: 56 days
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Time frame: 28 days
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Time frame: 28 days
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Time frame: 28 days
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Time frame: 28 days
Mean Avidity Index for Serum Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Time frame: 28 days
Mean Avidity Index for Serum Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Time frame: 28 days
Mean Avidity Index for Serum Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Time frame: 28 days
Mean Avidity Index for Serum Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Time frame: 28 days