Effect of early two-dose measles vaccination on childhood mortality and modification by maternal measles antibody in Guinea-Bissau, West Africa: A single-centre open-label randomised controlled trial.
Heterologous effecs
Maternal antibody
Maternal priming
Measles
Mortality
Non-specific effects
Vaccines
Journal
EClinicalMedicine
ISSN: 2589-5370
Titre abrégé: EClinicalMedicine
Pays: England
ID NLM: 101733727
Informations de publication
Date de publication:
Jul 2022
Jul 2022
Historique:
received:
22
02
2022
revised:
26
04
2022
accepted:
05
05
2022
entrez:
24
6
2022
pubmed:
25
6
2022
medline:
25
6
2022
Statut:
epublish
Résumé
Early 2-dose measles vaccine (MV) at 4 and 9 months of age vs. the WHO strategy of MV at 9 months of age reduced all-cause child mortality in a previous trial. We aimed to test two hypotheses: 1) a 2-dose strategy reduces child mortality between 4 and 60 months of age by 30%; 2) receiving early MV at 4 months in the presence versus absence of maternal measles antibodies (MatAb) reduces child mortality by 35%. Single-centre open-label community-based randomised controlled trial in Guinea-Bissau, with 2:1 block-randomisation by sex to a 2-dose (4 + 9 months) vs. 1-dose (9 months) MV strategy. Healthy children were eligible 4 weeks after the 3rd diphtheria-tetanus-pertussis-containing vaccine. Before randomisation a blood sample was collected to determine MatAb level. The primary outcome was all-cause mortality. Hazard ratios (HR) were derived from Cox regression in the per protocol population. We tested for interactions with national campaigns with oral polio vaccine (C-OPV). Trial registration: NCT01486355. Between August 2011-April 17th 2015, 6,636 children were enroled, 6,598[n The main result contrasts with previous findings but may, though based on a small number of events, be explained by frequent OPV campaigns that reduced the mortality rate, but apparently interacted negatively with early MV. The beneficial non-specific effects of MV in the presence of MatAb should be investigated further. ERC, Danish National Research Foundation, the Danish Council for Development Research, Ministry of Foreign Affairs, Novo Nordisk Foundation, European Union and the Lundbeck Foundation.
Sections du résumé
Background
UNASSIGNED
Early 2-dose measles vaccine (MV) at 4 and 9 months of age vs. the WHO strategy of MV at 9 months of age reduced all-cause child mortality in a previous trial. We aimed to test two hypotheses: 1) a 2-dose strategy reduces child mortality between 4 and 60 months of age by 30%; 2) receiving early MV at 4 months in the presence versus absence of maternal measles antibodies (MatAb) reduces child mortality by 35%.
Methods
UNASSIGNED
Single-centre open-label community-based randomised controlled trial in Guinea-Bissau, with 2:1 block-randomisation by sex to a 2-dose (4 + 9 months) vs. 1-dose (9 months) MV strategy. Healthy children were eligible 4 weeks after the 3rd diphtheria-tetanus-pertussis-containing vaccine. Before randomisation a blood sample was collected to determine MatAb level. The primary outcome was all-cause mortality. Hazard ratios (HR) were derived from Cox regression in the per protocol population. We tested for interactions with national campaigns with oral polio vaccine (C-OPV). Trial registration: NCT01486355.
Findings
UNASSIGNED
Between August 2011-April 17th 2015, 6,636 children were enroled, 6,598[n
Interpretation
UNASSIGNED
The main result contrasts with previous findings but may, though based on a small number of events, be explained by frequent OPV campaigns that reduced the mortality rate, but apparently interacted negatively with early MV. The beneficial non-specific effects of MV in the presence of MatAb should be investigated further.
Funding
UNASSIGNED
ERC, Danish National Research Foundation, the Danish Council for Development Research, Ministry of Foreign Affairs, Novo Nordisk Foundation, European Union and the Lundbeck Foundation.
Identifiants
pubmed: 35747181
doi: 10.1016/j.eclinm.2022.101467
pii: S2589-5370(22)00197-3
pmc: PMC9156892
doi:
Banques de données
ClinicalTrials.gov
['NCT01486355']
Types de publication
Journal Article
Langues
eng
Pagination
101467Informations de copyright
© 2022 The Authors.
Déclaration de conflit d'intérêts
OB received a scholarship from the Lundbeck Foundation. All other authors declare no competing interests.
Références
Lancet. 2003 Jun 28;361(9376):2183-8
pubmed: 12842371
Clin Infect Dis. 2021 May 18;72(10):e596-e603
pubmed: 32949460
Front Pediatr. 2020 Feb 07;8:20
pubmed: 32117827
Clin Infect Dis. 2014 Aug 15;59(4):484-92
pubmed: 24829213
AIDS. 2018 Jun 1;32(9):1193-1198
pubmed: 29683842
J Infect. 1984 Jan;8(1):13-21
pubmed: 6699411
Clin Infect Dis. 2018 May 2;66(10):1573-1580
pubmed: 29177407
Vaccine. 2002 Nov 22;21(1-2):120-6
pubmed: 12443670
Pediatr Infect Dis J. 2003 Sep;22(9):798-805
pubmed: 14506371
BMJ. 2008 Jul 24;337:a661
pubmed: 18653640
Lancet Infect Dis. 2020 Oct;20(10):e274-e283
pubmed: 32645296
Proc Natl Acad Sci U S A. 2012 Oct 23;109(43):17537-42
pubmed: 22988082
EBioMedicine. 2016 Aug;10:312-7
pubmed: 27498365
Wkly Epidemiol Rec. ;92(17):205-27
pubmed: 28459148
BMJ. 1995 Aug 19;311(7003):481-5
pubmed: 7647643
Int J Epidemiol. 2003 Feb;32(1):106-16
pubmed: 12690020
Trends Immunol. 2013 Sep;34(9):431-9
pubmed: 23680130
Lancet. 1981 Apr 4;1(8223):764-7
pubmed: 6110963
BMJ. 2010 Nov 30;341:c6495
pubmed: 21118875
Pediatr Infect Dis J. 2007 Mar;26(3):247-52
pubmed: 17484223
J Pediatric Infect Dis Soc. 2020 Apr 30;9(2):166-172
pubmed: 30715451
Clin Infect Dis. 2019 May 2;68(10):1758-1760
pubmed: 30329030
BMJ Open. 2016 Dec 23;6(12):e013335
pubmed: 28011813
Front Public Health. 2018 Feb 02;6:13
pubmed: 29456992
Trans R Soc Trop Med Hyg. 2015 Jan;109(1):16-28
pubmed: 25573106
Clin Infect Dis. 2017 Aug 1;65(3):420-421
pubmed: 28407072
Vaccine. 2017 Mar 1;35(9):1211
pubmed: 25804705
J Infect Dis. 2014 Sep 1;210(5):693-700
pubmed: 24688075