A Two-Center Randomized Trial of an Additional Early Dose of Measles Vaccine: Effects on Mortality and Measles Antibody Levels. (21st November 2017)

• Record Type: Journal Article
• Authors: Fisker, Ane B; Nebie, Eric; Schoeps, Anja; Martins, Cesario; Rodrigues, Amabelia; Zakane, Alphonse; Kagone, Moubassira; Byberg, Stine; Thysen, Sanne M; Tiendrebeogo, Justin; Coulibaly, Boubacar; Sankoh, Osman; Becher, Heiko; Whittle, Hilton C; van der Klis, Fiona R M; Benn, Christine S; Sie, Ali; Müller, Olaf; Aaby, Peter
• Is Part Of: Clinical infectious diseases. Volume 66:Number 10(2018)
• Page Start: 1573
• Page End: 1580
• Publication Date: 2017-11-21
• Subjects: measles vaccination -- heterologous (nonspecific) effects of vaccines -- child mortality -- measles antibody levels; Communicable diseases -- Periodicals; 616.905
• DOI: 10.1093/cid/cix1033
• Languages: English
• ISSNs: 1058-4838

Abstract

Abstract : In a randomized trial of an extra dose of early measles vaccine in Burkina Faso and Guinea-Bissau, we found no effect on mortality. Children had low antibody levels at enrollment and responded well to early vaccination. Abstract: Background: In addition to protecting against measles, measles vaccine (MV) may have beneficial nonspecific effects. We tested the effect of an additional early MV on mortality and measles antibody levels. Methods: Children aged 4–7 months at rural health and demographic surveillance sites in Burkina Faso and Guinea-Bissau were randomized 1:1 to an extra early standard dose of MV (Edmonston-Zagreb strain) or no extra MV 4 weeks after the third diphtheria-tetanus-pertussis-hepatitis B- Haemophilus influenzae type b vaccine. All children received routine MV at 9 months. We assessed mortality through home visits and compared mortality from enrollment to age 3 years using Cox proportional hazards models, censoring for subsequent nontrial MV. Subgroups of participants had blood sampled to assess measles antibody levels. Results: Among 8309 children enrolled from 18 July 2012 to 3 December 2015, we registered 145 deaths (mortality rate: 16/1000 person-years). The mortality was lower than anticipated and did not differ by randomization group (hazard ratio, 1.05; 95% confidence interval, 0.75–1.46). At enrollment, 4% (16/447) of children in Burkina Faso and 21% (90/422) in Guinea-Bissau had protective measles antibody levels. By age 9 months, no measles-unvaccinated/-unexposed child had protective levels, while 92% (306/333) of early MV recipients had protective levels. At final follow-up, 98% (186/189) in the early MV group and 97% (196/202) in the control group had protective levels. Conclusions: Early MV did not reduce all-cause mortality. Most children were susceptible to measles infection at age 4–7 months and responded with high antibody levels to early MV. Clinical Trials Registration: NCT01644721.