Evidence map›Paper›PMID 29571817›Full record

Trial reportThe Lancet. Infectious diseases2018

Immunogenicity of type 2 monovalent oral and inactivated poliovirus vaccines for type 2 poliovirus outbreak response: an open-label, randomised controlled trial.

Khalequ Zaman, Concepción F Estívariz, Michelle Morales, Mohammad Yunus, Cynthia J Snider, Howard E Gary, William C Weldon, M Steven Oberste, Steven G Wassilak, Mark A Pallansch and 1 more

Open access · greenAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.0field-weighted citation impact, top 22% 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

8 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
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  5. Review
  6. Article
  7. Article
  8. Reflections on Modeling Poliovirus Transmission and the Polio Eradication Endgame.Risk analysis : an official publication of the Society for Risk Analysis · 2021
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 2 countries.

Khalequ ZamanInternational Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.
Concepción F EstívarizCenters for Disease Control and Prevention, Atlanta, GA, USA.
Michelle MoralesCenters for Disease Control and Prevention, Atlanta, GA, USA.
Mohammad YunusInternational Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.
Cynthia J SniderCenters for Disease Control and Prevention, Atlanta, GA, USA.
Howard E GaryCenters for Disease Control and Prevention, Atlanta, GA, USA.
William C WeldonCenters for Disease Control and Prevention, Atlanta, GA, USA.
M Steven ObersteCenters for Disease Control and Prevention, Atlanta, GA, USA.
Steven G WassilakCenters for Disease Control and Prevention, Atlanta, GA, USA.
Mark A PallanschCenters for Disease Control and Prevention, Atlanta, GA, USA.
Abhijeet AnandCenters for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: aanand@cdc.gov.
Centers for Disease Control and Prevention · USInternational Centre for Diarrhoeal Disease Research · BD

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

backgroundMonovalent type 2 oral poliovirus vaccine (mOPV2) and inactivated poliovirus vaccine (IPV) are used to respond to type 2 poliovirus outbreaks. We aimed to assess the effect of two mOPV2 doses on the type 2 immune response by varying the time interval between mOPV2 doses and IPV co-administration with mOPV2.

methodsWe did a randomised, controlled, parallel, open-label, non-inferiority, inequality trial at two study clinics in Dhaka, Bangladesh. Healthy infants aged 6 weeks (42-48 days) at enrolment were randomly assigned (1:1:1:1) to receive two mOPV2 doses (each dose consisting of two drops [0·1 mL in total] of about 10

findingsBetween Dec 7, 2015, and Jan 5, 2016, we randomly assigned 760 infants to receive two mOPV2 doses at intervals of 1 week (n=191), 2 weeks (n=191), 4 weeks (n=188), or 4 weeks plus IPV (n=190). Immune responses after two mOPV2 doses were observed in 161 (93%) of 173 infants with testable serum samples in the 1 week group, 169 (96%) of 177 in the 2 week group, and 176 (97%) of 181 in the 4 week group. 1 week and 2 week intervals between two mOPV2 doses were non-inferior to 4 week intervals because the lower bound of the absolute differences in the percentage of immune responses were greater than -10% (-4·2% [90% CI -7·9 to -0·4] in the 1 week group and -1·8% [-5·0 to 1·5] in the 2 week group vs the 4 week group). The immune response elicited by two mOPV2 doses 4 weeks apart was not different when IPV was added to the first dose (176 [97%] of 182 infants with IPV vs 176 [97%] of 181 without IPV; p=1·0). During the trial, two serious adverse events (pneumonia; one [1%] of 186 patients in the 1 week group and one [1%] of 182 in the 4 week group) and no deaths were reported; the adverse events were not attributed to the vaccines.

interpretationAdministration of mOPV2 at short intervals does not interfere with its immunogenicity. The addition of IPV to the first mOPV2 dose did not improve poliovirus type 2 immune response.

fundingUS Centers for Disease Control and Prevention.

Indexed as

BangladeshDisease OutbreaksFemaleHumansInfantMalePoliomyelitisPoliovirus Vaccine, InactivatedPoliovirus Vaccine, OralPoliovirus Vaccine, InactivatedPoliovirus Vaccine, Oral

Identifiers

PMID29571817
PMCPMC10495755
OpenAlexW2792804150

What OpenQuestion holds

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LicenceTDM
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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 OpenQuestion graph.