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Peter A Patriarca - One of the best experts on this subject based on the ideXlab platform.

  • evaluation of the safety reactogenicity and immunogenicity of flublok trivalent recombinant baculovirus expressed Hemagglutinin Influenza vaccine administered intramuscularly to healthy adults 50 64 years of age
    Vaccine, 2011
    Co-Authors: Roger Baxter, Peter A Patriarca, K Ensor, Ruvim Izikson, Karen L Goldenthal, Manon M J Cox
    Abstract:

    Abstract Background Alternative methods for Influenza vaccine production are needed to ensure adequate supplies. Methods Healthy adults 50–64 years were assigned randomly to receive one intramuscular injection of trivalent recombinant Hemagglutinin (rHA) or U.S. licensed trivalent inactivated vaccine (TIV) containing H1, H3 and B antigens (Ag) derived from 2007 to 2008 Influenza virus strains A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004. Each rHA dose contained 45 μg HA/strain of the 2007–2008 FDA-recommended Ag vs. 15 μg/strain for TIV. Antibody (Ab) responses were measured using a hemagglutination-inhibition (HAI) assay at baseline and 28 days post-vaccination. Respiratory samples for viral culture were collected from subjects with Influenza-like illness (ILI) during the 2007–2008 season in the U.S. Results 601 subjects were enrolled. Vaccines were well tolerated. Seroconversion (the percentage of subjects with either (a) a pre-vaccination HAI titer ≤10 and a post-vaccination HAI titer ≥40 or (b) a pre-vaccination titer ≥10 and a minimum four-fold rise in post-vaccination HAI antibody titer) in the TIV and rHA groups, respectively, was obtained in 66% vs. 72% for H1; 44% vs. 61% for H3; and 41% vs. 41% for B. Proportions achieving titers ≥40 were 96% vs. 96% for H1, 75% vs. 85% for H3, and 94% vs. 93% vs. B. Geometric mean titer ratios at day 28 (TIV/rHA) were 0.77 for H1; 0.58 for H3; and 1.05 for B, respectively. ILI frequencies were low and similar in both groups. Conclusions Both vaccines were safe and immunogenic. Ab responses vs. H1 and H3 Ags were significantly higher in the rHA group, with similar responses to B. Furthermore, the FluBlok group had a statistically significantly higher seroconversion rate against Influenza A/H3N2 compared to the TIV group.

  • evaluation of the safety reactogenicity and immunogenicity of flublok trivalent recombinant baculovirus expressed Hemagglutinin Influenza vaccine administered intramuscularly to healthy children aged 6 59 months
    Vaccine, 2009
    Co-Authors: James C King, Manon M J Cox, Keith S Reisinger, James Hedrick, Irene Graham, Peter A Patriarca
    Abstract:

    Abstract Background Recombinant baculovirus-expressed Hemagglutinin (rHA [FluBlok®]) Influenza vaccine is unique in avoiding production in eggs and its rapid production capability. Objective Compare the safety and immunogenicity of trivalent FluBlok to egg-grown trivalent Influenza vaccine (TIV) in children. Methods Healthy children were randomized to receive two doses of study vaccines. TIV (7.5 μg HA/antigen), FluBlok-22.5 (22.5 μg rHA/antigen), or FluBlok-45 (45 μg rHA/antigen) were given to 115 children ages 6–35 months. TIV (15 μg HA/antigen) or FluBlok-45 was given to 41 children ages 36–59 months. Safety and reactogenicity data were collected post-vaccination. Serum hemagglutination-inhibition antibody (HI) titers were measured before and 28 days after vaccination. Results No serious vaccine-related adverse events occurred and reactogenicity events to equal volumes of TIV or FluBlok were generally similar. However, in the younger children, selected local and systemic symptoms were recorded significantly more frequently to 0.5 mL FluBlok-45 than to 0.25 mL doses of either the FluBlok-22.5 or 7.5 μg TIV vaccines. In the younger children, the immunogenicity to TIV was generally significantly superior to FluBlok. Serologic responses to FluBlok were higher in the older children than the younger group, but were still somewhat lower compared to TIV. Conclusion These data suggests that FluBlok is as safe but less immunogenic than similar volumes of TIV, particularly in the youngest children. The immunogenicity data is the converse of what has been observed in adults. Further studies examining the immunogenicity of FluBlok in older children are warranted.

