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Vaccines Jan 2024The multidose Sabin-strain inactivated poliovirus vaccine (sIPV) has the potential to significantly aid in the eradication of poliomyelitis, particularly in low- and...
Immune Persistence following Primary Immunization and the Immunogenicity and Safety of a Booster Dose of a Multidose Sabin Strain-Based Inactivated Polio Vaccine in Infants Aged 18 Months.
BACKGROUND
The multidose Sabin-strain inactivated poliovirus vaccine (sIPV) has the potential to significantly aid in the eradication of poliomyelitis, particularly in low- and middle-income countries. As part of a phase III clinical trial in which infants were given three doses of primary immunization at 2, 3, and 4 months of age, this study aimed to evaluate immune persistence following primary immunization, as well as the safety and immunogenicity of a booster of the 5-dose sIPV in infants aged 18 months.
METHODS
Infants aged 18 months were given one booster dose of 5-dose sIPV in stage one, which was open-label. Unblinding was performed for stage two after completing primary immunization, which was randomized, blinded, and controlled; infants aged 18 months in the test group I-III, IPV group, and single-dose sIPV group were given one booster dose of 5-dose sIPV, conventional IPV, and single-dose sIPV, respectively, in stage two.
RESULTS
This study included 1438 infants in the immune persistence and safety set and 1387 infants in the booster per-protocol set. Fourteen months after primary immunization, the seropositivity rates (≥1:8) for types 1-3 were 100%, 99.88%, and 99.53% in the 5-dose sIPV groups; 100%, 98.97%, and 97.23% in the IPV group; and 99.66%, 100%, and 99.66% in the single-dose sIPV group. A total of 30 days after booster immunization, the seropositivity rates (≥1:8) of 3 serotypes in all the groups reached 100%. The geometric mean titers of neutralizing antibodies for types 1-3 in the 5-dose sIPV group were 9962.89, 10273, and 7870.21, with geometric mean increases of 15.76, 33.15, and 24.5, compared to the pre-booster level. The overall incidence of adverse reactions was 8.97%, with fever being the most common, observed at rates of 7.1%, 5.52%, and 7.96% in the 5-dose sIPV, IPV, and single-dose groups, respectively ( = 0.4845).
CONCLUSIONS
The 5-dose sIPV has shown promising immune persistence and robust immune response following a booster immunization, coupled with an acceptable safety profile.
PubMed: 38400106
DOI: 10.3390/vaccines12020123 -
Vaccines Jan 2024Structural and functional commonalities between poliovirus and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) suggest that poliovirus inoculation may...
BACKGROUND
Structural and functional commonalities between poliovirus and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) suggest that poliovirus inoculation may induce antibodies that mitigate the coronavirus disease (COVID-19). No known studies have evaluated COVID-19 risk factors in adults recently vaccinated against poliovirus.
STUDY OBJECTIVE
Among adults with no history of COVID-19 infection or vaccination, who recently received an inactivated poliovirus vaccine (IPV), we sought to determine which biological factors and social determinants of health (SDOH) may be associated with (1) testing positive for SARS-CoV-2, (2) experiencing COVID-19 symptoms, and (3) a longer duration of COVID-19 symptoms.
METHODS
The influence of biological factors and SDOH on SARS-CoV-2 infection and COVID-19 symptoms were evaluated among 282 adults recently inoculated with IPV. Participant-reported surveys were analyzed over 12 months post-enrollment. Bivariate and multivariate linear and logistic regression models identified associations between variables and COVID-19 outcomes.
RESULTS
Adjusting for COVID-19 vaccinations, variants, and other SDOH, secondary analyses revealed that underlying conditions, employment, vitamin D, education, and the oral poliovirus vaccination (OPV) were associated with COVID-19 outcomes. The odds of testing positive for SARS-CoV-2 and experiencing symptoms were significantly reduced among participants who took vitamin D (OR 0.12 and OR 0.09, respectively). Unemployed or part-time working participants were 72% less likely to test positive compared with full-time workers. No prior dose of OPV was one of the strongest predictors of SARS-CoV-2 infection (OR 4.36) and COVID-19 symptoms (OR 6.95).
