Pregnant women at risk for iodine deficiency but adequate iodine intake in school-aged children of Zhejiang Province, China.

The median urinary iodine concentration (UIC) of school-aged children has been commonly used as a surrogate to assess iodine status of a population including pregnant women. However, pregnant women have higher iodine requirements than children due to increased production of thyroid hormones. The aim of the study was to evaluate the iodine status of pregnant women and children as well as their household salt iodine concentration (SIC) in Quzhou, Zhejiang Province, China. Eligible pregnant women and children from all six counties of Quzhou in 2021 were recruited into the study. They were asked to complete a socio-demographic questionnaire and provide both a spot urine and a household table salt sample for the determination of UIC and SIC. A total of 629 pregnant women (mean age and gestation weeks of 29.6 years and 21.6 weeks, respectively) and 1273 school-aged children (mean age of 9 years and 49.8% of them were females) were included in the study. The overall median UIC of pregnant women and children in our sample was 127 (82, 193) µg/L and 222 (147, 327) µg/L, respectively, indicating sufficient iodine status in children but a risk of mild-to-moderate iodine deficiency in pregnant women. Distribution of iodine nutrition in children varied significantly according to their sex and age (P < 0.05). The rate of adequately household iodised salt samples (18-33 mg/kg) provided by pregnant women and children was 92.4% and 90.6%, respectively. In conclusion, our results indicated a risk of insufficient iodine status in pregnant population of China, but iodine sufficiency in school-aged children. Our data also suggested that median UIC of children may not be used as a surrogate to assess iodine status in pregnant women.

Comparison of the effectiveness four years after Homo/Hetero prime-boost with 10 µg HP and 20 µg CHO recombinant hepatitis B vaccine at 1 and 6 months in maternal HBsAg-negative children.

Introduction: Limited data were available on the effectivenessfour years after Homo or Hetero prime-boost with 10 µg Hansenulapolymorpha recombinant hepatitis B vaccine (HepB-HP) and 20 µgChinese hamster ovary cell HepB (HepB-CHO). Methods: A crosssectional study was performed in maternalhepatitis B surface antigen (HBsAg)-negative children whoreceived one dose of 10 µg HepB-HP at birth, Homo or Heteroprime-boost with 10 µg HepB-HP and 20 µg HepB-CHO at 1 and 6months. HBsAg and hepatitis B surface antibody (anti-HBs) fouryears after immunization were quantitatively detected by achemiluminescent microparticle immunoassay (CMIA). Results: A total of 359 children were included; 119 childrenreceived two doses of 10 µg HepB-HP and 120 children receivedtwo doses of 20 µg HepB-CHO, called Homo prime-boost; 120children received Hetero prime-boost with 10 µg HepB-HP and 20µg HepB-CHO. All children were HBsAg negative. The geometricmean concentration (GMC) and overall seropositivity rate (SPR) ofanti-HBs were 59.47 (95%CI: 49.00 - 72.16) mIU/ml and 85.51%(307/359). Nearly 15% of the study subjects had an anti-HBsconcentration < 10 mIU/ml and 5.01% had an anti-HBsconcentration ≤ 2.5 mIU/ml. The GMC of the 20 µg CHO Homoprime-boost group [76.05 (95%CI: 54.97 - 105.19) mIU/ml] washigher than that of the 10 µg HP Homo group [45.86 (95%CI:31.94 - 65.84) mIU/ml] (p = 0.035). The GMCs of the Heteroprime-boost groups (10 µg HP-20 µg CHO and 20 µg CHO-10 µgHP) were 75.86 (95% CI: 48.98 - 107.15) mIU/ml and 43.65(95%CI: 27.54 - 69.18) mIU/ml, respectively (p = 0.041). Aftercontrolling for sex influence, the SPR of the 20 µg CHO Homoprime-boost group was 2.087 times than that of the 10 µg HPHomo group. Discussion: The HepB booster was not necessary in the generalchildren, Homo/Hetero prime-boost with 20 µg HepB-CHO wouldincrease the anti-HBs concentration four years after immunization,timely testing and improved knowledge about the self-pay vaccinewould be good for controlling hepatitis B.

A case of congenital rubella syndrome and epidemiology of related cases in China, 2014-2023.

Rubella is a major cause of congenital defects, and the presence of rubella infection in a pregnant woman may lead to fetal death or congenital defects known as congenital rubella syndrome(CRS). Since China has not yet established a national CRS surveillance system, the true incidence cannot be determined. To understand the disease burden and epidemiological characteristics of CRS cases in China, the article reports the first case of CRS in Quzhou, China, and conducts a retrospective analysis of related cases that have been reported in China over the past decade. Because the availability of rubella-containing vaccines (RCV) was not widespread in China before 2008, women of childbearing age born before 2008 are generally unvaccinated against RCV. Due to the lack of routine CRS monitoring and screening, CRS is underreported in China. Vaccination of nonimmune women of childbearing age with RCV and establishing a sensitive and timely case-based CRS surveillance system can accelerate the elimination of rubella and CRS.

