Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
J Acquir Immune Defic Syndr. 2013 May 1;63(1):1-8. doi: 10.1097/QAI.0b013e31827f1c2d.
The development of a safe and effective vaccine against HIV type 1 for the prevention of mother-to-child transmission of HIV would significantly advance the goal of eliminating HIV infection in children. Safety and feasibility results from phase 1, randomized, double-blind, placebo-controlled trial of ALVAC-HIV vCP1521 in infants born to HIV type 1-infected women in Uganda are reported.
HIV-exposed infants were enrolled at birth and randomized (4:1) to receive vaccine or saline placebo intramuscular injections at birth, 4, 8, and 12 weeks of age. Vaccine reactogenicity was assessed at vaccination and days 1 and 2 postvaccination. Infants were followed until 24 months of age. HIV infection status was determined by HIV DNA polymerase chain reaction.
From October 2006 to May 2007, 60 infants (48 vaccine and 12 placebo) were enrolled with 98% retention at 24 months. One infant was withdrawn, but there were no missed visits or vaccinations among the 59 infants retained. Immune responses elicited by diphtheria, polio, hepatitis B, haemophilus influenzae type B, and measles vaccination were similar in the 2 arms. The vaccine was well tolerated with no severe or life-threatening reactogenicity events. Adverse events were equally distributed across both study arms. Four infants were diagnosed as HIV infected [3 at birth (2 vaccine and 1 placebo) and 1 in vaccine arm at 2 weeks of age].
The ALVAC-HIV vCP1521 vaccination was feasible and safe in infants born to HIV-infected women in Uganda. The conduct of high-quality infant HIV vaccine trials is achievable in Africa.
开发一种安全有效的 HIV-1 疫苗用于预防母婴传播 HIV 将极大地推进消除儿童中 HIV 感染的目标。本文报道了在乌干达感染 HIV-1 的妇女所生婴儿中进行的 1 期、随机、双盲、安慰剂对照试验中，ALVAC-HIV vCP1521 的安全性和可行性结果。
HIV 暴露婴儿在出生时入组并随机（4:1）接受疫苗或生理盐水安慰剂肌内注射，分别于出生、4、8 和 12 周时接种。在接种疫苗和接种后第 1 和第 2 天评估疫苗的反应原性。婴儿随访至 24 个月。通过 HIV DNA 聚合酶链反应确定 HIV 感染状态。
从 2006 年 10 月至 2007 年 5 月，共有 60 名婴儿（48 名疫苗和 12 名安慰剂）入组，24 个月时的保留率为 98%。1 名婴儿退出，但在保留的 59 名婴儿中无漏诊或漏种。在两组中，白喉、脊髓灰质炎、乙型肝炎、流感嗜血杆菌 B 型和麻疹疫苗接种引起的免疫反应相似。疫苗耐受性良好，无严重或危及生命的反应原性事件。不良事件在两个研究组中分布均匀。有 4 名婴儿被诊断为 HIV 感染[3 名在出生时（2 名疫苗和 1 名安慰剂），1 名在疫苗组在 2 周龄时]。
ALVAC-HIV vCP1521 疫苗在乌干达感染 HIV 的妇女所生婴儿中是可行和安全的。在非洲进行高质量的婴儿 HIV 疫苗试验是可行的。
