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Vaccine Sep 2023To inform response strategies, we examined type 1 humoral and intestinal immunity induced by 1) one fractional inactivated poliovirus vaccine (fIPV) dose given with... (Randomized Controlled Trial)
Randomized Controlled Trial
Poliovirus type 1 systemic humoral and intestinal mucosal immunity induced by monovalent oral poliovirus vaccine, fractional inactivated poliovirus vaccine, and bivalent oral poliovirus vaccine: A randomized controlled trial.
BACKGROUND
To inform response strategies, we examined type 1 humoral and intestinal immunity induced by 1) one fractional inactivated poliovirus vaccine (fIPV) dose given with monovalent oral poliovirus vaccine (mOPV1), and 2) mOPV1 versus bivalent OPV (bOPV).
METHODS
We conducted a randomized, controlled, open-label trial in Dhaka, Bangladesh. Healthy infants aged 5 weeks were block randomized to one of four arms: mOPV1 at age 6-10-14 weeks/fIPV at 6 weeks (A); mOPV1 at 6-10-14 weeks/fIPV at 10 weeks (B); mOPV1 at 6-10-14 weeks (C); and bOPV at 6-10-14 weeks (D). Immune response at 10 weeks and cumulative response at 14 weeks was assessed among the modified intention-to-treat population, defined as seroconversion from seronegative (<1:8 titers) to seropositive (≥1:8) or a four-fold titer rise among seropositive participants sustained to age 18 weeks. We examined virus shedding after two doses of mOPV1 with and without fIPV, and after the first mOPV1 or bOPV dose. The trial is registered at ClinicalTrials.gov (NCT03722004).
FINDINGS
During 18 December 2018 - 23 November 2019, 1,192 infants were enrolled (arms A:301; B:295; C:298; D:298). Immune responses at 14 weeks did not differ after two mOPV1 doses alone (94% [95% CI: 91-97%]) versus two mOPV1 doses with fIPV at 6 weeks (96% [93-98%]) or 10 weeks (96% [93-98%]). Participants who received mOPV1 and fIPV at 10 weeks had significantly lower shedding (p < 0·001) one- and two-weeks later compared with mOPV1 alone. Response to one mOPV1 dose was significantly higher than one bOPV dose (79% versus 67%; p < 0·001) and shedding two-weeks later was significantly higher after mOPV1 (76% versus 56%; p < 0·001) indicating improved vaccine replication. Ninety-nine adverse events were reported, 29 serious including two deaths; none were attributed to study vaccines.
INTERPRETATION
Given with the second mOPV1 dose, fIPV improved intestinal immunity but not humoral immunity. One mOPV1 dose induced higher humoral and intestinal immunity than bOPV.
FUNDING
U.S. Centers for Disease Control and Prevention.
Topics: Humans; Infant; Bangladesh; Immunity, Mucosal; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; United States; Poliomyelitis
PubMed: 37652822
DOI: 10.1016/j.vaccine.2023.08.055 -
Frontiers in Immunology 2022Considering that vaccination with the sIPV and DTaP overlap at the ages of 3 and 4 months in China, to reduce the burden of treatment on parents and increase vaccination... (Randomized Controlled Trial)
Randomized Controlled Trial
Immunogenicity and safety of concomitant administration of the chinese inactivated poliovirus vaccine with the diphtheria-tetanus-acellular pertussis (DTaP) vaccine in children: A multicenter, randomized, non-inferiority, controlled trial.
KEY POINT
Considering that vaccination with the sIPV and DTaP overlap at the ages of 3 and 4 months in China, to reduce the burden of treatment on parents and increase vaccination coverage rates, we designed a postmarket clinical study of co-administration.
BACKGROUND
The Sabin-strain-based inactivated poliovirus vaccine (sIPV) and the diphtheria-tetanus-acellular pertussis vaccine (DTaP) have been licensed in China for many years. To conduct a clinical study on the safety and immunogenicity of the sIPV when administered concomitantly with the DTaP.
METHODS
The study population was divided into three groups: group 1 was the sIPV+ DTaP concomitant administration group, group 2 was the sIPV inoculation group, and group 3 was the DTaP inoculation group. Blood samples were collected prevaccination and 30 days postvaccination, and serum antibody levels were detected.