Immuno-persistence of the different primary polio vaccine schedules and immunogenicity of the booster dose by sabin inactivated or bivalent oral poliovirus vaccine in children aged 4 years: an open-label, randomised, controlled phase 4 trial in China.

Background: Sabin inactivated and bivalent oral poliovirus vaccine (sIPV, bOPV) were commonly used in China since 2016. We conducted an open-label, randomised, controlled phase 4 trial to assess immune persistence following sequential immunisation with sIPV or bOPV, and immunogenicity and safety of a booster dose of poliovirus vaccine in children aged 4 years. Methods: Participants from a previous clinical trial with three different sequential schedules with sIPV (I) or bOPV (B) at ages 2, 3, and 4 months (Groups I-B-B, I-I-B, I-I-I) in 2017 were followed-up. The children were further divided into five subgroups after sIPV was given for Group I-B-B, and sIPV or bOPV randomly given for Group I-I-B and Group I-I-I (128 children in Groups I-B-B-I, 60 in Group I-I-B-B, 64 in Group I-I-B-I, 68 in Group I-I-I-B, 67 in Group I-I-I-I). Immune persistence and immunogenicity were assessed by measuring poliovirus type-specific antibodies, and safety were analysed in all children who received the booster dose. Findings: Between Dec 5, 2020 and Jun 30, 2021, we respectively enrolled 381 participants in the immune persistence analysis, and 352 participants in per protocol (PP) analysis of the immunogenicity of the booster immunisation. Seropositivity rates of antibodies against poliovirus types 1 and 3 were all >90% four years after primary immunisation, while for poliovirus type 2 were 46.83%, 75.41%, and 90.23% (χ2 = 60.948, P < 0.001) for Groups I-B-B, I-I-B, and I-I-I, respectively. After the booster dose, seropositivity rates were 100% for all three serotypes in Group I-B-B-I, I-I-B-I and I-I-I-I; In Group I-I-B-B and I-I-I-B, the seropositivity rates for types 1 and 3 were all 100%, for type 2 were 92.59% and 98.46%. The geometric mean titres (GMTs) against poliovirus 1 and 3 were all high in five groups (>1860.73), and the GMTs against type 2 were significantly lower in groups booster with bOPV: Group I-I-B-B (50.60) and Group I-I-I-B (247.84). There was no significant difference in seropositivity rates or GMTs for all three serotypes (P > 0.05) between Group I-I-B-I and I-I-I-I. No serious adverse events occurred during the study. Interpretation: Our findings suggest that at least two sIPV doses are needed in the current routine poliovirus immunisation schedule, and schedules containing 3 or 4 doses of sIPV provide better protection against poliovirus type 2 than the current sIPV-sIPV-bOPV-bOPV schedule in China. Funding: Medical and Health Science and Technology of Zhejiang Province (2021KY118). This trial was registered with ClinicalTrials.gov (NCT04576910).

Effectiveness of COVID-19 vaccines against SARS-CoV-2 Omicron variants during two outbreaks from March to May 2022 in Quzhou, China.

Limited data are available on the effectiveness of COVID-19 vaccines used in China in real-world outbreaks - especially against Omicron variants in vaccinated individuals. Two outbreaks of SARS-CoV-2 Omicron variants - the first involving the sub-lineage BA.2 and the second the BA.1 variant - occurred in Quzhou. Infected people and their close contacts were divided according to vaccination status: unvaccinated, partially vaccinated, fully vaccinated, and boosted. The Cox proportional-hazard regression model was used to estimate the evolving hazard for vaccinated individuals after their first immunization. 138 people had been infected with the SARS-CoV-2 Omicron BA.2 variant and 13 with the BA.1 variant. Of the 151 infections, 99.34% (150/151) were mild or asymptomatic and 90.07% (136/151) were vaccine breakthrough cases. The total vaccine effectiveness (VE) of partial, full, and booster vaccinations during the two outbreaks was 47.4% (95%CI: 0-93.1%), 28.9% (95%CI: 0-60.2%), and 27.5% (95%CI: 0-58.3%). The VE of booster vaccination against the Omicron BA.1 variant was higher than that for the BA.2 variant. The cumulative hazard began to increase 220 days after the first immunization. The transmissibility of the Omicron BA.2 variant as for BA.1 did not increase in vaccinated individuals; booster vaccination after a primary course substantially increased protection. Our study found that the SARS-CoV-2 Omicron variant caused less severe illness and that the VE of boosters against the Omicron variant was less than 30%. Timely administration of the booster dose was important, especially for individuals aged over 80 years old.

