booster immunization
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BACKGROUND: Transplacentally transferred antibodies induced by maternal pertussis vaccination interfere with infant immune responses to pertussis primary vaccination. We evaluated whether this interference remains in toddlers after booster vaccination. METHODS: In a prior phase IV, observer-blind, placebo-controlled, randomized study (NCT02377349), pregnant women in Australia, Canada and Europe received intramuscular tetanus-reduced-antigen-content diphtheria-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) at 270/7-366/7 weeks' gestation, with crossover immunization postpartum. Their infants were primed (study NCT02422264) and boosted (at 11-18 months; current study NCT02853929) with diphtheria-tetanus-three-component acellular pertussis-hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b vaccine (DTaP-HepB-IPV/Hib) and 13-valent pneumococcal conjugate vaccine. Immunogenicity before and after booster vaccination, and reactogenicity and safety of the booster were evaluated descriptively. RESULTS: 263 (Tdap group) and 277 (control group) toddlers received a DTaP-HepB-IPV/Hib booster. Pre-booster vaccination, observed geometric mean concentrations (GMCs) for the three pertussis antigens and diphtheria were 1.4-1.5-fold higher in controls than in the Tdap group. No differences were observed for the other DTaP-HepB-IPV/Hib antigens. One month post-booster vaccination, booster response rates for pertussis antigens were ≥ 92.1% and seroprotection rates for the other DTaP-HepB-IPV/Hib antigens were ≥ 99.2% in both groups (primary objective). Higher post-booster GMCs were observed in controls versus the Tdap group for anti-filamentous hemagglutinin (1.2-fold), anti-pertussis toxoid (1.5-fold) and anti-diphtheria (1.4-fold). GMCs for the other DTaP-HepB-IPV/Hib antigens were similar between groups. Serious adverse events were reported for three toddlers (controls, not vaccination-related). One death occurred pre-booster (Tdap group, not vaccination-related). CONCLUSIONS: As a consequence of interference of maternal pertussis antibodies with infant immune responses to pertussis primary vaccination, pertussis antibody concentrations were still lower in toddlers from Tdap-vaccinated mothers before DTaP-HepB-IPV/Hib booster vaccination. After the booster, antibody concentrations were lower for filamentous hemagglutinin and pertussis toxoid but not for pertactin. The clinical significance of this interference requires further evaluation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02853929.
- Klíčová slova
- Blunting, Booster, Maternal immunization, Pertussis, Tdap vaccine, Toddlers,
- MeSH
- difterie * prevence a kontrola MeSH
- hemofilové vakcíny * MeSH
- imunita MeSH
- kojenec MeSH
- kombinované vakcíny MeSH
- lidé MeSH
- následné studie MeSH
- pertuse * prevence a kontrola MeSH
- poliovirová vakcína inaktivovaná MeSH
- předškolní dítě MeSH
- protilátky bakteriální MeSH
- sekundární imunizace MeSH
- těhotenství MeSH
- tetanus * prevence a kontrola MeSH
- vakcína proti diftérii, tetanu a pertusi MeSH
- vakcína proti záškrtu, tetanu a černému kašli * MeSH
- vakcinace MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- předškolní dítě MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Austrálie MeSH
- Evropa MeSH
- Kanada MeSH
- Názvy látek
- hemofilové vakcíny * MeSH
- kombinované vakcíny MeSH
- poliovirová vakcína inaktivovaná MeSH
- protilátky bakteriální MeSH
- vakcína proti diftérii, tetanu a pertusi MeSH
- vakcína proti záškrtu, tetanu a černému kašli * MeSH
