Dataset Information

The responses of Aboriginal Canadians to adjuvanted pandemic (H1N1) 2009 influenza vaccine.

ABSTRACT: Because many Aboriginal Canadians had severe cases of pandemic (H1N1) 2009 influenza, they were given priority access to vaccine. However, it was not known if the single recommended dose would adequately protect people at high risk, prompting our study to assess responses to the vaccine among Aboriginal Canadians.We enrolled First Nations and Métis adults aged 20-59 years in our prospective cohort study. Participants were given one 0.5-mL dose of ASO3-adjuvanted pandemic (H1N1) 2009 vaccine (Arepanrix, GlaxoSmithKline Canada). Blood samples were taken at baseline and 21-28 days after vaccination. Paired sera were tested for hemagglutination-inhibiting antibodies at a reference laboratory. To assess vaccine safety, we monitored the injection site symptoms of each participant for seven days. We also monitored patients for general symptoms within 7 days of vaccination and any use of the health care system for 21-28 days after vaccination.We enrolled 138 participants in the study (95 First Nations, 43 Métis), 137 of whom provided all safety data and 136 of whom provided both blood samples. First Nations and Métis participants had similar characteristics, including high rates of chronic health conditions (74.4%-76.8%). Pre-existing antibody to the virus was detected in 34.3% of the participants, all of whom boosted strongly with vaccination (seroprotection rate [titre ? 40] 100%, geometric mean titre 531-667). Participants with no pre-existing antibody also responded well. Fifty-eight of 59 (98.3%) First Nations participants showed seroprotection and a geometric mean titre of 353.6; all 30 Métis participants with no pre-existing antibody showed seroprotection and a geometric mean titre of 376.2. Pain at the injection site and general symptoms frequently occurred but were short-lived and generally not severe, although three participants (2.2%) sought medical attention for general symptoms.First Nations and Métis adults responded robustly to ASO3-adjuvanted pandemic (H1N1) 2009 vaccine. Virtually all participants showed protective titres, including those with chronic health conditions.

SUBMITTER: Rubinstein E

PROVIDER: S-EPMC3176866 | biostudies-other | 2011 Sep

REPOSITORIES: biostudies-other

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The responses of Aboriginal Canadians to adjuvanted pandemic (H1N1) 2009 influenza vaccine.

Rubinstein Ethan E Predy Gerald G Sauvé Laura L Hammond Greg W GW Aoki Fred F Sikora Chris C Li Yan Y Law Barbara B Halperin Scott S Scheifele David D

CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 20110725 13

<h4>Background</h4>Because many Aboriginal Canadians had severe cases of pandemic (H1N1) 2009 influenza, they were given priority access to vaccine. However, it was not known if the single recommended dose would adequately protect people at high risk, prompting our study to assess responses to the vaccine among Aboriginal Canadians.<h4>Methods</h4>We enrolled First Nations and Métis adults aged 20-59 years in our prospective cohort study. Participants were given one 0.5-mL dose of ASO3-adjuvante ...[more]

PMID: 21788422

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Project description:Preliminary studies suggested that Aboriginal Canadians had disproportionately higher rates of infection, hospitalization, and critical illness due to pandemic Influenza A(H1N1)pdm09.We used a prospective cohort study of critically ill patients with laboratory confirmed or probable H1N1 infection in Canada between April 16 2009 and April 12 2010. Baseline characteristics, medical interventions, clinical course and outcomes were compared between Aboriginal and non-Aboriginal patients. The primary outcome was hospital mortality.Of 647 critically ill adult patients with known ethnicity, 81 (12.5%) were Aboriginal, 566 (87.5%) were non-Aboriginal. Aboriginal patients were younger (mean [SD] age 40.7[13.7] v. 49.0[14.9] years, p < 0.001) and more frequently female (64.2% v. 51.1%, p = 0.027). Rates of any co-morbid illnesses (Aboriginal v. non-Aboriginal, 92.6% v. 91.0%, p = 0.63), time from symptom onset to hospital admission (median [interquartile range] 4 [2-7] v. 4 [2-7] days, p = 0.84), time to ICU admission (5 [3-8] v.5 [3-8] days, p = 0.91), and severity of illness (mean APACHE II score (19.9 [9.6] v. 21.1 [9.9], p = 0.33) were similar. A similar proportion of Aboriginal patients received antiviral medication before ICU admission than non-Aboriginal patients (91.4% v. 93.8%, p = 0.40). Among Aboriginal versus non-Aboriginal patients, the need for mechanical ventilation (93.8% v. 88.6%, p = 0.15), ventilator-free days (14 [3-23] v. 17 [0-24], p = 0.62), durations of stay in ICU (13[7-19.5] v. 11 [5-8] days, p = 0.05), hospital (19 [12.5-33.5] v. 18 [11-35] days, p = 0.63), and hospital mortality were similar (19.8% v. 22.6%, p = 0.56). In multiple logistic regression analyses, higher APACHE II score (1.06; 1.04-1.09, p<0.001) was independently associated with an increased risk of death; antiviral treatment with a lower risk of death (0.34; 0.15 - 0.78, p = 0.01). Ethnicity was not associated with mortality.During the 2009-2010 Influenza A (H1N1) pandemic, Aboriginal and non-Aboriginal Canadians with H1N1-related critical illness had a similar risk of death, after adjusting for potential confounding factors.

