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Meta-Analysis
. 2019 Dec 5;12(12):CD011260.
doi: 10.1002/14651858.CD011260.pub2.

Sequential inactivated (IPV) and live oral (OPV) poliovirus vaccines for preventing poliomyelitis

Agustín Ciapponi  1 , Ariel Bardach  1 , Lucila Rey Ares  1 , Demián Glujovsky  1   2 , María Luisa Cafferata  1 , Silvana Cesaroni  1 , Aikant Bhatti  3
Affiliations
Meta-Analysis

Sequential inactivated (IPV) and live oral (OPV) poliovirus vaccines for preventing poliomyelitis

Agustín Ciapponi et al. Cochrane Database Syst Rev. .

Abstract

Background: Poliomyelitis mainly affects unvaccinated children under five years of age, causing irreversible paralysis or even death. The oral polio vaccine (OPV) contains live attenuated virus, which can, in rare cases, cause a paralysis known as vaccine-associated paralytic polio (VAPP), and also vaccine-derived polioviruses (VDPVs) due to acquired neurovirulence after prolonged duration of replication. The incidence of poliomyelitis caused by wild polio virus (WPV) has declined dramatically since the introduction of OPV and later the inactivated polio vaccine (IPV), however, the cases of paralysis linked to the OPV are currently more frequent than those related to the WPV. Therefore, in 2016, the World Health Organization (WHO) recommended at least one IPV dose preceding routine immunisation with OPV to reduce VAPPs and VDPVs until polio could be eradicated.

Objectives: To assess the effectiveness, safety, and immunogenicity of sequential IPV-OPV immunisation schemes compared to either OPV or IPV alone.

Search methods: In May 2019 we searched CENTRAL, MEDLINE, Embase, 14 other databases, three trials registers and reports of adverse effects on four web sites. We also searched the references of identified studies, relevant reviews and contacted authors to identify additional references.

Selection criteria: Randomised controlled trials (RCTs), quasi-RCTs, controlled before-after studies, nationwide uncontrolled before-after studies (UBAs), interrupted time series (ITS) and controlled ITS comparing sequential IPV-OPV schedules (one or more IPV doses followed by one or more OPV doses) with IPV alone, OPV alone or non-sequential IPV-OPV combinations.

Data collection and analysis: We used standard methodological procedures expected by Cochrane.