BACKGROUND: A serogroup B meningococcal vaccine (4CMenB) is licensed for infant use in countries including Canada, Australia and those of the European Union. Data on serum bactericidal antibody (hSBA) waning and the ideal timing of a "toddler" booster dose are essential to optimize vaccine utilization. METHODS: An open-labeled, multicenter phase-2b follow-on European study conducted from 2009 to 2012. Participants previously receiving 4CMenB with routine vaccines at 2, 4 and 6 or 2, 3 and 4 months (246Con and 234Con) or at 2, 4 and 6 months intercalated with routine vaccines (246Int) received a booster dose at 12, 18 or 24 months. 4CMenB-naïve "Control" participants aged 12, 18 or 24 months received 2 doses of 4CMenB 2 months apart. RESULTS: One thousand five hundred eighty-eight participants were recruited. At 12 months, before any booster doses, the proportions with hSBA titers ≥1:5 for strain 44/76-SL (testing vaccine component fHBP) were 73% (120/165) for the "246Con" group, 85% (125/147) for "246Int," 57% (51/90) for "234Con" and 13% (26/199) for Controls. For strain 5/99 (NadA) proportions were ≥96% (all 4CMenB-recipients) and 1% (Controls). For strain NZ98/254 (PorA), these were 18-35% (4CMenB-recipients) and 1% (Controls). By 24 months, 4CMenB-recipient proportions were 13-22% (44/76-SL), 82-94% (5/99) and 7-13% (NZ98/254) and in controls ≤4%. After a 12-month booster-dose, ≥95% of previously immunized participants had titers ≥1:5 (all strains). CONCLUSIONS: A 4CMenB booster-dose can overcome waning hSBA titers after early-infant immunization. Administration at 12 months could help to maintain immunity during an age of high risk, and the persistence of this response requires further study.
- MeSH
- hodnocení výsledků zdravotní péče MeSH
- kojenec MeSH
- lidé MeSH
- meningokoková meningitida prevence a kontrola MeSH
- meningokokové vakcíny aplikace a dávkování škodlivé účinky imunologie MeSH
- Neisseria meningitidis séroskupiny B imunologie MeSH
- očkovací schéma MeSH
- předškolní dítě MeSH
- protilátky bakteriální krev imunologie MeSH
- sekundární imunizace * MeSH
- vakcinace MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- mužské pohlaví MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Evropa MeSH
- Názvy látek
- meningokokové vakcíny MeSH
- protilátky bakteriální MeSH
Long-term vaccination programs are recommended for individuals living in regions endemic for tick-borne encephalitis (TBE). Current recommendations suggest a first booster vaccine be administered 3 years after a conventional regimen or 12-18 months after a rapid regimen. However, the research supporting subsequent booster intervals is limited. The aim of this study was thus to evaluate the long-term persistence of TBE antibodies in adults and adolescents after a first booster dose with Encepur(®). A total of 323 subjects aged 15 years and over, who had received one of four different primary TBE vaccination series in a parent study, participated in this follow-up Phase IV trial. Immunogenicity and safety were assessed for up to five years after a first booster dose, which was administered three years after completion of the primary series. One subset of subjects was excluded from the booster vaccination since they had already received their booster prior to enrollment. For comparison, immune responses were still recorded for these subjects on Day 0 and on an annual basis until Year 5, but safety information was not collected. Following a booster vaccination, high antibody titers were recorded in all groups throughout the study. Neutralization test (NT) titers of ≥ 10 were noted in at least 94% of subjects at every time point post-booster (on Day 21 and through Years 1-5). These results demonstrated that a first booster vaccination following any primary immunization schedule results in high and long-lasting (>5 years) immune responses. These data lend support to the current belief that subsequent TBE booster intervals could be extended from the current recommendation. NCT00387634.
