The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform
Lode Schuerman - One of the best experts on this subject based on the ideXlab platform.
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immunogenicity safety and Reactogenicity of a booster dose of the 10 valent pneumococcal nontypeable h influenzae protein d conjugate vaccine coadministered with dtpa ipv hib in dutch children a randomized controlled trial
Pediatric Infectious Disease Journal, 2016Co-Authors: Menno R Van Den Bergh, Lode Schuerman, Judith Spijkerman, Nancy Francois, Kristien Swinnen, Dorota Borys, Reinier H Veenhoven, Elisabeth A M SandersAbstract:Background:Immune responses and safety profiles may be affected when vaccines are coadministered. We evaluated the immunogenicity, safety and Reactogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D-conjugate (PHiD-CV; Synflorix GSK Vaccines) and DT
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immunogenicity safety and Reactogenicity of the 10 valent pneumococcal nontypeable haemophilus influenzae protein d conjugate vaccine and dtpa ipv hib when coadministered as a 3 dose primary vaccination schedule in the netherlands a randomized contro
Pediatric Infectious Disease Journal, 2011Co-Authors: Menno R Van Den Bergh, Lode Schuerman, Judith Spijkerman, Nancy Francois, Kristien Swinnen, Dorota Borys, Reinier H Veenhoven, Elisabeth A M SandersAbstract:Background Recent reviews have highlighted the unpredictability of immunologic interference when multivalent conjugated vaccines are coadministered with other pediatric vaccines. Objective To evaluate immunogenicity, safety, and Reactogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV; Synflorix, GlaxoSmithKline Biologicals) and DTPa-IPV-Hib (Pediacel, Sanofi Pasteur MSD) when coadministered as a 3-dose primary vaccination course. Material and methods In a single-blind, single-center, randomized controlled trial in the Netherlands, healthy infants (n = 780) were randomly assigned (1:1:1) to receive either (1) PHiD-CV + DTPa-HBV-IPV/Hib (Infanrix Hexa, GlaxoSmithKline Biologicals), (2) PHiD-CV + DTPa-IPV-Hib, or (3) 7-valent pneumococcal conjugate vaccine (Prevenar/Prevnar, Pfizer Inc.) + DTPa-IPV-Hib at 2, 3, and 4 months of age. Blood samples were collected 1 month after dose 3. Diary cards were used to record safety and Reactogenicity. Results Antibody concentrations elicited by PHiD-CV coadministered with DTPa-IPV-Hib were noninferior to those following DTPa-HBV-IPV/Hib coadministration for 9 of 10 vaccines pneumococcal serotypes and protein D. For serotype 18C (conjugated to tetanus toxoid), the antibody concentration was higher with DTPa-HBV-IPV/Hib coadministration (1.73 vs. 1.07 μg/mL). The percentages of infants with antibody concentrations ≥0.2 μg/mL (68.9%-100% in the PHiD-CV + DTPa-HBV-IPV/Hib group vs. 64.9%-100% in the PHiD-CV + DTPa-IPV-Hib group) and with measurable opsonophagocytic activity (56.1%-100% in the PHiD-CV + DTPa-HBV-IPV/Hib group vs. 61.1%-100% in the PHiD-CV + DTPa-IPV-Hib group) were comparable for all serotypes in both PHiD-CV groups. Group differences in antibody responses to the DTPa-IPV-Hib antigens remained within the predefined limit for noninferiority. Safety and Reactogenicity profiles were comparable across groups. Conclusions : PHiD-CV and DTPa-IPV-Hib were immunogenic and well tolerated when coadministered as a 3-dose primary vaccination course.
