OBJECTIVETo evaluate immunogenicity after primary vaccination by different sequential program of inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV).

METHODSChildren of 2 months old (60-89 days) selected in Beijing were assigned to 4 groups, 1 dose IPV plus 2 doses OPV (I-O-O, 122 children), 2 doses IPV plus 1 dose OPV(I-I-O, 103 children), 3 doses IPV (I-I-I, 114 children), and 3 doses OPV (O-O-O, 106 children), and were vaccinated at the age of 2, 3, 4 months. Polio neutralizing antibody titers against poliovirus types 1, 2, and 3 were tested and protective rates were calculated before the 1st dose, after the last dose, and after the 1st and 2nd dose of IPV.

RESULTSAfter the primary immunization, geometric mean titers (GMT) of polio neutralizing antibody titers against poliovirus types 1, 2, and 3 were 788.32, 738.42 and 631.17 in O-O-O group, 212.02, 262.30 and 537.52 in I-I-I group, 940.35, 929.72 and 940.35 in I-O-O group and 901.09, 1102.68 and 1110.12 in I-I-O group (F values were 47.71, 53.84, and 9.81 respectively, all P values<0.01). The protective rate of three types among each group was 98.1% (104/106)-100.0% and the difference was not statistically significant (P>0.05). After the 1(st) dose of IPV, the GMT were 18.88, 37.77, 24.64 and the protective rate was 82.6% (122/138)-96.4% (133/138); after the 2nd dose of IPV, GMT were 177.03, 168.25, 321.86 and the protective rate was 99.1% (108/109)-100.0% (109/109) in antibody types 1, 2 and 3, respectively.

CONCLUSIONGMT of polio neutralizing antibody titers against poliovirus is higher after vaccination by sequential program of IPV and OPV than that by IPV or OPV 3-doses program. High level of protective rate after 2 doses of IPV in I-I-O group may lead to better protection from vaccine associated paralytic poliomyelitis (VAPP). Sequential program of IPV and OPV can be used to maintain high level of herd immunity and to prevent VAPP, and the I-I-O sequential program should be the first choice.

Humans ; Immunization Schedule ; Infant ; Poliovirus Vaccine, Inactivated ; administration & dosage ; immunology ; Poliovirus Vaccine, Oral ; administration & dosage ; immunology ; Vaccines, Attenuated ; immunology

OBJECTIVETo evaluate safety of different sequential immunization schedules of inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV) primary vaccination.

METHODSInfants of 2 months old (60-89 days) selected in Beijing, were assigned to four groups, 1 dose IPV plus 2 doses OPV (I-O-O), 2 doses IPV plus 1 dose OPV(I-I-O), 3 doses IPV (I-I-I), and 3 doses OPV (O-O-O), and were vaccinated at the age of 2, 3, 4 months, from 2009 to 2011. The frequencies of systemic as well as local injection site reactions after every dose were recorded and calculated. A total of 553 infants were enrolled in the study and 89 infants were quit, 1492 diseases were observed.

RESULTSThe incidence of adverse events in I-O-O, I-I-O, I-I-I, O-O-O were 22.9% (94/410), 18.4% (60/327), 22.0% (78/354) and 17.7% (71/401) with no statistical differences (χ(2) = 4.84, P = 0.184). Dose 1 (22.7% (32/141)-35.3% (54/153) ) was more frequently than dose 2 and dose 3. No serious adverse events (SAE) were reported during the study. The incidence of systemic adverse reactions in I-O-O, I-I-O, I-I-I, O-O-O were 21.5% (88/410), 17.7% (58/327) , 20.1% (71/354) and 17.7% (71/401) with no statistical differences (χ(2) = 2.53, P = 0.472). Abnormal crying were the most frequency reactions (7.2% (29/401)-11.3% (37/327) ) in 4 groups. Rarely severe reactions were observed of abnormal crying, somnolence, irritability and mild or medium reactions occurred in other symptoms. Local adverse reactions such as injection site pain, scleroma and swelling were reported by 2.2% (5/229)-5.6% (22/393) ,0-0.9% (2/229) and 0-1.0% (4/393) in I-O-O,I-I-O and I-I-I, and most reactions were mild.

