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A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59 Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59 Clinical research trials and A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59 healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59. A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59 Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59 clinical trial. Human subjects often obtain the finest healthcare possible for their A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59 condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59  A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59
A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59
For Condition: HIV Infections,HIV Seronegativity
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Biocine
Synopsis: To evaluate the safety of a fixed antigen dose with an increasing dose of adjuvant (MTP-PE/MF59, a substance to enhance the immune response to vaccine) in volunteers. To evaluate local and systemic reactions (Part A). To determine the safety and immunogenicity of Env 2-3 in combination with MTP-PE/MF59 in volunteers (Part B). The vaccine Env 2-3 is created from one of the viral proteins that make up HIV called envelope glycoprotein gp120. A problem with many immunogens, including candidate HIV vaccines, is that they may evoke relatively weak immune responses, particularly in humans and in nonhuman primates. Thus, there is considerable interest in the development of "adjuvants" (substances that augment immune responses to vaccines). MTP-PE/MF59 is an adjuvant that appears to be particularly promising, and is selected for the studies with this HIV vaccine candidate.
Details: The vaccine Env 2-3 is created from one of the viral proteins that make up HIV called envelope glycoprotein gp120. A problem with many immunogens, including candidate HIV vaccines, is that they may evoke relatively weak immune responses, particularly in humans and in nonhuman primates. Thus, there is considerable interest in the development of "adjuvants" (substances that augment immune responses to vaccines). MTP-PE/MF59 is an adjuvant that appears to be particularly promising, and is selected for the studies with this HIV vaccine candidate. This study is being conducted in two parts: Part A examines the safety of the adjuvant MTP-PE/MF59 alone; Part B examines the safety and immunogenicity of Env 2-3 in combination with MTP-PE/MF59. In Part A, three volunteers receive MTP-PE/MF59, and one volunteer receives emulsion alone at each dose level. Initiation of each dose level is separated by at least 72 hours. Doses of adjuvant emulsion are administered at day 0 and day 30 for the highest tolerated dose. If significant reactions are encountered, additional subjects may be studied at lower doses. In Part B, six doses of MTP-PE adjuvant (0, 5, 10, 25, 50, or 100 mcg) in the MF59 emulsion are studied. Six volunteers receive Env 2-3/MTP-PE/MF59 and two receive MTP-PE/MF59 alone at each dose level. There is a minimum 1-week interval between dose escalations. Per amendment, volunteers may receive an additional dose of Env 2-3 or placebo in MF59 emulsion only, administered 12-18 months post initial inoculation.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Safety Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Volunteers are: - Normal, healthy adults (by history and physical examination) who fully comprehend the purpose and details of the study. Part A: - Available for 60 days. Part B: - Available for 1 year of follow-up. Exclusion Criteria Co-existing Condition: Volunteers with the following conditions or symptoms are excluded: Part B: - Positive syphilis serology (such as VDRL) unless positive test is due to a documented clinical event that occurred and was treated 5 or more years prior to enrollment. Circulating hepatitis B antigenemia. Volunteers with the following are excluded: - History of immunodeficiency, chronic illness, autoimmune disease. - Evidence of depression or under treatment for psychiatric problems during the past year. Prior Medication: Excluded: - Immunosuppressive medications. Prior Treatment: Excluded: Part B: - Blood transfusion or cryoprecipitates within the past 6 months. Risk Behavior: Excluded: Part B: Identifiable high-risk behavior for HIV infection, including: - history of intravenous drug use; syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the last 6 months; more than two sexual partners, or sexual contact with a high-risk partner, in the preceding 6 months.
Total Enrollment: 64
Location and Contact Information:
Overall Study Official:
DolinR, Study Chair,
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Vanderbilt Univ Hosp
Nashville, Tennessee, 37232
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Additional Information:
Study ID Numbers: AVEG 005A/B;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000972
Other Hiv Seronegativity Studies:
1. HIV Prevention Preparedness Study
2. Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
3. A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules
4. A Study of Immune System Activity in Healthy Adults
5. Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
Related Studies:
Other HIV Seronegativity Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59
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