Lambert J S, Keefer M, Mulligan M J, Schwartz D, Mestecky J, Weinhold K, Smith C, Hsieh R, Moldoveanu Z, Fast P, Forrest B, Koff W
Institute of Human Virology, University of Maryland, 725 West Lombard Street, Baltimore, MD21201, USA.
Vaccine. 2001 Apr 30;19(23-24):3033-42. doi: 10.1016/s0264-410x(01)00051-2.
Thirty-three HIV-seronegative adults were recruited into a Phase I safety and immunogenicity HIV-1 vaccine trial. The immunogens were as follows: a synthetic, monovalent, octameric HIV-1 MN V3 peptide in aluminum hydroxide (alum) adjuvant administered by intramuscular delivery; and a similar product encapsulated in biodegradable micro-spheres composed of co-polymers of lactic and glycolic acids, administered by the oral route. These were administered in three sequential oral doses, followed by a parenteral boost. No serious adverse experiences were observed. Oral administration of this vaccine, alone or in combination with parenteral boosting, resulted in no significant humoral, cellular, or mucosal immune responses.
33名HIV血清阴性的成年人被招募进入一项I期HIV-1疫苗安全性和免疫原性试验。免疫原如下：一种合成的单价八聚体HIV-1 MN V3肽，在氢氧化铝（明矾）佐剂中，通过肌肉注射给药；以及一种类似的产品，封装在由乳酸和乙醇酸共聚物组成的可生物降解微球中，通过口服途径给药。这些以三个连续的口服剂量给药，随后进行一次肠胃外加强注射。未观察到严重不良事件。单独口服这种疫苗或与肠胃外加强注射联合使用，均未产生显著的体液、细胞或黏膜免疫反应。
