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ABSTRACT: BACKGROUND: Household transmission of influenza-like illness (ILI) may vary with viral and demographic characteristics. We examined the effect of these factors in a population-based sample of adults with ILI. METHODS: We conducted a prospective cohort study in community-dwelling Australian adults nested within an influenza vaccine effectiveness trial. On presentation with ILI, participants were swabbed for a range of respiratory viruses and asked to return a questionnaire collecting details of household members with or without similar symptoms. We used logistic and Poisson regression to assess the key characteristics of household transmission. RESULTS: 258 participants from multi-occupancy households experienced 279 ILI episodes and returned a questionnaire. Of these, 183 were the primary case in the household allowing assessment of factors associated with transmission. Transmission was significantly associated in univariate analyses with female sex (27% vs. 13%, risk ratio (RR) = 2.13 (1.08, 4.21)) and the presence of a child in the house (33% vs. 17%, RR = 1.90 (1.11, 3.26)). The secondary household attack proportion (SHAP) was 0.14, higher if influenza was isolated (RR = 2.1 (1.0, 4.5)). Vaccinated participants who nonetheless became infected with influenza had a higher SHAP (Incidence RR = 5.24 (2.17, 12.6)). CONCLUSIONS: The increased SHAP in households of vaccinated participants who nonetheless had confirmed influenza infection supports the hypothesis that in years of vaccine mismatch, not only is influenza vaccine less protective for the vaccine recipient, but that the population's immunity is also lower.
BMC Infectious Diseases 12/2012; 12(1):345. · 3.12 Impact Factor
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ABSTRACT: Objective : To review Australian contributions to global immunisation. Approach : We summarise Australian scientific and program contributions to vaccines and global immunisation, describe key developments and strengths in Australia's national immunisation program, and outline how both of these can link with Australia's increasing international development budget to build Australia's future contribution to global immunisation. Conclusions : Australian contributions to vaccines and immunisation have been substantial, and Australia offers a range of good practices in its domestic and development approaches. There are major opportunities to build on this strong track record. These include committing to help roll out important new life-saving vaccines against pneumococcal disease, rotavirus and human papilloma virus (HPV) to the children who need them most, but whose communities can least afford them. Implications : Australia is one of a few countries expanding their aid budgets towards 0.7% development assistance and other development commitments. Given the importance of immunisation to health gains, Australia is well placed to expand its investment in immunisation within its development portfolio. The GAVI Alliance is the best-established global mechanism to do this. Additionally, however, Australia could harness other national and regional mechanisms to support low and middle-income countries, thereby complementing GAVI's focus and global needs.
Australian and New Zealand Journal of Public Health 12/2012; 36(6):564-9. · 1.20 Impact Factor
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Robert Booy,
Peter Richmond, Terry Nolan,
Jodie McVernon,
Helen Marshall,
Michael Nissen,
Graham Reynolds,
John B Ziegler,
Tanya Stoney,
Leon Heron,
Stephen Lambert,
Narcisa Mesaros,
Kavitha Peddiraju,
Jacqueline M Miller
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ABSTRACT: BACKGROUND:: Persistence of seroprotective bactericidal antibody titers is important for long-term protection against meningococcal serogroup C disease in young children. Antibody persistence values were determined in children up to 3 years after vaccination with a single dose of the combined Haemophilus influenzae type b-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine (Hib-MenC-TT; www.ClinicalTrials.gov: NCT00326118). METHODS:: The children had been randomized at age 12 to 18 months to receive either 1 dose of Hib-MenC-TT (Hib-MenC group) or separately administered Hib-tetanus toxoid (Hib-TT) conjugate vaccine and MenC-CRM197 vaccine (Hib+MCC group). All children had been primed in infancy with a Hib vaccine. Antibodies against MenC were measured by a serum bactericidal assay using rabbit complement (rSBA-MenC) and antibodies against Hib polyribosylribitol phosphate (PRP) were assessed by enzyme-linked immunosorbent assay. RESULTS:: rSBA-MenC titers ≥1:8 were demonstrated 3 years post-vaccination in 64.2% and 53.2% of participants in the Hib-MenC group and Hib+MCC group, respectively. Anti-PRP concentrations ≥0.15 µg/mL persisted in more than 98% of participants in both groups. rSBA-MenC geometric mean titers and anti-PRP geometric mean concentrations remained higher 3 years post-vaccination than before vaccination. No serious adverse events assessed by the investigator as being related to vaccination were reported. CONCLUSION:: In this antibody persistence study of Hib-primed but MenC-naïve toddlers who received a single dose of Hib-MenC-TT, protective antibody levels against Hib and MenC were maintained in the majority of children 3 years after vaccination.
