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A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months Clinical research trials and A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months. A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, 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 the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months clinical trial. Subjects often receive the most expert healthcare possible for their A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months  A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Biocine
Synopsis: To evaluate in healthy volunteers the safety and immune response to 200 mcg gp120 candidate vaccine in MF59 emulsion without MTP-PE at 0, 1 and 6 months. Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest.
Details: Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest. Ten healthy volunteers receive 200 mcg gp120 in MF59 emulsion, and four volunteers receive placebo consisting of MF59 emulsion in PBS vehicle. Injections are given at months 0, 1, and 6. Patients are followed for 12 months following the third injection.
Eligibility:
Study Type: Interventional, Prevention, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Subjects must have: - Normal history and physical exam. - Negative ELISA for HIV. - Normal cell-mediated immune responses using Merieux skin test. - Normal urinalysis. Exclusion Criteria Co-existing Condition: Subjects with the following conditions are excluded: - Evidence of psychological or psychiatric problems that may lead to noncompliance with study requirements. - Positive syphilis serology. If serology is documented as a false positive or is due to a remote (> 6 months) treated infection, subject is eligible. - Circulating hepatitis B surface antigen. Subjects with the following prior conditions are excluded: - History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. - History of anaphylaxis or other adverse reactions to vaccines. Prior Medication: Excluded: - Prior HIV vaccines. - Immunoglobulins or vaccines within the past 3 months. - Experimental agents within the past 30 days. Prior Treatment: Excluded: - Blood transfusions or cryoprecipitates within the past 3 months. Identifiable high-risk behavior for HIV infection, including: - Any history of intravenous (IV) drug use within the past year. - Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. - More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.
Total Enrollment: 14
Location and Contact Information:
Overall Study Official:
GrahamB, Study Chair,
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Univ of Washington / Pacific Med Ctr
Seattle, Washington, 98144
United States
Vanderbilt Univ Hosp
Nashville, Tennessee, 37232
United States
Additional Information:
Study ID Numbers: AVEG 007C;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000749
Other Hiv Infections Studies:
1. A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
2. A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4+ Counts >= 50 and <= 350 Cells/mm3
3. A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS
4. A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients with Advanced HIV Infection
5. A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group
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A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months
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