Main results: We included 21 studies: 16 RCTs involving 6407 healthy infants (age range 96 to 975 days, mean 382 days), one ITS with 28,330 infants and four nationwide studies (two ITS, two UBA). Ten RCTs were conducted in high-income countries; five in the USA, two in the UK, and one each in Chile, Israel, and Oman. The remaining six RCTs were conducted in middle-income countries; China, Bangladesh, Guatemala, India, and Thailand. We rated all included RCTs at low or unclear risk of bias for randomisation domains, most at high or unclear risk of attrition bias, and half at high or unclear risk for conflict of interests. Almost all RCTs were at low risk for the remaining domains. ITSs and UBAs were mainly considered at low risk of bias for most domains. IPV-OPV versus OPV It is uncertain if an IPV followed by OPV schedule is better than OPV alone at reducing the number of WPV cases (very low-certainty evidence); however, it may reduce VAPP cases by 54% to 100% (three nationwide studies; low-certainty evidence). There is little or no difference in vaccination coverage between IPV-OPV and OPV-only schedules (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.96 to 1.06; 1 ITS study; low-certainty evidence). Similarly, there is little or no difference between the two schedule types for the number of serious adverse events (SAEs) (RR 0.88, 95% CI 0.46 to 1.70; 4 studies, 1948 participants; low-certainty evidence); or the number of people with protective humoral response P1 (moderate-certainty evidence), P2 (for the most studied schedule; two IPV doses followed by OPV; low-certainty evidence), and P3 (low-certainty evidence). Two IPV doses followed by bivalent OPV (IIbO) may reduce P2 neutralising antibodies compared to trivalent OPV (moderate-certainty evidence), but may make little or no difference to P1 or P2 neutralising antibodies following an IIO schedule or OPV alone (low-certainty evidence). Both IIO and IIbO schedules may increase P3 neutralising antibodies compared to OPV (moderate-certainty evidence). It may also lead to lower mucosal immunity given increased faecal excretion of P1 (low-certainty evidence), P2 and P3 (moderate-certainty evidence) after OPV challenge. IPV-OPV versus IPV It is uncertain if IPV-OPV is more effective than IPV alone at reducing the number of WPV cases (very low-certainty evidence). There were no data regarding VAPP cases. There is no clear evidence of a difference between IPV-OPV and OPV schedules for the number of people with protective humoral response (low- and moderate-certainty evidence). IPV-OPV schedules may increase mean titres of P1 neutralising antibodies compared to OPV alone (low- and moderate-certainty evidence), but the effect on P2 and P3 titres is not clear (very low- and moderate-certainty evidence). IPV-OPV probably reduces the number of people with P3 poliovirus faecal excretion after OPV challenge with IIO and IIOO sequences (moderate-certainty evidence), and may reduce the number with P2 (low-certainty evidence), but not with P1 (very low-certainty evidence). There may be little or no difference between the schedules in number of SAEs (RR 0.92, 95% CI 0.60 to 1.43; 2 studies, 1063 participants, low-certainty evidence). The number of persons with P2 protective humoral immunity and P2 neutralising antibodies are probably lower with most sequential schemes without P2 components (i.e. bOPV) than with trivalent OPV or IVP alone (moderate-certainty evidence). IPV (3)-OPV versus IPV (2)-OPV One study (137 participants) showed no clear evidence of a difference between three IPV doses followed by OPV and two IPV doses followed by OPV, on the number of people with P1 (RR 0.98, 95% CI 0.93 to 1.03), P2 (RR 1.00, 95% CI 0.97 to 1.03), or P3 (RR 1.01, 95% CI 0.97 to 1.05) protective humoral and intestinal immunity; all moderate-certainty evidence. This study did not report on any other outcomes.

Authors' conclusions: IPV-OPV compared to OPV may reduce VAPPs without affecting vaccination coverage, safety or humoral response, except P2 with sequential schemes without P2 components, but increase poliovirus faecal excretion after OPV challenge for some polio serotypes. Compared to IPV-only schedules, IPV-OPV may have little or no difference on SAEs, probably has little or no effect on persons with protective humoral response, may increase neutralising antibodies, and probably reduces faecal excretion after OPV challenge of certain polio serotypes. Using three IPV doses as part of a IPV-OPV schedule does not appear to be better than two IPV doses for protective humoral response. Sequential schedules during the transition from OPV to IPV-only immunisation schedules seems a reasonable option aligned with current WHO recommendations. Findings could help decision-makers to optimise polio vaccination policies, reducing inequities between countries.

PubMed Disclaimer

Conflict of interest statement

A preliminary version of this review was supported by a grant from the Pan American Health Organization (PAHO). The PAHO commissioned the review team to analyse the evidence for sequential inactivated (IPV) and live oral (OPV) poliovirus vaccines for the prevention of poliomyelitis, to assist their decision‐making process. Agustín Ciapponi, Ariel Bardach, Lucila Rey‐Ares, Demián Glujovsky, María Luisa Cafferata, and Silvana Cesaroni all received payments from this grant. They have no other conflicts of interest to declare.

Aikant Bhatti ‐ none known.

Disclaimer: the views herein are those of the authors and not necessarily those of the PAHO.

