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临床试验/NCT00168558
NCT00168558已完成4 期

Measles Vaccination in Guinea-Bissau. Strategies to Reduce Disease Burden and Improve Child Survival

Bandim Health Project2 个研究点 分布在 1 个国家目标入组 5,879 人开始时间: 2003年7月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
5,879
试验地点
2
主要终点
Vaccine efficacy

研究概览

简要总结

The specific aims are to examine in Guinea-Bissau:

  • whether the standard titre Schwarz (SW) or standard-titre Edmonston-Zagreb (EZ) measles vaccine will be the best vaccine strain for use in a routine one-dose measles vaccination schedule and a two-dose measles vaccination schedule in terms of antibody response, protection against measles and child survival, and
  • whether the standard-titre Edmonston-Zagreb (EZ) vaccine will be suitable for use in a very early two-dose schedule vaccinating at 4½ and 9 months of age

详细描述

BACKGROUND:

Two dose schedules:

After the failure of the high-titre measles vaccine, which was to be administered at 6 months of age it was suggested to perform trials of early two-dose measles vaccination schedules to lower the age of vaccination. The standard titre SW measles vaccine has been shown to be associated with a non-specific beneficial effect on child mortality that cannot be ascribed to the protection against measles. The two measles vaccines most commonly used in the Expanded Programme on Immunization (EPI) are the standard titre SW and the standard titre EZ vaccine. Surprisingly, these two vaccines have never been compared in a randomised trial with child mortality as end-point, and it is not clear which would be most suitable for use in a two-dose vaccination schedule.

From 1995 to 2002, all children in the BHP study area were included in an early two-dose measles vaccination trial from 6 months of age. The children were randomised to either a one-dose group receiving an inactivated polio vaccine (IPV) at 6 months of age and a measles vaccine at 9 months of age, or a two-dose group receiving two doses of measles vaccine at 6 and 9 months of age. For the first 6 months of the trial, the standard-titre EZ measles vaccine was used, for the rest of the trial the standard-titre SW vaccine was used. Results from the trial showed that an early two-dose schedule increased coverage considerably and provided better protection against measles among infants than the recommended one-dose at 9 months of age schedule. The EZ and the SW vaccine were used in two different cohorts - so a direct comparison was not possible, but the EZ vaccine seemed to boost a secondary immune response better than the SW vaccine. Further, the SW vaccine was less able to induce a protective level of antibodies when used from 6 months of age than the EZ vaccine. The preliminary data that we have on long-term vaccine efficacy supports that the SW vaccine might be less suitable than the EZ vaccine for use in very early measles vaccine schedules (unpublished data). On the other hand, trials performed during the 1980's in Mexico and Bangladesh have shown that administration of the standard-titre EZ vaccine to infants as young as 4-6 months of age gave good seroconversion results.

The Global Measles Strategic Plan 2001-2005 developed by the WHO and UNICEF states that all children should be guaranteed a second opportunity for measles vaccination either through campaigns or routine immunisation. The best strategy for protection of infants living in overcrowded urban African societies and who run a great risk of contracting measles before the recommended age of immunisation, will probably be early vaccination followed by a second vaccination later in childhood. If, in a vaccination campaign strategy, administration of the first vaccine is postponed this could dramatically increase the measles incidence in children below the age of vaccination. To this add that vaccination campaigns have not yet been evaluated in Africa in terms of childhood mortality relative to the routine schedule. Some children might get two, three or even more measles vaccines in an uncontrolled and not necessarily beneficial manner. Thus finding the best schedule and vaccine strain for use in a routine two-dose schedule seems a better approach for this region.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
4 Months 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants of 4½ months of age registered in the Bandim Health Project registration system and currently living in the Bandim Health Project areas: Bandim I, Bandim II, Belem, Mindará and Cuntum; and who received all three diphtheria-tetanus-pertussis vaccinations at least 4 weeks before enrollment

排除标准

  • Severe illness requiring immediate hospitalisation

结局指标

主要结局

Vaccine efficacy

时间窗: Assessed by study completion

Measles specific mortality

时间窗: Assessed by study completion

All cause sex-specific mortality until 3 years of age

时间窗: Assessed by study completion

次要结局

  • Measles antibody level at 4½, 9, 18 and 24 months of age(Assessed by study completion)
  • Morbidity from 4½ to 12 months of age(Assessed by study completion)
  • Anthropometric measures at 4½, 9, 18 and 24 months of age(Assessed by study completion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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