Quality and reliability of vaccination documentation in the routine childhood immunization program in Burkina Faso: Results from a cross-sectional survey

IntroductionAccurate and timely vaccination data are important to the Expanded Program on Immunization (EPI) to assess individual vaccination status and to monitor performance and vaccine coverage (VC). Since 2013, Burkina Faso introduced several new vaccines into the routine childhood immunization schedule. However, sustained efforts for a timely update and alignment of immunization home-based (HBRs) and health facility-based records (FBRs) with the evolving schedule were not implemented.MethodsIn 2016–17, we conducted a 6-week cross-sectional survey in 30 health facilities (HFs) across 10 health districts (HDs), targeting children aged < 24 months and their caregivers. Data collected included sociodemographics, availability of vaccination recording fields in HBRs, and vaccination dates. We evaluated the characteristics, completion patterns, and concordance of HBRs and FBRs to determine their reliability as data sources in estimating VC. A standard HBR was defined as one that had recording fields for all recommended 17 vaccine doses of the schedule, and discordance between HBR and FBR as having different vaccination dates recorded, or vaccination information missing in one of the records. We computed proportions and concordance statistics, and used logistic regression to explore predictors of discordance.ResultsWe recruited 619 children, including 74% (n = 458) aged 0–11 months. Half (50.6%) of HBRs were non-standard. About two-thirds (64.6%) of children were concerned with discordant information. Compared to HBRs, FBRs were generally associated with low negative predictive values (median: 0.41; IQR: 0.16–0.70). Multivariate logistic regression model showed that standard HBR was protectively associated with discordant information (OR = 0.46, 95% CI: 0.26–0.81, p = 0.010).ConclusionWe documented a lack of standardization of HBRs and frequent information discordance with FBRs. There is a pressing need to update and standardize vaccination recording tools and ensure their continuous availability in HFs to improve data quality in Burkina Faso.     

Vaccine timeliness and prevalence of undervaccination patterns in children ages 0–19 months,U.S., National Immunization Survey-Child 2017

ObjectivesTypically, early childhood vaccination coverage in the U.S. is measured as the proportion of children by age 24 months who completed recommended vaccine series. However, these measures do not reflect whether vaccine doses were received at the ages recommended by the U.S. Advisory Committee on Immunization Practices, or whether children received vaccines concomitantly, per the ACIP recommended schedule. This study’s objective was to quantify vaccine timeliness and prevalence of specific patterns of undervaccination in U.S. children ages 0–19 months.MethodsUsing 2017 National Immunization Survey-Child data, we calculated days undervaccinated for the combined 7-vaccine series and distinguished undervaccination patterns indicative of parental vaccine hesitancy, such as spreading out vaccines across visits (“shot-limiting”) or starting some but not all recommended vaccine series (“selective vaccination”), from other non-hesitancy patterns, such as missing final vaccine doses or receiving all doses, with some or all late. We measured associations between demographic, socioeconomic and other characteristics with undervaccination patterns using multivariable log-linked binomial regression. Analyses accounted for the complex survey design.ResultsAmong n = 15,333 U.S. children, only 41.2% received all recommended vaccine doses on-time by age 19 months. Approximately 20.9% of children had an undervaccination pattern suggestive of parental vaccine hesitancy, and 36.2% had other undervaccination non-hesitancy patterns. Uninsured children and those with lower levels of maternal education were more likely to exhibit undervaccination patterns suggestive of parental hesitancy. Lower levels of maternal education were also associated with other non-hesitancy undervaccination patterns.ConclusionsMore than half of children in the U.S. are undervaccinated at some point by 19 months of age. Ongoing assessment of vaccine timeliness and immunization schedule adherence could facilitate timely and targeted public health interventions in populations with high levels of undervaccination.     