RESULTS
This study showed that the seropositive and seroconversion rates of type 1, 2 and 3 poliovirus in group 1 were higher than those in group 2, with no statistically significant difference after vaccination (P>0.05). Groups 1 and 3 also showed similar responses for all vaccine antigens except anti-FHA (97.65 (94.09-99.36) vs. 100 (97.89-100)). The geometric mean titers (GMTs) for the DTaP and sIPV among the groups were comparable, and the non-inferiority t test result was P<0.001. The number of local adverse events (AEs) reported in group 1 (29.91%) were larger than those in group 2 (12.39%) and group 3 (21.93%), among which the most common was redness. Similarly, the most common systemic AE was fever. All 5 severe AE (SAE) cases were determined by experts to be unrelated to the vaccines during the study.
CONCLUSIONS
The evidence of similar seroconversion and safety with co-administered DTaP and sIPV supports the co-administration supports the introduction of a strategy of simultaneous administration of both vaccines into routine infant immunization, and it could increase vaccination coverage and protect more infants from morbidity and mortality from these related diseases.
CLINICAL TRIAL REGISTRATION
https://clinicaltrials.gov/ct2/show/NCT04054882?term=NCT04054882&cntry=CN&draw=2&rank=1, identifier NCT04054882.
Topics: Antibodies, Bacterial; Child; Diphtheria; Diphtheria-Tetanus-acellular Pertussis Vaccines; Humans; Infant; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Tetanus; Vaccines, Combined; Whooping Cough
PubMed: 35958596
DOI: 10.3389/fimmu.2022.905634 -
Journal of Pharmaceutical Sciences May 2021Upscaling the production capacity of inactivated poliovirus vaccines (IPV) is urgently needed to eradicate polio worldwide. For the development of a robust manufacturing...
Upscaling the production capacity of inactivated poliovirus vaccines (IPV) is urgently needed to eradicate polio worldwide. For the development of a robust manufacturing process for IPV, the impact of stresses on the properties of the poliovirus during manufacturing needs to be carefully evaluated. In this study, the physicochemical properties of Sabin poliovirus after low pH exposure were analyzed by asymmetrical flow field-flow fractionation coupled to multi-angle laser light scattering (AF4-MALS), sedimentation velocity analytical ultracentrifugation (SV-AUC), transmission electron microscopy (TEM), dynamic light scattering (DLS) and surface plasmon resonance (SPR). Low pH stress caused structural changes and aggregation of inactivated poliovirus virions, whereas degraded virion particles would not revert to native virions even after neutralization. Importantly, a complete loss of the D-antigenicity of IPV by low pH stress, followed by neutralization, was observed in SPR. These results suggest that the exposure of poliovirus particle to low pH stress would induce irreversible denaturation and aggregation of virus particles and lead to the loss of D-antigenicity; thus, low pH stress during the manufacturing of poliovirus vaccine should be minimized. The analytical methods above can be efficiently utilized in the development of high-integrity manufacturing processes and high-quality vaccines.
Topics: Humans; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Surface Plasmon Resonance; Virion
PubMed: 33340531
DOI: 10.1016/j.xphs.2020.12.012 -
Vaccine Aug 2017The European Region, certified polio-free in 2002, remains at risk of wild poliovirus reintroduction and emergence of circulating vaccine-derived polioviruses (cVDPV)... (Review)
Review
BACKGROUND
The European Region, certified polio-free in 2002, remains at risk of wild poliovirus reintroduction and emergence of circulating vaccine-derived polioviruses (cVDPV) until global polio eradication is achieved, as demonstrated by the cVDPV1 outbreak in Ukraine in 2015.
METHODS
We reviewed epidemiologic, clinical and virology data on cVDPV cases, surveillance and immunization coverage data, and reports of outbreak-related surveys, country missions, and expert group meetings.
