Acute adverse events and pregnancy outcome after inactivated COVID-19 vaccination in first trimester / 中华围产医学杂志

Objective:To investigate acute adverse events and pregnancy outcome after vaccination of inactivated COVID-19 vaccine in the first trimester of pregnancy.Methods:The retrospective-prospective cohort study was conducted among pregnant women of 11-13 +6 weeks of gestation who visited the obstetric clinics for prenatal check in Lianyungang Maternal and Child Health Hospital from May to November in 2021, after registration for perinatal health cards in the community. Those who met the inclusion criteria were recruited and were divided into vaccination group and non-vaccination group according to whether they received inactivated COVID-19 vaccine in the first trimester. Women in the vaccination group were further divided into 1-dose group and 2-dose group. Information, including pregnancy-related screening, pregnancy complications, pregnancy outcome and acute adverse events, were collected and compared with independent samples t-test or ANOVA, Kruskal- Wallis H test or Mann-Whitney U test, χ2 test or Fisher's exact probability method. Results:Totally, 105 pregnant women were analyzed in 1-dose group, 90 in 2-dose group, and 194 in non-vaccination group. (1) There were no statistically significant differences in the occurrence of acute adverse events [1-dose group: 2.86% (3/105); 2-dose group: 6.67% (6/90); non-vaccination group: 4.63% (9/194); χ2=1.59; vaccination group was 4.61% (9/195), when compared with non-vaccination group, χ2=0.00], abnormal pregnancy-related screening indicators and abnormal pregnancy outcome among the three groups (all P>0.05), neither between the vaccination and non-vaccination group (all P>0.05). The acute adverse events in these women included fever, pain at the inoculation site, fatigue, local induration and rash.(2) The differences in hypertensive disorders in pregnancy among the three groups were statistically significant [1-dose group: 10.5%(11/105); 2-dose group: 17.8%(16/90); non-vaccination group: 7.7%(15/194); χ2=6.46, P=0.040], and the incidence was higher in the 2-dose group than that in the non-vaccination group (adjusted by Bonferroni, P<0.017). (3) Regarding other pregnancy complications, no difference was found among the three groups (all P>0.05), neither between the vaccination and non-vaccination group (all P>0.05). Conclusion:The risk of acute adverse events and adverse pregnancy outcome is similar in pregnant women who received inactivated COVID-19 vaccine versus those who did not in the first trimester, and regular blood pressure monitoring is recommended for those who received two doses of inactivated COVID-19 vaccine.

[General principles of vaccination under immunosuppression]. / Allgemeine Prinzipien des Impfens unter Immunsuppression.

The number of patients suffering from immunodeficiency is increasing; however, the vaccination rate of these patients is below average. Administration of inactivated vaccines is harmless but does not reliably trigger a persistent immune response. Live vaccines provide a reliable protection but can cause severe disease in immunocompromised patients. Live vaccines can be administered under defined levels of immunosuppression, e.g. against measles, mumps, rubella and varicella (MMRV). In addition, the immunization of the domestic environment plays an important role in preventing infectious diseases.

[Research progress on immune efficacy, safety, vaccination intention and immunization strategy of domestic enterovirus 71 vaccine after its marketing].

Enterovirus 71 (EV71) is one of the main pathogens of hand, foot and mouth disease (HFMD) and the main pathogen of severe HFMD. In 2015, three EV71 vaccines were successively marketed in China as powerful prevention and control tools for HFMD caused by EV71. To understand the efficacy, immunogenicity, safety and quality stability of the domestic EV71 vaccine after entering into the market and analyze potential problems in its application, this article incorporates research regarding the immune effect, population effect, safety, quality testing and evaluation results, vaccination willingness and vaccination behavior survey to explore the vaccination strategies for the donll stic EV71 vaccine. EV71 vaccine has good immunogenicity, safety, protective efficacy, and good quality stability after entering into the market, however, only a few study focused on its safety when inoculating with other immunization planning vaccines simultaneously. Strengthen safety monitoring and discuss the safety of the EV71 vaccine especially when simultaneously inoculate with other immunization program vaccines are still necessary. Enterovirus evolution and recombination, whilst the probable impact of the EV71 vaccine can be the reason for future changes of HFMD epidemic strains, hence continuous monitoring of antigenic mutations and genetic evolution of enterovirus should be responded to. Encouraging the R&D of polyvalent vaccines against HFMD is also necessary. Parents' lack of HFMD and EV71 vaccine knowledge was common, therefore HFMD knowledge should be strengthened at the same time when introducing the EV71 vaccine to the public. Also, it should be emphasized that the EV71 vaccine can only prevent HFMD caused by EV71.

