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☆

Baxter, Roger; Patriarca, P.; Ensor, Kathleen; Izikson, Ruvim; Goldenthal, Karen L.; Cox, Manon

doi:10.1016/j.vaccine.2011.01.039

Cited by 87 publications

(75 citation statements)

References 17 publications

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“…Although RIV3 was licensed initially for use in persons aged 18 through 49 years, in October 2014, the approved age indication was expanded to ≥18 years on the basis of data from randomized trials demonstrating adequate immunogenicity among persons aged ≥50 years (275,276); effectiveness data are not yet available for this age group.…”

Section: Comparisons Of Laiv3/4 and Iiv Efficacy Or Effectivenessmentioning

confidence: 99%

Prevention and Control of Seasonal Influenza with Vaccines

Grohskopf

Sokolow²,

Broder³

et al. 2016

MMWR Recomm. Rep.

374

279

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Section: Comparisons Of Laiv3/4 and Iiv Efficacy Or Effectivenessmentioning

confidence: 99%

Prevention and Control of Seasonal Influenza with Vaccines

Grohskopf

Sokolow²,

Broder³

et al. 2016

MMWR Recomm. Rep.

374

279

View full text Add to dashboard Cite

“…The vaccine contains three times (45 mg) the usual quantity of HA for each of the three subtypes and has been highly immunogenic in young and older adults but not in children. [26][27][28][29] A field efficacy trial in healthy young adults during the 2007-08 influenza season demonstrated an efficacy of 44.6% against laboratory-confirmed CDC-defined influenza-like illness, which, in the context of a significant mismatch between strains contained in the vaccine and circulating viruses that season, was within expectations and consistent with the reported efficacy of mismatched conventional trivalent inactivated influenza vaccine (TIV). 30 Although the efficacy trial is the first to demonstrate that an HA-only vaccine is sufficient to protect against infection and disease, formulations containing recombinant NA are in development.…”

Section: Recombinant Subunit-based Influenza Vaccinesmentioning

confidence: 61%

New technologies for influenza vaccines

Dormitzer

Tsai

Giudice

2012

Human Vaccines & Immunotherapeutics

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“…Animals given HR-Tet did not develop any adverse effects due to vaccination, and there was no evidence of reactogenicity at the site of vaccination. Preliminary studies with wild-types strains of DENV indicate that the HR-Tet strains of DENV can be grown to adequate titers in Sf9 cells, which are a clonal cell line of Spodoptera frugiperdia (Fall armyworm) and have been used in the production of the FDA-approved live viral vaccine FluBlok (60)(61)(62). Collectively, these data suggest that HRTet warrants development as a LAV vaccine for use in humans.…”

Section: Discussionmentioning

confidence: 99%

Live Attenuated Tetravalent Dengue Virus Host Range Vaccine Is Immunogenic in African Green Monkeys following a Single Vaccination

Briggs

Smith

Piper

et al. 2014

J Virol

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The causative agent of dengue fever, dengue virus (DENV), is transmitted by mosquitoes, and as distribution of these insects has expanded, so has dengue-related disease. DENV is a member of the Flaviviridae family and has 4 distinct serotypes (DENV-1, -2, -3, and -4). No lasting cross protection is afforded to heterologous serotypes following infection by any one of the individual serotypes. The presence of nonneutralizing antibodies to one serotype can facilitate the occurrence of more-severe dengue hemorrhagic fever through immune enhancement upon infection with a second serotype. For this reason, the development of a safe, tetravalent vaccine to produce a balanced immune response to all four serotypes is critical. We have developed a novel approach to produce safe and effective live-attenuated vaccines for DENV and other insect-borne viruses. Host range (HR) mutants of each DENV serotype were created by truncating transmembrane domain 1 of the E protein and selecting for strains of DENV that replicated well in insect cells but not mammalian cells. These vaccine strains were tested for immunogenicity in African green monkeys (AGMs). No vaccine-related adverse events occurred. The vaccine strains were confirmed to be attenuated in vivo by infectious center assay (ICA). Analysis by 50% plaque reduction neutralization test (PRNT 50 ) established that by day 62 postvaccination, 100% of animals seroconverted to DENV-1, -2, -3, and -4. Additionally, the DENV HR tetravalent vaccine (HR-Tet) showed a tetravalent anamnestic immune response in 100% (16/16) of AGMs after challenge with wild-type (WT) DENV strains. IMPORTANCEWe have generated a live attenuated viral (LAV) vaccine capable of eliciting a strong immune response in African green monkeys (AGMs) in a single dose. This vaccine is delivered by injecting one of four attenuated serotypes into each limb of the animal. 100% of animals given the vaccine generated antibodies against all 4 serotypes, and this response was found to be balanced in nature. This is also one of the first studies of dengue in AGMs, and our study suggests that viremia and antibody response in AGMs may be similar to those seen in DENV infection in humans.

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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☆

Cited by 87 publications

References 17 publications

Prevention and Control of Seasonal Influenza with Vaccines

Prevention and Control of Seasonal Influenza with Vaccines

New technologies for influenza vaccines

Live Attenuated Tetravalent Dengue Virus Host Range Vaccine Is Immunogenic in African Green Monkeys following a Single Vaccination

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