Motivational interviewing and vaccine acceptance in children: The MOTIVE study

Background and ObjectiveVaccine coverage have been less than desired in young children in part due to parental vaccine hesitancy. Addressing health beliefs through patient-centered communication approaches such as motivational interviewing (MI) may improve vaccine confidence. Thus, the objective of this study was to determine the difference in paediatric vaccination coverage rates based on the Advisory Committee on Immunization Practices (ACIP) and Centers for Disease Control and Prevention (CDC) recommended schedule in children 0–6 years of age after an educational intervention for providers and integration of an MI-based communication tool, MOTIVE (MOtivational Interviewing Tool to Improve Vaccine AcceptancE).MethodsPaediatric and family practice providers in a federally qualified health center in the United States completed an educational intervention regarding vaccine hesitancy and use of the MOTIVE tool. Providers then implemented the MOTIVE tool to address common health beliefs using strong, presumptive vaccine recommendations and an MI framework during encounters with patients 0–6 years of age. Data were collected from 1-year pre-educational intervention (July 2018-June 2019, N = 2504) and post-intervention (July 2019-March 2020, N = 1954) to examine differences in vaccination coverage rates and documented vaccine refusals.ResultsUse of the MOTIVE tool was associated with a statistically significant increase in IIV vaccination coverage rate in children 6 months to 6 years of age (32.4% versus 43.9%, p < 0.01). A significantly increased Hib vaccination coverage rate was observed in children 0–18 months of age. Patients with commercial insurance also had significantly higher vaccination coverage rates for the DTaP, IPV, and VAR vaccines during the intervention period. Use of the MOTIVE tool was associated with a decrease in documented vaccine refusals per 100 patients in children 0–6 years of age (31.5 versus 17.6, p < 0.01).ConclusionUse of an MI-based communication tool may decrease vaccine refusals and improve childhood vaccination coverage rates, particularly for IIV.Clinical Trial Registration: ClinicalTrials.gov, NCT03934008, https://clinicaltrials.gov/ct2/show/NCT03934008, deidentified individual participant data will not be made available.     

Changes and remaining challenges for the Japanese immunization program: Closing the vaccine gap

The Japanese immunization program has made considerable progress since 2009: several new vaccines have been introduced and most are included in the National Immunization Program (NIP). In October 2020, the Japanese law on immunization was revised, which resulted in a few laudable achievements. First, rotavirus vaccines were added to the NIP, 10 years after their introduction, and noteworthy studies of vaccine effectiveness and the incidence of intussusception in Japanese children were published. Second, rules on vaccine intervals—which had been a longstanding concern—were withdrawn. In addition to this revision of the law, the Japanese version of the Vaccine Information Statement (VIS) was released by the Japan Pediatric Society in 2018. The VIS provides useful caregiver information on general immunization concepts and individual vaccines. Further challenges for the Japanese immunization program include (1) administering a booster dose of pertussis-containing vaccine to preschool children or teenagers, (2) reestablishing the active recommendation for human papilloma virus vaccines, (3) adding the mumps and influenza vaccines to the NIP, and (4) ensuring optimal dosing of seasonal influenza vaccines. During the current coronavirus disease 2019 (COVID-19) pandemic, vaccination rates among children have been decreasing in many countries. In Japan, vaccination rates have been stable in infants, but declining among toddlers and school-aged children, despite public awareness of the need for timely administration of vaccines during the pandemic. Clearly, further action is needed if we are to adequately protect children living in Japan from vaccine-preventable diseases.     

Vaccination coverage and factors associated with routine childhood vaccination uptake in rural Vellore,southern India, 2017

BackgroundVellore district in southern India was selected for intensified immunization efforts through India’s Mission Indradhanush campaign based on 74% coverage in the National Family Health Survey in 2015. As rural households rely almost entirely on the Universal Immunization Program (UIP), we assessed routine immunization coverage and factors associated with vaccination status of children in rural Vellore.MethodsWe conducted a cross-sectional household survey among parents or primary caretakers of children aged 12–23 months during August–September 2017 using two-stage, EPI cluster sampling. We verified vaccination histories from vaccination cards and collected data on sociodemographic and non-socio-demographic characteristics by using mobile data capture. Associations with vaccination status were examined with univariate and multivariate logistic regression models.ResultsA total of 643 children were included. Coverage of BCG, third dose pentavalent/DPT, measles/MR vaccines and full vaccination (BCG, three doses of polio and pentavalent/DPT and measles/MR vaccines) among children with vaccination cards (n = 606) was 94%, 96%, 93% and 84%, respectively. Of children with vaccination cards, 70.8% had received all recommended doses according to the UIP schedule. No socio-demographic differences were identified, but parents’ familiarity with the schedule (Adjusted Prevalence Odds Ratio (aPOR): 2.06, 95%CI = 1.26–3.38) and receiving information on recommended vaccinations during antenatal visits (aPOR: 2.16, 95% CI = 1.13–4.12) were significantly associated with full vaccination status of the children.ConclusionsWe found higher UIP antigen coverage and proportion of fully vaccinated children than previously reported from rural Vellore. However, adherence to the recommended schedule was still not optimal. Our study highlights the potential of improving parental awareness of vaccination schedule and targeting health education interventions at pregnant women during antenatal visits to sustain and improve routine immunization coverage.     