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safety and immunogenicity of a booster dose of the 10 valent pneumococcal nontypeable haemophilus influenzae protein d conjugate vaccine coadministered with dtpw hbv hib and poliovirus vaccines
Pediatric Infectious Disease Journal, 2011Co-Authors: Nancy Bermal, Salvacion Gatchalian, Leszek Szenborn, Edison Alberto, Marina Hernandez, Jerzy Pejcz, Ewa Majdastanislawska, Aurelie Fanic, Ilse Dieussaert, Lode SchuermanAbstract:The safety and Reactogenicity profiles of the 10-valent pneumococcal conjugate vaccine, PHiD-CV, and 7vCRM were comparable within the Philippines and Poland when coadministered as a booster dose with DTPw-HBV/Hib and poliovirus vaccines to toddlers primed with the same vaccines. Robust immune responses for all 10 vaccine pneumococcal serotypes and protein D following PHiD-CV booster vaccination were indicative of effective priming.
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neonatal vaccination with an acellular pertussis vaccine accelerates the acquisition of pertussis antibodies in infants
The Journal of Pediatrics, 2008Co-Authors: Markus Knuf, Claire-anne Siegrist, Lode Schuerman, Heinzjoesf Schmitt, Joanne Wolter, Jeannemarie Jacquet, Dorothee Kieninger, Fred ZeppAbstract:Objectives Because young infants are at highest risk of pertussis complications, this study assessed whether neonatal acellular pertussis (aP) vaccination could provide earlier immunity. Study design Neonates (n = 121) were randomly assigned (1:1) to receive either aP or hepatitis B vaccine (HBV) (controls) vaccine at birth, followed by vaccination with DTaP-HBV-IPV/Hib at 2, 4 and 6 months. Immune responses were measured. Reactogenicity was assessed for 7 days after each dose. Results The aP birth dose was followed by few adverse events. Reactogenicity of subsequent vaccine doses did not differ between groups. Seven serious adverse events were reported from each group; none were related to the study vaccines. At 3 months of age, vaccination with aP at birth had induced significantly higher antibody responses to the 3 pertussis antigens compared with controls. At 7 months, geometric mean/concentrations of antibodies against pertussis antigens were similar in both groups, and all subjects had reached “seroprotective” antibody concentrations against diphtheria, tetanus, and poliovirus types 1, 2, and 3. Geometric mean/concentrations of antibodies to haemophilus influenzae type b (Hib) and HBV were significantly lower in the aP group. Conclusions Early neonatal immunization with aP was safe, well tolerated, and resulted in earlier antibody responses, seen after the first dose of a DTaP combination vaccine. Birth dose of aP did not induce immunologic tolerance to pertussis antigens but appear to dampen responses to Hib and HBV vaccines.
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Reactogenicity and immunogenicity profiles of a novel pentavalent diphtheria tetanus whole cell pertussis hepatitis b and haemophilus influenzae type b vaccine a randomized dose ranging trial of the hib tetanus conjugate content
Pediatric Infectious Disease Journal, 2006Co-Authors: Khin Hla Hla, Hans L Bock, Saw Aung Myat Thein, Aye Mya Min Aye, H H Han, Mariepierre David, Lode SchuermanAbstract:BACKGROUND Combined vaccines containing diphtheria-tetanus-pertussis whole-cell (DTPw), Haemophilus influenzae type b (Hib), and hepatitis-B vaccines are essential for the continuing success of vaccination programs in developing nations. This randomized, dose-ranging study assessed the immunogenicity and Reactogenicity of primary and booster vaccination with pentavalent DTPw-HBV/Hib vaccines containing 10, 5 or 2.5 microg of polyribosylribitol phosphate (PRP) conjugated to tetanus toxoid (trials Hib-052/064). METHODS Six hundred eighty infants were randomized to receive one of 5 vaccine combinations at 6, 10, and 14 weeks of age. Of these, 351 received the same vaccine at 15-24 months of age. The immune response was evaluated on blood samples collected 1 month after the 3-dose primary course and before and 6 weeks after the booster dose. Reactogenicity was assessed during a 4-day period after each vaccine dose using diary cards. RESULTS After primary vaccination, all subjects had seroprotective anti-PRP antibody concentrations (> or = 0.15 microg/mL) and > 95% had concentrations > or = 1.0 microg/mL, irrespective of the PRP dose administered. Anti-PRP antibody avidity after primary vaccination and antibody persistence until the second year of life were similar among groups. The booster dose induced marked increases in anti-PRP antibody GMCs and antibody avidity, indicative of effective priming and the presence of immune memory. All vaccination regimens elicited good immune responses and comparable antibody persistence to the other vaccine antigens, with significant increases in all antibody concentrations observed after boosting. All vaccination regimens were safe, with similar overall Reactogenicity profiles. CONCLUSION Hib conjugate vaccines containing reduced amounts of PRP can be effectively combined with the licensed DTPw-HBV vaccine to provide protection against 5 major childhood pathogens in a single injection.
