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The Lancet. Infectious Diseases Aug 2021Since WHO recommended introduction of at least a single dose of inactivated poliovirus vaccine (IPV) in routine immunisation schedules, there have been global IPV... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Since WHO recommended introduction of at least a single dose of inactivated poliovirus vaccine (IPV) in routine immunisation schedules, there have been global IPV shortages. Fractional-dose IPV (fIPV) administration is one of the strategies to ensure IPV availability. We reviewed studies comparing the effects of fractional with full-dose IPV vaccination to determine when seroconversion proportions with each strategy become similar in children aged 5 years and younger.
METHOD
In this systematic review and meta-analysis, we searched 16 databases in July, 2019, for trials and observational studies, including ongoing studies that compare immunogenicity and adverse events of fractional-dose (0·1 mL) to full-dose (0·5 mL) IPV in healthy children aged 5 years or younger regardless of study design, number of doses, and route of administration. Screening, selection of articles, data extraction, and risk of bias assessment were done in duplicate, and conflicts were resolved by discussion or arbitration by a third author. We assessed immunogenicity, the main outcome, as proportion of seroconverted participants and changes in geometric mean titres of anti-poliovirus antibodies. Timepoints were eligible for analysis if measurements were done at least 4 weeks after vaccination. Summary estimates were pooled by use of random-effects meta-analysis. Analysis was stratified by study design, type of outcome measure, type of poliovirus, and number of doses given. We assessed heterogeneity using the χ test of homogeneity and quantified it using the I statistic. We assessed risk of bias using the Cochrane risk of bias tool, and the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach. The study is registered with PROSPERO, CRD42018092647.
FINDINGS
860 records were screened for eligibility, of which 36 potentially eligible full-text articles were assessed and 14 articles were included in the final analysis: two ongoing trials and 12 articles reporting on ten completed studies. For poliovirus type 2, there were no significant differences in the proportions of seroconversions between fractional and full doses of IPV for two or three doses: the risk ratio for serconversion at one dose was 0·61 (95% CI 0·51-0·72), at two doses was 0·90 (0·82-1·00), and at three doses was 0·95 (0·91-1·00). Geometric mean titres (GMTs) for poliovirus type 2 were lower for fIPV than for full-dose IPV: -0·51 (95% CI -0·87 to -0·14) at one dose, -0·49 (-0·70 to -0·28) at two doses, and -0·98 (-1·46 to -0·51) at three doses. The seroconversion meta-analysis for the three-dose comparison was homogeneous (p=0·45; I=0%), whereas heterogeneity was observed in the two-dose (p<0·00001; I=88%) and one-dose (p=0·0004; I=74%) comparisons. Heterogeneity was observed in meta-analyses of GMTs for one-dose (p<0·00001; I=92%), two-dose (p=0·002; I=80%), and three-dose (p<0·00001; I=93%) comparisons. Findings for types 1 and 3 were similar to those for type 2. The certainty of the evidence was high for the three-dose comparisons and moderate for the rest of the comparisons.
INTERPRETATION
There is no substantial difference in seroconversion between three doses of fIPV and three doses of full-dose IPV, although the full dose gives higher titres of antibodies for poliovirus type 1, 2, and 3. Use of fractional IPV instead of the full dose can stretch supplies and possibly lower the cost of vaccination.
FUNDING
South African Medical Research Council and the National Research Foundation of South Africa.
Topics: Administration, Oral; Antibodies, Viral; Child, Preschool; Dose-Response Relationship, Immunologic; Humans; Immunization Schedule; Immunogenicity, Vaccine; Injections, Intradermal; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Randomized Controlled Trials as Topic; Seroconversion
PubMed: 33939958
DOI: 10.1016/S1473-3099(20)30693-9 -
The Lancet. Infectious Diseases Oct 2019The eradication of wild and vaccine-derived poliovirus requires the global withdrawal of oral poliovirus vaccines (OPVs) and replacement with inactivated poliovirus... (Comparative Study)
Comparative Study Meta-Analysis
BACKGROUND
The eradication of wild and vaccine-derived poliovirus requires the global withdrawal of oral poliovirus vaccines (OPVs) and replacement with inactivated poliovirus vaccines (IPVs). The first phase of this effort was the withdrawal of the serotype 2 vaccine in April 2016, with a switch from trivalent OPVs to bivalent OPVs. The aim of our study was to produce comparative estimates of humoral and intestinal mucosal immunity associated with different routine immunisation schedules.