The Pediatric Infectious Disease Journal 10/2012; · 3.58 Impact Factor
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Kristina Bryant,
Jodie McVernon,
Colin Marchant, Terry Nolan,
Gary Marshall,
Peter Richmond,
Helen Marshall,
Michael Nissen,
Stephen Lambert,
Emmanuel Aris,
Narcisa Mesaros,
Jacqueline Miller
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ABSTRACT: A pooled analysis was conducted of 1257 toddlers who received a fourth dose of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY-TT) or Hib conjugate vaccine (Hib polysaccharide conjugated to N. meningitidis outer membrane protein) coadministered with measles-mumps-rubella (MMR) and varicella (VAR) vaccines (NCT00134719/NCT00289783). Noninferiority of immunological responses to MMR and VAR was demonstrated between groups and incidences of MMR- and VAR-specific solicited symptoms were similar, indicating that HibMenCY-TT can be coadministered with MMR and VAR.
Human vaccines & immunotherapeutics. 08/2012; 8(8).
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ABSTRACT: Please cite this paper as: Howard et al. (2012) Virus detection and its association with symptoms during influenza-like illness in a sample of healthy adults enrolled in a randomised controlled vaccine trial. Influenza and Other Respiratory Viruses DOI: 10.1111/j.1750-2659.2012.00395.x. Background Viral respiratory infections are associated with significant morbidity and mortality. Many new aetiological agents have been described recently. Objectives We looked for respiratory viruses in a population-based sample of healthy adults with influenza-like illness (ILI). We investigated host and spatio-temporal associations with virus isolation and host, spatio-temporal and virus associations with self-reported symptoms. Patients/Methods We recruited 586 participants experiencing 651 illness episodes from a population of healthy adults enrolled in an influenza vaccine effectiveness trial. At ILI assessment visits, a respiratory swab was collected and tested for viruses using a combination of polymerase chain reaction (PCR) assays. Participants also completed a questionnaire detailing their clinical course in 336 episodes. Results Of 643 samples analysed, a virus was identified in 44%. Half were picornaviruses, with influenza and coronaviruses the next most common. Individuals with influenza were significantly less likely to have been immunised than the reference (virus negative) population (OR = 0·52 (0·31, 0·87) P = 0·01). The mean symptom score (95% CI) reported by individuals with influenza was significantly higher than in all other episodes [Influenza: 10·2 (9·4, 10·9); Other: 7·4 (7·2, 7·7); Difference (95% CI): 2·5 (1·5, 3·5); P < 0·001]. In an analysis restricted to influenza-positive cases, the symptom score was not attenuated by vaccination. Conclusions Our findings indicate that a greater number of symptoms are displayed by individuals presenting with influenza confirmed ILI compared with other agents that cause ILI. While influenza vaccination reduced the probability of influenza virus detection, symptom score for influenza-positive ILI was not attenuated.
Influenza and Other Respiratory Viruses 06/2012; · 4.16 Impact Factor
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ABSTRACT: The safety profile of HibMenCY was compared with licensed Hib conjugate vaccines in a pooled analysis that included more than 8,500 subjects who were administered a four-dose series of HibMenCY or commercially available Hib vaccines at 2, 4, 6 and 12-15 mo of age in two primary vaccination and two fourth dose phase 3 studies. In all studies, HibMenCY or Hib vaccine was co-administered with age-appropriate, routinely recommended vaccines. In one primary and one fourth dose study (n = 4180), local and general symptoms were solicited using diary cards for 4 d after each dose. Serious adverse events (SAEs) and the occurrence of adverse events (AEs) indicating new onset of chronic disease (NOCD), rash, and conditions prompting Emergency Room (ER) visits were reported from dose 1 until 6 mo after dose 4. The incidences of solicited local and general symptoms were similar following HibMenCY and commercially available Hib vaccines. For some solicited symptoms (pain at the injection site and irritability), rates were lower in the HibMenCY group compared with the Hib control group (p value < 0.05). There were no statistically significant differences between groups in the incidences of SAEs, NOCDs, rash, or AEs leading to ER visits, with the exceptions of anemia and viral gastroenteritis, which occurred significantly less frequently in those receiving HibMenCY than those receiving commercially available Hib vaccines. In this pooled safety analysis, the safety profile of HibMenCY was similar to the safety profile of licensed monovalent Hib vaccines, despite the addition of meningococcal antigens. These studies are registered at www.clinicaltrials.gov NCT00345579 (primary vaccination study), NCT00345683 (fourth dose vaccination study) and NCT00289783 (primary and fourth dose vaccination studies).