- Klíčová slova
- Booster immunization, Immunogenicity, Persistence, Tick-borne encephalitis,
- MeSH
- dospělí MeSH
- klíšťová encefalitida prevence a kontrola MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- následné studie MeSH
- neutralizační testy MeSH
- očkovací schéma MeSH
- protilátky virové krev MeSH
- sekundární imunizace * MeSH
- virové vakcíny terapeutické užití MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze IV MeSH
- práce podpořená grantem MeSH
- Názvy látek
- Encepur MeSH Prohlížeč
- protilátky virové MeSH
- virové vakcíny MeSH
An evaluation of the relationship between predictors and immune response was conducted using data obtained from a clinical trial in 200 Czech healthy adults aged 24-65 years receiving a booster dose of a monovalent tetanus vaccine in 2017. The response was determined from ELISA antibody concentrations of paired sera obtained before and 4 weeks after the immunisation. While all subjects with initial antibody levels 2.2 IU/ml. The immune response was not affected by sex, age, tetanus vaccine type, concomitant medication, related adverse events or post-vaccination period since there were no significant differences in geometric mean concentrations or seroconversion rates. The seroconversion rate of 56% in smokers was significantly lower than that of 73% achieved in non-smokers. Although the seroconversion rates did not differ between individuals with normal or higher body weight, the adjusted odds ratio (1.3; 95% Cl 1.08-1.60) revealed a positive correlation between seroconversion rate and body mass index (BMI). Although the vaccine-induced response was influenced by pre-vaccination antibody levels, smoking or BMI, the booster immunisation against tetanus produced a sufficient response regardless the predictors.
- Klíčová slova
- BMI, pre-vaccination levels, seroconversion rate, smoking, tetanus vaccination,
- MeSH
- dospělí MeSH
- ELISA MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- protilátky bakteriální krev MeSH
- sekundární imunizace metody MeSH
- senioři MeSH
- tetanový toxoid aplikace a dávkování imunologie MeSH
- tetanus prevence a kontrola MeSH
- tvorba protilátek * MeSH
- zdraví dobrovolníci pro lékařské studie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika MeSH
- Názvy látek
- protilátky bakteriální MeSH
- tetanový toxoid MeSH
BACKGROUND: Vaccination is the best mode of protection against tick-borne encephalitis (TBE) and its sequelae. The duration of protection and the optimal interval of repeat booster doses are still debated. The current study evaluated the persistence of the antibody response 11-15 years after a first booster vaccination following different primary vaccination schedules with a TBE vaccine (Encepur Adults, manufactured by Bavarian Nordic, previously by GSK). METHODS: This phase IV, open-label, mono-centric extension study enrolled adults who had received (at ≥ 12 years of age) primary vaccination with one of three randomly assigned TBE vaccine schedules (rapid [group R], conventional [group C], or accelerated conventional schedule [group A]) followed by a booster dose 3 years later. The antibody response was measured annually from 11 to 15 years post-booster using a TBE virus neutralization test (NT). An NT titer of ≥ 10 was considered as a clinically meaningful threshold and surrogate for protection. RESULTS: In total, 194 participants were enrolled and included in the per-protocol set; 188 completed the study. The percentage of participants with an NT titer ≥ 10 was 100% in group R and 99.0% in group A at all visits and ranged from 100% (year 11) to 95.8% (year 15) in group C. NT geometric mean titers were similar in the three study groups (181-267 in group R, 142-227 in group C, 141-209 in group A). NT geometric mean titers also remained high among participants ≥ 50 years old (98-206) and ≥ 60 years old (91-191) across study groups and time points. CONCLUSIONS: This study showed neutralizing antibody persistence for at least 15 years after a first booster dose of the Encepur Adults TBE vaccine in all age groups evaluated, regardless of which primary vaccination schedule was given to adolescents or adults. Trialregistry: ClinicalTrials.gov: NCT03294135.
