跳至主要内容
临床试验/NCT00000832
NCT00000832已完成1 期

A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers

National Institute of Allergy and Infectious Diseases (NIAID)7 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2001年8月31日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
30
试验地点
7

研究概览

简要总结

To determine the safety and immunogenicity of rgp120/HIV-1SF2 combined with MF59 adjuvant emulsion versus MF59 alone in HIV-negative volunteers.

One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.

详细描述

One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.

Healthy volunteers receive intramuscular injections of rgp120/HIV-1SF2 with MF59 adjuvant emulsion or MF59 alone at months 0, 1, 6, 9, 10 and 12 (was months 0, 1, 6 and 10, amended 12/19/96).

研究设计

研究类型
Interventional
主要目的
Prevention
盲法
Double

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (7)

Loading locations...

相似试验

已完成
1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Compare the Safety and Immunogenicity of Recombinant Envelope Protein rgp120/HIV-1SF2 (BIOCINE) Combined With Seven Adjuvants in Healthy HIV-1 Uninfected IndividualsHIV Infections
NCT00001042National Institute of Allergy and Infectious Diseases (NIAID)112
已完成
1 期
Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 AdjuvantHIV Infections
NCT00001019National Institute of Allergy and Infectious Diseases (NIAID)48
已完成
2 期
A Phase II Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of the Recombinant HIV-1 Envelope Vaccines SF-2 rgp120 (CHO) [Chiron Vaccines] in MF59 Adjuvant and MN rgp120/HIV-1 [VaxGen] in Alum Adjuvant in Healthy AdultsHIV Infections
NCT00001031National Institute of Allergy and Infectious Diseases (NIAID)296
已完成
1 期
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy AdultsHIV Infections
NCT00001052National Institute of Allergy and Infectious Diseases (NIAID)110
撤回
1 期
Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)PregnancyHIV SeronegativityHIV Infections
NCT00001046National Institute of Allergy and Infectious Diseases (NIAID)