Human vaccines & immunotherapeutics. 03/2012; 8(3):304-11.
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ABSTRACT: Neisseria meningitidis is a leading cause of meningitis and septicemia globally. Recent shifts in serogroup dominance in some settings highlight the desirability of polysaccharide-conjugate vaccines with broader meningococcal coverage than serogroup C vaccines in widespread use.
We assessed the safety and immunogenicity of a single dose of meningococcal quadrivalent (A, C, W-135, Y) tetanus conjugate vaccine (TetraMen-T), administered at 1 year of age. A total of 378 children were randomized to 1 of 6 groups--5 received alternative formulations of TetraMen-T, the sixth licensed adjuvanted serogroup C conjugate vaccine (Neisvac-C). Solicited adverse event reports were collected from day 0 to 7 after vaccination and unsolicited and serious adverse event reports throughout study participation. Immunogenicity was assessed by serum bactericidal assays containing either a human (hSBA) or baby rabbit (rSBA) complement source before and 1 month after immunization.
All vaccine formulations were safe and well tolerated. Using the various measures of immunogenicity, no consistent relationships were observed between the dose of either polysaccharide or carrier and serogroup-specific response for any one antigen. The highest-dose vaccine provided optimal coverage for all 4 serogroups, with the percentage of recipients achieving hSBA titers ≥ 8 against each as follows: A, 92%; C, 96%; W-135, 71%; Y, 82% (corresponding proportions with rSBAs titers >8 all exceeded 90%). The investigational vaccines were less immunogenic against the serogroup C capsular polysaccharide than the licensed comparator.
Studies are ongoing that will help to identify optimal scheduling of quadrivalent meningococcal conjugate vaccines, to facilitate their inclusion into national immunization programs seeking extended serogroup coverage against meningococci.
The Pediatric Infectious Disease Journal 11/2011; 31(1):e15-23. · 3.58 Impact Factor
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Kristina A Bryant,
Gary S Marshall,
Colin D Marchant,
Noris Pavia-Ruiz, Terry Nolan,
Stephen Rinderknecht,
Mark Blatter,
Emmanuel Aris,
Pascal Lestrate,
Dominique Boutriau,
Leonard R Friedland,
Jacqueline M Miller
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ABSTRACT: Meningococcal disease incidence is highest in children younger than 2 years of age, yet there is no US-licensed vaccine for this age group. A phase III study evaluated the immunogenicity and safety of an investigational Haemophilus influenzae type b (Hib)-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY).
A total of 4180 infants were randomly assigned to receive the HibMenCY at the ages of 2, 4, 6, and 12 to 15 months or the licensed Hib tetanus toxoid conjugate vaccine (ActHIB) at 2, 4, and 6 months and Hib conjugated to N meningitidis outer membrane protein (PedvaxHIB) at 12 to 15 months. Routinely scheduled vaccines were coadministered. Serum bactericidal activity using human complement and anti-polyribosylribitol phosphate antibodies were assessed in 991 subjects. Local and systemic adverse reactions were recorded for 4 days after each dose.
The percentage of HibMenCY recipients with serum bactericidal assay using human complement titers of 1:8 or higher after dose 3 was 98.8% for N meningitidis serogroup C (MenC) and 95.8% for N meningitidis serogroup Y (MenY). After dose 4, the percentages were 98.5% and 98.8%, respectively. The percentage of HibMenCY recipients with postdose 3 anti-polyribosylribitol phosphate antibody levels of ≥ 1.0 μg/mL was noninferior to that of control (96.3% vs 91.2%). After dose 4, MenC and MenY serum bactericidal assay using human complement antibody titers increased 12-fold over pre-dose 4 levels. Incidence of pain, redness, and swelling at the HibMenCY injection sites tended to be lower than with Hib type b after the first 3 doses and after the fourth dose. Rates of systemic symptoms were similar across groups.
