Protective efficacy of standard Edmonston-Zagreb measles vaccination in infants aged 4.5 months: interim analysis of a randomised clinical trial.
OBJECTIVE
To examine the protective efficacy of measles vaccination in infants in a low income country before 9 months of age.


METHODS
Randomised clinical trial.


METHODS
1333 infants aged 4.5 months: 441 in treatment group and 892 in control group.


METHODS
Urban area in Guinea-Bissau.


METHODS
Measles vaccination using standard titre Edmonston-Zagreb vaccine at 4.5 months of age.


METHODS
Vaccine efficacy against measles infection, admission to hospital for measles, and measles mortality before standard vaccination at 9 months of age.


RESULTS
28% of the children tested at 4.5 months of age had protective levels of maternal antibodies against measles at enrolment. After early vaccination against measles 92% had measles antibodies at 9 months of age. A measles outbreak offered a unique situation for testing the efficacy of early measles vaccination. During the outbreak, 96 children developed measles; 19% of unvaccinated children had measles before 9 months of age. The monthly incidence of measles among the 441 children enrolled in the treatment arm was 0.7% and among the 892 enrolled in the control arm was 3.1%. Early vaccination with the Edmonston-Zagreb measles vaccine prevented infection; vaccine efficacy for children with serologically confirmed measles and definite clinical measles was 94% (95% confidence interval 77% to 99%), for admissions to hospital for measles was 100% (46% to 100%), and for measles mortality was 100% (-42% to 100%). The number needed to treat to prevent one case of measles between ages 4.5 months and 9 months during the epidemic was 7.2 (6.8 to 9.2). The treatment group tended to have lower overall mortality (mortality rate ratio 0.18, 0.02 to 1.36) although this was not significant.


CONCLUSIONS
In low income countries, maternal antibody levels against measles may be low and severe outbreaks of measles can occur in infants before the recommended age of vaccination at 9 months. Outbreaks of measles may be curtailed by measles vaccination using the Edmonston-Zagreb vaccine as early as 4.5 months of age. TRIAL REGISTRATION CLINICAL TRIALS: NCT00168558 [ClinicalTrials.gov].
Martins
Cesário L
CL
Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau.
Garly
May-Lill
ML
Balé
Carlito
C
Rodrigues
Amabelia
A
Ravn
Henrik
H
Whittle
Hilton C
HC
Lisse
Ida M
IM
Aaby
Peter
P
D000914:Antibodies, Viral / Q000097:blood; D004196:Disease Outbreaks; D006169:Guinea-Bissau / Q000453:epidemiology; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D008457:Measles / Q000517:prevention & control*; D008458:Measles Vaccine; D018103:Morbillivirus / Q000276:immunology; D011379:Prognosis; D014504:Urban Health; D014611:Vaccination / Q000706:statistics & numerical data
D000914:Antibodies, Viral; D008458:Measles Vaccine