The eradication of poliomyelitis is a landmark achievement in the history of public health, providing strong protection for children's health. The introduction of the Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine is a prerequisite and safeguard for the large-scale production and use of domestically produced live poliovirus vaccines, serving as an indispensable component of vaccine safety. This article, based on archival documents, letters, collections of essays, and oral interviews, examines the historical experience of the development of Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine. It contends that the emphasis on localization and the active engagement in international cooperation are critical factors in the swift introduction of Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine.
Child ; Humans ; Poliovirus Vaccine, Inactivated ; Poliomyelitis/epidemiology* ; Disease Outbreaks ; China

Objective: To compare the immunogenicity of three kinds immunization programs with poliovirus vaccine. Methods: Healthy infants aged 2 months or over were selected and divided into three groups by complete randomization method. Basic immunization with Sabin inactivated poliovirus vaccine(sIPV) and bivalent oral poliovirus vaccine(bOPV) were completed. Three kinds of basic immunization procedures were 1sIPV+2bOPV,2sIPV+1bOPV and 3sIPV, respectively.Two qualified serums that before basic immunization and 28-42 days later were collected, and measured the poliovirus neutralizing antibody with microcell neutralization method. To compare the difference by analysis of variance, rank test and χ² test. Results: After the basic immunization, 205 subjects of the positive conversion rate of poliovirus neutralizing antibodies of types Ⅰ, Ⅱ and Ⅲwere all higher than 97.00%, and the positive rates were all higher than 98.00%, the geometric mean titer (GMT) of neutralizing antibody was significantly higher than that before basic immunization in three groups.There were significant differences in the positive rate and GMT before and after basic immunization of typeⅠ, Ⅱand Ⅲ in the three (P<0.05). The highest GMT in three groups after basic immunization were all typeⅠ, followed by type Ⅲ, and the lowest in type Ⅱ. The GMT of type Ⅱin 2sIPV+1bOPV and 3sIPV groups were both higher than that in sIPV+2bOPV group. Conclution: After three kinds of basic immunization, the poliovirus neutralizing antibodies of serum were all at high levels in three groups, which could form an effective immune barrier against poliovirus. The immunogenicity of three kinds of basic immunization programs were all well, but there were certain differences of neutralizing antibodies among three kinds basic immunization programs. The immunogenicity in 2sIPV+1bOPV and 3sIPV groups against typeⅡpoliovirus were better than that in 1sIPV+2bOPV group.
Antibodies, Neutralizing ; Antibodies, Viral ; Humans ; Immunization Schedule ; Infant ; Poliovirus ; Poliovirus Vaccine, Inactivated ; Poliovirus Vaccine, Oral

History, 20th Century ; Humans ; Philately ; Poliomyelitis ; history ; prevention & control ; Poliovirus Vaccine, Inactivated ; history ; United States

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

OBJECTIVETo evaluate the immunogenicity and safety of a boost dose of inactivated polio vaccine (IPV) among children aged 18 months who had been administered with primary doses of IPV.

METHODSForm 2011 to 2012, a total of 97 children were enrolled in the present study who were vaccinated with IPV at 2, 3, 4 months of age and boosted with the same vaccine at 18 months of age. Anti-poliovirus neutralizing antibody titers in serum were measured before and after booster vaccination, geometric mean titers (GMT) and seroprotection rate were calculated. Adverse events occurring within 30 days after booster vaccination were observed, including pain, redness/swelling and induration at the injection site, fever, vomit, abnormal crying, drowsiness, loss of appetite, irritability, and all other physical discomfort and related medications were also recorded. A descriptive analysis was performed for the safety assessment.

RESULTSImmunogenicity was assessed in 84 subjects. The pre-booster seropositivity rates of neutralizing antibody against poliovirus type 1, 2, 3 before booster were all 100% (84/84) and the corresponding GMT (95% CI) was 1: 148.5 (116.49-189.29) , 1: 237.68 (178.39-316.67) and 1: 231.87 (181.27-296.58) , respectively. The seropositivity rates of neutralizing antibody against the three types of poliovirus after booster were all 100% (84/84) and the corresponding GMT (95% CI) was 1: 1612.14 (1470.57-1767.34) , 1: 1854.92 (1715.83-2005.29) and 1: 1625.50 (1452.12-1819.58) , respectively. The pre-booster titer of neutralizing antibody against poliovirus type 1, 2, 3 mainly ranged 1: 128-1: 512, which accounted for 65% (55/84) , 55% (46/84) , 74% (62/84) in each type. After the booster immunization, titers of neutralizing antibody against type 1, 2, 3 were increased as subjects with titer ≥ 1: 1024 accounted for 94% (78/84) , 95% (80/84) , 92% (77/84) , respectively.Safety was evaluated in 96 subjects, of which 16 subjects reported adverse events with the rate of 17%. The observed local events were mainly tenderness 3% (3/96) , redness/swelling and induration were not reported. The systemic adverse events included loss of appetite (8%, 8/96) , irritability (8%, 8/96) , fever (7%, 7/96) , abnormal crying (6%, 6/96) , drowsiness (6%, 6/96) and vomit (1%, 1/96) . All reported adverse events were mild or moderate. All of the local events occurred in the day of vaccination and lasted for 1-2 days, while systemic events almost developed within 2 days after vaccination and last less than 3 days.