CONCLUSIONThree IPV immunization and IPV/OPV sequential immunization as well as three OPV immunization demonstrated safe.

Humans ; Immunization Schedule ; Infant ; Poliovirus Vaccine, Inactivated ; administration & dosage ; adverse effects ; Vaccines, Attenuated ; administration & dosage ; adverse effects

OBJECTIVEIn order to search the preparation process and optimazing dosage ratio of adsorbed diphtheria-tetanus-acellular pertussis and sabin inactivated poliovirus combined vaccine (DTaP-sIPV), the neutralizing antibody titers of IPV induced by different concentration of DTaP-sIPV were investigated on rats.

METHODSTwo batches of DTaP-sLPV were produced using different concentration of sIPV and the quality control was carried. Together with sabin-IPV and DTaP-wIPV ( boostrix-polio, GSK, Belgium) as control group, the DTaP-sIPV were administrated on three-dose schedule at 0, 1, 2 month on rats. Serum sample were collected 30 days after each dose and neutralizing antibody titers against three types poliovirus were determined using micro-neutralization test.

RESULTSTwo batches of prepared DTaP-sIPV and control sLPV were according to the requirement of Chinese Pharmacopoeia (Volume III, 2005 edition) and showed good stability. The seropositivity rates were 100% for sabin inactivated poliovirus antigen in all groups. The GMTs (Geometric mean titers) of neutralizing antibodies against three types poliovirus increased.

CONCLUSIONThe prepared DTaP-sIPV was safe, stable and effective and could induced high level neutralizing antibody against poliovirus on rats.

Animals ; Antibodies, Viral ; immunology ; Diphtheria-Tetanus-acellular Pertussis Vaccines ; immunology ; Female ; Male ; Poliovirus Vaccine, Inactivated ; immunology ; Rats ; Rats, Wistar ; Vaccines, Combined ; immunology

Objectives: The World Health Organization recently revised their recommendations and considered healthy children and adolescents as low priority group for COVID-19 vaccine. This review comprehensively assessed existing clinical evidence on COVID-19 vaccine in 12-17 years old. Methods: Included in this review were any type of study that investigated the efficacy, immunogenicity, safety, and effectiveness of COVID-19 vaccine on protection against SARS-COV-2 infection in 12-17 years old. Various electronic databases were searched up to March 15, 2023. Studies were screened, data extracted, risk of bias appraised, and certainty of evidence was judged using GRADE. Review Manager 5.4 was used to estimate pooled effects. Difference between the two groups was described as mean difference for continuous variables and as relative risk or odds ratio for categorical variables. Results: There were six randomized controlled trials and 16 effectiveness studies (8 cohorts and 8 case control). Low certainty evidence showed that BNT162b2 (Pfizer) was effective, immunogenic, and safe in healthy adolescents. There were 15 effectiveness studies on BNT162b2 (Pfizer) in healthy adolescent and one on immunocompromised patients. It was protective against infection with any of the variants, with higher protection against Delta than Omicron. BNT162b2 is protective against hospitalization and emergency and urgent care (high certainty); and critical care and MIS-C (low). Very low certainty evidence noted that BNT 162b2 was also immunogenic in 12-21 years old with rheumatic diseases while on immunomodulatory treatment but with possible increased exacerbation of illness. Low certainty evidence demonstrated that mRNA-1273 (Moderna) was effective, immunogenic, and safe. Low to very low certainty evidence were noted on the safety and immunogenicity of two vector base vaccines (ChAdOx1-19 and Ad5 vector COVID vaccine) and two inactivated vaccines (CoronaVac and BBIBP CorV). Conclusion There is presently low certainty evidence on the use of RNA vaccines in 12-17 years old. The recommendation on its use is weak. There is presently insufficient evidence for the use of inactivated and vector-based COVID-19 vaccines. Different countries should consider whether to vaccinate healthy adolescent without comprising the other recommended immunization and health priorities that are crucial for this age group. Other factors including cost-effectiveness of vaccination and disease burden should be accounted.
mRNA Vaccines ; Vaccines, Inactivated

INTRODUCTIONChildren in Singapore receive vaccination against hepatitis B virus (HBV) at 0, 1 and 5 or 6 months of age, and vaccination against pertussis, diphtheria, tetanus, and polio at 3, 4 and 5 months of age. Parents often choose to vaccinate with the combined acellular-pertussis-inactivated polio-Hib vaccine (DTPa-IPV/Hib). We investigated whether a combined hexavalent vaccine, DTPa-HBV-IPV/Hib, could replace the separate administration of DTPa-IPV/Hib and HBV for the final vaccination at 5 months of age (Trial DTPa-HBV-IPV-075).

