AIM: To establish the safety and efficacy of an indigenously developed r-hepatitis B vaccine using an accelerated schedule and to highlight the social awareness and commitment in preventing the spreading of hepatitis ...AIM: To establish the safety and efficacy of an indigenously developed r-hepatitis B vaccine using an accelerated schedule and to highlight the social awareness and commitment in preventing the spreading of hepatitis B virus infection. METHODS: The study was a multicentric, double blind, randomized (3:1) study using three doses of vaccine immunization schedule (20μg for those above 10 years old and 10 μg for those below 10 years old) on d 0, 30 and 60. One hundred and sixty-six subjects were enrolled (87 males and 76 females aged 5-35 years). The main outcome measure was assessment of immunogenicity and safety. RESULTS: A 100% seroconversion response was observed on the 30th d after the 1st injection in both the experimental groups. The sero-protection data reported a 41.2-65.6% response on the 30th d after the 1st injection and reached 100% on the 60th d. Descriptive statistical analysis showed a geometric mean titer value of 13.77 mIU/mL in the test (BEVAC) group and 10.95 mlU/mL in the commercial control (ENGERIX-B) group on the 30th d after the 1st injection. The response on the 60th d showed a geometric mean titre value (GMT) of 519.84 mlU/mL in the BEVAC group and 475.46 mlU/mL in the ENGERIX-B group. On the 90th d, the antibody titer response was observed to be 2627.58 mlU/mL in the BEVAC group and 2272.72 mlU/mL in the ENGERIX-B group. Two subjects in each group experienced pains at injection site after the first vaccination. A total of six subjects in both groups experienced a solicited adverse reaction, which included pains, swelling and redness at the injection site, three subjects in the group-B had a pain at the injection site after the third dose. No other serious adverse events occurred and no dose-related local or general symptoms were observed during the study. CONCLUSION: The vaccine is safe, efficacious and immunogenic in comparison with the well documented ENGERIX-B.展开更多
Background:Data on the immunogenicity and safety of heterologous immunization schedules are inconsistent.This study aimed to evaluate the immunogenicity and safety of homologous and heterologous immunization schedules...Background:Data on the immunogenicity and safety of heterologous immunization schedules are inconsistent.This study aimed to evaluate the immunogenicity and safety of homologous and heterologous immunization schedules.Methods:Multiple databases with relevant studies were searched with an end date of October 31,2021,and a website including a series of Coronavirus disease 2019 studies was examined for studies before March 31,2022.Randomized controlled trials(RCTs)that compared different heterologous and homologous regimens among adults that reported immunogenicity and safety outcomes were reviewed.Primary outcomes included neutralizing antibodies against the original strain and serious adverse events(SAEs).A network meta-analysis(NMA)was conducted using a random-effects model.Results:In all,11 RCTs were included in the systematic review,and nine were ultimately included in the NMA.Among participants who received two doses of CoronaVac,another dose of mRNA or a non-replicating viral vector vaccine resulted in a significantly higher level of neutralizing antibody than a third CoronaVac 600 sino unit(SU);a dose of BNT162b2 induced the highest geometric mean ratio(GMR)of 15.24,95%confidence interval[CI]:9.53–24.39.Following one dose of BNT162b2 vaccination,a dose of mRNA-1273 generated a significantly higher level of neutralizing antibody than BNT162b2 alone(GMR=1.32;95%CI:1.06–1.64),NVX-CoV2373(GMR=1.60;95%CI:1.16–2.21),or ChAdOx1(GMR=1.80;95%CI:1.25–2.59).Following one dose of ChAdOx1,a dose of mRNA-1273 was also more effective for improving antibody levels than ChAdOx1(GMR=11.09;95%CI:8.36–14.71)or NVX-CoV2373(GMR=2.87;95%CI:1.08–3.91).No significant difference in the risk for SAEs was found in any comparisons.Conclusions:Relative to vaccination with two doses of CoronaVac,a dose of BNT162b2 as a booster substantially enhances immunogenicity reactions and has a relatively acceptable risk for SAEs relative to other vaccines.For primary vaccination,schedules including mRNA vaccines induce a greater immune 展开更多
The purpose of this study was to identify vaccination patterns of both general pediatricians and subspecialists with regards to their own children and projected progeny. A 14 question survey was sent randomly to 1000 ...The purpose of this study was to identify vaccination patterns of both general pediatricians and subspecialists with regards to their own children and projected progeny. A 14 question survey was sent randomly to 1000 members of the Academy of Pediatrics in 2009. Two categories of questions included 1) how physicians with children vaccinated them in the past, and 2) how all respondents would vaccinate a child in 2009. A comparison was made between the answers of general and specialty pediatricians. 582 valid questionnaires were received (58.2% response rate) of which 431 were general pediatricians and 151 subspecialists. No statistical difference was found between general and specialty pediatricians on how they vaccinated their children up until 2009 (95% vs 93%). When asked about vaccinating a future child, a significant proportion of respondents would deviate from CDC guidelines, specialists more than general pediatricians (21% vs 9%). Generalists were more likely to give a future child Hepatitis A (OR: 3.6;95% CI 1.3 - 10.4), Rotavirus (OR: 2.2;95% CI 1.1 - 4.4), Meningococcal (OR: 9.9;95% CI 3.3-29.9), and influenza (OR: 5.4;95% CI 1.1 - 26.7) vaccines. Specialists were more likely to postpone MMR vaccinetion (OR: 4.4 95% CI 2.3 - 8.6). Safety was listed by both groups as the most common reason for altering the recommended immunization schedule. Until 2009, general pediatricians and pediatric specialists have largely adhered to ACIP recommendations, but due to vaccine safety and other concerns, both groups, albeit a higher percentage of specialists, reported greater numbers willing to diverge from these recommendations.展开更多