METHODS
We did a random-effect meta-analysis with single proportions and a network meta-analysis in a Bayesian framework to synthesise direct and indirect data. We searched MEDLINE and the Cochrane Library Central Register of Controlled Trials for randomised controlled trials published from Jan 1, 1980, to Nov 1, 2018, comparing poliovirus immunisation schedules in a primary series. Only trials done outside western Europe or North America and without variation in age schedules (ie, age at administration of the vaccine) between study groups were included in the analyses, because trials in high-income settings differ in vaccine immunogenicity and schedules from other settings and to ensure consistency within the network of trials. Data were extracted directly from the published reports. We assessed seroconversion against poliovirus serotypes 1, 2, and 3, and intestinal immunity against serotype 2, measured by absence of shedding poliovirus after a challenge OPV dose.
FINDINGS
We identified 437 unique studies; of them, 17 studies with a maximum of 8279 evaluable infants were eligible for assessment of humoral immunity, and eight studies with 4254 infants were eligible for intestinal immunity. For serotype 2, there was low between-trial heterogeneity in the data (τ=0·05, 95% credible interval [CrI] 0·009-0·15) and the risk ratio (RR) of seroconversion after three doses of bivalent OPVs was 0·14 (95% CrI 0·11-0·17) compared with three doses of trivalent OPVs. The addition of one or two full doses of an IPV after a bivalent OPV schedule increased the RR to 0·85 (0·75-1·0) and 1·1 (0·98-1·4). However, the addition of an IPV to bivalent OPV schedules did not significantly increase intestinal immunity (0·33, 0·18-0·61), compared with trivalent OPVs alone. For serotypes 1 and 3, there was susbstantial inconsistency and between-trial heterogeneity between direct and indirect effects, so we only present pooled estmates on seroconversion, which were at least 80% for serotype 1 and at least 88% for serotype 3 for all vaccine schedules.
INTERPRETATION
For WHO's polio eradication programme, the addition of one IPV dose for all birth cohorts should be prioritised to protect against paralysis caused by type 2 poliovirus; however, this inclusion will not prevent transmission or circulation in areas with faecal-oral transmission.
FUNDING
UK Medical Research Council.
Topics: Antibodies, Viral; Disease Eradication; Feces; Humans; Immunity, Humoral; Immunity, Mucosal; Immunization Schedule; Immunogenicity, Vaccine; Infant; Infant, Newborn; Intestinal Mucosa; Network Meta-Analysis; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Seroconversion; Serogroup; Vaccination; Virus Shedding
PubMed: 31350192
DOI: 10.1016/S1473-3099(19)30301-9 -
Expert Opinion on Drug Safety May 2024Vaccine-associated paralytic poliomyelitis (VAPP) is a rare adverse event of oral poliovirus vaccines (OPV), particularly affecting immunodeficient individuals.
BACKGROUND
Vaccine-associated paralytic poliomyelitis (VAPP) is a rare adverse event of oral poliovirus vaccines (OPV), particularly affecting immunodeficient individuals.
RESEARCH DESIGN AND METHODS
This study aimed to (1) Assess the association between OPV and VAPP using Vaccine Adverse Event Reporting System (VAERS) database (2) Outline patient characteristics and risk factors associated with the occurrence of VAPP in OPV recipients through a systematic review of case reports and case series. A disproportionality analysis was conducted using the data from VAERS, encompassing adverse events reported from 1990 till February 2023. Additionally, we conducted a systematic review of case reports and case series using PubMed, Scopus, and Embase databases.
RESULTS
The VAERS data revealed 130 VAPP reports among 1,739,903 OPV linked adverse events, with year 2010 reporting the strongest association. The systematic review of 37 studies highlighted VAPP occurrence within 2 months to 4 years post-vaccination, typically with acute flaccid paralysis. Immunodeficiency and perianal abscess emerged as major risk factors. Out of the 37 included studies, 27 showed consistent causal association of VAPP with OPV using WHO-AEFI causality assessment tool.
CONCLUSION
The study emphasized the seriousness of VAPP and highlights its association with OPV, identifying immunodeficiency as a prominent contributor to VAPP manifestation.