Vaccinations in Infants and Children

@#We have effective vaccines against some of the common and dangerous infections in children. Most of these vaccines have a high safety profile. Vaccines available for routine immunisations belong to different categories. Live viral vaccines are highly effective and provides a good protective effect against the infections caused by those viruses. Conjugate and toxoid bacterial vaccines are also very effective. An overview of all the recommended childhood vaccines, along with their dosing schedule and specific contraindications are discussed. We have looked at situations where vaccinations should be delayed or avoided. Catch up vaccination recommendations for missed or delayed vaccinations are briefly discussed.

[Immunogenicity analysis of sequential inoculation of different strains of poliomyelitis vaccines in Shanghai].

Objective: To evaluate the immunogenicity of different strains of inactivated poliomyelitis vaccines (IPV) by sequential program. Methods: This parallel-group controlled trial was conducted in immunization clinics in Shanghai from March 2016 to September 2017. Sabin strains inactivated poliomyelitis vaccines (sIPV), WPV strains inactivated poliomyelitis vaccines (wIPV) and live poliomyelitis Type Ⅰ Type Ⅲ vaccine (bOPV) as the investigational vaccine were used at 2, 3, 4 months old in 325 infants in Shanghai. Infants vaccinated by four sequential program were divided into 4 groups: sIPV+sIPV+bOPV, sIPV+wIPV+bOPV, wIPV+sIPV+bOPV and wIPV+wIPV+bOPV. A total of 230 investigators' blood samples were collected before primary immunization and 163 investigators' blood samples were collected after primary immunization. A total of 151 investigators (36, 44, 30 and 41 in each group) finished primary immunization and blood sampling before and after the primary immunization. The geometric mean titer (GMT) of poliovirus typesⅠ and Ⅲ neutralizing antibody was tested and calculated, and the positive results of antibody before and after primary immunization were analyzed. Results: Among the 151 investigators, the age were (2.27±0.61) months and birth weight were (3.27±0.43) kg, and 70 were male. The positive rates of typeⅠwas 98.68% (149 cases), and type Ⅲ was 97.35% (147 cases); the number of investigators tested in each group was 36, 44, 30 and 41, respectively; the positive rates of typeⅠwas 97.22% (35 cases), 100.00% (44 cases), 96.67% (29 cases) and 100.00% (41 cases) (P=0.345); the positive rates of type Ⅲ were 97.22% (35 cases), 95.45% (42 cases), 96.67% (29 cases) and 100.00% (41 cases) (P=0.614). Conclusion: Using sIPV and wIPV simultaneously or alternately for sequential immunization of poliomyelitis vaccines showed good immunogenicity for infants at appropriate age.

Immunogenicity analysis of sequential inoculation of different strains of poliomyelitis vaccines in Shanghai / 中华预防医学杂志

Objective@#To evaluate the immunogenicity of different strains of inactivated poliomyelitis vaccines (IPV) by sequential program.@*Methods@#This parallel-group controlled trial was conducted in immunization clinics in Shanghai from March 2016 to September 2017. Sabin strains inactivated poliomyelitis vaccines (sIPV), WPV strains inactivated poliomyelitis vaccines (wIPV) and live poliomyelitis Type Ⅰ Type Ⅲ vaccine (bOPV) as the investigational vaccine were used at 2, 3, 4 months old in 325 infants in Shanghai. Infants vaccinated by four sequential program were divided into 4 groups: sIPV+sIPV+bOPV, sIPV+wIPV+bOPV, wIPV+sIPV+bOPV and wIPV+wIPV+bOPV. A total of 230 investigators′ blood samples were collected before primary immunization and 163 investigators′ blood samples were collected after primary immunization. A total of 151 investigators (36, 44, 30 and 41 in each group) finished primary immunization and blood sampling before and after the primary immunization. The geometric mean titer (GMT) of poliovirus typesⅠ and Ⅲ neutralizing antibody was tested and calculated, and the positive results of antibody before and after primary immunization were analyzed.@*Results@#Among the 151 investigators, the age were (2.27±0.61) months and birth weight were (3.27±0.43) kg, and 70 were male. The positive rates of typeⅠwas 98.68% (149 cases), and type Ⅲ was 97.35% (147 cases); the number of investigators tested in each group was 36, 44, 30 and 41, respectively; the positive rates of typeⅠwas 97.22% (35 cases), 100.00% (44 cases), 96.67% (29 cases) and 100.00% (41 cases) (P=0.345); the positive rates of type Ⅲ were 97.22% (35 cases), 95.45% (42 cases), 96.67% (29 cases) and 100.00% (41 cases) (P=0.614).@*Conclusion@#Using sIPV and wIPV simultaneously or alternately for sequential immunization of poliomyelitis vaccines showed good immunogenicity for infants at appropriate age.