Manon M J Cox - One of the best experts on this subject based on the ideXlab platform.

  • evaluation of the safety reactogenicity and immunogenicity of flublok trivalent recombinant baculovirus expressed Hemagglutinin Influenza vaccine administered intramuscularly to healthy adults 50 64 years of age
    Vaccine, 2011
    Co-Authors: Roger Baxter, Peter A Patriarca, K Ensor, Ruvim Izikson, Karen L Goldenthal, Manon M J Cox
    Abstract:

    Abstract Background Alternative methods for Influenza vaccine production are needed to ensure adequate supplies. Methods Healthy adults 50–64 years were assigned randomly to receive one intramuscular injection of trivalent recombinant Hemagglutinin (rHA) or U.S. licensed trivalent inactivated vaccine (TIV) containing H1, H3 and B antigens (Ag) derived from 2007 to 2008 Influenza virus strains A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004. Each rHA dose contained 45 μg HA/strain of the 2007–2008 FDA-recommended Ag vs. 15 μg/strain for TIV. Antibody (Ab) responses were measured using a hemagglutination-inhibition (HAI) assay at baseline and 28 days post-vaccination. Respiratory samples for viral culture were collected from subjects with Influenza-like illness (ILI) during the 2007–2008 season in the U.S. Results 601 subjects were enrolled. Vaccines were well tolerated. Seroconversion (the percentage of subjects with either (a) a pre-vaccination HAI titer ≤10 and a post-vaccination HAI titer ≥40 or (b) a pre-vaccination titer ≥10 and a minimum four-fold rise in post-vaccination HAI antibody titer) in the TIV and rHA groups, respectively, was obtained in 66% vs. 72% for H1; 44% vs. 61% for H3; and 41% vs. 41% for B. Proportions achieving titers ≥40 were 96% vs. 96% for H1, 75% vs. 85% for H3, and 94% vs. 93% vs. B. Geometric mean titer ratios at day 28 (TIV/rHA) were 0.77 for H1; 0.58 for H3; and 1.05 for B, respectively. ILI frequencies were low and similar in both groups. Conclusions Both vaccines were safe and immunogenic. Ab responses vs. H1 and H3 Ags were significantly higher in the rHA group, with similar responses to B. Furthermore, the FluBlok group had a statistically significantly higher seroconversion rate against Influenza A/H3N2 compared to the TIV group.

  • evaluation of the safety reactogenicity and immunogenicity of flublok trivalent recombinant baculovirus expressed Hemagglutinin Influenza vaccine administered intramuscularly to healthy children aged 6 59 months
    Vaccine, 2009
    Co-Authors: James C King, Manon M J Cox, Keith S Reisinger, James Hedrick, Irene Graham, Peter A Patriarca
    Abstract:

    Abstract Background Recombinant baculovirus-expressed Hemagglutinin (rHA [FluBlok®]) Influenza vaccine is unique in avoiding production in eggs and its rapid production capability. Objective Compare the safety and immunogenicity of trivalent FluBlok to egg-grown trivalent Influenza vaccine (TIV) in children. Methods Healthy children were randomized to receive two doses of study vaccines. TIV (7.5 μg HA/antigen), FluBlok-22.5 (22.5 μg rHA/antigen), or FluBlok-45 (45 μg rHA/antigen) were given to 115 children ages 6–35 months. TIV (15 μg HA/antigen) or FluBlok-45 was given to 41 children ages 36–59 months. Safety and reactogenicity data were collected post-vaccination. Serum hemagglutination-inhibition antibody (HI) titers were measured before and 28 days after vaccination. Results No serious vaccine-related adverse events occurred and reactogenicity events to equal volumes of TIV or FluBlok were generally similar. However, in the younger children, selected local and systemic symptoms were recorded significantly more frequently to 0.5 mL FluBlok-45 than to 0.25 mL doses of either the FluBlok-22.5 or 7.5 μg TIV vaccines. In the younger children, the immunogenicity to TIV was generally significantly superior to FluBlok. Serologic responses to FluBlok were higher in the older children than the younger group, but were still somewhat lower compared to TIV. Conclusion These data suggests that FluBlok is as safe but less immunogenic than similar volumes of TIV, particularly in the youngest children. The immunogenicity data is the converse of what has been observed in adults. Further studies examining the immunogenicity of FluBlok in older children are warranted.

  • safety and immunogenicity of a baculovirus expressed Hemagglutinin Influenza vaccine a randomized controlled trial
    JAMA, 2007
    Co-Authors: John J. Treanor, Gilbert M Schiff, Frederick G Hayden, Rebecca C Brady, Mhorag C Hay, Anthony L Meyer, Jeanne Holdenwiltse, Hua Liang, Adam Gilbert, Manon M J Cox
    Abstract:

    ContextA high priority in vaccine research is the development of Influenza vaccines that do not use embryonated eggs as the substrate for vaccine production.ObjectiveTo determine the dose-related safety, immunogenicity, and protective efficacy of an experimental trivalent Influenza virus Hemagglutinin (rHA0) vaccine produced in insect cells using recombinant baculoviruses.Design, Setting, and ParticipantsRandomized, double-blind, placebo-controlled clinical trial at 3 US academic medical centers during the 2004-2005 Influenza season among 460 healthy adults without high-risk indications for Influenza vaccine.InterventionsParticipants were randomly assigned to receive a single injection of saline placebo (n = 154); 75 μg of an rHA0 vaccine containing 15 μg of Hemagglutinin from Influenza A/New Caledonia/20/99(H1N1) and Influenza B/Jiangsu/10/03 virus and 45 μg of Hemagglutinin from Influenza A/Wyoming/3/03(H3N2) virus (n = 153); or 135 μg of rHA0 containing 45 μg of Hemagglutinin each from all 3 components (n = 153). Serum samples were taken before and 30 days following immunization.Main Outcome MeasuresPrimary safety end points were the rates and severity of solicited and unsolicited adverse events. Primary immunogenicity end points were the rates of 4-fold or greater increases in serum Hemagglutinin inhibition antibody to each of the 3 vaccine strains before and 28 days after inoculation. The prespecified primary efficacy end point was culture-documented Influenza illness, defined as development of Influenza-like illness associated with Influenza virus on a nasopharyngeal swab.ResultsRates of local and systemic adverse effects were low, and the rates of systemic adverse effects were not different in either vaccine group than in the placebo group. Hemagglutinin inhibition antibody responses to the H1 component were seen in 3% of placebo, 51% of 75-μg vaccine, and 67% of 135-μg vaccine recipients, while responses to B were seen in 4% of placebo, 65% of 75-μg vaccine, and 92% of 135-μg vaccine recipients. Responses to the H3 component occurred in 11% of placebo, 81% of 75-μg vaccine, and 77% of 135-μg vaccine recipients. Influenza infections in the study population were due to Influenza B and A(H3N2), and Influenza A infections were A/California/7/2004–like viruses, an antigenically drifted strain. Seven cases of culture-confirmed CDC-defined Influenza-like illness occurred in 153 placebo recipients (4.6%) compared with 2 cases (1.3%) in 150 recipients of 75 μg of vaccine, and 0 cases in recipients of 135 μg of vaccine.ConclusionsIn this study, a trivalent rHA0 vaccine was safe and immunogenic in a healthy adult population. Preliminary evidence of protection against a drifted Influenza A(H3N2) virus was obtained, but the sample size was small. Inclusion of a neuraminidase component did not appear to be required for protection.Trial Registrationclinicaltrials.gov Identifier: NCT00328107

John J. Treanor - One of the best experts on this subject based on the ideXlab platform.