CONCLUSIONS
Findings suggest that prophylactic measures and mucosal immunity may mitigate the risk and severity of COVID-19 outcomes. Larger-scale studies may inform future policies.
PubMed: 38400105
DOI: 10.3390/vaccines12020121 -
Medecine Tropicale Et Sante... Dec 2023Thirty-five years after its launch, the Global Polio Eradication Initiative has yet to reach its original goal of 2000. Not only is the wild type 1 polio virus still...
Thirty-five years after its launch, the Global Polio Eradication Initiative has yet to reach its original goal of 2000. Not only is the wild type 1 polio virus still endemic in two countries, but a new outbreak due to viruses derived from the live attenuated virus used for the oral vaccine has been spreading since 2016. The National Immunization Days (NID), during which teams go door-to-door and attract children to be vaccinated, have provoked violent opposition particularly in Northern Nigeria and in the area of India, Pakistan, Afghanistan. In both regions, the same rumor has developed that the vaccine contains sterilizing products, in order to limit the Muslim population. The organizers of the campaign multiplied in vain the NIDs to overcome the resistance, but pockets of insufficiently vaccinated population have persisted. This has allowed the wild virus to remain endemic and the new outbreak of vaccine-derived viruses to progress. We can wonder what the campaign would have become if its organizers had taken the time to reflect and reorient their strategy to rely on the routine vaccination of the Expanded Program on Immunization that does not arouse such opposition.
Topics: Child; Humans; Poliovirus Vaccine, Oral; Poliovirus Vaccine, Inactivated; Poliomyelitis; Poliovirus; Vaccination
PubMed: 38390018
DOI: 10.48327/mtsi.v3i4.2023.402 -
Vaccine Mar 2024There has been no data on the immunogenicity and safety of the 4 booster dose of the sIPV immunization in 18-24 months old children in post-marketing studies of large... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
There has been no data on the immunogenicity and safety of the 4 booster dose of the sIPV immunization in 18-24 months old children in post-marketing studies of large cohort providing with robust results.
METHOD
In a phase Ⅳ randomized, double-blinded clinical trial, 1200 participants aged 2 months were immunized with three consecutive doses of sIPV at 2, 3, and 4 months old to complete primary immunization. Out of the 1200 participants, 1129 received the 4 dose of sIPV as booster immunization. Immunogenicity was evaluated in 1100 participants.
RESULTS
Seropositive rates of the anti-poliovirus type 1, 2, and 3 neutralizing antibodies were 99.9 %, 98.0 %, 98.2 %, respectively, with GMTs of 557.0, 146.1, 362.0 one year after primary vaccination. After booster vaccination between 18 and 24 months old, the seropositive rates for 3 types all reached 100.0 %, with GMTs of 8343.6, 5039.6, 5492.0, respectively. Particularly for the anti-poliovirus type 2 antibody, the GMT was 230.4 after primary immunization, maintained to 146.1 one year after primary immunization, and increased to as high as 5039.6 after booster vaccination. The GMT ratios between each batch groups after booster immunization were between 0.67 and 1.50, meeting the immunological equivalence criteria. The incidence rate of adverse reaction was 23.0 %, which was comparable to those in the phase Ⅲ trial but had a lower incidence. Furthermore, no SUSAR was reported in this study.
INTERPRETATION
In conclusion, as the anti-poliovirus antibodies gradually waned one year post sIPV primary vaccination, especially the type 2 antibody waned to a very low level, suggesting the importance of the booster immunization for children at the age of 18-24 months old. The booster shot can greatly enhance the antibody level and protect children from the potential risk of infection with WPV and VDPV by supplementing the anti-poliovirus type 2 immunity gap in the current real world. Clinic Trial Registration. NCT04224519.
Topics: Child; Humans; Infant; Child, Preschool; Poliomyelitis; Poliovirus Vaccine, Oral; Antibodies, Viral; Poliovirus; Poliovirus Vaccine, Inactivated; China; Immunogenicity, Vaccine
PubMed: 38388236
DOI: 10.1016/j.vaccine.2024.02.042 -
Cureus Jan 2024The Expanded Program on Immunization (EPI) of Cameroon contributes to the reduction of polio, but the rate of non-polio acute flaccid paralysis (NPAFP) is still high....