- Klíčová slova
- Antibody persistence, Booster vaccination, Immunization, Neutralizing antibodies, Primary vaccination, Tick-borne encephalitis,
- MeSH
- dospělí MeSH
- klíšťová encefalitida * prevence a kontrola MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- následné studie MeSH
- očkovací schéma MeSH
- předškolní dítě MeSH
- protilátky virové MeSH
- sekundární imunizace MeSH
- vakcinace MeSH
- virové vakcíny * MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- předškolní dítě MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze IV MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- protilátky virové MeSH
- virové vakcíny * MeSH
- Klíčová slova
- COVID-19, COVID-19 vaccination, SARS-CoV-2, booster vaccination, immune response, immunity, vaccines,
- MeSH
- COVID-19 * prevence a kontrola MeSH
- lidé MeSH
- sekundární imunizace MeSH
- vakcíny proti COVID-19 * aplikace a dávkování MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- úvodníky MeSH
- Názvy látek
- vakcíny proti COVID-19 * MeSH
Bordetella pertussis (Bp), the causative agent of pertussis, continues to circulate despite widespread vaccination programs. An important question is whether and how (sub)clinical infections shape immune memory to Bp, particularly in populations primed with acellular pertussis vaccines (aP). Here, we examine the prevalence of mucosal antibodies against non-vaccine antigens in aP-primed children and adolescents of the BERT study (NCT03697798), using antibody binding to a Bp mutant strain lacking aP antigens (Bp_mut). Our study identifies increased levels of mucosal IgG and IgA binding to Bp_mut in older aP-primed individuals, suggesting different Bp exposure between aP-primed birth cohorts, in line with pertussis disease incidence data. To examine whether Bp exposure influences vaccination responses, we measured mucosal antibody responses to aP booster vaccination as a secondary study outcome. Although booster vaccination induces significant increases in mucosal antibodies to Bp in both cohorts, the older age group that had higher baseline antibodies to Bp_ mut shows increased persistence of antibodies after vaccination.
- MeSH
- antigeny bakteriální MeSH
- Bordetella pertussis * genetika MeSH
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- pertuse * prevence a kontrola MeSH
- protilátky MeSH
- sekundární imunizace MeSH
- tvorba protilátek MeSH
- vakcinace MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- Publikační typ
- časopisecké články MeSH
- klinická studie MeSH
- práce podpořená grantem MeSH
- Názvy látek
- antigeny bakteriální MeSH
- protilátky MeSH
The emerging SARS-CoV-2 variants and waning vaccine-elicited immunity are two public health challenges that occurred simultaneously and synergistically during the summer of 2021 and led to a surging demand for COVID-19 vaccine booster dose (BD) rollout. This study aimed to evaluate the COVID-19 vaccine booster hesitancy (VBH) among Czech healthcare workers to explore the potential determinants of VBH. A national cross-sectional survey-based study was carried out between 3 and 11 November 2021, using an online self-administered questionnaire (SAQ) that explored the participants' demographic characteristics, COVID-19 infection and vaccine anamneses, willingness to receive COVID-19 vaccine BD, and the psychosocial drivers of VBH. A total of 3454 HCW properly responded to the online SAQ, of which 80.9% were females, 30.3% were medical professionals, and 50.5% were ≤47 years old. Most of the participants were already inoculated against SARS-CoV-2 (95.2%), and BTN162b2 was the most commonly administered vaccine (90.7%). As the study sample was planned to represent the target population, it revealed a high level of BD acceptance (71.3%) among Czech HCW, while 12.2% were still hesitant and 16.6% were against the currently available BD. These results are consistent with other recent results from central Europe. Medical professional, male, and older participants were more likely to accept BD rather than allied health professional, female, and younger participants. The BDs' perceived effectiveness against severe illness, symptomatic infection, and community transmission was a significant and strong predictor for BD acceptance, while the effectiveness against the circulating variants was not that important for our target population. The BDs' perceived safety and ethical dilemmas of vaccine justice should be addressed sufficiently while communicating with HCW and other population groups. The altruistic reasons for BD acceptance, i.e., family protection, patient protection, and community health protection, underpin the recommendation of postponing the COVID-19 vaccine mandating in favour of stressing these altruistic concerns amid public health messaging.
