SAFETY OF MINERAL OIL AS AN ADJUVANT FOR AIDS VACCINES

一种疫苗要想对艾滋病有效，它必须足够 抗原性，以诱导高水平的保护性抗体。在… 目前，预计艾滋病毒本身的制剂或 从它衍生的馏分或表位是不够的 抗原性，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，但 已经表达了对可能的长期不利影响的担忧 无论是免疫系统的影响，还是由于 恶毒。这项研究的目的是确定这一点 担忧是实实在在的。 在1951-1953年间，18000名男性接种了带有佐剂的流感疫苗 用矿物油和Arlacel A的混合物来确定 使用这种佐剂可能与长期的不良反应有关。 效果，这些人的死亡体验将被比较 而接受对照接种的22,000名男性 正规化Slaine溶液。死亡将被确定为 受益人身份识别和记录定位器的搜索 退伍军人管理局的子系统(BILS)。据估计 2,000个“匹配”将是可疑的，并将对照 圣路易斯唱片中心的缩微胶片唱片。死亡 证书将从退伍军人管理局获得；如果在那里没有， 然后从适当的州开始。死亡人数将由以下人员分析 时间和原因，主要涉及与以下情况有关的死亡 使用其的免疫系统的恶性肿瘤或疾病 9和17执行的早期分析中使用的标准 在接种疫苗数年后。这项研究是在33-35年后进行的 疫苗接种，将覆盖预期的最长诱导期 恶性疾病。如果死因和死亡时间没有差别 可以在这两组男人之间建立，它将是 矿物油-ALACEL A混合物作为助剂的可行性 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.