The HibMenCY was immunogenic against MenC and MenY and induced anti-polyribosylribitol phosphate antibody levels noninferior to those of licensed Hib conjugate vaccine. The safety profile of the HibMenCY was clinically acceptable and comparable to Hib conjugate vaccine.
PEDIATRICS 06/2011; 127(6):e1375-85. · 4.47 Impact Factor
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ABSTRACT: Neisseria meningitidis serogroups B, C, and Y cause most meningococcal disease in industrialized countries. A Haemophilus influenzae type b-meningococcal serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY-TT) was evaluated.
A total of 1104 infants (randomized 3:1:1) were vaccinated at 2, 4, and 6 months with HibMenCY-TT, MenC-CRM197 + Hib-TT, or Hib-TT. At 12 to 15 months, HibMenCY-TT and MenC-CRM-primed children received HibMenCY-TT; Hib-TT-primed received N. meningitidis serogroup B Hib-outer membrane protein complex. Antibody concentrations and rabbit/human complement serum bactericidal antibody titers (rSBA/hSBA) were determined. Safety was monitored after each dose (diary cards for first 31 days) until 6 months postdose 4.
Postdose 3, rates of antipolyribosylribitol phosphate ≥ 1 μg/mL and rSBA-MenC ≥1:128 in HibMenCY-TT recipients were noninferior to licensed controls. Percentages reaching 0.15 μg/mL (1.0 μg/mL postdose 3) and antipolyribosylribitol phosphate GMC were significantly higher after HibMenCY-TT than Hib-TT postdose 2 and postdose 3. The GMC remained significantly higher before and after dose 4. Proportions of HibMenCY-TT recipients with rSBA ≥ 1:8 were 95.6% (MenC), 98.6% (MenY) postdose-2, ≥ 99% for MenC/Y postdose 3 and 4; hSBA ≥ 1:4 were 95.5% (MenC), 89.8% (MenY) postdose 2, >97% for MenC/Y postdose 3 and 4. HibMenCY-TT had a similar safety profile to control vaccines.
HibMenCY-TT induced noninferior Hib and MenC responses compared with monovalent Hib and MenC conjugates with a comparable safety profile. Bactericidal antibodies against MenC/Y were induced after 2 doses of HibMenCY-TT.
The Pediatric Infectious Disease Journal 03/2011; 30(3):190-6. · 3.58 Impact Factor
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ABSTRACT: Panvax(®) (CSL Biotherapies, Parkville, Australia) is one of a number of pandemic influenza A (H1N1) 2009 (pH1N1) vaccines fast-tracked for production, clinical trials and licensure in response to the emergence of the novel pH1N1 strain in early-mid-2009. Unexpectedly good immunogenicity following a single 15-µg dose was demonstrated in expedited clinical trials in adults and children. This facilitated early licensure and then rapid rollout for population immunization from October 2009. The vaccine's safety profile in the Australian population has been excellent.
Expert Review of Vaccines 01/2011; 10(1):35-43. · 4.25 Impact Factor
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ABSTRACT: Early outbreaks of the pandemic influenza A (H1N1) 2009 virus predominantly involved young children, who fuelled transmission through spread in homes and schools. Seroprevalence studies conducted on stored serum collections indicated low levels of antibody to the novel strain in this age group, leading many to recommend priority immunisation of paediatric populations.
In a prospective study, we sought evidence of cross-reactive antibodies to the pandemic virus in children who were naïve to seasonal influenza vaccines, at baseline and following two doses of the 2009 Southern Hemisphere trivalent influenza vaccine (TIV).
Twenty children were recruited, with a median age of 4 years (interquartile range 3-5 years); all received two age appropriate doses of TIV. Paired sera were collected pre- and post-vaccination for the assessment of vaccine immunogenicity, using haemagglutination inhibition and microneutralisation assays against vaccine-related viruses and influenza A (H1N1) 2009.