PubMed: 38813942
DOI: 10.1080/14740338.2024.2359616 -
Vaccines Dec 2019The growing number of available vaccines that can be potentially co-administered makes the assessment of the safety of vaccine co-administration increasingly relevant... (Review)
Review
The growing number of available vaccines that can be potentially co-administered makes the assessment of the safety of vaccine co-administration increasingly relevant but complex. We aimed to synthesize the available scientific evidence on the safety of vaccine co-administrations in children by performing a systematic literature review of studies assessing the safety of vaccine co-administrations in children between 1999 and 2019, in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Fifty studies compared co-administered vaccines versus the same vaccines administered separately. The most frequently studied vaccines included quadrivalent meningococcal conjugate (MenACWY) vaccine, diphtheria and tetanus toxoids and acellular pertussis (DTaP) or tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccines, diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B, inactivated poliovirus and type b conjugate (DTaP-HepB-IPV/Hib) vaccine, measles, mumps, and rubella (MMR) vaccine, and pneumococcal conjugate 7-valent (PCV7) or 13-valent (PCV13) vaccines. Of this, 16% (n = 8) of the studies reported significantly more adverse events following immunization (AEFI) while in 10% (n = 5) significantly fewer adverse events were found in the co-administration groups. Statistically significant differences between co-administration and separate administration were found for 16 adverse events, for 11 different vaccine co-administrations. In general, studies briefly described safety and one-third of studies lacked any statistical assessment of AEFI. Overall, the evidence on the safety of vaccine co-administrations compared to separate vaccine administrations is inconclusive and there is a paucity of large post-licensure studies addressing this issue.
PubMed: 31906218
DOI: 10.3390/vaccines8010012 -
Expert Review of Vaccines Mar 2021: The hexavalent vaccine DT3aP-HBV-IPV-Hib (, GSK) was first licensed in Europe in 2000. DT2aP-HBV-IPV-Hib (, Sanofi Pasteur), and DT5aP-HBV-IPV-Hib (, MCM Vaccine... (Meta-Analysis)
Meta-Analysis
: The hexavalent vaccine DT3aP-HBV-IPV-Hib (, GSK) was first licensed in Europe in 2000. DT2aP-HBV-IPV-Hib (, Sanofi Pasteur), and DT5aP-HBV-IPV-Hib (, MCM Vaccine Company) were licensed in the EU in 2013 and 2016, respectively, based largely on studies demonstrating non-inferiority to DT3aP-HBV-IPV-Hib for immunogenicity and comparable reactogenicity profiles.: We conducted a systematic literature review looking for direct head-to-head trials comparing DT2aP-HBV-IPV-Hib and DT5aP-HBV-IPV-Hib with DT3aP-HBV-IPV-Hib. The incidence of solicited local and systemic reactions following primary series administration of DT3aP-HBV-IPV-Hib or DT2aP-HBV-IPV-Hib were meta-analyzed.: A total of 317 unique records were retrieved from the search; nine met the predefined inclusion criteria; seven reported studies comparing DT3aP-HBV-IPV-Hib and DT2aP-HBV-IPV-Hib. Six trials assessing outcomes of the primary vaccination series were identified. Odds ratios and 95% confidence intervals (OR; 95%CI) were computed for DT3aP-HBV-IPV-Hib, using DT2aP-HBV-IPV-Hib as reference, for redness (0.72; 0.63-0.83), pain (0.74; 0.62-0.89), swelling (0.86; 0.74-0.99) at injection site, fever (0.67; 0.54-0.83), persistent crying (0.72; 0.61-0.84), drowsiness (0.82; 0.71-0.94), irritability (0.82; 0.69-0.98), anorexia (0.83; 0.72-0.95), and vomiting (0.96; 0.83-1.11).: ORs of analyzed local and systemic solicited adverse reactions after primary vaccination with DT3aP-HBV-IPV-Hib appear to be slightly lower than with DT2aP-HBV-IPV-Hib.
Topics: Diphtheria-Tetanus-Pertussis Vaccine; Diphtheria-Tetanus-acellular Pertussis Vaccines; Europe; Haemophilus Vaccines; Hepatitis B Vaccines; Humans; Infant; Odds Ratio; Poliovirus Vaccine, Inactivated; Vaccination; Vaccines, Combined
PubMed: 33660582
DOI: 10.1080/14760584.2021.1892493 -
Vaccines Mar 2020Live-attenuated vaccines (LAV) are currently contraindicated during pregnancy, given uncertain safety records for the mother-infant pair. LAV might, however, play an... (Review)
Review
Live-attenuated vaccines (LAV) are currently contraindicated during pregnancy, given uncertain safety records for the mother-infant pair. LAV might, however, play an important role to protect them against serious emerging diseases, such as Ebola and Lassa fever. For this systematic review we searched relevant databases to identify studies published up to November 2019. Controlled observational studies reporting pregnancy outcomes after maternal immunization with LAV were included. The ROBINS-I tool was used to assess risk of bias. Pooled odds ratios (OR) were obtained under a random-effects model. Of 2831 studies identified, fifteen fulfilled inclusion criteria. Smallpox, rubella, poliovirus, yellow fever and dengue vaccines were assessed in these studies. No association was found between vaccination and miscarriage (OR 0.98, 95% CI 0.87-1.10), stillbirth (OR 1.04, 95% CI 0.74-1.48), malformations (OR 1.09, 95% CI 0.98-1.21), prematurity (OR 0.99, 95% CI 0.90-1.08) or neonatal death (OR 1.06, 95% CI 0.68-1.65) overall. However, increased odds of malformations (OR 1.24; 95% CI 1.03-1.49) and miscarriage after first trimester immunization (OR 4.82; 95% CI 2.38-9.77) was found for smallpox vaccine. Thus, we did not find evidence of harm related to LAV other than smallpox with regards to pregnancy outcomes, but quality of evidence was very low. Overall risks appear to be small and have to be balanced against potential benefits for the mother-infant pair.