Figures

1
1
Study flow diagram.
2
2
'Risk of bias' graph by experimental / quasi‐experimental design: review authors' judgements about each risk of bias item presented as percentages across all studies
3
3
A summary table of review authors' judgements for each 'Risk of bias' item for each study
4
4
Funnel plot of comparison: 1 IPV‐OPV vs OPV, outcome: 1.1 Persons with P1 Protective humoral response.
5
5
Funnel plot of comparison: 2 IPV‐OPV vs IPV, outcome: 2.1 Persons with P1 Protective humoral response.
1.1
1.1. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 1 Persons with P1 Protective humoral response.
1.2
1.2. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 2 Persons with P1 Protective humoral response by time of first dose.
1.3
1.3. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 3 Persons with P1 Protective humoral response by type of dose sequence.
1.4
1.4. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 4 Persons with P1 Protective humoral response by countries' income.
1.5
1.5. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 5 Persons with P2 Protective humoral response.
1.6
1.6. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 6 Persons with P2 Protective humoral response by time of first dose.
1.7
1.7. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 7 Persons with P2 Protective humoral response by type of dose sequence.
1.8
1.8. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 8 Persons with P2 Protective humoral response by countries' income.
1.9
1.9. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 9 Persons with P3 Protective humoral response.
1.10
1.10. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 10 Persons with P3 Protective humoral response by time of first dose.
1.11
1.11. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 11 Persons with P3 Protective humoral response by type of dose sequence.
1.12
1.12. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 12 Persons with P3 Protective humoral response by countries' income.
1.13
1.13. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 13 Mean titres of P1 neutralising antibody.
1.14
1.14. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 14 Mean titres of P2 neutralising antibody.
1.15
1.15. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 15 Mean titres of P3 neutralising antibody.
1.16
1.16. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 16 Long term mean titres of P1 neutralising antibody.
1.17
1.17. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 17 Long term mean titres of P2 neutralising antibody.
1.18
1.18. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 18 Long term mean titres of P3 neutralising antibody.
1.19
1.19. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 19 Persons with polio faecal excretion after OPV challenge.
1.20
1.20. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 20 Vaccination coverage.
1.21
1.21. Analysis
Comparison 1 IPV‐OPV versus OPV, Outcome 21 Serious adverse events classified by MedDRA.
2.1
2.1. Analysis
Comparison 2 IPV‐OPV versus IPV, Outcome 1 Persons with P1 Protective humoral response.
2.2
2.2. Analysis
Comparison 2 IPV‐OPV versus IPV, Outcome 2 Persons with P2 Protective humoral response.
2.3
2.3. Analysis
Comparison 2 IPV‐OPV versus IPV, Outcome 3 Persons with P3 Protective humoral response.
2.4
2.4. Analysis
Comparison 2 IPV‐OPV versus IPV, Outcome 4 Mean titres of P1 neutralising antibody.
2.5
2.5. Analysis
Comparison 2 IPV‐OPV versus IPV, Outcome 5 Mean titres of P2 neutralising antibody.
2.6
2.6. Analysis
Comparison 2 IPV‐OPV versus IPV, Outcome 6 Mean titres of P3 neutralising antibody.
2.7
2.7. Analysis
Comparison 2 IPV‐OPV versus IPV, Outcome 7 Long term mean titres of P1 neutralising antibody.
2.8
2.8. Analysis
Comparison 2 IPV‐OPV versus IPV, Outcome 8 Long term mean titres of P2 neutralising antibody.
2.9
2.9. Analysis
Comparison 2 IPV‐OPV versus IPV, Outcome 9 Long term mean titres of P3 neutralising antibody.
2.10
2.10. Analysis
Comparison 2 IPV‐OPV versus IPV, Outcome 10 Persons with polio faecal excretion after OPV challenge.
2.11
2.11. Analysis
Comparison 2 IPV‐OPV versus IPV, Outcome 11 Serious adverse events (≥1 symptom related to study drug or not).
3.1
3.1. Analysis
Comparison 3 IPV(3)‐OPV versus IPV(2)‐OPV, Outcome 1 Persons with polio protective humoral response.
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References to other published versions of this review

Ciapponi 2014
    1. Ciapponi A, Bardach A, Rey Ares L, Glujovsky D, Cafferata ML, Romano M, et al. Sequential inactivated (IPV) and live oral (OPV) poliovirus vaccines for preventing poliomyelitis. Cochrane Database of Systematic Reviews 2014, Issue 8. [DOI: 10.1002/14651858.CD011260] - DOI - PMC - PubMed

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