Robust responses to H3N2 were observed regardless of age or pre-vaccination titre, with 100% seroconversion. Fewer seroconverted to the seasonal H1N1 component. Only two children were weakly seropositive (HI titre 40) to the pandemic H1N1 strain at study entry, and none showed evidence of seroconversion by HI assay following TIV administration.
Administration of 2009 Southern Hemisphere TIV did little to elicit cross-reactive antibodies to the pandemic H1N1 virus in children, in keeping with assay results on stored sera from studies of previous seasonal vaccines. Our findings support the recommendations for influenza A (H1N1) 2009 vaccination of children in preparation for the 2010 winter season.
Influenza and Other Respiratory Viruses 01/2011; 5(1):7-11. · 4.16 Impact Factor
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Robert Booy,
Peter Richmond, Terry Nolan,
Jodie McVernon,
Helen Marshall,
Michael Nissen,
Graham Reynolds,
John B Ziegler,
Leon Heron,
Stephen Lambert,
Magalie Caubet,
Narcisa Mesaros,
Dominique Boutriau
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ABSTRACT: Hib-primed but MenC-naive toddlers (N = 433) were randomized to receive 1 dose of Hib-MenC-TT or separate Hib-TT and MenC-CRM197 vaccines. One month later, noninferiority was demonstrated for serum bactericidal anti-MenC antibodies (rSBA) and Hib antipolyribosylribitol phosphate (PRP) antibodies; >99% in both groups had rSBA titer ≥ 8 or anti-PRP concentration ≥ 0.15 μg/mL. After 12 months, rSBA titer ≥ 8 persisted in 86.7% and 76.4%, and anti-PRP concentration ≥ 0.15 μg/mL persisted in 98.8% and 100% of children, respectively.
The Pediatric Infectious Disease Journal 11/2010; 30(4):340-2. · 3.58 Impact Factor
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ABSTRACT: This study compared the long-term persistence of anti-hepatitis A (anti-HAV) and B (anti-HBs) antibodies, 5 years after vaccination of subjects aged 1-11 years with a combined hepatitis A and B vaccine either in a two-dose (0, 6 months, Adult formulation) or a three-dose (0, 1, 6 months, Paediatric formulation) schedule. At the end of the 5 years, all subjects (100%) in both groups continued to have anti-HAV antibodies > or =15mIU/mL, while 94-97% of subjects in both groups had anti-HBs antibody concentrations > or =10mIU/mL. Subjects with anti-HBs antibody concentration < or =10mIU/mL were administered a challenge dose of hepatitis B vaccine. All subjects mounted a vigorous immune response to the challenge indicating the presence of immunological memory to HBV.
Vaccine 06/2010; 28(27):4411-5. · 3.77 Impact Factor
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Terry Nolan,
Jodie McVernon,
Maryanne Skeljo,
Peter Richmond,
Ushma Wadia,
Stephen Lambert,
Michael Nissen,
Helen Marshall,
Robert Booy,
Leon Heron,
Gunter Hartel,
Michael Lai,
Russell Basser,
Charmaine Gittleson,
Michael Greenberg
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ABSTRACT: In the ongoing influenza pandemic, a safe and effective vaccine against 2009 influenza A(H1N1) is needed for infants and children.
To assess the immunogenicity and safety of a 2009 influenza A(H1N1) vaccine in children.
Randomized, observer-blind, age-stratified, parallel group study assessing 2 doses of an inactivated, split-virus 2009 influenza A(H1N1) vaccine in 370 healthy infants and children aged 6 months to less than 9 years living in Australia.
Intramuscular injection of 15 microg or 30 microg of hemagglutinin antigen dose of monovalent, unadjuvanted 2009 influenza A(H1N1) vaccine in a 2-dose regimen, administered 21 days apart.
Hemagglutination inhibition assay to estimate the proportion of participants with antibody titers of 1:40 or greater, seroconversion, or a significant antibody titer increase, and factor increase in geometric mean titer. Assessments of solicited adverse events during 7 days and unsolicited adverse events for 21 days after each vaccination.