[Immunogenicity of inacitivated quadrivalent influenza vaccine in adults aged 18-64 years: A systematic review and Meta-analysis].

Objective: To evaluate the immunogenicity of inactivated quadrivalent influenza vaccine (QIV) in adults aged 18-64 years, through a Meta-analysis. Methods: Literature was retrieved by searching the Medline, Cochrane Library, Science Direct in the past decade. All the studies were under random control trial (RCT) and including data related to immunogenicity which involving sero-protection rate (SPR) and sero-conversion rate (SCR) of the QIV, versus inactivated trivalent influenza vaccine (TIV) in the population aged 18 to 64. Revman 5.3 software was employed to manipulate the pooled date of the included literature. Result: A total of 8 studies for the SPR and SCR of the shared strains (two A lineage and one B lineage) were included. There appeared no significant differences in the response rates between the two vaccines. As for QIV versus TIV (B/Yamagata), the pooled RR of the SPR for B/Victoria was 1.28 (95%CI: 1.08-1.51, P<0.05), with the pooled RR of the SCR for B/Victoria as 1.94 (95%CI: 1.50-2.50, P<0.05). For QIV versus TIV (B/Victoria), the pooled RR of the SPR for B/Yamagata as 1.10 (95%CI: 1.02-1.18, P<0.05), and the pooled RR of SCR for B/Yamagata as 1.99 (95%CI: 1.34-2.97, P<0.05). Conclusion: In the population aged 18-64 years, inactivated QIV was equivalently immunogenic against the shared three strains included in the activated TIV while a superior immunogenic effect was noticed in the vaccine strain which did not include the inactivated QIV.

Immunogenicity of inacitivated quadrivalent influenza vaccine in adults aged 18-64 years: A systematic review and Meta-analysis / 中华流行病学杂志

Objective To evaluate the immunogenicity of inactivated quadrivalent influenza vaccine (QIV) in adults aged 18-64 years,through a Meta-analysis.Methods Literature was retrieved by searching the Medline,Cochrane Library,Science Direct in the past decade.All the studies were under random control trial (RCT) and including data related to immunogenicity which involving sero-protection rate (SPR) and sero-conversion rate (SCR) of the QIV,versus inactivated trivalent influenza vaccine (TIV) in the population aged 18 to 64.Revman 5.3 software was employed to manipulate the pooled date of the included literature.Result A total of 8 studies for the SPR and SCR of the shared strains (two A lineage and one B lineage) were included.There appeared no significant differences in the response rates between the two vaccines.As for QIV versus TIV (B/Yamagata),the pooled RR of the SPR for B/Victoria was 1.28 (95％CI:1.08-1.51,P＜0.05),with the pooled RR of the SCR for B/Victoria as 1.94 (95％CI:1.50-2.50,P＜0.05).For QIV versus TIV (B/Victoria),the pooled RR of the SPR for B/Yamagata as 1.10 (95％CI:1.02-1.18,P＜0.05),and the pooled RR of SCR for B/Yamagata as 1.99 (95％CI:1.34-2.97,P＜0.05).Conclusion In the population aged 18-64 years,inactivated QIV was equivalently immunogenic against the shared three strains included in the activated TIV while a superior immunogenic effect was noticed in the vaccine strain which did not include the inactivated QIV.