RESULTS
In Ukraine, 3-dose polio vaccine coverage declined from 91% in 2008 to 15% by mid-2015. In summer, 2015, two unrelated children from Zakarpattya province were paralyzed by a highly divergent cVDPV1. The isolates were 20 and 26 nucleotide divergent from prototype Sabin strain (with 18 identical mutations) consistent with their common origin and ∼2-year evolution. Outbreak response recommendations developed with international partner support included conducting three nationwide supplementary immunization activities (SIAs) with tOPV, strengthening surveillance and implementing communication interventions. SIAs were conducted during October 2015-February 2016 (officially reported coverage, round 1-64.4%, round 2-71.7%, and round 3-80.7%). Substantial challenges to outbreak response included lack of high-level support, resistance to OPV use, low perceived risk of polio, widespread vaccine hesitancy, anti-vaccine media environment, economic crisis and military conflict. Communication activities improved caregiver awareness of polio and confidence in vaccination. Surveillance was enhanced but did not consistently meet applicable performance standards. Post-outbreak assessments concluded that cVDPV1 transmission in Ukraine has likely stopped following the response, but significant gaps in population immunity and surveillance remained.
CONCLUSIONS
Chronic under-vaccination in Ukraine resulted in the accumulation of children susceptible to polioviruses and created favorable conditions for VDPV1 emergence and circulation, leading to the outbreak. Until programmatic gaps in immunization and surveillance are addressed, Ukraine will remain at high-risk for VDPV emergence and circulation, as well as at risk for other vaccine-preventable diseases.
Topics: Adolescent; Child; Disease Eradication; Disease Outbreaks; Female; Humans; Infant; Male; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Oral; Poliovirus Vaccines; Ukraine; Vaccination; Vaccination Refusal
PubMed: 28528761
DOI: 10.1016/j.vaccine.2017.04.036 -
The Journal of Infectious Diseases Jul 2017The Polio Eradication and Endgame Strategic plan outlines the phased removal of oral polio vaccines (OPVs), starting with type 2 poliovirus-containing vaccine and...
The Polio Eradication and Endgame Strategic plan outlines the phased removal of oral polio vaccines (OPVs), starting with type 2 poliovirus-containing vaccine and introduction of inactivated polio vaccine in routine immunization to mitigate against risk of vaccine-associated paralytic polio and circulating vaccine-derived poliovirus. The objective includes strengthening routine immunization as the primary pillar to sustaining high population immunity. After 2 years without reporting any wild poliovirus (July 2014-2016), the region undertook the synchronized switch from trivalent OPV (tOPV) to bivalent OPV (bOPV) as recommended by the Strategic Advisory Group of Experts on Immunization. Consequently the 47 countries of the World Health Organization (WHO) African Region switched from the use of tOPV to bOPV within the stipulated period of April 2016. Planning started early, routine immunization was strengthened, and technical and financial support was provided for vaccine registration, procurement, destruction, logistics, and management across countries by WHO in collaboration with the United Nations Children's Fund (UNICEF) and partners. National commitment and ownership, as well as strong coordination and collaboration between UNICEF and WHO and with partners, ensured success of this major, historic public health undertaking.
Topics: Africa; Disease Eradication; Global Health; Humans; Immunization Programs; Poliomyelitis; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; World Health Organization
PubMed: 28838178
DOI: 10.1093/infdis/jiw616 -
Human Vaccines & Immunotherapeutics Dec 2024This open-label, randomized, phase 3 study in China (V260-074; NCT04481191) evaluated the immunogenicity and safety of concomitant and staggered administration of three... (Randomized Controlled Trial)
Randomized Controlled Trial
A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China.