  • Induction of a potent immune response in the elderly using the TLR-5 agonist, flagellin, with a recombinant Hemagglutinin Influenza–flagellin fusion vaccine (VAX125, STF2.HA1 SI)
    Vaccine, 2011
    Co-Authors: David N. Taylor, John J. Treanor, Cynthia Strout, Casey P. Johnson, Theresa Fitzgerald, Uma Kavita, Karen Ozer, Lynda Tussey, Alan Shaw
    Abstract:

    Background Influenza vaccines perform poorly in the elderly with reduced serological response and vaccine efficacy. We evaluated a novel Influenza vaccine consisting of the globular head of the HA1 domain of the A/Solomon Islands/3/2006 (H1N1) Influenza virus (VAX125) genetically fused to the TLR5 ligand, flagellin, and produced in Escherichia coli. Methods 120 subjects ≥65 years old were enrolled at three clinical centers. VAX125 vaccine was administered at doses of 0.5, 1, 2, 3, 5 or 8 μg delivered i.m. as a single dose vaccination on Day 0 using a dose-escalation with 20 subjects in each dose level. Subjects were followed for adverse events and sera were tested by hemagglutination-inhibition (HAI) against egg-grown virus on days 0, 7, 14, and 28. Serum C-reactive protein (CRP) and anti-flagellin antibody were also assessed. Results The mean age was 71 years. The vaccine was well tolerated at all dose levels, with no more than mild to moderate local or systemic symptoms. The geometric mean titers (GMT) increased in all dose groups. In the 5 μg group the day 14 post-vaccination HAI titer was 1:226 showing a 12-fold increase over baseline. The 8 μg group showed a similar post-vaccination GMT increase (∼8-fold). In the combined 5 and 8 μg groups, the seroconversion rate was 75% and the seroprotection rate was 98%. Conclusions A 5 μg dose of VAX125 was safe and able to induce a greater than 10-fold increase HAI antibody levels and nearly complete seroprotection in subjects over 65 years old. The use of flagellin to adjuvant Influenza vaccines via the TLR5 innate immune pathway appears to be a useful approach to overcome poor immune responses in the elderly. VAX125 is a promising new candidate for prevention of Influenza A disease in both young adults and the elderly.

  • safety and immunogenicity of a recombinant Hemagglutinin Influenza flagellin fusion vaccine vax125 in healthy young adults
    Vaccine, 2010
    Co-Authors: John J. Treanor, David N. Taylor, Theresa Fitzgerald, Uma Kavita, Lynda Tussey, Christine M Hay, Carrie Nolan, Ge Liu, Langzhou Song, Irving Dark
    Abstract:

    Abstract Background The need for worldwide seasonal and pandemic vaccine production has increased interest in the development of innovative technologies for Influenza vaccine production. We evaluated a novel Influenza vaccine consisting of the globular head of the HA1 domain of the A/Solomon Islands/3/2006 (H1N1) Influenza virus (VAX125) genetically fused to the TLR5 ligand, flagellin, and produced in E. coli. Methods 128 healthy adult subjects 18–49 years old were enrolled in a clinical trial conducted in three stages at a single center. Stage 1 was an open-label, dose escalation study in which the VAX125 vaccine was administered intramuscularly (im) at doses of 0.1 μg, 0.3 μg, 1 μg, 2 μg, 3 μg, 5 μg and 8 μg to groups of 8 subjects each. Stage 2 was a double-blind, placebo-controlled study in which subjects were randomized to receive 1.0 μg and 2.0 μg VAX125 vaccine doses or placebo, with 16 subjects per group. Finally, an additional 24 subjects received a 0.5 μg dose of VAX125 in stage 3, which was a non-randomized, open label study. In all parts subjects were followed for adverse events and sera was tested by hemagglutination-inhibition (HAI) and microneutralization (MN) against egg-grown virus on days 0, 7, 14, and 28. Serum C-reactive protein (CRP), cytokine levels, and anti-flagellin antibody were also assessed. Results Vaccine was generally well tolerated and there were no serious adverse events. Pain at the injection site was the most common local adverse event, and was mild or moderate in intensity. Systemic symptoms after vaccination include fatigue and headache, and two subjects, who received either 3 or 8 μg, had moderately severe systemic symptoms accompanied by substantial increases in serum CRP. Serum antibody responses against SI were seen by HAI and MN in most study subjects, with the geometric mean titer of post vaccination antibody increasing in a dose-dependent fashion. Overall, four-fold or greater serum HAI responses were seen in 61 of 96 (64%) subjects who received doses of 0.5 μg or greater, including in 46 of 72 subjects who received doses from 0.5 μg to 2 μg. Conclusions The globular head of the Influenza HA expressed in a prokaryotic system was able to induce a functional antibody response against native virions. Vigorous responses were seen at relatively low doses of HA antigen suggesting that the addition of flagellin provided a substantial adjuvanting effect. The high levels of immune response at low doses of antigen and the relative ease of production associated with E. coli expression suggests that this approach may represent an effective strategy for enhancing the global Influenza vaccine supply.

  • safety and immunogenicity of a baculovirus expressed Hemagglutinin Influenza vaccine a randomized controlled trial
    JAMA, 2007
    Co-Authors: John J. Treanor, Gilbert M Schiff, Frederick G Hayden, Rebecca C Brady, Mhorag C Hay, Anthony L Meyer, Jeanne Holdenwiltse, Hua Liang, Adam Gilbert, Manon M J Cox
    Abstract:

    ContextA high priority in vaccine research is the development of Influenza vaccines that do not use embryonated eggs as the substrate for vaccine production.ObjectiveTo determine the dose-related safety, immunogenicity, and protective efficacy of an experimental trivalent Influenza virus Hemagglutinin (rHA0) vaccine produced in insect cells using recombinant baculoviruses.Design, Setting, and ParticipantsRandomized, double-blind, placebo-controlled clinical trial at 3 US academic medical centers during the 2004-2005 Influenza season among 460 healthy adults without high-risk indications for Influenza vaccine.InterventionsParticipants were randomly assigned to receive a single injection of saline placebo (n = 154); 75 μg of an rHA0 vaccine containing 15 μg of Hemagglutinin from Influenza A/New Caledonia/20/99(H1N1) and Influenza B/Jiangsu/10/03 virus and 45 μg of Hemagglutinin from Influenza A/Wyoming/3/03(H3N2) virus (n = 153); or 135 μg of rHA0 containing 45 μg of Hemagglutinin each from all 3 components (n = 153). Serum samples were taken before and 30 days following immunization.Main Outcome MeasuresPrimary safety end points were the rates and severity of solicited and unsolicited adverse events. Primary immunogenicity end points were the rates of 4-fold or greater increases in serum Hemagglutinin inhibition antibody to each of the 3 vaccine strains before and 28 days after inoculation. The prespecified primary efficacy end point was culture-documented Influenza illness, defined as development of Influenza-like illness associated with Influenza virus on a nasopharyngeal swab.ResultsRates of local and systemic adverse effects were low, and the rates of systemic adverse effects were not different in either vaccine group than in the placebo group. Hemagglutinin inhibition antibody responses to the H1 component were seen in 3% of placebo, 51% of 75-μg vaccine, and 67% of 135-μg vaccine recipients, while responses to B were seen in 4% of placebo, 65% of 75-μg vaccine, and 92% of 135-μg vaccine recipients. Responses to the H3 component occurred in 11% of placebo, 81% of 75-μg vaccine, and 77% of 135-μg vaccine recipients. Influenza infections in the study population were due to Influenza B and A(H3N2), and Influenza A infections were A/California/7/2004–like viruses, an antigenically drifted strain. Seven cases of culture-confirmed CDC-defined Influenza-like illness occurred in 153 placebo recipients (4.6%) compared with 2 cases (1.3%) in 150 recipients of 75 μg of vaccine, and 0 cases in recipients of 135 μg of vaccine.ConclusionsIn this study, a trivalent rHA0 vaccine was safe and immunogenic in a healthy adult population. Preliminary evidence of protection against a drifted Influenza A(H3N2) virus was obtained, but the sample size was small. Inclusion of a neuraminidase component did not appear to be required for protection.Trial Registrationclinicaltrials.gov Identifier: NCT00328107