Elisabeth A M Sanders - One of the best experts on this subject based on the ideXlab platform.
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immunogenicity safety and Reactogenicity of a booster dose of the 10 valent pneumococcal nontypeable h influenzae protein d conjugate vaccine coadministered with dtpa ipv hib in dutch children a randomized controlled trial
Pediatric Infectious Disease Journal, 2016Co-Authors: Menno R Van Den Bergh, Lode Schuerman, Judith Spijkerman, Nancy Francois, Kristien Swinnen, Dorota Borys, Reinier H Veenhoven, Elisabeth A M SandersAbstract:Background:Immune responses and safety profiles may be affected when vaccines are coadministered. We evaluated the immunogenicity, safety and Reactogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D-conjugate (PHiD-CV; Synflorix GSK Vaccines) and DT
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immunogenicity safety and Reactogenicity of the 10 valent pneumococcal nontypeable haemophilus influenzae protein d conjugate vaccine and dtpa ipv hib when coadministered as a 3 dose primary vaccination schedule in the netherlands a randomized contro
Pediatric Infectious Disease Journal, 2011Co-Authors: Menno R Van Den Bergh, Lode Schuerman, Judith Spijkerman, Nancy Francois, Kristien Swinnen, Dorota Borys, Reinier H Veenhoven, Elisabeth A M SandersAbstract:Background Recent reviews have highlighted the unpredictability of immunologic interference when multivalent conjugated vaccines are coadministered with other pediatric vaccines. Objective To evaluate immunogenicity, safety, and Reactogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV; Synflorix, GlaxoSmithKline Biologicals) and DTPa-IPV-Hib (Pediacel, Sanofi Pasteur MSD) when coadministered as a 3-dose primary vaccination course. Material and methods In a single-blind, single-center, randomized controlled trial in the Netherlands, healthy infants (n = 780) were randomly assigned (1:1:1) to receive either (1) PHiD-CV + DTPa-HBV-IPV/Hib (Infanrix Hexa, GlaxoSmithKline Biologicals), (2) PHiD-CV + DTPa-IPV-Hib, or (3) 7-valent pneumococcal conjugate vaccine (Prevenar/Prevnar, Pfizer Inc.) + DTPa-IPV-Hib at 2, 3, and 4 months of age. Blood samples were collected 1 month after dose 3. Diary cards were used to record safety and Reactogenicity. Results Antibody concentrations elicited by PHiD-CV coadministered with DTPa-IPV-Hib were noninferior to those following DTPa-HBV-IPV/Hib coadministration for 9 of 10 vaccines pneumococcal serotypes and protein D. For serotype 18C (conjugated to tetanus toxoid), the antibody concentration was higher with DTPa-HBV-IPV/Hib coadministration (1.73 vs. 1.07 μg/mL). The percentages of infants with antibody concentrations ≥0.2 μg/mL (68.9%-100% in the PHiD-CV + DTPa-HBV-IPV/Hib group vs. 64.9%-100% in the PHiD-CV + DTPa-IPV-Hib group) and with measurable opsonophagocytic activity (56.1%-100% in the PHiD-CV + DTPa-HBV-IPV/Hib group vs. 61.1%-100% in the PHiD-CV + DTPa-IPV-Hib group) were comparable for all serotypes in both PHiD-CV groups. Group differences in antibody responses to the DTPa-IPV-Hib antigens remained within the predefined limit for noninferiority. Safety and Reactogenicity profiles were comparable across groups. Conclusions : PHiD-CV and DTPa-IPV-Hib were immunogenic and well tolerated when coadministered as a 3-dose primary vaccination course.