Trends in vaccination schedules and up-to-date status of children 19–35 months,United States, 2015–2020

ObjectivesTo estimate trends in, and factors associated with, vaccination patterns and up-to-date immunization status of U.S. children by 19 to 35 months of age.MethodsData from the 2015 to 2020 National Immunization Surveys were used to assess trends in vaccination patterns, up-to-date status, and zero vaccination status of U.S. children by 19–35 months. Vaccination patterns were categorized as: 1) recommended, 2) alternate, or 3) unknown or unclassifiable. Multivariable analyses were conducted to examine factors associated with each vaccination pattern and up-to-date status for all recommended vaccines.ResultsFrom 2015 to 2020, the proportion of U.S. children completing the recommended schedule increased from 62.5% to 69.4%, alternative schedule decreased from 21.6% to 16.2%, and unknown or unclassifiable schedules decreased from 15.9% to 14.3%. In addition, being not up-to-date decreased from 39.7% to 35.6%. There was no change in the percentage of children receiving zero vaccinations from 2015 to 2020 (0.9% to 0.9%). Respondents with lower household income or who were uninsured were more likely to follow an alternate or unknown/unclassifiable schedule, or not be up-to-date with vaccines.ConclusionFollowing any schedule other than the recommended schedule was associated with not being up-to-date on immunizations. Increased efforts to catch up on recommended vaccines is important for protecting children’s health. Further efforts should be made to improve timely adherence to recommended vaccination schedules, particularly among populations with the largest disparities in coverage through a tailored approach to increase confidence in and access to vaccines.     

Development of a cumulative metric of vaccination adherence behavior and its application among a cohort of 12-month-olds in western Kenya

ObjectivesThe timely receipt of the recommended vaccination regimen, i.e. vaccination maintenance, is an underexplored, but important, indicator of public health. There is currently no standardized method for quantifying cumulative vaccination maintenance, however, and no simple way to explore predictors of adherence to vaccination schedules. We therefore sought to (1) develop a Vaccination Maintenance Score (VMS) and (2) apply this score to determine the predictors of vaccination behavior among infants in western Kenya (n = 245).MethodsWomen in western Kenya were enrolled during pregnancy and surveyed repeatedly through one year postpartum. Data were collected on a range of sociodemographic and health indicators and vaccinations. For each infant, we analyzed receipt of 11 vaccines recommended by the Kenyan Ministry of Health. We operationalized VMS as the total number of vaccines received on schedule. Vaccines that were not received or received off schedule were scored 0. VMS was modeled using multivariable tobit regression models.ResultsWe found that 85.7% of infants were fully immunized, but only 42.4% had optimal VMS, i.e. scored 11. The median (IQR) VMS was 10 (3). In multivariable regression, each one-point increase in maternal quality of life score (range: 0–32) was associated with a 0.22-point increase in VMS; each additional child in the household was associated with a 0.34-point increase in VMS; and initiating breastfeeding at birth was associated a 2.01-point increase in VMS.ConclusionsCoverage of the recommended vaccinations (85.7%) was nearly twice as high as cumulative timely receipt (42.4%). The VMS satisfies a need for a location-specific but easily adaptable metric of vaccination adherence behavior. It can be used to complement traditional methods of vaccination coverage and timeliness to better understand underlying behaviors that influence vaccination events, and thereby inform interventions to improve vaccination rates and decrease the burden of vaccine-preventable disease.Clinical Trial RegistrationNCT02974972 and NCT02979418.     