MATERIALS AND METHODSIn an open study, 150 children were randomised to complete their vaccination schedule with DTPa-IPV/Hib + HBV or DTPa-HBV-IPV/Hib.

RESULTSOne month after the final vaccination, there was no difference between groups in seroprotection rates or antibody concentrations against HBV. Seroprotection rates against diphtheria, tetanus, Hib and polio, as well as vaccine response rates to pertussis antigens were also similar between groups. Local and general symptoms occurred at a similar rate after the third dose of either vaccine.

CONCLUSIONThe immunogenicity and reactogenicity of the hexavalent vaccine DTPa-HBV-IPV/Hib (Infanrix hexa, GSK) group is comparable to that of separately administered DTPa-IPV/Hib and HBV vaccines. Combined hexavalent vaccine, DTPa-HBV-IPV/Hib, could replace the separate administration of DTPa-IPV/Hib and HBV for vaccination at 5 months of age, thereby reducing the number of injections required.

Diphtheria ; immunology ; Diphtheria-Tetanus-Pertussis Vaccine ; Female ; Haemophilus Vaccines ; Haemophilus influenzae ; immunology ; Hepatitis B ; prevention & control ; Hepatitis B Antibodies ; blood ; Hepatitis B Vaccines ; administration & dosage ; Humans ; Immunization Schedule ; Infant ; Infant, Newborn ; Male ; Poliovirus Vaccine, Inactivated ; Singapore ; Tetanus ; immunology ; Vaccination ; Vaccines, Combined ; administration & dosage ; Vaccines, Inactivated

The application of the cholera vaccine is one of the cholera prevention and control strategies. Cholera vaccines stimulate mucosal immune to play the role of antibacteria and antitoxin. When the cholera toxin B subunit is added in the cholera vaccine, it could also defend against some diarrhea associated pathogens by cross-protection. Oral inactivated cholera vaccines are commercially available now. The oral live vaccine candidates are under development. The development of cholera vaccine is not only on the technical aspect, based on the situations of epidemic areas and population, cost, storage and transportation condition should also be considered. Though the argument on the use of cholera vaccine in epidemic areas and population in high risk existed previously, its vaccination has reached agreement now based on the clinical trials and evaluations during epidemic period.
Administration, Oral ; Cholera ; Cholera Toxin ; Cholera Vaccines ; Cross Protection ; Diarrhea ; Humans ; Vaccination ; Vaccines, Attenuated ; Vaccines, Inactivated

Japanese encephalitis (JE) virus is the leading cause of vaccine-preventable encephalitis in Asia and the Western Pacific, which mainly invades central nervous system. Vaccination is the most important strategy to prevent JE. Currently, both live attenuated Japanese encephalitis vaccines (JE-L) and inactivated vaccines (JE-I) are in use. Due to the supply of vaccines and the personal choice of recipients, there will be a demand for interchangeable immunization of these two vaccines. However, relevant research is limited. By reviewing domestic and foreign research evidence, this article summarizes the current situation of the interchangeable use of JE-L and JE-I, and makes recommendations when the interchangeable immunization is in urgent need, so as to provide reference for practical vaccination and policymaking in China.
Encephalitis Virus, Japanese ; Encephalitis, Japanese/prevention & control* ; Humans ; Immunization ; Japanese Encephalitis Vaccines ; Vaccination ; Vaccines, Inactivated

Humans ; Vaccines, Inactivated ; COVID-19/prevention & control* ; Vaccination ; Viral Vaccines ; Immunity ; Antibodies, Viral

