HIV陽性嬰兒對PCV耐受性良好


  July 7, 2003 -根據一項發表在六月份的Pediatrics的隨機試驗結果指出,HIV(人類免疫缺陷病毒)陽性嬰兒對七價肺炎雙球菌結合疫苗耐受性好且沒有相關的副作用,但是,研究人員還是警告,如果要用在有症狀HIV疾病病人身上,還需要進一步的研究。
  
  紐約州立大學健康科學中心的Sharon Nachman, MD博士表示,已經有研究證實,七價肺炎雙球菌結合疫苗 (PCV) 用在健康嬰兒和孩童身上是安全有效的,但是,對於疫苗用在已經出現HIV感染以及已知發生肺炎雙球菌感染危險增加的孩子身上,我們所知很少,這項研究計畫名為Pediatric AIDS Clinical Trials Group Study 292。
  
  這項雙盲試驗,HIV感染嬰兒以2:1被隨機分組,接受PCV 或者安慰劑疫苗,兩個月間隔三次,從出生後56天到180天,增強劑量在15個月的時候開始。
  
  PCV治療組的30個嬰兒和15個安慰劑組嬰兒的基線特徵沒有差異,其中四個曾有嚴重急性反應的嬰兒,三個在PCV組,一個在安慰劑組,所有的嬰兒在研究開始的時候有症狀性疾病。
  
  新診斷的數量和時間涵蓋24個月,包括中耳炎的診斷,在兩組都是相似的,但是,在症狀的個體,第一個新診斷在PCV組更快發生,隨訪期間的三個死亡病例,兩個在PCV組,一個在安慰劑組,但是都與研究疫苗無關。
  
  主要的產生免疫性指標,根據血清型特異性免疫球蛋白G滴度四倍變化合成物,顯示PCV組反應率顯著增高,無症狀和有症狀嬰兒接受PCV對所有血清型有相似的免疫反應,這項研究的侷限包括比較安全性指標的低效能以及缺少免疫反應壽命的長期資料。
  
  作者寫到,這項研究表明七價PCV 耐受性良好且與疫苗相關副作用沒有關係,更重要的是,該疫苗在HIV感染嬰兒身上可產生免疫性,但是,該疫苗或其他疫苗用在症狀性HIV疾病病人身上,研究的時候必須特別加以注意,因為這些病人對任何抗原出現副作用的危險性是較高的。

Heptavalent Pneumococcal Conju

By Laurie Barclay, MD
Medscape Medical News

July 7, 2003 — The heptavalent pneumococcal conjugate vaccine is well tolerated in human immunodeficiency virus (HIV)-positive infants without associated adverse effects, according to the results of a randomized trial published in the July issue of Pediatrics. However, the investigators caution that further research is needed for use in symptomatic HIV disease.

"Heptavalent pneumococcal conjugate vaccine (PCV) has been shown to be safe and effective in healthy infants and children," write Sharon Nachman, MD, from State University of New York Health Science Center at Stony Brook, and colleagues from the Pediatric AIDS Clinical Trials Group Study 292 Team. "However, little is known about its use in children who have HIV infection and are known to be at increased risk of developing pneumococcal infections."

In this double-blind trial, infants with HIV infection were randomized 2:1 to receive heptavalent PCV or placebo vaccinations, three doses at two-month intervals, starting at ages 56 to 180 days, and a booster dose at 15 months of age.

There were no differences in baseline characteristics in 30 infants who received PCV compared with 15 who received placebo. Of four subjects who experienced five severe acute reactions, three were in the PCV group and one was in the placebo group, and all had symptomatic disease at study entry.

The number and timing of new diagnoses through 24 months of age, including diagnoses of otitis media, were similar in both groups. However, among symptomatic subjects, the first new diagnosis occurred more rapidly among PCV recipients. Of three deaths during follow-up, two were in the PCV arm and one was in the placebo arm, and all were thought to be unrelated to study vaccine.

Primary immunogenicity measures, based on composites of fourfold changes in serotype-specific immunoglobulin G titers from preimmunization levels, showed significantly higher rates of response in the PCV arm. Asymptomatic and symptomatic infants who received PCV had similar immunologic responses for all serotypes.

Study limitations include low power to compare safety measures across arms and lack of long-term data on the longevity of the immune response.

"This study demonstrates that heptavalent PCV was well tolerated and not associated with vaccine-associated adverse reactions. Most important, this vaccine was immunogenic in the infant with HIV infection," the authors write. "However, additional studies of this vaccine (or others) must pay special attention to patients with symptomatic HIV disease, as they seem to be at higher risk for adverse events to any antigen."

One of the authors is employed by and has a direct financial interest in Wyeth, maker of the vaccine used in this study. Dr. Nachman serves as a consultant for Abbott, Bristol-Myers Squibb, GlaxoSmithKline, Wyeth, Boehringer Ingelheim, and Pfizer.

Pediatrics. 2003;112:66-73

Reviewed by Gary D. Vogin, MD

    
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