PubMed: 32168941
DOI: 10.3390/vaccines8010124 -
Vaccine Feb 2024Delays in achieving polio eradication have led to ongoing risks of poliovirus importations that may cause outbreaks in polio-free countries. Because of the low, but...
Trade-offs of different poliovirus vaccine options for outbreak response in the United States and other countries that only use inactivated poliovirus vaccine (IPV) in routine immunization.
Delays in achieving polio eradication have led to ongoing risks of poliovirus importations that may cause outbreaks in polio-free countries. Because of the low, but non-zero risk of paralysis with oral poliovirus vaccines (OPVs), countries that achieve and maintain high national routine immunization coverage have increasingly shifted to exclusive use of inactivated poliovirus vaccine (IPV) for all preventive immunizations. However, immunization coverage within countries varies, with under-vaccinated subpopulations potentially able to sustain transmission of imported polioviruses and experience local outbreaks. Due to its cost, ease-of-use, and ability to induce mucosal immunity, using OPV as an outbreak control measure offers a more cost-effective option in countries in which OPV remains in use. However, recent polio outbreaks in IPV-only countries raise questions about whether and when IPV use for outbreak response may fail to stop poliovirus transmission and what consequences may follow from using OPV for outbreak response in these countries. We systematically reviewed the literature to identify modeling studies that explored the use of IPV for outbreak response in IPV-only countries. In addition, applying a model of the 2022 type 2 poliovirus outbreak in New York, we characterized the implications of using different OPV formulations for outbreak response instead of IPV. We also explored the hypothetical scenario of the same outbreak except for type 1 poliovirus instead of type 2. We find that using IPV for outbreak response will likely only stop outbreaks for polioviruses of relatively low transmission potential in countries with very high overall immunization coverage, seasonal transmission dynamics, and only if IPV immunization interventions reach some unvaccinated individuals. Using OPV for outbreak response in IPV-only countries poses substantial risks and challenges that require careful consideration, but may represent an option to consider for some outbreaks in some populations depending on the properties of the available vaccines and coverage attainable.
Topics: Humans; United States; Poliovirus Vaccine, Inactivated; Poliovirus; Poliovirus Vaccine, Oral; Poliomyelitis; Disease Outbreaks; Vaccination; New York
PubMed: 38218668
DOI: 10.1016/j.vaccine.2023.12.081 -
Expert Review of Vaccines Sep 2019: In Asia Pacific, most countries recommend a monovalent hepatitis B virus (HBV) vaccine dose at birth followed by primary vaccination series including three or four...
Integration of hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B virus, inactivated poliomyelitis and Haemophilus influenzae type b conjugate vaccine within existing national recommendations following a birth dose of monovalent hepatitis B virus vaccine: results of a systematic...
: In Asia Pacific, most countries recommend a monovalent hepatitis B virus (HBV) vaccine dose at birth followed by primary vaccination series including three or four doses of combination vaccines against diphtheria, tetanus, and pertussis, with or without type b (Hib), HBV or poliomyelitis antigens. If hexavalent conjugate vaccines against diphtheria-tetanus-acellular pertussis-HBV-inactivated poliovirus-Hib (DTPa-HBV-IPV/Hib) replace the vaccines included in the primary vaccination series, co-administration of lower-valent vaccines would be avoided but infants would receive ≥4 doses of HBV-containing vaccines before the age of 2 years. : We searched for clinical trials conducted in the South-East Asia and Western Pacific Regions (World Health Organization geographic definition), investigating vaccination regimens with >3 doses of HBV-containing vaccines in infants, including a monovalent HBV vaccine birth dose and ≥1 dose of GSK's hexavalent DTPa-HBV-IPV/Hib vaccine. : The six clinical trials included in this review showed that infants who received the monovalent HBV vaccine at birth and three or four doses of DTPa-HBV-IPV/Hib vaccine achieved protective immunogenic titers with a clinically acceptable safety profile. Our results support the integration of hexavalent DTPa-HBV-IPV/Hib vaccine within existing national recommendations in the Asia Pacific region to reduce the number of injections during infancy.
