SAFETY OF MINERAL OIL AS AN ADJUVANT FOR AIDS VACCINES

要使疫苗对艾滋病有效，它必须充分 抗原性以引发高水平的保护性抗体。 在 目前，预计艾滋病毒本身或 从其衍生的片段或表位将不足以 抗原性的，并将需要使用佐剂。 矿物油- Arlacel A已被证明是一种非常有效的佐剂， 人们对可能产生的长期不利影响表示担忧， 影响，无论是免疫系统或通过发展 恶性肿瘤 这项研究的目的是确定这是否 关心是真实的。 1951-1953年，18，000名男性接种了含佐剂的流感疫苗， 由矿物油和Arlacel A. 以确定是否 这种佐剂的使用可能与长期不良反应有关 影响，这些人的死亡经验将进行比较， 22，000名接受控制接种的男性， 福尔马林盐水溶液。 死亡将由 查阅受益人识别及记录 退伍军人管理局的子系统（BIRLS）。 估计 2,000个“匹配”将是可疑的，并将根据 圣路易斯唱片中心的微缩胶片唱片 死亡 将从VA获得证书;如果那里没有， 然后从适当的状态。 死亡人数将由 时间和原因，主要关注与以下方面有关的死亡 恶性肿瘤或免疫系统疾病 标准已被用于较早的分析进行了9和17 接种疫苗后几年。 这项研究在33-35年后进行， 疫苗接种，将涵盖最大预期诱导期， 恶性疾病 如果死因和死亡时间没有差异 在这两组人之间建立起来， 以矿物油-Arlacel A混合物为佐剂是可行的 HIV或其裂解产物或表位。

For a vaccine to be effective against AIDS, it must be sufficiently antigenic to elicit a high level of protective antibodies. At present, it is expected that the preparations of the HIV itself or fractions or epitopes derived from it will not be sufficiently antigenic and will require the use of an adjuvant. Mineral oil- Arlacel A has been shown to be a very effective adjuvant, but concern has been expressed over possible long-term adverse effects, either of the immune system or by the development of malignancy. The purpose of this study is to ascertain whether this concern is real. In 1951-1953, 18,000 men were given influenza vaccine adjuvanted by a mixture of mineral oil and Arlacel A. To determine whether the use of this adjuvant may be associated with long-term adverse effects, the mortality experience of these men will be compared to that of 22,000 men who received a control inoculation of formalinized slaine solution. Deaths will be as certained by search of the Beneficiary Identification and Records Locator Subsystem (BIRLS) of the Veteran's Administration. An estimated 2,000 "matches" will be doubtful, and will be checked against the microfilm records at the St. Louis Records Center. Death certificates will be obtained from the VA; if not available there, then from the appropriate state. The deaths will be analyzed by time and cause, with principle interest in deaths related to malignancy or diseases of the immune system using the same criteria that had been used in earlier analyses carried out 9 and 17 years after vaccination. This study, carried out 33-35 years after vaccination, will cover the maximal expected induction period for malignant disease. If no differences in causes and times of death can be established between these two groups of men, it will be feasible to use the mineral oil-Arlacel A mixture as an adjuvant to HIV or split products or epitopes thereof.