CONCLUSIONIPV booster dose has good immunogenicity and safety profile, which provides effective protection against poliovirus.

Antibodies, Neutralizing ; blood ; Antibodies, Viral ; blood ; China ; Female ; Humans ; Immunization, Secondary ; adverse effects ; Infant ; Male ; Poliomyelitis ; prevention & control ; Poliovirus Vaccine, Inactivated ; adverse effects ; immunology ; therapeutic use

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 study the immunological effectiveness of inactivated poliomyelitis vaccine (IPV) for children's primary vaccination in China and to compare with the oral poliomyelitis vaccine (OPV) used in routine vaccination.

METHODSThe 2-month-old children were randomly immunized with IPV and OPV, with 208 subjects in each group. The pre- and post-vaccination blood samples were collected. Micro-neutralization method was used to measure the antibody response against 3 types of polioviruses. chi2 test was used to evaluate the statistical difference of protection rates between two groups, while the antibody titers were transformed by logarithm and analyzed by Z-test. P < 0.05 was always used to define the significance of analysis.

RESULTSAfter 3 doses of immunization, the protection rates in IPV group reached to 100.0% (186/186), 97.3% (181/186), 98.9% (184/186) for poliovirus type 1, 2, 3, respectively, and in OPV group were 97.4% (188/193), 100.0% (193/193), 95.3% (184/193), respectively. The geometry mean titers (GMTs) were 151.2, 86.7, 211.3 for IPV group; and 1089.5, 538.2, 203.7 for OPV group. IPV showed comparable protection rates with OPV for type 1 and 2 (chi2(I) = 2.991, P = 0.084; chi2(II) = 3.512, P = 0.061), while type 3 was higher than OPV (chi2(III) = 4.143, P = 0.042). The GMT of type 1 and 2 in IPV group were lower than OPV group (Z(I) = 12.537, P = 0.000; Z(II) = 13.415, P = 0.000), while the GMT of type 3 were comparable in two groups (Z(III) = 0.067, P = 0.947).

CONCLUSIONIPV showed roughly comparable immunological effectiveness in young children. The protection rates for type 1 and 2 were similar to OPV, while type 3 was higher than in OPV group; In terms of GMT,type 1 and 2 in IPV group were lower than OPV, but type 3 were comparable to OPV group.

Antibodies, Viral ; blood ; Humans ; Infant ; Poliomyelitis ; prevention & control ; Poliovirus Vaccine, Inactivated ; immunology ; Poliovirus Vaccine, Oral ; immunology

OBJECTIVETo investigate the effect of 2-phenoxyethanol on potency of Sabin inactivated poliomyelitis vaccine (IPV).

METHODSSabin IPV samples containing 5 mg or 7 mg 2-phenoxyethanol each dosage respectively were placed separately at 4 degrees C, 37 degrees C for 2 days and 7 days. D-antigen contents were tested with ELISA method. Then neutralizing antibodies in mice and guinea pigs were detected. The safety experiment was performed according to unusual toxicity test of China requirement for biological product.

RESULTSAfter addition of 2-phenoxyethanol, the I, II, and III D-antigen contents of Sabin IPV did not change. The antibody levels in mice and guinea pigs were not different between experimental group and control group. Animals were safe during observation period.

CONCLUSION2-Phenoxyethanol had no effect on potency and safety of Sabin IPV. It can be used as antiseptic for Sabin IPV.

Animals ; Anti-Infective Agents, Local ; administration & dosage ; pharmacology ; toxicity ; Antigens, Viral ; analysis ; immunology ; Body Weight ; drug effects ; Cercopithecus aethiops ; Drug Stability ; Enzyme-Linked Immunosorbent Assay ; Ethylene Glycols ; administration & dosage ; pharmacology ; toxicity ; Guinea Pigs ; Mice ; Neutralization Tests ; Poliovirus Vaccine, Inactivated ; administration & dosage ; immunology ; toxicity ; Vero Cells

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

OBJECTIVETo analyze the event and cause of vaccine derived polio virus (VDPV) circle happened at Yaoshang Village, Wanlan Township, Zhenfeng County, Qianxinan Prefecture, Guizhou Province in August 2004.

METHODSVirus isolation was performed for stool specimens collected from two children cases with acute flaccid paralysis (AFP) reported at Yaoshang Village and 21 normal children under five years old in the same village. And, routine immunization coverage at the Village and AFP incidence and performance of AFP surveillance system in Zhenfeng County were investigated, as well.

RESULTSVaccine derived polio virus 1 (VDPV1) was identified in the feces of two affected children at Yaoshang Village and three other normal children at the same village. Totally, seven cases of AFP have been underreported in Zhenfeng County since 2002. Routine immunization coverage was rather low at Wanlan Township, and nearly nil at Yaoshang Village.

CONCLUSIONSOral polio vaccine (OPV) with attenuated live virus has been used in China for many years to prevent polio. Circulation of VDPV in Zhenfeng County issues a new challenge to eradication of polio. It is necessary to strengthen routine immunization and AFP surveillance to prevent occurrence of VDPV event.

Child, Preschool ; China ; epidemiology ; Feces ; virology ; Humans ; Incidence ; Infant ; Male ; Poliomyelitis ; epidemiology ; transmission ; virology ; Poliovirus ; immunology ; isolation & purification ; Poliovirus Vaccine, Inactivated ; adverse effects ; Poliovirus Vaccine, Oral ; adverse effects