BACKGROUND
The Expanded Program on Immunization (EPI) of Cameroon contributes to the reduction of polio, but the rate of non-polio acute flaccid paralysis (NPAFP) is still high. The aim of this study was to describe the immunization profile of NPAFP cases and the performance of polio surveillance in the Far North Region of Cameroon between 2015 and 2019.
METHODS
A retrospective secondary data analysis was conducted using the national EPI and regional AFP surveillance case-based database from 2015 to 2019. Analyses were carried out using Epi-Info statistical software (version 7) (Centers for Disease Control and Prevention, Atlanta, GA).
RESULTS
The surveillance network of the region reported 848 cases of NPAFP between 2015 and 2019. The sex distribution of the AFP cases revealed that 43.3% were females and 56.7% were males. Cases with AFP aged less than five years accounted for the largest proportion of cases (67.2%). Overall, 733/848 (86.4%) of the AFP cases received at least three doses of the oral polio vaccine (OPV). The AFP detection rate substantially increased in the region after the introduction of community-based surveillance in 2016. The mean NPAFP level during the study period was 7.3/100,000 children aged less than 15 years. The mean proportion of AFP cases with two adequate stools was 668/848 (78.7%), and the mean proportion of stools to the national reference laboratory within three days was 466/848 (54.9%).
CONCLUSION
Only 86.4% of AFP cases received three or more doses of OPV required for immunization. The stool specimen management indices were not good enough to confirm that no case of poliovirus was missed in the laboratory. To strengthen the country's polio-free status, surveillance should be strengthened in least-performing health districts to improve the quality of AFP case investigations after detection.
PubMed: 38384598
DOI: 10.7759/cureus.52740 -
NPJ Vaccines Feb 2024A fully liquid hexavalent containing Diphtheria (D), Tetanus (T) toxoids, whole cell Pertussis (wP), Hepatitis B (Hep B), type 1, 2, 3 of inactivated poliovirus (IPV)...
A fully liquid hexavalent containing Diphtheria (D), Tetanus (T) toxoids, whole cell Pertussis (wP), Hepatitis B (Hep B), type 1, 2, 3 of inactivated poliovirus (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (DTwP-HepB-IPV-Hib vaccine, HEXASIIL) was tested for lot-to-lot consistency and non-inferiority against licensed DTwP-HepB-Hib + IPV in an open label, randomized Phase II/III study. In Phase III part, healthy infants received DTwP-HepB-IPV-Hib or DTwP-HepB-Hib + IPV vaccines at 6, 10 and 14 weeks of age. Blood samples were collected prior to the first dose and 28 days, post dose 3. Non inferiority versus DTwP-HepB-Hib + IPV was demonstrated with 95% CIs for the treatment difference for seroprotection/seroconversion rates. For DTwP-HepB-IPV-Hib lots, limits of 95% CI for post-vaccination geometric mean concentration ratios were within equivalence limits (0.5 and 2). Vaccine was well-tolerated and no safety concerns observed.Clinical Trial Registration - CTRI/2019/11/022052.
PubMed: 38383584
DOI: 10.1038/s41541-024-00828-w -
Factors associated with full childhood vaccination coverage among young mothers in Northern Nigeria.The Pan African Medical Journal 2024wide regional variation in immunization coverage still persists in Nigeria. Full Immunization Coverage (FIC) for more than 80% of all states in the northern region is...
INTRODUCTION
wide regional variation in immunization coverage still persists in Nigeria. Full Immunization Coverage (FIC) for more than 80% of all states in the northern region is lower than 40% relative to their southern counterpart. Studies focusing on young women in the north remain sparse, despite the high prevalence of early marriage and poor health-seeking behavior. This study examines FIC among young women in northern Nigeria.