基金Supported by the Biological E Limited, Hyderabad, India
文摘AIM: To establish the safety and efficacy of an indigenously developed r-hepatitis B vaccine using an accelerated schedule and to highlight the social awareness and commitment in preventing the spreading of hepatitis B virus infection. METHODS: The study was a multicentric, double blind, randomized (3:1) study using three doses of vaccine immunization schedule (20μg for those above 10 years old and 10 μg for those below 10 years old) on d 0, 30 and 60. One hundred and sixty-six subjects were enrolled (87 males and 76 females aged 5-35 years). The main outcome measure was assessment of immunogenicity and safety. RESULTS: A 100% seroconversion response was observed on the 30th d after the 1st injection in both the experimental groups. The sero-protection data reported a 41.2-65.6% response on the 30th d after the 1st injection and reached 100% on the 60th d. Descriptive statistical analysis showed a geometric mean titer value of 13.77 mIU/mL in the test (BEVAC) group and 10.95 mlU/mL in the commercial control (ENGERIX-B) group on the 30th d after the 1st injection. The response on the 60th d showed a geometric mean titre value (GMT) of 519.84 mlU/mL in the BEVAC group and 475.46 mlU/mL in the ENGERIX-B group. On the 90th d, the antibody titer response was observed to be 2627.58 mlU/mL in the BEVAC group and 2272.72 mlU/mL in the ENGERIX-B group. Two subjects in each group experienced pains at injection site after the first vaccination. A total of six subjects in both groups experienced a solicited adverse reaction, which included pains, swelling and redness at the injection site, three subjects in the group-B had a pain at the injection site after the third dose. No other serious adverse events occurred and no dose-related local or general symptoms were observed during the study. CONCLUSION: The vaccine is safe, efficacious and immunogenic in comparison with the well documented ENGERIX-B.
基金National Key R&D Program of China(No.2021YFC2301601)
文摘Background:Data on the immunogenicity and safety of heterologous immunization schedules are inconsistent.This study aimed to evaluate the immunogenicity and safety of homologous and heterologous immunization schedules.Methods:Multiple databases with relevant studies were searched with an end date of October 31,2021,and a website including a series of Coronavirus disease 2019 studies was examined for studies before March 31,2022.Randomized controlled trials(RCTs)that compared different heterologous and homologous regimens among adults that reported immunogenicity and safety outcomes were reviewed.Primary outcomes included neutralizing antibodies against the original strain and serious adverse events(SAEs).A network meta-analysis(NMA)was conducted using a random-effects model.Results:In all,11 RCTs were included in the systematic review,and nine were ultimately included in the NMA.Among participants who received two doses of CoronaVac,another dose of mRNA or a non-replicating viral vector vaccine resulted in a significantly higher level of neutralizing antibody than a third CoronaVac 600 sino unit(SU);a dose of BNT162b2 induced the highest geometric mean ratio(GMR)of 15.24,95%confidence interval[CI]:9.53–24.39.Following one dose of BNT162b2 vaccination,a dose of mRNA-1273 generated a significantly higher level of neutralizing antibody than BNT162b2 alone(GMR=1.32;95%CI:1.06–1.64),NVX-CoV2373(GMR=1.60;95%CI:1.16–2.21),or ChAdOx1(GMR=1.80;95%CI:1.25–2.59).Following one dose of ChAdOx1,a dose of mRNA-1273 was also more effective for improving antibody levels than ChAdOx1(GMR=11.09;95%CI:8.36–14.71)or NVX-CoV2373(GMR=2.87;95%CI:1.08–3.91).No significant difference in the risk for SAEs was found in any comparisons.Conclusions:Relative to vaccination with two doses of CoronaVac,a dose of BNT162b2 as a booster substantially enhances immunogenicity reactions and has a relatively acceptable risk for SAEs relative to other vaccines.For primary vaccination,schedules including mRNA vaccines induce a greater immune
文摘The purpose of this study was to identify vaccination patterns of both general pediatricians and subspecialists with regards to their own children and projected progeny. A 14 question survey was sent randomly to 1000 members of the Academy of Pediatrics in 2009. Two categories of questions included 1) how physicians with children vaccinated them in the past, and 2) how all respondents would vaccinate a child in 2009. A comparison was made between the answers of general and specialty pediatricians. 582 valid questionnaires were received (58.2% response rate) of which 431 were general pediatricians and 151 subspecialists. No statistical difference was found between general and specialty pediatricians on how they vaccinated their children up until 2009 (95% vs 93%). When asked about vaccinating a future child, a significant proportion of respondents would deviate from CDC guidelines, specialists more than general pediatricians (21% vs 9%). Generalists were more likely to give a future child Hepatitis A (OR: 3.6;95% CI 1.3 - 10.4), Rotavirus (OR: 2.2;95% CI 1.1 - 4.4), Meningococcal (OR: 9.9;95% CI 3.3-29.9), and influenza (OR: 5.4;95% CI 1.1 - 26.7) vaccines. Specialists were more likely to postpone MMR vaccinetion (OR: 4.4 95% CI 2.3 - 8.6). Safety was listed by both groups as the most common reason for altering the recommended immunization schedule. Until 2009, general pediatricians and pediatric specialists have largely adhered to ACIP recommendations, but due to vaccine safety and other concerns, both groups, albeit a higher percentage of specialists, reported greater numbers willing to diverge from these recommendations.