Following the first dose of vaccine, antibody titers of 1:40 or greater were observed in 161 of 174 infants and children in the 15-microg group (92.5%; 95% confidence interval [CI], 87.6%-95.6%) and in 168 of 172 infants and children in the 30-microg group (97.7%; 95% CI, 94.2%-99.1%). Corresponding seroconversion rates were 86.8% (95% CI, 80.9%-91.0%) and 94.2% (95% CI, 89.6%-96.8%), and factor increases in geometric mean titer were 13.6 (95% CI, 11.8-15.6) and 18.3 (95% CI, 15.7-21.4). All participants demonstrated antibody titers of 1:40 or greater after the second vaccine dose. Immune responses were robust regardless of age, baseline serostatus, or seasonal influenza vaccination status. The majority of adverse events were mild to moderate in severity.
One 15-microg dose of vaccine was immunogenic in infants and children starting at 6 months of age and vaccine-associated reactions were mild to moderate in severity.
clinicaltrials.gov Identifier: NCT00940108.
JAMA The Journal of the American Medical Association 12/2009; 303(1):37-46. · 30.03 Impact Factor
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ABSTRACT: Few prospective studies of inactivated split virion influenza vaccine have been conducted in infants and children. Our objective was to evaluate the safety, reactogenicity and immunogenicity of a thimerosal-free inactivated influenza vaccine (Fluvax; CSL Limited, Parkville, Australia) in children aged 6 months to <9 years.
A prospective, open-label, phase III clinical trial was conducted in 298 healthy children previously unvaccinated with influenza, commencing in the Southern Hemisphere 2005 autumn. Participants were divided into two groups (Group A: > or =6 months to <3 years; Group B: > or =3 years to <9 years), and received two doses of the 2005 vaccine, and one dose of the 2006 vaccine one year later (Group A: 0.25 ml per dose; Group B: 0.5 ml per dose). Vaccine safety and reactogenicity was evaluated for 30 days after each dose. Immunogenicity was assessed using hemagglutination inhibition and single radial hemolysis assays.
There were no withdrawals due to adverse events (AEs). The majority of solicited local and systemic AEs were of mild severity. A maximum intensity of severe was reported for injection site pain and fever by only 3.0% and 3.4% of participants, respectively. The vaccine was immunogenic for all antigens, with > or =95% of both younger and older children achieving seroprotection after dose 2.
This thimerosal-free inactivated influenza vaccine had a favorable safety profile and was immunogenic in children aged > or =6 months and <9 years. Primary and booster vaccination produced consistently immunogenic responses including in children under 3 years of age receiving 0.25 ml doses of vaccine.
Influenza and Other Respiratory Viruses 11/2009; 3(6):315-25. · 4.16 Impact Factor
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ABSTRACT: Immunogenicity and reactogenicity of DTPa and reduced antigen dTpa booster vaccines were compared to a hepatitis A control vaccine in DTPa-primed toddlers aged 18 - 20 months. Post-booster, all DTPa and dTpa recipients were seroprotected against diphtheria and tetanus, and > or = 93.3% had a booster response to pertussis. There were similar reactogenicity rates in the DTPa and dTpa vaccine recipients. Few Grade 3 symptoms were reported. Just over one in four children in the control group had diphtheria antibody at or potentially below the correlate of protection benchmark (0.016IU/ml). Larger studies should evaluate potential benefits of reduced antigen vaccines and seroprotection in children who do not receive a booster dose of DTPa at this age, including protection against diphtheria until subsequent booster doses are given.
Vaccine 05/2009; 27(18):2410-3. · 3.77 Impact Factor
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BRONWYN PARRY-FIELDER BAPPSC(SPEECHPATH) MEDSTUD,
KEVIN COLLINS MBBS,
JOHN FISHER LACST MA(APPLING,
EDDIE KEIR BA(PSYCH) TTCTD,
VICKI ANDERSON PHD,
RANI JACOBS PHD,
INGRID E SCHEFFER MBBS PHD,
TERRY NOLAN MBBS PHD,
BRONWYN PARRY‐FIELDER,
KEVIN COLLINS,
JOHN FISHER,
EDDIE KEIR,
VICKI ANDERSON,
RANI JACOBS,
INGRID E SCHEFFER, TERRY NOLAN
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ABSTRACT: Earlier research has suggested a link between epileptiform activity in the electroencephalogram (EEG) and developmental speech-language disorder (DSLD). This study investigated the strength of this association by comparing the frequency of EEG abnormalities in 45 language-normal children (29 males, 16 females; mean age 6y 11mo, SD 1y 10mo, range 4y–9y 10mo) and 54 community-ascertained children (35 males, 19 females; mean age 5y 7mo, SD 1y 6mo, range 4y–9y 11mo) with a diagnosis of severe DSLD, defined as a score at least 2 SD below the mean on at least one speech-language measure, and a performance IQ of at least 80 points. All participants underwent sleep EEGs after sedation. Children with DSLD also had detailed speech-language, hearing, and psychological assessments. Results failed to support the previously identified strong association between abnormal EEG and DSLD. There was a weak, non-significant relationship between DSLD and epileptiform EEG. Epileptiform EEG was significantly associated with low performance IQ (p=0.04). This study draws into question previously reported associations between epileptiform activity and DSLD probably because it examined a purer cohort of children with more severe language difficulties who did not have seizures.