Adult immunization against hepatitis B: Does the number of jabs matter?

BackgroundAt least one-half of adults beginning an immunization series with a three-dose hepatitis B virus (HBV) vaccine (ENGERIX-B, RECOMBIVAX-B) have been reported not to receive the third dose. Use of a two-dose vaccine may improve adherence and lead to greater overall levels of seroprotection.ObjectiveTo examine expected levels of adherence and overall seroprotection at one year among adults in routine clinical settings beginning an immunization series with either ENGERIX-B or the two-dose HBV vaccine, HEPLISAV-B.MethodsDecision-analytic model comparing expected levels of adherence and overall seroprotection at one year among a hypothetical cohort of one million previously unvaccinated adults aged ≥ 30 years receiving first doses of either ENGERIX-B or HEPLISAV-B in a routine clinical setting. We stratified the population by age (30–49 years vs ≥ 50 years) to allow for possible differences in adherence and seroprotection. We estimated our model using published adherence rates for HBV vaccines, and reported seroprotection rates by number of doses administered. We also compared total expected costs of HBV immunization with each vaccine.ResultsUse of a two-dose rather than three-dose HBV vaccine would increase the expected number of adults seroprotected at one year by 275,000 per one million persons beginning immunization series, largely reflecting a gain of 290,000 in the expected number of persons fully vaccinated. Results were similar for the two age groups. While the cost per dose of HEPLISAV-B exceeds that of ENGERIX-B, its estimated mean cost per person seroprotected at one year is $50-$70 (～15%) lower.ConclusionsUse of a two-dose HBV vaccine would increase the number of adults fully seroprotected at one year compared with the number expected with a three-dose vaccine. Notwithstanding its higher unit cost, mean expected cost per person seroprotected is substantially lower for HEPLISAV-B than ENGERIX-B as a result of much higher levels of seroprotection.     

Validation of parental reports of rotavirus vaccination of their children compared to the national immunization registry

BackgroundThe introduction of rotavirus vaccines into national immunization programs necessitates vaccine effectiveness evaluations. Parental report of vaccination status is a simple and accessible source of information; however, its validity is unclear.AimsTo validate parental reports of rotavirus immunization compared to documentation of vaccination in national immunization registry, and to assess vaccine effectiveness by each method.MethodsParents of 1272 children aged 2–59 months from northern Israel hospitalized for gastroenteritis in 2011–2015 were interviewed on the sociodemographics and rotavirus vaccination status of their child. Rotavirus immunization status based on parental report was compared to that documented in the national immunization registry, which was considered the gold standard. Stool samples collected from patients were tested for rotavirus antigen by immunochromotgraphy. In a rotavirus test-negative case-control study, vaccination history was compared between children found positive for rotavirus and those who tested negative. Vaccine effectiveness for ≥ 1 dose vs. zero doses was calculated as: (1-adjusted odds ratio) * 100.ResultsThe sensitivity and specificity of parental report of their child's immunization with a rotavirus vaccine were 97% (95% CI 96–98), and 75% (95% CI 65–82), respectively. Kappa coefficient was 0.69 (p < 0.001) for the agreement between the two methods. Rotavirus vaccine effectiveness was 72% (95% CI 54–84) when using parental report of rotavirus immunization and 79% (95% CI 62–88) when using the registry.ConclusionParental report of their child's immunization with a rotavirus vaccine demonstrated high sensitivity, although the specificity was relatively low. Vaccine effectiveness was similar regardless of method used to determine rotavirus immunization status. Parental report of vaccination status can be useful in vaccine effectiveness assessment.     