John J. Mekalanos - One of the best experts on this subject based on the ideXlab platform.
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Live Attenuated Cholera Vaccines: Flagella and Reactogenicity
Replicating Vaccines, 2010Co-Authors: D. Ewen Cameron, John J. MekalanosAbstract:The rational design of attenuated Vibrio cholerae strains has been an attractive method for live cholera vaccine development because the major mechanisms of V. cholerae virulence are well defined and convalescence from cholera, the disease it causes, is a strongly immunizing process. After decades of effort to develop safe live attenuated cholera vaccines, however, the appearance of Reactogenicity, defined as adverse symptoms in immunized volunteers, has precluded further development of most live vaccine candidates. We now know that V. cholerae flagellar motility is associated with human and animal Reactogenicity in early live attenuated cholera vaccines, and recently developed nonflagellated V. cholerae mutant strains have shown great promise as live attenuated vaccines in volunteer studies. This chapter briefly summarizes our current understanding of V. cholerae pathogenesis and describes efforts to use this knowledge to design immunogenical and nonreactogenic live cholera vaccines.
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Reactogenicity of live-attenuated Vibrio cholerae vaccines is dependent on flagellins
Proceedings of the National Academy of Sciences of the United States of America, 2010Co-Authors: Haopeng Rui, Jennifer M Ritchie, Roderick T Bronson, John J. Mekalanos, Yuanxing Zhang, Matthew K WaldorAbstract:Cholera is a severe diarrheal disease caused by the motile Gram-negative rod Vibrio cholerae. Live-attenuated V. cholerae vaccines harboring deletions of the genes encoding cholera toxin have great promise for reducing the global burden of cholera. However, development of live vaccines has been hampered by the tendency of such strains to induce noncholeric reactogenic diarrhea in human subjects. The molecular bases of Reactogenicity are unknown, but it has been speculated that reactogenic diarrhea is a response to V. cholerae's flagellum and/or the motility that it enables. Here, we used an infant rabbit model of Reactogenicity to determine what V. cholerae factors trigger this response. We found that V. cholerae ctx mutants that produced flagellins induced diarrhea, regardless of whether the proteins were assembled into a flagellum or whether the flagellum was functional. In contrast, approximately 90% of rabbits infected with V. cholerae lacking all five flagellin-encoding genes did not develop diarrhea. Thus, flagellin production, independent of flagellum assembly or motility, is sufficient for Reactogenicity. The intestinal colonization and intraintestinal localization of the nonreactogenic flagellin-deficient strain were indistinguishable from those of a flagellated motile strain; however, the flagellin-deficient strain stimulated fewer mRNA transcripts coding for proinflammatory cytokines in the intestine. Thus, reactogenic diarrhea may be a consequence of an innate host inflammatory response to V. cholerae flagellins. Our results suggest a simple genetic blueprint for engineering defined nonreactogenic live-attenuated V. cholerae vaccine strains.
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association of protease activity in vibrio cholerae vaccine strains with decreases in transcellular epithelial resistance of polarized t84 intestinal epithelial cells
Infection and Immunity, 2000Co-Authors: Stephanie F Mel, Karla Jean Fullner, Susan Wimermackin, Wayne I Lencer, John J. MekalanosAbstract:Culture supernatants prepared from reactogenic strains of Vibrio cholerae cause a decrease in the transcellular epithelial resistance of T84 intestinal cells. This decrease correlates with the presence of hemagglutinin/protease but not with the presence of other potential accessory toxins or proteases. These data suggest a possible role for hemagglutinin/protease in Reactogenicity, although other factors may also contribute.