Immunogenicity of inacitivated quadrivalent influenza vaccine in adults aged 18-64 years: A systematic review and Meta-analysis / 中华流行病学杂志

Objective To evaluate the immunogenicity of inactivated quadrivalent influenza vaccine (QIV) in adults aged 18-64 years,through a Meta-analysis.Methods Literature was retrieved by searching the Medline,Cochrane Library,Science Direct in the past decade.All the studies were under random control trial (RCT) and including data related to immunogenicity which involving sero-protection rate (SPR) and sero-conversion rate (SCR) of the QIV,versus inactivated trivalent influenza vaccine (TIV) in the population aged 18 to 64.Revman 5.3 software was employed to manipulate the pooled date of the included literature.Result A total of 8 studies for the SPR and SCR of the shared strains (two A lineage and one B lineage) were included.There appeared no significant differences in the response rates between the two vaccines.As for QIV versus TIV (B/Yamagata),the pooled RR of the SPR for B/Victoria was 1.28 (95％CI:1.08-1.51,P＜0.05),with the pooled RR of the SCR for B/Victoria as 1.94 (95％CI:1.50-2.50,P＜0.05).For QIV versus TIV (B/Victoria),the pooled RR of the SPR for B/Yamagata as 1.10 (95％CI:1.02-1.18,P＜0.05),and the pooled RR of SCR for B/Yamagata as 1.99 (95％CI:1.34-2.97,P＜0.05).Conclusion In the population aged 18-64 years,inactivated QIV was equivalently immunogenic against the shared three strains included in the activated TIV while a superior immunogenic effect was noticed in the vaccine strain which did not include the inactivated QIV.

Prevention of serious events in adults 65 years of age or older: A comparison between high-dose and standard-dose inactivated influenza vaccines.

BACKGROUND: A recent study showed that a high-dose inactivated influenza vaccine (IIV-HD) was 24.2% more efficacious than a standard-dose inactivated influenza vaccine (IIV-SD) in preventing laboratory-confirmed symptomatic influenza in adults ≥65 years. Here we evaluate the effectiveness of IIV-HD compared to IIV-SD in preventing serious illnesses considered potential sequelae or complications of influenza infection. METHODS: The original study was a double-blind, randomized, active-controlled, multicenter trial. Participants were adults ≥65 years randomized to receive IIV-HD or IIV-SD, and followed for 6-8 months post-vaccination for the occurrence of influenza and serious adverse events (SAEs). SAEs were events: leading to death or hospitalization (or its prolongation); considered life-threatening or medically important; or resulting in disability. For the present analysis, reported SAEs were classified as possibly related to influenza by three blinded physicians and rates per 1000 participant-seasons were calculated. Relative vaccine effectiveness (rVE) was estimated as (1-Rate Ratio)×100. RESULTS: 31,989 participants were enrolled, with 15,991 and 15,998 randomized to receive IIV-HD and IIV-SD, respectively. IIV-HD was significantly more effective than IIV-SD in preventing SAEs possibly related to influenza overall (rVE, 17.7%; 95% confidence interval [CI], 6.6-27.4%) and serious pneumonia (rVE, 39.8%; 95% CI, 19.3-55.1%). Borderline significance was observed for the efficacy of IIV-HD relative to IIV-SD for the prevention of all-cause hospitalizations (rVE, 6.9%; 95% CI, 0.5-12.8%). CONCLUSIONS: Compared to IIV-SD, IIV-HD reduced the risk of SAEs possibly related to influenza. The observed relative effectiveness against serious pneumonia is particularly noteworthy considering the burden of influenza and pneumonia in older adults.

Efficacy and immunogenicity of high-dose influenza vaccine in older adults by age, comorbidities, and frailty.