Addressing logistical barriers to childhood vaccination using an automated reminder system and online resource intervention: A randomized controlled trial

BackgroundAs the rates of vaccination decline in children with logistical barriers to vaccination, new strategies to increase vaccination are needed. The goal of this study was to develop and evaluate the effectiveness of the Vaccines For Babies (VFB) intervention, an automated reminder system with online resources to address logistical barriers to vaccination in caregivers of children enrolled in an integrated healthcare system. Effectiveness was evaluated in a randomized controlled trial.MethodsQualitative interviews were conducted with parents of children less than two years old to identify logistical barriers to vaccination that were used to develop the VFB intervention. VFB included automated reminders to schedule the 6- and 12-month vaccine visit linking caregivers to resources to address logistic barriers, sent to the preferred mode of outreach (text, email, and/or phone). Parents of children between 3 and 10 months of age with indicators of logistical barriers to vaccination were randomized to receive VFB or usual well child care (UC). The primary outcome was percentage of days undervaccinated at 2 years of life. A difference in differences analysis was conducted.ResultsQualitative interviews with 6 parents of children less than 2 years of age identified transportation, scheduling challenges, and knowledge of vaccine timing as logistical barriers to vaccination. We enrolled 250 participants in the trial, 45% were loss to follow-up. There were no significant differences in vaccination uptake between those enrolled in UC or the VFB intervention (0.51%, p = 0.86). In Medicaid enrolled participants, there was a modest decrease in percentage of days undervaccinated in the VFB intervention compared to UC (6.3%, p = 0.07).ConclusionAutomated Reminders and with links to heath system resources was not shown to increase infant vaccination uptake demonstrating additional resources are needed to address the needs of caregivers experiencing logistical barriers to vaccination.     

Vaccination rates and adherence in premature infants before and after pneumococcal conjugate vaccine schedule change for term infants – A claims database analysis in Germany

BackgroundIn 2015, the German Standing Committee on Vaccination (STIKO) changed the pneumococcal conjugate vaccination (PCV) schedule for mature infants from a 3+1 scheme (2, 3, 4, and 11–14 months of age) to a 2+1 scheme (2, 4, and 11–14 months of age). For premature infants, the 3+1 scheme remained. The aim of this study was to assess vaccination rates, completeness, and timeliness for PCV in premature infants before and after the modified recommendation.MethodsA retrospective claims data analysis using the “Institut für angewandte Gesundheitsforschung Berlin” Research Database was conducted. Premature infants born in 2013 and 2016 with an individual follow-up of 24 months were included. Hexavalent combination (HEXA) vaccination with a consistent 3+1 recommendation for mature and premature infants was analyzed as reference vaccination.ResultsAfter 24 months, the PCV rate for at least one dose remained stable in premature newborns of 2016 compared to 2013, while the HEXA vaccination rate increased slightly. However, a significant decrease of a completed PCV schedule (4 doses) in premature infants was noted, whereas the completeness of HEXA vaccination did not change. The timeliness of PCV in premature newborns increased for the first and the booster PCV, while the timeliness of HEXA immunization did not change from 2013 to 2016.ConclusionAlthough STIKO still recommends a 3+1 PCV schedule for premature infants in Germany, premature infants were vaccinated according to the changed recommendations for mature born infants. A substantial share of premature infants remained unvaccinated, and their vaccinations were often delayed.     

Effects of rotavirus vaccine on all-cause acute gastroenteritis and rotavirus hospitalizations in Israel: A nationwide analysis

BackgroundIn December 2010, the pentavalent rotavirus vaccine (RotaTeq) was added to the national immunization program in Israel. The study aim was to examine national reductions in all-cause acute gastroenteritis (AGE) and rotavirus gastroenteritis (RVGE) hospitalizations among children aged 0–59 months following the introduction of universal rotavirus immunization in Israel.MethodsWe extracted data from the Israel National Hospital Discharge Database. Hospitalization rates were calculated by dividing the annual number of all-cause AGE and RVGE hospitalizations by the number of children aged 0–59 months residing Israel. To assess rate reductions, we compared the mean hospitalization rate for the pre-vaccine years (2002–2008) with that for the universal vaccination years (2011–2017). Interrupted time-series analyses were undertaken. During 2008–2010 rotavirus vaccines were partially available.ResultsA total of 131,116 AGE hospitalizations were reported, of which 13,111 (10.0%) were coded as RVGE hospitalizations. The average annual all-cause AGE hospitalization rate during the pre-vaccine period was 147.9 (95% CI 146.7–149.0) per 10,000 children aged 0–59 months, and declined by 38.7–53.0% during the universal vaccination years. The average annual pre-vaccine RVGE hospitalization rate was 16.9 (95% CI 16.5–17.3) per 10,000 children, and declined by 89.1% during 2016–2017.Findings from interrupted time-series analyses showed significant impact of introducing universal rotavirus immunization on the declines of all-cause AGE and RVGE hospitalizations rates. A multivariable Autoregressive Integrated Moving Average model showed that the variable “immunization period” was a significant predictor of RVGE hospitalizations (t = 7.3, p < 0.001) for the universal vaccination years.The declines in hospitalizations rates of all-cause AGE were lower among Arab children compared to Jewish children, but the declines in RVGE rates were similar between the groups.ConclusionsNational hospitalization data demonstrated substantial and consistent reductions in all-cause AGE and RVGE hospitalizations following the implementation of universal rotavirus vaccination program.     

