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Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults Clinical research trials and Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults. Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults  Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults
Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will evaluate the safety of and immune response to a new HIV vaccine. The vaccine in this trial uses pieces of HIV DNA and HIV proteins. The vaccine itself cannot cause HIV infection or AIDS.
Details: Unlike other viruses for which effective vaccines have been developed, HIV-1 has evolved mechanisms to evade immune control over virus replication. These mechanisms include the extraordinary genetic diversity of the virus, viral latency, and targeting of the immune system. Evolutional variations of the envelope gene have not only resulted in the development of different groups (M, N, and O) and subgroups (clades) in diverse geographic regions of the world, but also significant genomic variations within clades. These clade variants of HIV will require novel vaccine approaches to elicit population-based protective immunity. Viral latency is the ability of the virus to remain dormant for long periods through integrating its viral DNA into the host genome. Viral latency requires vaccines to produce immune response that are robust enough to kill the virus and that can be maintained over extended periods of time to produce lasting immunity. Finally, HIV-1 targets CD4 cells and thus compromises the immune surveillance mechanisms critical to maintaining both cellular and humoral immunity to HIV-1. Therefore, an effective vaccine against HIV-1 must bolster the development of broadly reactive neutralizing antibodies against genetic variants of HIV-1, as well as induce an effective HIV-specific CTL response to eliminate virus-infected cells. The ideal vaccine approach will produce long-term responses within these arms of host immunity. This study is designed to evaluate the safety, tolerability, and immunogenicity of a novel prophylactic vaccine consisting of DNA priming followed by a protein boost. The first vaccine component administered in this study is a DNA vaccination; the second component is a recombinant protein vaccination. This combination will be used to determine whether the vaccine strategy can induce a balanced humoral and cell mediated immune responses to HIV-1. Two HIV antigens, Gag and Env, are included in this study’s vaccine formulation. Studies have shown that HIV-1 Gag is a potent inducer of cell mediated immune responses, while Env is the target of neutralizing antibody responses. The vaccine used in this study contains a 5-valent Env design (Env derived from one of 5 clades of HIV) in order to examine if a polyvalent Env formulation may expand the breadth of neutralizing antibody responses induced in human volunteers. For both DNA priming and protein boosting, a set of Env antigens from clades A, B, C, and E of HIV-1 M group will be produced (2 Env antigens from clade B and 1 Env each from the other three clades). All 5 Env antigens are selected from the primary HIV-1 viral isolates with the hope of producing broad antibody responses against the primary viruses circulating in the worldwide human population. Thirty-six healthy volunteers will be randomized to one of five groups. Groups 1, 2, and 3 will receive different doses of the vaccine to determine the optimal dose. Groups 4 and 5 will receive the vaccine through either intradermal or intramuscular administration. Each group will receive 3 doses of DNA vaccination at weeks 0, 4, and 12, and 2 doses of protein vaccination at weeks 20 and 28. Blood sampling throughout the duration of the study will provide an assessment of the safety and immunogenicity of the vaccine in healthy volunteers. It is expected that volunteers will be enrolled in this study for 1 year.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HIV uninfected - Good general health as determined by medical history, physical examination, vital signs, and clinical laboratory measurements - Body Mass Index (BMI) =< 32 - Hepatitis B surface antigen negative - Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive - Low risk for HIV exposure - No co-existent endocrine conditions - No evidence of hepatic insufficiency, significant renal insufficiency, or proteinuria - Acceptable methods of contraception - Anticipated availability for the planned follow-up period of one year Exclusion Criteria - Certain medications during the 2 weeks prior to study entry - Donation of a unit of blood within 2 months prior to study entry - Participation in a study of investigational or marketed drugs within 1 month prior to study entry - Blood transfusion within 6 months prior to study entry - Pregnant, breastfeeding, or planning pregnancy during the study period - History of significant adverse reaction to any vaccine - Prior receipt of any experimental HIV vaccine - Morbid obesity (> 195% of ideal body weight) - Hypertension (patients may be taking concomitant antihypertensive medication during the study if approved by study officials) - History of chronic medical illness, malignancy, or autoimmune disorder - History of immunodeficiency or treatment with immunosuppressive medications - History of organ transplant - Medical or psychiatric obstacle to compliance with protocol - Significant urine concentration of any drug that could interfere with the study
Total Enrollment: 36
Location and Contact Information:
Overall Study Official:
JeffKennedy, Study Director, University of Massachusetts School of Medicine
University of Massachusetts School of Medicine *Recruiting*
Worcester, Massachusetts, 01655
United States
Recruiting Jeff Kennedy 508-856-4182
Additional Information:
Study ID Numbers: N01-AI05394;
Study Start Date: November 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061243
Other Hiv Infections Studies:
1. Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines
2. The Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir
3. A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
4. An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts
5. A Comparison of Two Dose Levels of Indinavir Combined with Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Massachusetts Clinical Trials
Other Worcester Clinical Trials
Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults
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