Ashwani Kumar Arora - One of the best experts on this subject based on the ideXlab platform.
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safety and immunogenicity of non typeable haemophilus influenzae moraxella catarrhalis vaccine
Vaccine, 2019Co-Authors: Pierre Van Damme, Corinne Vandermeulen, Geert Lerouxroels, Iris De Ryck, Annaelisa Tasciotti, Marie Dozot, Luca Moraschini, Marco Testa, Ashwani Kumar AroraAbstract:Abstract Non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) are frequent pathogens in acute exacerbations of COPD. We assessed the safety, Reactogenicity and immunogenicity of different investigational vaccine formulations containing surface proteins of NTHi (PD and PE-PilA) and Mcat (UspA2) in adults with smoking history ≥10 pack-years, to immunologically represent the COPD population. Participants received two doses 60 days apart in a randomised, observer-blind, placebo-controlled study (NCT02547974). In step 1, 30 healthy adults aged 18–40 years were randomised (1:1) to receive a non-adjuvanted formulation (10-10-PLAIN) or placebo. In step 2, 90 smokers/ex-smokers aged 50–70 years randomly (1:1:1) received an AS01-adjuvanted formulation containing either 10 µg of each antigen (10-10-AS01) or 10 µg of each NTHi antigen and 3.3 µg of Mcat antigen (10-3-AS01), or placebo. Incidences of solicited local adverse events (AEs) tended to be highest in the AS01-adjuvanted vaccine groups. Most solicited AEs had mild/moderate intensity. No vaccine-related serious AEs were reported. The 10-3-AS01 formulation induced the best humoral immune response against the NTHi antigens. Responses against the Mcat antigen were similar across groups, with waning immunogenicity after 30 days post-dose 2. The investigational NTHi-Mcat vaccine had an acceptable safety and Reactogenicity profile and good immunogenicity in older adults with a smoking history.
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comparison of the safety and immunogenicity of an mf59 adjuvanted with a non adjuvanted seasonal influenza vaccine in elderly subjects
Vaccine, 2014Co-Authors: Sharon E. Frey, Mari Rose Aplascade Los Reyes, Humberto Reynales, Nancy Nazaire Bermal, Uwe Nicolay, Vas Narasimhan, Eduardo Forleoneto, Ashwani Kumar AroraAbstract:Aim Adjuvanted influenza vaccines can overcome the poor antibody response of conventional non-adjuvanted vaccines in the elderly. We evaluated the immunogenicity, safety and clinical effectiveness of an MF59®-adjuvanted trivalent influenza vaccine (aTIV) compared with a non-adjuvanted vaccine (TIV) in subjects ≥65 years old, with or without co-morbidities. Methods In 2010–2011, subjects (N = 7082) were randomized to receive one dose of aTIV or TIV. Co-primary objectives were to assess lot-to-lot consistency of aTIV, non-inferiority, superiority and immunogenicity 22 days after vaccination. Clinical effectiveness, Reactogenicity and serious adverse events were monitored up to Day 366. Results The immunological equivalence of three lots of aTIV was demonstrated. aTIV was not only non-inferior to TIV but also elicited significantly higher antibody responses at Day 22 than TIV against all homologous and heterologous strains, even in subjects with co-morbidities. Superiority was not established. Reactogenicity was higher in the aTIV group, but reactions were mild to moderate and transient. Conclusions aTIV elicited a significantly higher antibody response than TIV, especially against A/H3N2 strains, although superiority by pre-defined criteria was not formally met. The study demonstrates potential immunological benefits of MF59-adjuvanted influenza vaccines for the elderly. This trial was registered with www.clinicaltrials.gov (NCT01162122).
Nick Andrews - One of the best experts on this subject based on the ideXlab platform.