Trend in varicella patients 4 years after implementation of universal two-dose varicella vaccination in Japan

ObjectiveTo elucidate the trend and clinical spectrum of virologically diagnosed varicella patients after implementation of universal vaccination as a national immunization program in Japan.Patients and methodsStudy subjects were patients suspected of varicella, less than 15 years of age, who visited 14 pediatric clinics in the Nagoya VZV Study Group from September 2015 to August 2019. Practitioners collected patient samples and information such as backgrounds, clinical symptoms, and previous immunization status. All patients were confirmed as having varicella based on molecular diagnostic assays.ResultsVaricella zoster virus (VZV) DNA was detected in swab samples from 506 (83.1%) of the 609 suspected patients. The 455 varicella patients for whom vaccination status was available were divided into two groups: 180 universal vaccination targets and 275 non-targets. Numbers of monthly varicella patients decreased gradually during the observation period. In the 2016/17 season, the seasonal epidemic of varicella became undetectable in the universal vaccination target group, and starting in the 2017/18 season, it was obscured even in the non-target group. The median age of patients was significantly lower in the universal vaccination target group (3 years) than the non-target group (7 years) (P < 0.001). Vaccination status differed significantly between the two groups (P < 0.001). Most varicella patients were in the non-target group, especially those who had been vaccinated once (60.4%). Frequency of fever (P < 0.001) and number of skin rashes at the time of the first hospital visit (P = 0.001) were significantly higher in the non-target group.ConclusionsAlthough the number of childhood varicella patients declined after implementation of national immunization with two doses of varicella vaccination, sporadic outbreaks still occurred, mainly in the non–universal vaccination target group. Insufficient vaccination of members of this group is likely to be a major reason for small local outbreaks.     

Optimizing needle length and site choice for adult immunization

BackgroundCurrent recommendations for needle length and vaccination site for intramuscular deltoid vaccinations are backed by minimal data.AimTo determine the ideal needle length and vaccination site for intramuscular deltoid vaccine administration.Methods120 shoulder CT scans were evaluated and grouped by patient weight and sex as recommended by the United States CDC: Group 1, <60 kg, Group 2, 60–70 kg, Group 3, females 70–90 kg and males 70–118 kg, and Group 4, females > 90 kg and males > 118 kg. For each group, distance from skin to deltoid fascia and deltoid muscle width were measured at 2, 4, and 6 cm distal to the posterolateral corner of the acromion for 5 unique trajectories. Needle lengths of 0.625″, 1.0″, and 1.5″ were simulated at each site to determine inoculation location relative to the deltoid.ResultsFor Group 1, a 0.625″ needle in the mid-lateral (ML) trajectory 4 cm distal to the posterolateral corner provided a perfect rate of successful inoculations (100 %). For Groups 2–3, a 1″ needle in the posterolateral (PL) trajectory 4 cm distal provided high rates (>80 %) of successful intramuscular inoculations with low rates of overpenetration (<15 %) while minimizing risk to the axillary nerve. For Group 4, a 1.5″ needle using the same strategy provided the highest rate of successful inoculations (96 %) and minimal overpenetration (4 %). Overpenetration was associated with more anterior and superior injection sites (P < 0.001 for both) for all needle lengths.ConclusionsThe overall ideal injection site to maximize successful intramuscular vaccine administration, minimize overpenetration, and avoid axillary nerve injury is 4 cm distal to and in line with the posterolateral corner of the acromion, a site more posterior and inferior than current CDC recommendations. We caution against use of a 1.5″ needle for patients < 118 kg due to high predicted rates of overpenetration.     