EV71 infection has become a serious public health threat especially among young children. Yet, at present, no specific antiviral drug against EV71 infection is available. A number of scientists are studying various kinds of vaccines, including inactivated vaccine, virus-like particle vaccine, DNA vaccine, synthetic peptide vaccines, and transgenic oral vaccine. This article reviews the recent advancement in the design of various kinds of vaccine against EV71 as well as their prospective usefulness, effectiveness, weakness and developments in the foreground.
Enterovirus A, Human ; immunology ; Hand, Foot and Mouth Disease ; immunology ; prevention & control ; Humans ; Vaccines, Attenuated ; immunology ; Vaccines, DNA ; immunology ; Vaccines, Inactivated ; immunology ; Vaccines, Synthetic ; immunology ; Viral Vaccines ; immunology

OBJECTIVETo investigate the effect of temperature on the stability of intermediate and final products of inactivated enterovirus 71 vaccine, which was prepared in human diploid cells.

METHODSThe different batches of harvest viral cultures, the vaccine stock solutions and the final productions of inactivated enterovirus 71 vaccine were stored at different temperatures. The samples of viral culture stored at -20°C or 4°C were harvested at 0, 6, 12 and 24 months later. The samples of vaccine stock solutions stored at -20°C were harvested at 0, 6, 12 and 24 months later, and that stored at 4°C were harvested at 0, 1, 3, 6 and 12 months later. The samples of finial products were harvested at different time points (0, 6, 12 and 24 months for storing at 4°C; 0, 7, 14, 28, 42 and 60 d for storing at 25°C; 0, 3, 7, 14 and 21 d for storing at 37°C). The viral titer, antigen content, antigen purity, endotoxin content, effectiveness, pH and appearance of samples were determined, respectively. A total of 1 800 BLAB/c mice were immunized by vaccine and 150 control mice were injected by diluents without antigen via intraperitoneal. The tail vein blood (500 µl per mouse) from 1 950 mice were harvested after 4 weeks post injected. The neutralization antibody titers of the serum were tested to calculate the half effective dose (ED50) of final products. All results were analyzed using analysis of variance to compare the differences of the above indexes.

RESULTSThe viral titers of harvest viral culture of inactivated EV71 vaccine were (6.67 ± 0.13), (6.56 ± 0.09), (6.52 ± 0.04), (6.39 ± 0.16) lgCCID50/ml (CCID50, the half cell culture infective dose) after 0, 6, 12 and 24 months storage at -20°C; and (6.67 ± 0.13), (6.41 ± 0.13), (6.19 ± 0.18), (5.97 ± 0.09) lgCCID50/ml at 4°C. The viral titers reduced with time (F = 9.81 or 44.16, P < 0.05). The antigen contents of the vaccine stock solution were maintained at (3 626.67 ± 1 382.56) EU/ml within 3 months at 4°C, but were (2 080.00 ± 876.36), (951.17 ± 346.35) EU/ml at 6 and 12 months, respectively. The ED50 of the final production were (31.00 ± 2.71), (32.93 ± 3.22), (39.37 ± 3.44) and (46.04 ± 3.25) EU/ml after 0, 6, 12 and 24 months storage at 4 °C, but were (31.00 ± 2.71), (32.23 ± 2.66), (34.70 ± 1.77), (40.04 ± 2.10), (47.78 ± 1.93) and (56.97 ± 0.50) EU/ml at 0, 7, 14, 28, 42 and 60 days at 25°C, and were (31.00 ± 0.00), (36.20 ± 0.00), (41.87 ± 0.50), (53.25 ± 0.50) and (64.84 ± 0.58) EU/ml at 0, 3, 7, 14 and 21 days at 37°C, respectively. The ED50 had increased with the time by and had significantly differences compared with the beginning level (F = 28.49, 215.15 or 156.12, P < 0.05).

CONCLUSIONThere is a good stability of the intermediate and final productions of inactivated enterovirus 71 (EV71) vaccines, within 24 months at -20°C or 6 months at 4°C storage for viral culture, 24 months at -20°C or 3 months at 4°C storage for stock solution and 24 months at 4°C or 28 d at 25°C or 7 d at 37°C storage for finial vaccine.

Animals ; Drug Storage ; methods ; Enterovirus A, Human ; Humans ; Immunization ; Mice ; Vaccination ; Vaccine Potency ; Vaccines, Inactivated