Safety and Immunogenicity of a Novel Influenza Subunit Vaccine Produced in Mammalian Cell Culture

Abstract

CCIV was well tolerated and highly immunogenic in adults 18 years of age or older. Cell culture may offer greater flexibility of supply during periods of high demand for both seasonal and pandemic vaccines.

Cell culture-based influenza vaccines: A necessary and indispensable investment for the future

“…112,[114][115][116][117]122,126 Similar to local AEs, systemic AEs are also lowest in the elderly. 114,116,118,122 However, in contrast to the local AEs, systemic AEs are only slightly lower in children as compared to that in adults. 114,122 Adjuvanted preparations typically produce higher local AEs but systemic AEs are either similar or only slightly more as compared to unadjuvanted vaccines.…”

“…[111][112][113][114] Other studies found that MDCK cell-derived vaccines were at least equivalent, and sometimes better and more efficacious as compared to ECEderived antigens. 111,112,[114][115][116][117][118][119][120] In one instance, it was reported that at risk adult and elderly subjects who did not respond serologically to a previous ECE-derived vaccine responded better when boosted with MDCK cell-derived vaccine as compared to an ECE-based vaccine. 121 Since the early 1990s, reports of more than 20 clinical studies involving greater than 20,000 subjects in over a dozen countries, as well as large-scale immunization programs have further confirmed the safety and immunogenicity of MDCK cell-derived influenza vaccines.…”

“…114,122,123,125 Total local AEs have ranged from 10% to 84%, 112,[114][115][116][117]122,124,126 again, typically higher in adults than in children, and lowest in the elderly. 114,116,118,122 Local AEs are also higher in the case of adjuvanted vaccine formulations as compared to unadjuvanted vaccine. 122,123,126 The most common local AE has been pain at injection site (12-75%), followed by erythema (2-20%), induration (6-15%), swelling (2-15%), and ecchymosis (0-18%).…”

“…122,123,126 The most common local AE has been pain at injection site (12-75%), followed by erythema (2-20%), induration (6-15%), swelling (2-15%), and ecchymosis (0-18%). 112,115,[116][117][118][119][120]122,123,[125][126][127][128][129] Some investigators have also reported limitation in movement, tenderness and bruising. 114,127 In general, the local reactions are mild, and are not significantly different from subjects administered ECE-derived vaccine or a placebo.…”

“…122,123,126 The commonest systemic AE is headache, being reported in 6.7-32% of the subjects, followed by myalgia (2-30%), fatigue (4-24%), malaise (3-25%), sweating (0-16%), chills (0-14%), and arthralgia (0-15%). 112,[114][115][116][117][118][119][120]122,123,125,126,128,129 Other systemic AEs, which are typically observed in less than 10% of the subjects, include nausea, loss of appetite, diarrhea, vomiting, fever and rash. A wider variety of systemic reactions, including sleepiness, inappetence, irritability, and unusual crying have been reported in young children.…”