Safety and immunogenicity of a pichia pastoris-expressed bivalent human papillomavirus (types 16 and 18) L1 virus-like particle vaccine in healthy Chinese women aged 9–45 years: A randomized,double-blind,placebo-controlled phase 1 clinical trial

BackgroundWe evaluated the safety and immunogenicity of high and low doses of a novel pichia pastoris-expressed bivalent (types 16 and 18) human papillomavirus (HPV) virus-like particle vaccine.MethodsIn this randomized, double-blind, placebo-controlled phase 1 trial, we enrolled 160 healthy females aged 9–45 years in Guangxi, China who were randomized (1:1:2) to receive either low (0.5 mL) or high (1.0 mL) dosages of bivalent HPV vaccine, or placebo (aluminum adjuvant) in a 0, 2, 6 months schedule. Adverse events and other significant conditions that occurred within 30 days after each vaccination were recorded throughout the trial. Sera were collected at days 0, 60, 180 and 210 to measure anti-HPV 16/18 neutralizing antibodies.ResultsA total of 160 participants received at least one dose of the HPV vaccine and 152 completed the three dose vaccination series. Reporting rates of adverse events in placebo, low dose (0.5 mL) and high dose (1.0 mL) groups were 47.5 %, 55.0 % and 55.0 %, respectively. No serious adverse events occurred during this trial. 100 % of the participants who received three doses of the HPV vaccine produced neutralizing antibodies against HPV 16/18 vaccine. For HPV 16 and HPV 18, the geometric mean titers (GMTs) were similar between the low dose group (GMT_{HPV 16} = 10816 [95 % CI: 7824–14953]), GMT_{HPV 18} = 3966 [95 % CI: 2693–5841]) and high dose group (GMT _{HPV 16} = 14482 [95 % CI: 10848–19333], GMT _{HPV 18} = 3428 [95 % CI: 2533–4639]).ConclusionThe pichia pastoris-expressed bivalent HPV vaccine was safe and immunogenic in Chinese females aged 9–45 years. The low dosage (0.5 mL) was selected for further immunogenicity and efficacy study.     

Duration of influenza vaccine effectiveness in the elderly in Japan: A retrospective cohort study using large-scale population-based registry data

BackgroundThe immune response to influenza vaccination in the elderly is likely to be lower than that in young adults. Clinical protection may not persist year-round in the elderly. However, the effectiveness of influenza vaccine in the elderly has not been adequately studied, especially in terms of the duration of effectiveness.MethodsWe used a linked database of healthcare administrative claims data and vaccination records maintained by the municipality of a city in Kanto region of Japan. We studied individuals who were aged 65 years or older at baseline and were followed up between April 1, 2014 to March 31, 2020. The duration of influenza vaccine effectiveness by age category was analyzed using a time-dependent piecewise Cox proportional hazard model with time-dependent vaccine status, prior season vaccination and covariates confirmed in the baseline period (age, sex, cancer, diabetes, chronic obstructive pulmonary diseases, asthma, chronic kidney diseases, and cardiovascular diseases).ResultsWe identified an analysis population of 83,146 individuals, of which 7,401 (8.9%) had experienced influenza and 270 (0.32%) underwent influenza-related hospitalization. Individuals who were vaccinated during the first season (n = 47,338) were older than non-vaccinated individuals (n = 35,808) (average age, 75.8 vs. 74.1 years, respectively). The multivariable analysis showed a lower incidence of influenza in vaccinated individuals (hazard ratio [HR], 0.47; 95% confidence interval [CI], 0.43–0.51; P < 0.001), while the incidence of hospitalization for influenza did not differ significantly by vaccination status (HR, 0.79; 95% CI, 0.53–1.18; P = 0.249). Protective effectiveness against incidence was maintained for 4 or 5 months after vaccination in those aged 65–69 and 80-years, 5 months in 70–79 years.ConclusionsOur study identified moderate vaccine effectiveness in preventing the incidence of influenza in the Japanese elderly. Vaccine effectiveness showed a trend of gradual attenuation. Clinicians should suspect influenza infection even in those vaccinated, especially in elderly individuals who had received vaccination more than 4 or 5 months previously.     