This open-label, randomized, phase 3 study in China (V260-074; NCT04481191) evaluated the immunogenicity and safety of concomitant and staggered administration of three doses of an oral, live, pentavalent rotavirus vaccine (RV5) and three doses of an intramuscular, inactivated poliomyelitis vaccine (IPV) in 400 healthy infants. The primary objective was the non-inferiority of neutralizing antibody (nAb) responses in the concomitant- versus the staggered-use groups. Antibody responses were measured at baseline and 1-month post-dose 3 (PD3). Parents/legal guardians recorded adverse events for 30 or 15 d after study vaccinations in the concomitant-use or staggered-use groups, respectively. At PD3, >98% of participants seroconverted to all three poliovirus types, and the primary objective was met as lower bounds of the two-sided 95% CI for between-group difference in nAb seroconversion percentages ranged from - 4.3% to - 1.6%, for all poliovirus types, < .001. At PD3, geometric mean titers (GMTs) of nAb responses to poliovirus types 1, 2, and 3 in the concomitant-use group and the staggered-use group were comparable; 100% of participants had nAb titers ≥1:8 and ≥1:64 for all poliovirus types. Anti-rotavirus serotype-specific IgA GMTs and participants with ≥3-fold rise in postvaccination titers from baseline were comparable between groups. Administration of RV5 and IPV was well tolerated with comparable safety profiles in both groups. The immunogenicity of IPV in the concomitant-use group was non-inferior to the staggered-use group and RV5 was immunogenic in both groups. No safety concerns were identified. These data support the concomitant use of RV5 and IPV in healthy Chinese infants.
Topics: Humans; Infant; Antibodies, Neutralizing; Antibodies, Viral; China; Immunogenicity, Vaccine; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Rotavirus Vaccines; Vaccines, Attenuated
PubMed: 38509699
DOI: 10.1080/21645515.2024.2324538 -
Clinical Chemistry Sep 2020
Topics: Animals; COVID-19; Haplorhini; History, 20th Century; Humans; Pandemics; Poliomyelitis; Poliovirus; Poliovirus Vaccines; SARS-CoV-2
PubMed: 32870989
DOI: 10.1093/clinchem/hvaa155 -
Vaccine Feb 2018Vaccine-associated paralytic poliomyelitis (VAPP) is one of the most important adverse effects of vaccines that are in current use globally. The Chinese national adverse...
INTRODUCTION
Vaccine-associated paralytic poliomyelitis (VAPP) is one of the most important adverse effects of vaccines that are in current use globally. The Chinese national adverse event following immunization information system (CNAEFIS) is a passive surveillance system which collects data on VAPP.
AIMS
To describe the epidemiological characteristics of VAPP and estimate the risk of recipient VAPP in China.
METHODS
We retrieved information from reported cases of recipient VAPP from CNAEFIS from 2010 to 2015, examined the demographic characteristics of the cases, and used administrative data on vaccination doses and the estimated number of births as denominators to calculate VAPP incidence.
RESULTS
During 2010-2015, 157 cases of recipient VAPP were reported to CNAEFIS (male-to-female ratio, 8.2:1); 151 cases (96.2%) were less than six months old. All cases were associated with trivalent OPV (tOPV), and 89.8% occurred after the receipt of first dose. Of the 157 recipient VAPP cases, type II, type III, and type I poliovirus vaccine strains were isolated from 27 (17.2%) , 25 (15.9%) , and 16 (10.2%) cases, respectively. One case died and one case recovered completely; the other 155 cases had various physical disabilities, such as monolateral or bilateral limping. Using the administered doses of OPV as the denominator, the incidence of recipient VAPP during the study period was estimated at 0.4 per million doses. The estimated recipient VAPP per million births ranged from 1.0 to 2.4 during 2010-2015.
CONCLUSION
The epidemiological characteristics of recipient VAPP cases in China, such as age distribution, were comparable to those in previous studies from other countries. The risk of recipient VAPP, using either estimated births or vaccination doses, was comparable to that in the US and Japan. We recommend using an inactive poliovirus vaccine to decrease the number of recipient VAPP cases in China.
Topics: China; Female; Humans; Immunization Programs; Infant; Infant, Newborn; Male; Poliomyelitis; Poliovirus Vaccine, Oral; Poliovirus Vaccines
PubMed: 29395524
DOI: 10.1016/j.vaccine.2018.01.019 -
Vaccine May 2023Sabin strain inactivated poliovirus vaccine (hereinafter as "sIPV") has been marketed globally in recent years, and more data on its immune persistence are needed. (Observational Study)
Observational Study
Immunogenicity and immune persistence in 4-year-old children completing four doses of Sabin strain or wild strain inactivated poliovirus vaccine: A phase IV, open-labeled, parallel-controlled observational study.