Topics: Databases, Factual; Diphtheria; Diphtheria-Tetanus-acellular Pertussis Vaccines; Haemophilus Infections; Haemophilus influenzae type b; Hepatitis B; Hepatitis B Vaccines; Hepatitis B virus; Humans; Immunization Schedule; Poliomyelitis; Tetanus; Vaccines, Combined; Vaccines, Conjugate; Whooping Cough
PubMed: 31328999
DOI: 10.1080/14760584.2019.1646643 -
Vaccine Jun 2023The introduction of anti-poliomyelitis vaccines has driven progress toward the global eradication of wild polioviruses, a millennium goal of the World Health... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
The introduction of anti-poliomyelitis vaccines has driven progress toward the global eradication of wild polioviruses, a millennium goal of the World Health Organization. With the vaccination campaigns carried out since 1964, in 2002 Italy was certified polio-free, considering that no cases had been recorded since 1983. Nevertheless, it is crucial to guarantee high level of immunization coverage also in low-endemicity countries, considering that sporadic polio cases can be recorded. To evaluate the presence of susceptible subjects in the population, seroepidemiological studies are key actions.
METHODS
We conducted a systematic review of the relevant literature to evaluate the prevalence of anti-PV neutralizing antibodies in Italian population. Seven studies, selected among scientific articles available in MEDLINE/PubMed, ISI Web of Knowledge and Scopus and published from January 1, 2012, to November 15, 2022, were included.
RESULTS
The pooled prevalence of subjects without PV1 neutralizing antibodies was 6.4% (95%CI = 0.5-16.9), for PV2 it was 5.3% (95%CI = 0.4-14.2), and for PV3 it was 13.0% (95%CI = 4.0-25.7; I2 = 98.5%). Levels of neutralizing antibodies appears to decrease with increasing age; this decline is a proxy for the real risk factor, which is the time since the last vaccine dose.
CONCLUSIONS
Public health institutions must be aware of the risk of reintroduction of wild PV in polio-free countries and therefore they must keep high level of immunization in population and reinforce the active surveillance systems.
Topics: Humans; Poliovirus; Prevalence; Antibodies, Viral; Poliomyelitis; Poliovirus Vaccines; Antibodies, Neutralizing; Italy; Poliovirus Vaccine, Oral
PubMed: 37121798
DOI: 10.1016/j.vaccine.2023.04.047 -
BMJ Global Health Nov 2021The Global Polio Eradication Initiative uses polio supplementary immunisation activities (SIAs) as a strategy to increase vaccine coverage and cease poliovirus...
INTRODUCTION
The Global Polio Eradication Initiative uses polio supplementary immunisation activities (SIAs) as a strategy to increase vaccine coverage and cease poliovirus transmission. Impact of polio SIAs on immunisation systems is frequently debated. We reviewed the impact of polio SIAs on routine immunisation and health systems during the modern era of polio eradication.
METHODS
We searched nine databases for studies reporting on polio SIAs and immunisation coverage, financial investment, workforce and health services delivery. We conducted a narrative synthesis of evidence. Records prior to 1994, animal, modelling or case studies data were excluded.
RESULTS
20/1637 unique records were included. Data on vaccine coverage were included in 70% (14/20) studies, workforce in 65% (13/20) and health services delivery in 85% (17/20). SIAs positively contributed to vaccination uptake of non-polio vaccines in seven studies, neutral in three and negative in one. Some polio SIAs contributed to workforce strengthening through training and capacity building. Polio SIAs were accompanied with increased social mobilisation and community awareness building confidence in vaccination programmes. Included studies were programmatic in nature and contained variable data, thus could not be justly critically appraised.
CONCLUSION
Polio SIAs are successful at increasing polio vaccine coverage, but the resources and infrastructures were not always utilised for delivery of non-polio vaccines and integration into routine service delivery. We found a gap in standardised tools to evaluate SIAs, which can then inform service integration. Our study provides data to inform SIAs evaluations, and provides important considerations for COVID-19 vaccine roll-out to strengthen health systems.
PROSPERO REGISTRATION NUMBER
CRD42020152195.
Topics: COVID-19; COVID-19 Vaccines; Humans; Immunization; Immunization Programs; Poliomyelitis; SARS-CoV-2; Vaccination
PubMed: 34776411
DOI: 10.1136/bmjgh-2021-006568