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understanding the Reactogenicity of 4cmenb vaccine comparison of a novel and conventional method of assessing post immunisation fever and correlation with pre release in vitro pyrogen testing
Vaccine, 2020Co-Authors: Marta Valente Pinto, Nick Andrews, Kimberly Davis, David Goldblatt, Ray Borrow, Jo Southern, Ida Karin Nordgren, Caroline Vipond, Emma Plested, E MillerAbstract:BACKGROUND Better understanding of vaccine Reactogenicity is crucial given its potential impact upon vaccine safety and acceptance. Here we report a comparison between conventional and novel (continuous) methods of monitoring temperature and evaluate any association between Reactogenicity and the monocyte activation test (MAT) employed for testing four-component capsular group B meningococcal vaccine (4CMenB) batches prior to release for clinical use in Europe. METHODS Healthy 7-12-week-old infants were randomised in two groups: group PCV13 2 + 1 (received pneumococcal conjugate vaccine 13 valent (PCV13) at 2, 4 and 12 months) and group PCV13 1 + 1 (received reduced schedule at 3 and 12 months). In both, infants received the remaining immunisations as per UK national schedule (including 4CMenB at 2, 4 and 12 months of age). Fever was measured for the first 24 h after immunisations using an axillary thermometer and with a wireless continuous temperature monitoring device (iButton®). To measure the relative pyrogenicity of individual 4CMenB batches, MAT was performed according to Ph. Eu. chapter 2.6.30 method C using PBMCs with IL-6 readout. RESULTS Fever rates detected by the iButton® ranged from 28.7% to 76.5% and from 46.6% to 71.1% in group PCV13 2 + 1 and PCV13 1 + 1 respectively, across all study visits. The iButton® recorded a higher number of fever episodes when compared with axillary measurements in both groups (range of axillary temperature fevers; group PCV13 2 + 1: 6.7%-38%; group PCV13 1 + 1: 11.4%-37.1%). An agreement between the two methods was between 0.39 and 0.36 (p < 0.001) at 8 h' time-point post primary immunisations. No correlation was found between MAT scores and fever rates, or other reported adverse events. CONCLUSIONS It is likely that conventional, intermittent, fever measurements underestimates fever rates following immunisation. 4CMenB MAT scores didn't predict Reactogenicity, providing reassurance that vaccine batches with the highest acceptable pyrogen level are not associated with an increase in adverse events. Clinicaltrials.gov identifier: NCT02482636.
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h1n1 antibody persistence 1 year after immunization with an adjuvanted or whole virion pandemic vaccine and immunogenicity and Reactogenicity of subsequent seasonal influenza vaccine a multicenter follow on study
Clinical Infectious Diseases, 2012Co-Authors: Woolf T. Walker, Nick Andrews, Katja Hoschler, Philip De Whalley, Clarissa Oeser, M Casey, Louise Michaelis, Caroline Harrill, Phoebe MoulsdaleAbstract:Background. We investigated antibody persistence in children 1 year after 2 doses of either an AS03B-adjuvanted split-virion or nonadjuvanted whole-virion monovalent pandemic influenza vaccine and assessed the immunogenicity and Reactogenicity of a subsequent dose of trivalent influenza vaccine (TIV). Methods. Children previously immunized at age 6 months to 12 years in the original study were invited to participate. After a blood sample was obtained to assess persistence of antibody against swine influenza A/H1N1(2009) pandemic influenza, children received 1 dose of 2010/2011 TIV, Reactogenicity data were collected for 7 days, and another blood sample was obtained 21 days after vaccination. Results. Of 323 children recruited, 302 received TIV. Antibody persistence (defined as microneutralization [MN] titer $1:40) 1 year after initial vaccination was significantly higher in the AS03B-adjuvanted compared with the whole-virion vaccine group, 100% (95% confidence interval [CI], 94.1%‐100%) vs 32.4% (95% CI, 21.5%‐44.8%) in children immunized ,3 years old and 96.9% (95% CI, 91.3%‐99.4%) vs 65.9% (95% CI, 55.3%‐75.5%) in those 3‐12 years old at immunization, respectively (P , .001 for both groups). All children receiving TIV had post-vaccination MN titers $1:40. Although TIV was well tolerated in all groups, Reactogenicity in children,5 years old was slightly greater in those who originally received AS03B-adjuvanted vaccine. Conclusions. This study provides serological evidence that 2 doses of AS03B-adjuvanted pandemic influenza vaccine may be sufficient to maintain protection across 2 influenza seasons. Administration of TIV to children who previously received 2 doses of either pandemic influenza vaccine is safe and is immunogenic for the H1N1 strain.
