Garly M L, Martins C L, Balé C, da Costa F, Dias F, Whittle H, Aaby P
Projecto de Saúde de Bandim, Bissau, Guinea-Bissau.
Int J Epidemiol. 1999 Apr;28(2):347-52. doi: 10.1093/ije/28.2.347.
Previous studies from Africa have suggested that there is little benefit to be gained from early two-dose measles vaccination schedules. Two-dose schedules have been associated with no improvement in coverage due to immunization of the same individuals on both occasions, low return rate, high refusal rate, low vaccine efficacy, and fear of blunting of the antibody response. Because of the poor results achieved previously with two-dose measles vaccination schedules, we studied patterns of participation, reasons for non-participation, vaccination coverage and relative efficacy of a one-dose versus a two-dose schedule in connection with the implementation of an early two-dose trial in Guinea-Bissau.
Children born from September 1994 to January 1996 were randomized into two groups receiving either two doses of measles vaccine at 6 and 9 months or one dose of inactivated polio vaccine (IPV) at 6 months and measles vaccine at 9 months.
At 6 months of age 86% (1869/2181) of the children participated, and at 9 months of age participation was 87% (1775/2035). The return rate for obtaining a second dose of vaccine was 93% (1647/1773). The main reason for not participating was travelling (78%). Around 50% of those who did not take part in one vaccination took part in the other. When only children participating the first time they were called for a measles vaccination were included, the measles vaccination coverage in the one-dose group was 59% versus 80% in the two-dose group, i.e. a 50% reduction in the risk of not being vaccinated (relative risk [RR] 0.50; confidence interval [CI]: 0.43-0.57). Few measles cases have occurred in the study area since the implementation of the trial making precise estimation of the relative efficacy of the two vaccine strategies difficult, but all seven clinically diagnosed measles cases occurred in the one-dose group making the relative efficacy for the two-dose group compared with the one-dose group 100% (95% CI: 35%-100%; two-tailed P = 0.016). When including maternal reports, the relative efficacy was 90% (95% exact confidence interval; two-tailed P = 25%-97%, P = 0.022).
In this study of a two-dose measles immunization schedule at 6 and 9 months of age there was no sign of low participation or poor return rates. The risk of not being vaccinated was lower in the two-dose group than in the one-dose group, and the relative efficacy of a two-dose versus a one-dose schedule was high. Although our results were obtained within a trial where dedicated personnel informed every participant personally about the study, we believe our results indicate that with thorough information about the population it may be possible to achieve a higher coverage with a two-dose measles vaccination schedule than a one-dose schedule. A two-dose schedule may be a feasible way to resolve the problems of low coverage and severe measles infection among infants.
非洲此前的研究表明,早期两剂次麻疹疫苗接种方案几乎没有益处。两剂次方案因两次均对同一人群进行免疫接种,导致覆盖率未得到提高,返回率低、拒绝率高、疫苗效力低,且担心抗体反应减弱。鉴于此前两剂次麻疹疫苗接种方案效果不佳,我们结合在几内亚比绍开展的早期两剂次试验,研究了参与模式、未参与原因、疫苗接种覆盖率以及单剂次与两剂次方案的相对效力。
1994年9月至1996年1月出生的儿童被随机分为两组,一组在6个月和9个月时接种两剂次麻疹疫苗,另一组在6个月时接种一剂次灭活脊髓灰质炎疫苗(IPV),并在9个月时接种麻疹疫苗。
6个月龄时,86%(1869/2181)的儿童参与,9个月龄时参与率为87%(1775/2035)。获得第二剂疫苗的返回率为93%(1647/1773)。未参与的主要原因是出行(78%)。约50%未参加一次疫苗接种的儿童参加了另一次接种。当仅纳入首次被邀请进行麻疹疫苗接种时参与的儿童,单剂次组的麻疹疫苗接种覆盖率为59%,而两剂次组为80%,即未接种疫苗的风险降低了50%(相对风险[RR]0.50;置信区间[CI]:0.43 - 0.57)。自试验实施以来,研究地区很少发生麻疹病例,这使得精确估计两种疫苗策略的相对效力变得困难,但所有7例临床诊断的麻疹病例均发生在单剂次组,使得两剂次组与单剂次组相比的相对效力为100%(95%CI:35% - 100%;双侧P = 0.016)。纳入母亲报告后,相对效力为90%(95%精确置信区间;双侧P = 25% - 97%,P = 0.022)。
在这项针对6个月和9个月龄两剂次麻疹免疫接种方案的研究中,没有参与率低或返回率差的迹象。两剂次组未接种疫苗的风险低于单剂次组,且两剂次方案相对于单剂次方案的相对效力较高。尽管我们的结果是在一项由专门人员亲自告知每位参与者有关研究的试验中获得的,但我们认为我们的结果表明,通过对人群进行充分告知,两剂次麻疹疫苗接种方案可能比单剂次方案实现更高的覆盖率。两剂次方案可能是解决婴儿中覆盖率低和严重麻疹感染问题的可行方法。