Article Text

The mortality effects of disregarding the strategy to save doses of measles vaccine: a cluster-randomised trial in Guinea-Bissau
  1. Stine Byberg1,2,3,4,
  2. Peter Aaby1,2,3,
  3. Amabelia Rodrigues1,
  4. Christine Stabell Benn1,2,3,5,
  5. Ane Baerent Fisker1,2,3
  1. 1Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau
  2. 2Bandim Health Project, OPEN, University of Southern Denmark, Copenhagen, Denmark
  3. 3Research Center for Vitamins and Vaccines, Statens Serum Institut, Copenhagen, Denmark
  4. 4Steno Diabetes Center Copenhagen, Gentofte, Denmark
  5. 5Danish Institute for Advanced Study, University of Southern Denmark, Odense, Denmark
  1. Correspondence to Dr Ane Baerent Fisker; afisker{at}health.sdu.dk

Abstract

Introduction Measles vaccine (MV) may improve health beyond measles protection. To avoid wastage from multi-dose vials, children in Guinea-Bissau are only measles vaccinated when aged 9–11 months and when six or more children are present. We assessed health impacts of providing MV to all measles-unvaccinated children 9–35 months.

Methods We cluster-randomised 182 village clusters under demographic surveillance in rural Guinea-Bissau to an ‘MV-for-all-policy’ arm where we offered MV regardless of age and number of children present at our bi-annual village visits, or a ‘Restrictive-MV-policy’ arm where we followed national policy. Measles-unvaccinated children aged 9–35 months were eligible for enrolment and followed to 5 years of age. In intention-to-treat analyses, we compared mortality using Cox regression analyses with age as underlying timescale. The primary analysis was for children aged 12–35 months at eligibility assessment. Interactions with several background factors were explored.

Results Between 2011 and 2016, we followed 2778 children in the primary analysis. MV coverage by 3 years was 97% among children eligible for enrolment under the MV-for-all-policy, and 48% under the Restrictive-MV-policy. Mortality was 59% lower than anticipated and did not differ by trial arm (MV-for-all-policy: 45/1405: Restrictive-MV-policy: 44/1373; HR: 0.95 (95% CI 0.64 to 1.43)). The effect of MV-for-all changed over time: The HR was 0.53 (95% CI 0.27 to 1.07) during the first 1½ years of enrolment but 1.47 (95% CI 0.87 to 2.50) later (p=0.02, test of interaction). Explorative analyses indicated that the temporal change may be related to interactions with other childhood interventions.

Conclusion The MV-for-all-policy increased MV coverage but had no overall effect on overall mortality.

Trial registration number NCT01306006.

  • child health
  • epidemiology
  • immunisation
  • public health
  • vaccines

Data availability statement

Data are available upon request. Requests for access to the data should be addressed to the corresponding author.

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Data availability statement

Data are available upon request. Requests for access to the data should be addressed to the corresponding author.

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Footnotes

  • Handling editor Seye Abimbola

  • Twitter @AneFisker

  • Contributors PA, AR, CSB and ABF designed the trial. SB and ABF supervised enrolments, follow-up, data entry and data cleaning. SB and ABF analysed the data. SB wrote the first draft of the paper. ABF has primary responsibility for the final content. All authors contributed to and approved the final version of the paper.

  • Funding The Danish National Research Foundation (grant: DNRF108) funded the data collection. Odense University Hospital (grant: A70) co-funded the salary of SB. Independent Research Fund Denmark (Sapere Aude Research Leader grant: 9060-00018B) and Lundbeck Foundation (Ascending Investigator grant: R313-2019-635) support ABF’s work.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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