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Predictors of immune response and Reactogenicity to AS03B-adjuvanted split virion and non-adjuvanted whole virion H1N1 (2009) pandemic influenza vaccines.
Vaccine, 2011Co-Authors: Nick Andrews, Pauline Waight, Woolf T. Walker, Adam Finn, Paul T. Heath, Andrew Collinson, Andrew J. Pollard, Matthew D. Snape, Saul N. Faust, Katja HoschlerAbstract:In 2009, 943 children aged 6 months to 10 years were randomised to receive two doses of an oil-in water AS03B-adjuvanted split virion or a non-adjuvanted whole virion H1N1 (2009) vaccine. The large numbers allowed investigation of possible predictors of immune response and Reactogenicity. We used regression analysis to examine the effect of variables including past receipt of seasonal vaccine, antipyretics post-vaccination, interval between doses and pre-existing antibodies to H1N1 (2009) on immunogenicity. We also examined the relationship between immunogenicity and Reactogenicity and whether prior infection or underlying conditions affected Reactogenicity. For both vaccines, haemagglutination-inhibition titres were 60% higher in children with fever ≥38 °C after vaccination and 29% lower in those previously given seasonal vaccine. Early use of antipyretics did not affect immunogenicity. Post-vaccination titres were higher with longer intervals between doses and in those with evidence of prior infection, but Reactogenicity in the latter was unaffected. In the adjuvanted vaccine group, reactions were more common in children with atopy. Both vaccines were safe and immunogenic in those with prior infection. Reduction in the interval between doses for earlier protection would be at the cost of reduced immunogenicity. The effect of seasonal vaccine on immunogenicity merits further investigation.
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immunogenicity and Reactogenicity of combined acellular pertussis tetanus low dose diphtheria vaccines given as a booster to uk teenagers
Vaccine, 2005Co-Authors: Jo Southern, Nick Andrews, Moya Burrage, Elizabeth MillerAbstract:Sustained high incidence of pertussis, particularly amongst unvaccinated infants, is of concern. Inclusion of pertussis vaccination with tetanus and low dose diphtheria (Td) teenage boosters may protect individuals through reproductive years, and prevent transmission to offspring. UK teenagers who had previously received only a three-dose primary course of whole cell pertussis vaccination in infancy and who were due to receive a Td booster (n=323) were randomised to four groups: Td, TdaP, TdaP-inactivated polio vaccine (IPV) (Aventis Pasteur), TdaP (GlaxoSmithKline). There were significant pre- to post-vaccination GMC and GMFR increase for vaccine-contained pertussis antigens (p<0.001) in recipients of aP-containing vaccine. All groups demonstrated significant increases pre- to 4 weeks post-vaccination in diphtheria (D)/tetanus (T) geometric mean concentrations (GMCs) and fold rises (GMFRs) (p<0.001). Groups all achieved similar D and T post-vaccination GMCs. Local Reactogenicity was generally similar between groups and was not associated with pre-booster diphtheria/tetanus antibody levels. A minority of vaccinees reported systemic symptoms with similar proportions between groups for each symptom assessed. This study demonstrated that addition of aP and/or IPV to Td vaccine did not materially alter Reactogenicity or immunogenicity of Td components, and induced immune responses to pertussis antigens in teenagers who had received no pertussis vaccine since infancy.