BACKGROUND: A randomized trial demonstrated that a high-dose inactivated influenza vaccine (IIV-HD) was 24.2% more efficacious than a standard-dose vaccine (IIV-SD) against laboratory-confirmed influenza illness in adults ≥65 years. To evaluate the consistency of IIV-HD benefits, supplemental analyses explored efficacy and immunogenicity by baseline characteristics of special interest. METHODS: Double-blind, randomized, active-controlled, multicenter trial. Adults ≥65 years were randomized 1:1 to receive IIV-HD or IIV-SD and followed for 6-8 months postvaccination for the occurrence of influenza. One third of participants were randomly selected to provide sera for measurement of hemagglutination inhibition antibody (HAI) titers. Efficacy (IIV-HD vs. IIV-SD) against laboratory-confirmed, protocol-defined influenza-like illness (PD-ILI) and HAI geometric mean titer (GMT) ratios (IIV-HD/IIV-SD) were evaluated by age, and number of high-risk comorbid and frailty conditions. RESULTS: Efficacy (95% confidence intervals) of IIV-HD relative to IIV-SD against laboratory-confirmed PD-ILI was 19.7% (0.4%; 35.4%) for participants 65-74 years, 32.4% (8.1%; 50.6%) for those ≥75 years, 22.1% (3.9%; 37.0%) for participants with ≥1 high-risk comorbidity, 23.6% (-3.2%; 43.6%) for those with ≥2 high-risk comorbidities, 27.5% (0.4%; 47.4%) for persons with 1 frailty condition, 23.9% (-9.0%; 47.2%) for those with 2 frailty conditions, and 16.0% (-16.3%; 39.4%) for those with ≥3 frailty conditions. There was no evidence of vaccine efficacy heterogeneity within age, comorbidity, and frailty strata (P-values 0.351, 0.875, and 0.838, respectively). HAI GMT ratios were significantly higher among IIV-HD recipients for all strains and across all subgroups. CONCLUSIONS: Estimates of relative efficacy consistently favored IIV-HD over IIV-SD. There was no significant evidence that baseline age, comorbidity, or frailty modified the efficacy of IIV-HD relative to IIV-SD. IIV-HD significantly improved HAI responses for all strains and in all subgroups. IIV-HD is likely to provide benefits beyond IIV-SD for adults ≥65 years, irrespective of age and presence of comorbid or frailty conditions.

Immunogenicity and safety of trivalent inactivated influenza vaccine: a randomized, double-blind, multi-center, phase 3 clinical trial in a vaccine-limited country.

Influenza vaccines are the primary method for controlling influenza and its complications. This study was conducted as a phase 3, randomized, double-blind, controlled, multi-center trial at seven university hospitals to evaluate the immunogenicity and safety of an inactivated, split, trivalent influenza vaccine (GC501, Green Cross Corporation, Yongin, Korea), which was newly manufactured in Korea in 2008. Between September 21 and 26, a total of 329 healthy subjects were recruited for the immunogenicity analysis, while 976 subjects were enrolled for the safety analysis. The GC501 vaccine met both FDA and EMEA criteria with ≥ 80% of subjects achieving post-vaccination titers ≥ 40 for all three subtypes, even in the elderly. The vaccine was well tolerated with only mild systemic and local adverse events. In summary, GC501 showed excellent immunogenicity and a good safety profile in both young adults and the elderly. The licensure of GC501 might be an important basis in preparation for the future influenza pandemic.

Immunogenicity and Safety of Trivalent Inactivated Influenza Vaccine: A Randomized, Double-Blind, Multi-Center, Phase 3 Clinical Trial in a Vaccine-Limited Country

Influenza vaccines are the primary method for controlling influenza and its complications. This study was conducted as a phase 3, randomized, double-blind, controlled, multi-center trial at seven university hospitals to evaluate the immunogenicity and safety of an inactivated, split, trivalent influenza vaccine (GC501, Green Cross Corporation, Yongin, Korea), which was newly manufactured in Korea in 2008. Between September 21 and 26, a total of 329 healthy subjects were recruited for the immunogenicity analysis, while 976 subjects were enrolled for the safety analysis. The GC501 vaccine met both FDA and EMEA criteria with > or = 80% of subjects achieving post-vaccination titers > or = 40 for all three subtypes, even in the elderly. The vaccine was well tolerated with only mild systemic and local adverse events. In summary, GC501 showed excellent immunogenicity and a good safety profile in both young adults and the elderly. The licensure of GC501 might be an important basis in preparation for the future influenza pandemic.

Effect of inactivated SARS coronavirus vaccine on mouse organs / 中国病理生理杂志

AIM: To study the pathological change in mouse organs immunitied by inactivated SARS-CoV vaccine. METHODS: Inactivated SARS-CoV vaccine was injected into BALB/c and C57BL/6 mice. Anti-SARS antibody was analyzed by ELISA. After 8 weeks, the immunitied mice were killed and those organs were analyzed by pathological methods. RESULTS: Anti-SARS antibody in mice was positive after 8 days. Only minimal injury was observed in a few lungs and livers, but the other organs were not. CONCLUSIONS: Inactivated SARS-CoV vaccine induced mice to create antibody, whereas they did not cause severe injury. This result will be valuable for vaccine into clinical research. [