- Klíčová slova
- COVID-19 vaccines, Czechia, booster immunization, decision making, health personnel,
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Tick borne encephalitis (TBE) endemic zones are expanding. We previously evaluated long term persistence of antibody 5 years after the first booster immunization following different primary immunization schedules with the polygeline-free inactivated TBE vaccine (TBEvac) in adults and adolescents. Here, we report anti-TBE virus (TBEV) antibody persistence from 6 to 10 years post-booster administration. METHODS: This was a phase IV, open-label, single-center, second extension study (NCT01562444), conducted in Czechia. Healthy adults and adolescents ≥12 years who had received 3 different primary vaccination schedules (rapid, conventional and accelerated conventional) in the parent study and a booster dose before (12-18 months post-primary series completion) or at the beginning (3 years post-primary series completion) of the first extension study were screened and enrolled in this study. Blood samples were collected yearly and anti-TBEV antibody response was evaluated by neutralizing test (NT) antibody assays. Analysis was performed overall and per age strata: 15-49 years, ≥50 years, and ≥60 years. RESULTS: Of 206 screened individuals, 191 completed the study. Overall, 90-100% of participants in the all-screened set and ≥97% in the per-protocol set had the clinically meaningful threshold of protection (NT titers ≥10) across all timepoints, regardless of the primary vaccination schedule. Overall, antibody geometric mean titers (GMTs) varied from 134 to 343 in the all-screened set. Older age groups showed overall lower GMTs, although GMTs remained higher than NT titers ≥10 up to year 10 in all groups. CONCLUSION: This study showed long-term persistence of anti-TBEV NT antibodies for up to 10 years after the first booster dose of TBEvac in all age groups, regardless of the primary vaccination schedule.
- Klíčová slova
- Adults, Booster, Encepur, Long-term persistence, Tick-borne encephalitis,
- MeSH
- časové faktory MeSH
- dítě MeSH
- dospělí MeSH
- klíšťová encefalitida prevence a kontrola MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- následné studie MeSH
- neutralizující protilátky krev MeSH
- očkovací schéma * MeSH
- protilátky virové krev MeSH
- sekundární imunizace * MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- virové vakcíny aplikace a dávkování imunologie MeSH
- viry klíšťové encefalitidy imunologie MeSH
- Check Tag
- dítě MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze IV MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika MeSH
- Názvy látek
- neutralizující protilátky MeSH
- protilátky virové MeSH
- virové vakcíny MeSH
Vivaxim is a combined hepatitis A/typhoid fever vaccine (HA/Vi) licensed for vaccination of travellers, but long-term protection against hepatitis A requires two immunisations at least 6 months apart. A randomised, controlled study was performed in 116 healthy adults primed with hepatitis A vaccine (Avaxim) to compare immune responses to HA/Vi and Avaxim given as booster doses 6 months later. Both vaccines elicited marked booster responses achieving antibody geometric mean titres (GMTs) of 4576 and 3760 mIU/ml in the HA/Vi and Avaxim groups, respectively. Although twice as frequent in the HA/Vi group, local reactions (mostly pain) were mainly mild and transient, probably reflecting the larger volume injected (1ml). Vivaxim offers a convenient means of administering both HA and typhoid fever vaccines in subjects already primed for hepatitis A.
- MeSH
- dospělí MeSH
- hepatitida - protilátky krev imunologie MeSH
- hepatitida A imunologie prevence a kontrola MeSH
- inaktivované vakcíny MeSH
- kombinované vakcíny MeSH
- lidé MeSH
- mladiství MeSH
- očkovací schéma MeSH
- sekundární imunizace MeSH
- vakcína proti hepatitidě A aplikace a dávkování škodlivé účinky MeSH
- vakcíny proti tyfu a paratyfu aplikace a dávkování škodlivé účinky MeSH
- virus lidské hepatitidy A imunologie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- hepatitida - protilátky MeSH
- inaktivované vakcíny MeSH
- kombinované vakcíny MeSH
- vakcína proti hepatitidě A MeSH
- vakcíny proti tyfu a paratyfu MeSH