David N. Taylor - One of the best experts on this subject based on the ideXlab platform.

  • Induction of a potent immune response in the elderly using the TLR-5 agonist, flagellin, with a recombinant Hemagglutinin Influenza–flagellin fusion vaccine (VAX125, STF2.HA1 SI)
    Vaccine, 2011
    Co-Authors: David N. Taylor, John J. Treanor, Cynthia Strout, Casey P. Johnson, Theresa Fitzgerald, Uma Kavita, Karen Ozer, Lynda Tussey, Alan Shaw
    Abstract:

    Background Influenza vaccines perform poorly in the elderly with reduced serological response and vaccine efficacy. We evaluated a novel Influenza vaccine consisting of the globular head of the HA1 domain of the A/Solomon Islands/3/2006 (H1N1) Influenza virus (VAX125) genetically fused to the TLR5 ligand, flagellin, and produced in Escherichia coli. Methods 120 subjects ≥65 years old were enrolled at three clinical centers. VAX125 vaccine was administered at doses of 0.5, 1, 2, 3, 5 or 8 μg delivered i.m. as a single dose vaccination on Day 0 using a dose-escalation with 20 subjects in each dose level. Subjects were followed for adverse events and sera were tested by hemagglutination-inhibition (HAI) against egg-grown virus on days 0, 7, 14, and 28. Serum C-reactive protein (CRP) and anti-flagellin antibody were also assessed. Results The mean age was 71 years. The vaccine was well tolerated at all dose levels, with no more than mild to moderate local or systemic symptoms. The geometric mean titers (GMT) increased in all dose groups. In the 5 μg group the day 14 post-vaccination HAI titer was 1:226 showing a 12-fold increase over baseline. The 8 μg group showed a similar post-vaccination GMT increase (∼8-fold). In the combined 5 and 8 μg groups, the seroconversion rate was 75% and the seroprotection rate was 98%. Conclusions A 5 μg dose of VAX125 was safe and able to induce a greater than 10-fold increase HAI antibody levels and nearly complete seroprotection in subjects over 65 years old. The use of flagellin to adjuvant Influenza vaccines via the TLR5 innate immune pathway appears to be a useful approach to overcome poor immune responses in the elderly. VAX125 is a promising new candidate for prevention of Influenza A disease in both young adults and the elderly.

  • safety and immunogenicity of a recombinant Hemagglutinin Influenza flagellin fusion vaccine vax125 in healthy young adults
    Vaccine, 2010
    Co-Authors: John J. Treanor, David N. Taylor, Theresa Fitzgerald, Uma Kavita, Lynda Tussey, Christine M Hay, Carrie Nolan, Ge Liu, Langzhou Song, Irving Dark
    Abstract:

    Abstract Background The need for worldwide seasonal and pandemic vaccine production has increased interest in the development of innovative technologies for Influenza vaccine production. We evaluated a novel Influenza vaccine consisting of the globular head of the HA1 domain of the A/Solomon Islands/3/2006 (H1N1) Influenza virus (VAX125) genetically fused to the TLR5 ligand, flagellin, and produced in E. coli. Methods 128 healthy adult subjects 18–49 years old were enrolled in a clinical trial conducted in three stages at a single center. Stage 1 was an open-label, dose escalation study in which the VAX125 vaccine was administered intramuscularly (im) at doses of 0.1 μg, 0.3 μg, 1 μg, 2 μg, 3 μg, 5 μg and 8 μg to groups of 8 subjects each. Stage 2 was a double-blind, placebo-controlled study in which subjects were randomized to receive 1.0 μg and 2.0 μg VAX125 vaccine doses or placebo, with 16 subjects per group. Finally, an additional 24 subjects received a 0.5 μg dose of VAX125 in stage 3, which was a non-randomized, open label study. In all parts subjects were followed for adverse events and sera was tested by hemagglutination-inhibition (HAI) and microneutralization (MN) against egg-grown virus on days 0, 7, 14, and 28. Serum C-reactive protein (CRP), cytokine levels, and anti-flagellin antibody were also assessed. Results Vaccine was generally well tolerated and there were no serious adverse events. Pain at the injection site was the most common local adverse event, and was mild or moderate in intensity. Systemic symptoms after vaccination include fatigue and headache, and two subjects, who received either 3 or 8 μg, had moderately severe systemic symptoms accompanied by substantial increases in serum CRP. Serum antibody responses against SI were seen by HAI and MN in most study subjects, with the geometric mean titer of post vaccination antibody increasing in a dose-dependent fashion. Overall, four-fold or greater serum HAI responses were seen in 61 of 96 (64%) subjects who received doses of 0.5 μg or greater, including in 46 of 72 subjects who received doses from 0.5 μg to 2 μg. Conclusions The globular head of the Influenza HA expressed in a prokaryotic system was able to induce a functional antibody response against native virions. Vigorous responses were seen at relatively low doses of HA antigen suggesting that the addition of flagellin provided a substantial adjuvanting effect. The high levels of immune response at low doses of antigen and the relative ease of production associated with E. coli expression suggests that this approach may represent an effective strategy for enhancing the global Influenza vaccine supply.

James C King - One of the best experts on this subject based on the ideXlab platform.

  • evaluation of the safety reactogenicity and immunogenicity of flublok trivalent recombinant baculovirus expressed Hemagglutinin Influenza vaccine administered intramuscularly to healthy children aged 6 59 months
    Vaccine, 2009
    Co-Authors: James C King, Manon M J Cox, Keith S Reisinger, James Hedrick, Irene Graham, Peter A Patriarca
    Abstract:

    Abstract Background Recombinant baculovirus-expressed Hemagglutinin (rHA [FluBlok®]) Influenza vaccine is unique in avoiding production in eggs and its rapid production capability. Objective Compare the safety and immunogenicity of trivalent FluBlok to egg-grown trivalent Influenza vaccine (TIV) in children. Methods Healthy children were randomized to receive two doses of study vaccines. TIV (7.5 μg HA/antigen), FluBlok-22.5 (22.5 μg rHA/antigen), or FluBlok-45 (45 μg rHA/antigen) were given to 115 children ages 6–35 months. TIV (15 μg HA/antigen) or FluBlok-45 was given to 41 children ages 36–59 months. Safety and reactogenicity data were collected post-vaccination. Serum hemagglutination-inhibition antibody (HI) titers were measured before and 28 days after vaccination. Results No serious vaccine-related adverse events occurred and reactogenicity events to equal volumes of TIV or FluBlok were generally similar. However, in the younger children, selected local and systemic symptoms were recorded significantly more frequently to 0.5 mL FluBlok-45 than to 0.25 mL doses of either the FluBlok-22.5 or 7.5 μg TIV vaccines. In the younger children, the immunogenicity to TIV was generally significantly superior to FluBlok. Serologic responses to FluBlok were higher in the older children than the younger group, but were still somewhat lower compared to TIV. Conclusion These data suggests that FluBlok is as safe but less immunogenic than similar volumes of TIV, particularly in the youngest children. The immunogenicity data is the converse of what has been observed in adults. Further studies examining the immunogenicity of FluBlok in older children are warranted.