A complementary approach to the vaccination promotion continuum: An immunization-specific motivational-interview training for nurses

AimTo develop and validate immunization-specific motivational-interview (MI) training for immunization nurses.BackgroundWe previously demonstrated that a MI-based intervention on immunisation, performed during postpartum by MI-trained healthcare workers at the hospital maternity ward, reduced parental vaccine hesitancy (VH) and increased vaccine coverage of their children. In this study, we propose immunization-specific MI training for immunization nurses. Together, MI-based training and interventions provide complementary approaches to existing strategies along the vaccination promotion continuum.DesignMultiple pretest/posttest design with questionnaires self-administered before and after each training days (4 time points).MethodsWe developed an in-person immunization-specific MI-training workshop for immunization nurses, held on two days three months apart, with 7 h of MI-training dispensed on day 1, and 4 h on day 2. The self-administered Motivational Interviewing Skills in Immunization (MISI) questionnaire was used at four time points (before and after each of the 2 training days) to evaluate three core aspects of participant MI training: (1) MI-knowledge acquisition; (2) MI-skills application and (3) self-rated self-confidence in applying MI knowledge and skills in vaccination clinical practice. Between November 2016 to December 2017, 34 immunization nurses enrolled in our MI-training workshops.ResultsThe immunization-specific MI-training improved the three core areas evaluated in participants i.e. MI-knowledge acquisition, MI-skills application, and self-rated self-confidence in applying these in vaccination clinical practice.ConclusionsOur immunization-specific MI-training enabled immunization nurses to significantly improve MI knowledge, skills and self-confidence in applying MI in the clinic. These results, taken together with those on the MI-based intervention for parents that we previously reported, support the notion of proposing validated immunization-specific MI training for immunization nurses in order to curb parental VH.ImpactImmunization-specific MI-training would be easily amenable for the training of other health professionals in the field of immunization to help promote vaccination and curb parental VH.     

Impact of tetanus-diphtheria-acellular pertussis immunization during pregnancy on subsequent infant immunization seroresponses: follow-up from a large randomized placebo-controlled trial

BackgroundPertussis immunization during pregnancy results in high pertussis antibody concentrations in young infants but may interfere with infant immune responses to post-natal immunization.MethodsThis phase IV, multi-country, open-label study assessed the immunogenicity and safety of infant primary vaccination with DTaP-HepB-IPV/Hib and 13-valent pneumococcal conjugate vaccine (PCV13). Enrolled infants (6–14 weeks old) were born to mothers who were randomized to receive reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) during pregnancy (27^0/7–36^6/7 weeks’ gestation) with crossover immunization postpartum. All infants received 2 or 3 DTaP-HepB-IPV/Hib and PCV13 doses according to national schedules. Immunogenicity was assessed in infants pre- and 1 month post-primary vaccination. The primary objective was to assess seroprotection/vaccine response rates for DTaP-HepB-IPV/Hib antigens 1 month post-primary vaccination.Results601 infants (Tdap group: 296; control group: 305) were vaccinated. One month post-priming, seroprotection rates were 100% (diphtheria; tetanus), ≥98.5% (hepatitis B), ≥95.9% (polio) and ≥94.5% (Hib) in both groups. Vaccine response rates for pertussis antigens were significantly lower in infants whose mothers received pregnancy Tdap (37.5–77.1%) versus placebo (90.0–99.2%). Solicited and unsolicited adverse event rates were similar between groups. Serious adverse events occurred in 2.4% (Tdap group) and 5.6% (control group) of infants, none were vaccination-related.ConclusionsPertussis antibodies transferred during pregnancy may decrease the risk of pertussis infection in the first months of life but interfere with the infant’s ability to produce pertussis antibodies, the clinical significance of which remains unknown. Safety and reactogenicity results were consistent with previous experience.Clinical Trial Registration: ClinicalTrials.gov: NCT02422264.