METHODS
we performed a secondary analysis of the 2013 and 2018 Nigeria Demographic and Health Survey on 1,198 women of children aged 12-23 months in 2013 and 405 in the 2018 dataset. Analysis was limited to young women 15-24 years, residing in Northern Nigeria. We used logistics regression to predict factors associated with FIC.
RESULTS
the proportion of fully immunized children was low, at 11% in 2013 and 18% in 2018. The coverage for most vaccines was low, except for the oral polio vaccine. The children of mothers who had health card [(aOR=18.1,95% C.I (8.1-40.7)], in 2013 and 2018 [(aOR=12.7, 95% C.I (5.9-27.1)], attended ANC [(aOR=8.6, 95% C.I (2.4-30.9)] in 2013 and had facility delivery [(aOR=2.0, 95% C.I (1.0-4.1)] in 2018 were more likely to be fully immunized.
CONCLUSION
the study found FIC among children of young women in Northern Nigeria was abysmally low. Ownership of health care, antenatal attendance, and facility delivery significantly predicted the odds of FIC. These findings suggest the need for approaches that remove barriers to good health-seeking behavior, especially among young mothers in Northern Nigeria.
Topics: Child; Female; Humans; Pregnancy; Infant; Vaccination Coverage; Nigeria; Health Surveys; Mothers; Poliovirus Vaccine, Oral; Vaccination
PubMed: 38371647
DOI: 10.11604/pamj.2024.47.4.37517 -
The Pan African Medical Journal 2023Nigeria made a coordinated effort to be certified by the World Health Organization's African Region for interrupting endemic transmission of wild poliovirus type-1... (Review)
Review
Nigeria made a coordinated effort to be certified by the World Health Organization's African Region for interrupting endemic transmission of wild poliovirus type-1 (WPV1) in August 2020 as a response to the resurgence of WPV1 cases in August 2016 after going two years without a case. The NEOC Data Working Group (DWG) was instrumental in providing quality and timely surveillance and campaign information for decision-making in order to interrupt WPV1 transmission and provide data toward documentation of its elimination for regional certification. The polio pre-campaign dashboard was used to assess the level of preparedness for Oral Poliovirus Vaccine (OPV) polio supplementary immunization activities (SIA) at three weeks, two weeks, one week, and three days to the start of each campaign implemented during 2016-2020. The administrative tally sheet, independent monitoring survey, and Lot Quality Assurance Sampling (LQAS) survey data collected and shared from the implementation level were analyzed by the EOC DWG to provide information by person, place, and time. Using a 90% threshold in LQAS surveys defining quality SIAs, the proportion of Local Government Areas (LGAs) in Nigeria's states in which post-SIA LQAS surveys were conducted that met this threshold were assessed over time. The highest level of preparedness attained by 3 days to a polio campaign during August 2016-February 2020 was 95% and the lowest attained was 77%. The admin, independent monitoring, and LQAS data analysis results were given to EOC working groups for assessing the performance and quality of each campaign. Twenty-twenty five percent of LGAs that failed LQAS were identified for repeat vaccination. Further, acute flaccid paralysis and environmental surveillance data and laboratory results were analyzed and shared with NEOC and partners. The government and partners used the information generated by the Data Working Group to take evidence-based action including determining the scope of the polio campaign, intensification of surveillance and routine immunization activities, and special intervention activities. On average, 12% of the 774 LGAs were identified as polio high risk LGAs for intervention using selected surveillance, routine immunization (RI), SIAs, and other relevant data sets. National Emergency Operation Centre Data Working Group provided quality and timely information that supported decision-making processes for the polio program in Nigeria. The quality and timely information enabled the NEOC to make evidence-based and timely decisions that contributed to gap identification and decision-making.