BACKGROUND
Sabin strain inactivated poliovirus vaccine (hereinafter as "sIPV") has been marketed globally in recent years, and more data on its immune persistence are needed.
METHODS
This is a phase IV, open-labeled, parallel-controlled observational study based on phase III clinical trial as required by the China National Medical Products Administration (NMPA). At least 450 subjects aged four years (48-54 months) who received four doses at 2, 3, 4 and 18 months of age of sIPV or wild strain poliovirus vaccine (wIPV) in phase III clinical trial enrolled at a 2:1 ratio and collected blood samples for neutralizing antibody testing.
RESULTS
A total of 500 subjects of four years old (334 in the sIPV group and 166 in wIPV group) were finally enrolled. The seropositivity rates (≥1:8) of neutralizing antibodies against serotype I-III were all 100.00% in all participants, and the geometric mean titers (GMT) were 1117.33 vs. 337.77 against serotype I, 632.72 vs. 267.34 against serotype Ⅱ, 1665.98 vs. 923.02 against serotype III in the sIPV group and wIPV group respectively at 4 years old. The seropositivity rates and GMTs of neutralizing antibodies in the test group were non-inferior to that of the control group against all three serotypes at different time points (P < 0.0001). The antibody GMT experienced a 10-fold, 8-fold, and 7-fold decline for serotypes I, Ⅱ, and III in the sIPV group, and a 13-fold, 7-fold, and 7-fold decline in the wIPV group from one month after booster vaccination to 4 years old.
CONCLUSIONS
The neutralizing antibody level is much higher than the seroprotection cutoff (≥1:8) among children of 4 years old who completed the four-dose vaccination of either sIPV or wIPV. Therefore, another booster vaccination is not recommended at 4 years old. Longer immune persistence observation is still ongoing.
REGISTRATION
ClinicalTrials.gov Identifier: NCT04989231.
Topics: Humans; Child, Preschool; Poliovirus; Poliovirus Vaccine, Inactivated; Poliomyelitis; Poliovirus Vaccine, Oral; Antibodies, Viral; Immunization Schedule; Antibodies, Neutralizing; Immunogenicity, Vaccine
PubMed: 37127526
DOI: 10.1016/j.vaccine.2023.03.012 -
Medecine Tropicale Et Sante... Jun 2021In 2019, the Central African Republic identified foci of circulating vaccine-derived poliovirus 2 (PVDV2c). The objective of this work is to describe the vaccination...
OBJECTIVE
In 2019, the Central African Republic identified foci of circulating vaccine-derived poliovirus 2 (PVDV2c). The objective of this work is to describe the vaccination status of children paralyzed by PVDV2c and their contacts and to assess the circulation of this strain in these contacts.
PATIENTS AND METHOD
The study population of this retrospective survey consists of children with acute flaccid paralysis (AFP) and their contacts. We included paralyzed children whose sequencing results showed the presence of PVDV2c.
RESULTS
A total of 21 children paralyzed by PVDVc and 64 contacts were enrolled in the survey. Fourteen out of 21 children who are paralyzed (66%) received at least one dose of bivalent oral polio vaccine (OPV) compared to 36 out of 64 contacts (57%, non-significant difference). Of the vaccinated patients, 7 had received less than three doses. For the injectable polio vaccine (IPV), vaccination coverage for both patients and contacts was 33%.The proportion of children who received both doses of OPV and IPV was 33% among patients and 25% in contacts. Contacts with VDPV2 were vaccinated with OPV and IPV, respectively 55 and 27%. VDPV2 and Sabin 2 were also found in contact stools, 34% and 9% respectively.
CONCLUSION
The absence or inadequacy of IPV vaccination has a serious impact on children by the occurrence of virus derived from the vaccine responsible for life-old paralysis. Protecting children from poliomyelitis requires a combination of a good cold chain, multiple doses and adherence to the vaccine schedule.
Topics: Central African Republic; Child; Humans; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Oral; Poliovirus Vaccines; Retrospective Studies
PubMed: 35586583
DOI: 10.48327/mtsibulletin.2021.114