Developmental Medicine & Child Neurology 02/2009; 51(3):228 - 234. · 2.92 Impact Factor
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ABSTRACT: Earlier research has suggested a link between epileptiform activity in the electroencephalogram (EEG) and developmental speech-language disorder (DSLD). This study investigated the strength of this association by comparing the frequency of EEG abnormalities in 45 language-normal children (29 males, 16 females; mean age 6y 11mo, SD 1y 10mo, range 4y-9y 10mo) and 54 community-ascertained children (35 males, 19 females; mean age 5y 7mo, SD 1y 6mo, range 4y-9y 11mo) with a diagnosis of severe DSLD, defined as a score at least 2 SD below the mean on at least one speech-language measure, and a performance IQ of at least 80 points. All participants underwent sleep EEGs after sedation. Children with DSLD also had detailed speech-language, hearing, and psychological assessments. Results failed to support the previously identified strong association between abnormal EEG and DSLD. There was a weak, non-significant relationship between DSLD and epileptiform EEG. Epileptiform EEG was significantly associated with low performance IQ (p=0.04). This study draws into question previously reported associations between epileptiform activity and DSLD probably because it examined a purer cohort of children with more severe language difficulties who did not have seizures.
Developmental Medicine & Child Neurology 02/2009; 51(3):228-34. · 2.92 Impact Factor
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Journal of Public Health 11/2008; 30(4):362-3. · 2.06 Impact Factor
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Terry Nolan,
Peter C Richmond,
Neil T Formica,
Katja Höschler,
Maryanne V Skeljo,
Tanya Stoney,
Jodie McVernon,
Gunter Hartel,
Daphne C Sawlwin,
Jillian Bennet,
David Ryan,
Russell L Basser,
Maria C Zambon
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ABSTRACT: Highly pathogenic avian influenza A virus (H5N1) is a leading candidate for the next influenza pandemic, and infants and children may play an important role in transmission in a pandemic. Our objective was to evaluate the safety and immunogenicity of a prototype inactivated, aluminium adjuvanted, split-virus, clade 1 H5N1 vaccine (A/Vietnam/1194/2004/NIBRG-14) in infants and children aged > or =6 months to < 9 years.
Healthy infants and children (N=150) received two doses of 30 microg or 45 microg H5 HA with AlPO4 adjuvant 21 days apart. Serum samples were collected for virus microneutralisation (MN) and haemagglutination inhibition (HI) assays on Days 0, 21, and 42. Six-month antibody persistence following second vaccine dose was assessed by MN, and cross-reactive HI antibodies to a clade 2 variant strain (INDO5/RG2) were evaluated at Day 42.
Both formulations were well-tolerated. Two doses of 30 microg or 45 microg H5 HA formulations elicited strong immune responses by both MN (98-99% > or =1:20) and HI assays (95-100% > or =1:32), with 80-87% of children having MN antibody persistence (> or =1:20) up to 6 months post-vaccination. Additionally, robust cross-clade HI antibody responses were elicited following two doses.
Two doses of prototype 30 microg or 45 microg aluminium-adjuvanted, H5N1 vaccines were highly immunogenic and well-tolerated, with considerable antibody persistence 6 months after the primary vaccination course. Additional cross-clade HI antibody responses and an acceptable safety and tolerability profile support the use of the either candidate vaccine formulations in infants and children in the event of a pandemic.
Vaccine 10/2008; 26(50):6383-91. · 3.77 Impact Factor