Topics: Humans; Lot Quality Assurance Sampling; Disease Eradication; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Oral; Nigeria; Immunization Programs
PubMed: 38370106
DOI: 10.11604/pamj.supp.2023.45.2.39489 -
The Pan African Medical Journal 2023In 2011, a dedicated consortium of experts commenced work on the development of the novel oral poliovirus vaccine type 2 (nOPV2). After careful and rigorous analysis of... (Review)
Review
In 2011, a dedicated consortium of experts commenced work on the development of the novel oral poliovirus vaccine type 2 (nOPV2). After careful and rigorous analysis of data to enable early, targeted use of the vaccine, World Health Organization´s (WHO´s) Strategic Advisory Group of Experts on Immunization (SAGE) reviewed data from accelerated clinical development of nOPV2 and endorsed entering assessment under WHO´s Emergency Use Listing (EUL) procedure. In November 2020, nOPV2 received an interim recommendation for use under EUL to enable rapid field availability and potential wider rollout of the vaccine. In December 2020, Nigeria initiated preparation to meet all criteria for initial use of nOPV2 in the country and the documentation process to verify meeting them. The process entailed addressing the status of meeting 25 readiness criteria in nine categories for nOPV2 use in Nigeria for response efforts to ongoing cVDPV2 outbreaks. During January-February 2021, Nigeria submitted the required documentation for all required indicators for nOPV2 initial use. In February 2021, the country obtained approval from the GPEI nOPV2 Readiness Verification Team to introduce nOPV2 and in March 2021, rolled out the novel vaccine in mass vaccination campaigns for outbreak response in Bayelsa, Delta, Niger, Sokoto and Zamfara states, and one area council in the Federal Capital Territory (FCT). The lessons learned from this rollout experience in Nigeria are being applied as the country streamlines and strengthens the nOPV2 rollout process across the remaining states.
Topics: Humans; Poliovirus Vaccine, Oral; Poliomyelitis; Nigeria; Poliovirus; Global Health; Disease Outbreaks
PubMed: 38370105
DOI: 10.11604/pamj.supp.2023.45.2.38033 -
The Pan African Medical Journal 2023in 2016, a switch from trivalent oral poliovirus vaccine (OPV) (containing serotypes 1,2,3) to bivalent OPV (types 1,3) was implemented globally. We assessed the...
INTRODUCTION
in 2016, a switch from trivalent oral poliovirus vaccine (OPV) (containing serotypes 1,2,3) to bivalent OPV (types 1,3) was implemented globally. We assessed the seroprevalence of poliovirus antibody levels in selected Nigerian states, before and after the switch, documented poliovirus type2 outbreak responses conducted and ascertained factors associated with immunity gaps based on seroprevalence rates.
METHODS
we conducted a secondary analysis of stored serum samples from the 2018 Nigeria National HIV/AIDS Indicator and Impact Survey. Serum from 1,185 children aged 0-119 months residing in one southern and four northern states were tested for serotype-specific PV neutralizing antibodies; seropositivity was a reciprocal titer ≥8. We conducted regression analysis to determine sociodemographic risk factors associated with low seroprevalence using SAS 9.4.
RESULTS
children aged 24-119 months (pre-switch cohort) had seroprevalence against PV1, PV2, and PV3, of 97.3% (95% CI:96.4-98.2), 93.8% (95% CI:92.2-95.5), and 91.3% (95% CI:89.2-93.4), while children aged <24 months (post-switch) had seroprevalence of 86.0% (95% CI:81.2-90.8), 55.6% (95% CI: 47.7-63.4), and 77.2% (95% CI:71.0-83.4) respectively. Regression analysis showed age <24 months was associated with lower seroprevalence against all PV serotypes, (p<0.0001); females had lower seroprevalence against PV1 (p=0.0184) and PV2 (p=0.0354); northern states lower seroprevalence against PV1 (p=0.0039), while well-water source lower seroprevalence against PV3 (p=0.0288).
CONCLUSION
this study showed high seroprevalence rates against PV 1, 2, and 3 in pre-switch children (aged 24-119 months). However, post-switch children (<24 months) had low immunity against PV2 despite outbreak responses. Strategies to increase routine immunization coverage and high-quality polio campaigns can increase immunity against polio virus.
Topics: Child; Female; Humans; Infant; Poliovirus; Antibodies, Viral; Seroepidemiologic Studies; Nigeria; Poliomyelitis; Poliovirus Vaccine, Oral; Poliovirus Vaccine, Inactivated
PubMed: 38370104
DOI: 10.11604/pamj.supp.2023.45.2.38098