Please use this identifier to cite or link to this item: https://doi.org/10.1186/1471-2334-14-142
Title: Long-term booster schedules with AS03A-adjuvanted heterologous H5N1 vaccines induces rapid and broad immune responses in Asian adults
Authors: Gillard, P
Chu, D.W.S
Hwang, S.-J
Yang, P.-C
Thongcharoen, P
Lim, F.S 
Dramé, M
Walravens, K
Roman, F
Keywords: CD4 antibody
CD40 ligand
gamma interferon
immunological adjuvant
influenza vaccine
interleukin 2
tumor necrosis factor alpha
immunological adjuvant
influenza vaccine
neutralizing antibody
acute kidney failure
adult
antibody response
antibody titer
appendicitis
article
Asian
avian influenza
benign tumor
brain disease
CD8+ T lymphocyte
cellular immunity
clavicle fracture
colon polyp
controlled study
drug safety
drug tolerability
drug withdrawal
face fracture
fatigue
female
flu like syndrome
Helicobacter infection
hemagglutination inhibition test
Hong Kong
human
humoral immunity
ileus
immune response
immunogenicity
immunoreactivity
influenza A (H5N1)
Influenza virus A H5N1
injection site pain
joint dislocation
ligament rupture
lung embolism
lymphadenopathy
major clinical study
male
myalgia
ovary tumor
pandemic influenza
phase 3 clinical trial
pyelonephritis
rhinopharyngitis
Singapore
Taiwan
Thailand
tonsillitis
tooth disease
vaccination
virus neutralization
virus strain
Article
cross reaction
evaluation study
influenza A (H5N1)
influenza vaccination
injection site reaction
open study
randomized controlled trial
Adult
alpha-Tocopherol
Animals
Antibodies, Neutralizing
Antibodies, Viral
Asian Continental Ancestry Group
Cross Reactions
Drug Combinations
Female
Humans
Immunization Schedule
Immunization, Secondary
Influenza A Virus, H5N1 Subtype
Influenza Vaccines
Male
Middle Aged
Polysorbates
Squalene
Young Adult
Issue Date: 2014
Citation: Gillard, P, Chu, D.W.S, Hwang, S.-J, Yang, P.-C, Thongcharoen, P, Lim, F.S, Dramé, M, Walravens, K, Roman, F (2014). Long-term booster schedules with AS03A-adjuvanted heterologous H5N1 vaccines induces rapid and broad immune responses in Asian adults. BMC Infectious Diseases 14 (1) : 142. ScholarBank@NUS Repository. https://doi.org/10.1186/1471-2334-14-142
Rights: Attribution 4.0 International
Abstract: Background: The pandemic potential of avian influenza A/H5N1 should not be overlooked, and the continued development of vaccines against these highly pathogenic viruses is a public health priority.Methods: This open-label extension booster study followed a Phase III study of 1206 adults who had received two 3.75 μg doses of primary AS03A-adjuvanted or non-adjuvanted H5N1 split-virus vaccine (A/Vietnam/1194/2004; clade 1) (NCT00449670). The aim of the extension study was to evaluate different timings for heterologous AS03A-adjuvanted booster vaccination (A/Indonesia/5/2005; clade 2.1) given at Month 6, 12, or 36 post-primary vaccination. Immunogenicity was assessed 21 days after each booster vaccination and the persistence of immune responses against the primary vaccine strain (A/Vietnam) and the booster strain (A/Indonesia) was evaluated up to Month 48 post-primary vaccination. Reactogenicity and safety were also assessed.Results: After booster vaccination given at Month 6, HI antibody responses to primary vaccine, and booster vaccine strains were markedly higher with one dose of AS03A-H5N1 booster vaccine in the AS03A-adjuvanted primary vaccine group compared with two doses of booster vaccine in the non-adjuvanted primary vaccine group. HI antibody responses were robust against the primary and booster vaccine strains 21 days after boosting at Month 12 or 36. At Month 48, in subjects boosted at Month 6, 12, or 36, HI antibody titers of ≥1:40 against the booster strain persisted in 39.2%, 61.2%, and 95.6% of subjects, respectively. Neutralizing antibody responses and cell-mediated immune responses also showed that AS03A-H5N1 heterologous booster vaccination elicited robust immune responses within 21 days of boosting at Month 6, 12, or 36 post-primary vaccination. The booster vaccine was well tolerated, and no safety concerns were raised.Conclusions: In Asian adults primed with two doses of AS03A-adjuvanted H5N1 pandemic influenza vaccine, strong cross-clade anamnestic antibody responses were observed after one dose of AS03A-H5N1 heterologous booster vaccine given at Month 6, 12, or 36 after priming, suggesting that AS03A-adjuvanted H5N1 vaccines may provide highly flexible prime-boost schedules. Although immunogenicity decreased with time, vaccinated populations could potentially be protected for up to three years after vaccination, which is likely to far exceed the peak of the a pandemic. © 2014 Gillard et al.; licensee BioMed Central Ltd.
Source Title: BMC Infectious Diseases
URI: https://scholarbank.nus.edu.sg/handle/10635/181506
ISSN: 14712334
DOI: 10.1186/1471-2334-14-142
Rights: Attribution 4.0 International
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