Assessment of mumps-containing vaccine effectiveness by dose during 2006 to 2020 in Quzhou, China.

Mumps cases were reported frequently when a routine dose measles-mumps-rubella(MMR) achieved high coverage in Quzhou. The supplementary immunization activities (SIA) using measles mumps (MM) was conducted to control mumps outbreaks. The effectiveness of one and two doses of mumps-containing vaccine (MuCV) was assessed using surveillance data in this study. Mumps cases and immunization information were retrieved from the National Notifiable Disease Reporting System (NNDRS) and the Zhejiang Provincial Immunization Information System (ZJIIS), respectively. Mumps cases of children born from 2006 to 2010 were included. Vaccine effectiveness by dose was calculated using the screening method. A total of 956 mumps cases were identified, of whom 754 (78.9%) had received one dose of MuCV; 108 (11.3%) had received two doses; 94 (9.8%) were unvaccinated. The coverage of one-dose MuCV in the 2006-2010 birth cohorts ranged from 91.6% to 98.9%. Except the 2009 birth cohort in which the coverage of two doses of MuCV was 55.1%, the others were less than 10%. Vaccine effectiveness (VE) of one dose ranged from 47.4% to 86.0%, while VE of two doses ranged from 64.0% to 92.4%. The VE of one and two doses of MuCV waned over time, but the VE of two doses was consistently higher than that of one dose in the same period. The vaccine schedule with two-dose MMR should be implemented among children in Quzhou. The optimal age for the second dose needs to be further evaluated.

Comparing the pertussis antibody levels of healthy children immunized with four doses of DTap-IPV/Hib (Pentaxim) combination vaccine and DTaP vaccine in Quzhou, China.

Despite the high coverage of pertussis vaccines in high-income countries, pertussis resurgence has been reported in recent years, and has stimulated interest in the effects of vaccines and vaccination strategies. Immunoglobulin G (IgG) antibodies against pertussis toxoid (PT), filamentous hemagglutinin (FHA), and pertactin (PRN) after immunization with four doses of co-purified or component vaccines were determined by enzyme-linked immunosorbent assay (ELISA). Serological data of PT-IgG geometric mean concentrations (GMCs) over time since vaccination were used to fit the mathematical models. A total of 953 children were included in this study; 590 participants received four doses of the component acellular vaccine and 363 participants received four doses of the co-purified acellular vaccine. The GMCs and the seropositivity rate of pertussis IgG were significantly influenced by the production methods, and the immunogenicity of the component acellular vaccine was superior to that of the co-purified acellular vaccine. The fitted mathematical models for the component acellular vaccine and the co-purified acellular vaccine were Y=91.20e-0.039x and Y=37.71x-0.493, respectively. The initial GMCs of the component acellular vaccine was higher than that of the co-purified acellular vaccine, but both were similar at 72 months after immunization. Pertussis IgG levels waned over time after four doses of acellular pertussis vaccine, regardless of whether component or co-purified vaccine was used. The development and promotion of component acellular pertussis vaccines should be accelerated in China, and booster doses of pertussis vaccine in adolescents, adults, and pregnant women should be employed.

Introduction of Two-Dose Mumps-Containing Vaccine into Routine Immunization Schedule in Quzhou, China, Using Cox-Proportional Hazard Model.

Mumps is a vaccine-preventable disease caused by the mumps virus, but the incidence of mumps has increased among the children who were vaccinated with one-dose measles-mumps-rubella (MMR) in recent years. In this study, we analyzed the influence of different doses of mumps-containing vaccine (MuCV) against mumps using Cox-proportional hazard model. We collected 909 mumps cases of children who were born from 2006 to 2010 and vaccinated with different doses of MuCV in Quzhou during 2006-2018, which were all clinically diagnosed. Kaplan-Meier survival methods and Cox-proportional hazard model were used to estimate the hazard probabilities. Kaplan-Meier curves showed that the cumulative hazard of male and female has no difference; lower hazards were detected among those who were vaccinated with two-dose MuCV, born in 2006, and infected after supplementary immunization activities (SIA). Cox-proportional hazard regression suggested that onset after SIA, born in 2006, and vaccinated with two-dose MuCV were protective factors against infection even after adjusting for potential confounding effects. Our study showed that it was necessary to revise the diagnostic criteria of mumps and identify RT-PCR as the standard for mumps diagnosis in China. We suggested that routine immunization schedule should introduce two doses of MMR and prevaccination screening should be performed before booster immunization in vaccinated populations.

Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: an open-label, randomised, controlled trial.

