Evidence map›Paper›PMID 28011813›Full record

Trial reportBMJ open2016

Does oral polio vaccine have non-specific effects on all-cause mortality? Natural experiments within a randomised controlled trial of early measles vaccine.

Peter Aaby, Andreas Andersen, Cesário L Martins, Ane B Fisker, Amabelia Rodrigues, Hilton C Whittle, Christine S Benn

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
1.9field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 66 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 3 countries.

Peter AabyBandim Health Project, Indepth Network, Bissau, Guinea-Bissau.
Andreas AndersenResearch Centre for Vitamins and Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark.
Cesário L MartinsBandim Health Project, Indepth Network, Bissau, Guinea-Bissau.
Ane B FiskerBandim Health Project, Indepth Network, Bissau, Guinea-Bissau.
Amabelia RodriguesBandim Health Project, Indepth Network, Bissau, Guinea-Bissau.
Hilton C WhittleThe London School of Hygiene and Tropical Medicine, London, UK.
Christine S BennBandim Health Project, Indepth Network, Bissau, Guinea-Bissau.
Bandim Health Project · GWStatens Serum Institut · DKLondon School of Hygiene & Tropical Medicine · GB

Funding

European Research Council 243149
6 · The paper itself

Abstract

backgroundBCG and measles vaccine (MV) may have beneficial non-specific effects (NSEs). If an unplanned intervention with a vaccine (a natural experiment) modifies the estimated effect in a randomised controlled trial (RCT), this suggests NSEs. We used this approach to test NSEs of triple oral polio vaccine (OPV).

methodsDuring an RCT of 2 doses of MV at 4.5 and 9 months versus 1 dose of MV at 9 months of age, we experienced 2 natural experiments with OPV. We assessed whether these OPV experiments modified the effect of 2-dose MV in the MV trial.

settingMV RCT conducted in urban Guinea-Bissau 2003-2009.

interventionsNatural experiments with OPV due to missing vaccine and the implementation of OPV campaigns.

main outcome measureChanges in the mortality rate ratio (MRR) for 2-dose MV versus 1-dose MV.

resultsFirst, the MRR (2-dose/1-dose MV) overall was 0.70 (0.52 to 0.94), but the MRR was 1.04 (0.53 to 2.04) when OPV at birth (OPV0) was not given, suggesting that early priming with OPV was important for the effect of 2-dose MV. The effect of OPV0 depended on age of administration; the MRR (2-dose/1-dose MV) was 0.45 (0.29 to 0.71) for children receiving OPV0 in the first week of life, but 3.63 (0.87 to 15.2) for those receiving OPV0 after the first month of life (p=0.007, test of no interaction). Second, campaign-OPV may have reduced the difference between the randomisation groups since the MRR (2-dose/1-dose MV) was 0.60 (0.42 to 0.85) for children who had not received campaign-OPV before RCT-enrolment versus 0.72 (0.23 to 2.31) and 1.42 (0.70 to 2.90) for children who had received 1 or 2 doses of campaign-OPV-before-enrolment, respectively.

conclusionsBissau had no polio infection during this trial, so OPV0 and campaign-OPV may have NSEs since they modified the effect of 2-dose MV in an RCT. Different interventions may interact to a much larger effect than usually assumed.

Indexed as

Child MortalityImmunity, HeterologousInfant MortalityPoliovirus Vaccine, OralVaccinationAge FactorsCause of DeathChild, PreschoolDrug Administration ScheduleFemaleGuinea-BissauHumansImmune SystemInfantInfant, NewbornMaleMeasles VaccinePoliovirus Vaccine, Oralage of administration,measles vaccine,natural experiment,non-specific effect of vaccinesOPV,oral polio vaccine,

Identifiers

PMID28011813
PMCPMC5223718
OpenAlexW2562287831

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.