Project description:ObjectivesTo assess the safety of an AS03-adjuvanted split virion H1N1 (2009) vaccine (Pandemrix) in persons vaccinated during the national pandemic influenza vaccination campaign in the UK.DesignProspective, cohort, observational, postauthorisation safety study.Setting87 general practices forming part of the Medical Research Council General Practice Research Framework and widely distributed throughout England.ParticipantsA cohort of 9143 individuals aged 7 months to 97 years who received at least one dose of the AS03-adjuvanted H1N1 pandemic vaccine during the national pandemic influenza vaccination campaign in the UK was enrolled. 94% completed the 6-month follow-up. Exclusion criteria were previous vaccination with other H1N1 pandemic vaccine and any child in care.Primary and secondary outcome measuresMedically attended adverse events (MAEs) occurring within 31 days after any dose, serious adverse events (SAEs) and adverse events of special interest (AESIs) following vaccination were collected for all participants. Solicited adverse events (AEs) were assessed in a subset of participants.ResultsMAEs were reported in 1219 participants and SAEs in 113 participants during the 31-day postvaccination period. The most frequently reported MAEs and SAEs were consistent with events expected to be reported during the winter season in this population: lower respiratory tract infections, asthma and pneumonia. The most commonly reported solicited AEs were irritability in young children aged <5 years (61.8%), muscle aches in children aged 5-17 years (61.9%) and adults (46.9%). 18 AESIs, experienced by 14 patients, met the criteria to be considered for the observed-to-expected analyses. AESIs above the expected number were neuritis (1 case within 31 days) and convulsions (8 cases within 181 days). There were 41 deaths during the 181-day period after vaccination, fewer than expected.ConclusionsResults indicate that the AS03-adjuvanted H1N1 pandemic vaccine showed a clinically acceptable reactogenicity and safety profile in all age and risk groups studied.Trial registrationClinicalTrials.gov, NCT00996853.

Project description:BackgroundThe efficacy of the H1N1 influenza vaccine relies on the induction of both humoral and cellular responses. This study evaluated the humoral and cellular responses to a monovalent non-adjuvanted pandemic influenza A/H1N1 vaccine in occupationally exposed subjects who were previously vaccinated with a seasonal vaccine.MethodsSixty healthy workers from a respiratory disease hospital were recruited. Sera and peripheral blood mononuclear cells (PBMCs) were obtained prior to and 1 month after vaccination with a non-adjuvanted monovalent 2009 H1N1 vaccine (Influenza A (H1N1) 2009 Monovalent Vaccine Panenza, Sanofi Pasteur). Antibody titers against the pandemic A/H1N1 influenza virus were measured via hemagglutination inhibition (HI) and microneutralization assays. Antibodies against the seasonal HA1 were assessed by ELISA. The frequency of IFN-?-producing cells as well as CD4+ and CD8+ T cell proliferation specific to the pandemic virus A/H1N peptides, seasonal H1N1 peptides and seasonal H3N2 peptides were assessed using ELISPOT and flow cytometry.ResultsAt baseline, 6.7% of the subjects had seroprotective antibody titers. The seroconversion rate was 48.3%, and the seroprotection rate was 66.7%. The geometric mean titers (GMTs) were significantly increased (from 6.8 to 64.9, p < 0.05). Forty-nine percent of the subjects had basal levels of specific IFN-?-producing T cells to the pandemic A/H1N1 peptides that were unchanged post-vaccination. CD4+ T cell proliferation in response to specific pandemic A/H1N1 virus peptides was also unchanged; in contrast, the antigen-specific proliferation of CD8+ T cells significantly increased post-vaccination.ConclusionOur results indicate that a cellular immune response that is cross-reactive to pandemic influenza antigens may be present in populations exposed to the circulating seasonal influenza virus prior to pandemic or seasonal vaccination. Additionally, we found that the pandemic vaccine induced a significant increase in CD8+ T cell proliferation.

Dataset Information

The responses of Aboriginal Canadians to adjuvanted pandemic (H1N1) 2009 influenza vaccine.

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The responses of Aboriginal Canadians to adjuvanted pandemic (H1N1) 2009 influenza vaccine.

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