BACKGROUND: The globally synchronised introduction of inactivated poliovirus vaccine (IPV) and replacement of trivalent oral poliovirus vaccine (OPV) with bivalent OPV (bOPV) were successfully implemented in China's routine immunisation programme in May, 2016. In response to the global shortage of Salk-strain IPV, Sabin-strain IPV production was encouraged to develop and use in low-income and middle-income countries. We assessed the immunogenicity of the current routine poliovirus vaccination schedule in China and compared it with alternative schedules that use Sabin-strain IPV (sIPV) and bOPV. METHODS: This open-label, randomised, controlled trial recruited healthy infants aged 60-75 days from two centres in Zhejiang, China. Eligible infants were full-term, due for their first polio vaccination, weighed more than 2·5 kg at birth, were healthy on physical examination with no obvious medical conditions, and had no contraindications to vaccination. Infants were randomly assigned (1:1:1) using permuted block randomisation (block size of 12) to one of three polio vaccination schedules, with the first, second, and third doses given at ages 2 months, 3 months, and 4 months, respectively: sIPV-bOPV-bOPV (1sIPV+2bOPV group; current regimen), sIPV-sIPV-bOPV (2sIPV+1bOPV group), or sIPV-sIPV-sIPV (3sIPV group). The primary endpoint was the proportion of infants with seroconversion to each of the three poliovirus serotypes 1 month after the third dose. Serious and medically important adverse events were monitored for up to 30 days after each vaccination. We assessed immunity in the per-protocol population (all children who completed all three vaccinations and had pre-vaccination and post-vaccination laboratory data) and safety in all children who received at least one dose of study vaccine. This trial is registered with Clinicaltrials.gov, NCT03147560. RESULTS: Between May 1, 2016, and Dec 1, 2017, we enrolled and randomly assigned 528 eligible infants to one of the three treatment groups (176 in each group); 473 infants (158 in the 1sIPV+2bOPV group, 152 in the 2sIPV+1bOPV group, and 163 in the 3sIPV group) were included in the per-protocol population. 100% seroconversion against poliovirus types 1 and 3 was observed in all three groups. Infants who received an immunisation schedule containing bOPV had significantly higher antibody titres against poliovirus types 1 and 3 than did the sIPV-only group (2048 in all three treatment groups; p<0·0001). Seroconversion against type 2 poliovirus was observed in 98 (62%) infants in the 1sIPV+2bOPV group, 145 (95%) infants in the 2sIPV+1bOPV group, and 161 (99%) infants in the 3sIPV group. No serious adverse events occurred during the study; 14 minor, transient adverse events were observed, with no significant differences across study groups. INTERPRETATION: All three study schedules were well tolerated and highly immunogenic against poliovirus types 1 and 3. Schedules containing two or three sIPV doses had higher seroconversion rates against poliovirus type 2 than did the schedule with a single dose of sIPV. Our findings support inclusion of two sIPV doses in the routine poliovirus vaccination schedule in China to provide better protection against poliovirus type 2 than provided by the current regimen. FUNDING: Chinese Center for Disease Control and Prevention and China National Biotec Group Company.

Assessing the Changes of Mumps Characteristics with Different Vaccination Strategies Using Surveillance Data: Importance to Introduce the 2-Dose Schedule in Quzhou of China.

BACKGROUND: From 2005 to 2016, the prevention and control of mumps in China have undergone three stages of transition. These include the use of MuCV as a self-supported vaccine, the introduction of one-dose MMR to the Expanded Program on Immunization (EPI), and the administration of two-dose MuCV following supplementary immunization activities (SIAs) using MM. Here, using surveillance data, we assessed the epidemiology of mumps during the three stages. METHODS: Children in Quzhou of China born from 2005 to 2016 and registered in the Zhejiang Provincial Immunization Information System (ZJIIS) were included. We analyzed the epidemic data and calculated incidence and MuCV coverage via birth cohorts. RESULTS: The average incidence of mumps in 2005-2006, 2007-2010, and 2011-2016 was 51.57, 41.02, and 12.53 per 100,000 individuals, respectively. The highest incidence was in children aged 6-14 years from 2005-2016, of which the majority were school students (67.84%). Approximately 90% of the reported outbreaks occurred in school children (primary school/middle school). The seasonal characteristics of mumps were less obvious from 2011 to 2016. The coverage of one-dose MMR in the 2005 birth cohort was 71.38%. For the 2006-2010 birth cohort, the coverage of one-dose MuCV was 96.82% and the coverage of two-dose MuCV was 17.68%. The children born from 2011 to 2016 were only free vaccinated with MMR; the coverage of one-dose MuCV was 99.10%. The mumps incidence in the three birth cohorts significantly declined (X 2 = 805.90, P < 0.001 for trend). Except the children less than two years old, the mumps incidence for the children born from 2006 to 2010 was higher than that for the children born from 2011 to 2016. CONCLUSION: The mumps incidence significantly declined following the introduction of one-dose MMR. The SIA using MM led to a rapid reduction of mumps cases. Therefore, we recommend a two-dose MuCV routine immunization schedule and improved vaccination coverage.