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No effect of an additional early dose of measles vaccine on hospitalization or mortality in children: A randomized controlled trial.

Abstract：

BACKGROUND:Non-specific effects (NSEs) of vaccines have increasingly gained attention in recent years. Recent studies suggest that live vaccines, such as measles vaccine (MV), have beneficial effects on health, while inactivated vaccines, such as the diphtheria-tetanus-pertussis (DTP) vaccine, may have harmful effects. If this is the case, it should improve child health to move MV closer to the last vaccination with DTP. The objective of this study was to investigate the NSEs of an additional early dose of MV on hospitalization or mortality. METHODS:Children were randomized to receive either the standard MV at 9 months (control) or an additional early dose of MV 4 weeks after the third dose of DTP-containing Pentavalent vaccine and the standard MV at 9 months (intervention). In this analysis of a secondary outcome in the trial, we investigated the effect of the intervention on a composite endpoint of over-night hospitalization with or without recovery, or death without previous hospitalization, in children between 4.5 and 36 months of age in the Nouna HDSS in Burkina Faso. We used Cox proportional hazards regression with repeated events and time since study enrolment as underlying time-scale. RESULTS:Among 2258 children in the intervention and 2238 children in the control group we observed a total of 464 episodes of hospitalization or mortality. There was no difference between intervention and control group (HR = 1.00, 95% Confidence Interval (CI) 0.83-1.20). Results from the per-protocol and intention-to-treat analysis were similar. Although no significant, results suggest a possible beneficial effect of early MV in children that had not been exposed to an OPV campaign after enrolment (HR = 0.83, 95% CI 0.55-1.29). CONCLUSIONS:We did not detect any effect of early MV on subsequent hospitalization or mortality. However, possible effects of early MV could have been obscured by NSEs of the frequent OPV campaigns. Registration: The trial was registered at ClinicalTrials.gov, NCT01644721.

journal_name

Vaccine

journal_title

Vaccine

authors

Schoeps A,Nebié E,Fisker AB,Sié A,Zakane A,Müller O,Aaby P,Becher H

doi

10.1016/j.vaccine.2018.02.104

subject

Has Abstract

pub_date

2018-04-05 00:00:00

pages

1965-1971

issue

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(18)30314-1

journal_volume

pub_type

临床试验,杂志文章,随机对照试验

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No effect of an additional early dose of measles vaccine on hospitalization or mortality in children: A randomized controlled trial.