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Home > "S" Clinical Trials Conditions > Safety of an Oral HIV Vaccine in HIV Uninfected Volunteers  Safety of an Oral HIV Vaccine in HIV Uninfected Volunteers
Safety of an Oral HIV Vaccine in HIV Uninfected Volunteers
For Condition: HIV Infections
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will test the safety of and immune response to an oral HIV vaccine in healthy volunteers. The vaccine in this study uses a weakened bacterium called Salmonella typhi to deliver an HIV gene into the body through the mouth. The body then produces an HIV protein from the gene; this protein stimulates an anti-HIV immune response. The vaccine contains only one of the many substances that HIV needs to make more copies of itself, so the vaccine itself cannot cause HIV or AIDS.
Details: The transmission of HIV-1 by both sexual and parenteral routes makes it likely that a successful preventive vaccine against this virus will need to induce protective immunity in both mucosal and systemic compartments. The long-term objective of this program is to develop an HIV-1 vaccine that elicits protective immunity in both the mucosal and systemic compartments. The study will evaluate the safety and immunogenicity of an oral recombinant Salmonella typhi HIV-1 gp120 vaccine (SCBaL/M9) in healthy human volunteers. This will be the first study in volunteers to use an intracellular bacterium to deliver a recombinant vector vaccine mucosally. The study will also develop an Env immunogen that elicits a broader spectrum of neutralizing antibodies than gp120 and that can be delivered by Salmonella typhi or as a soluble protein immunogen. This is a Phase I dose-escalation study of two vaccine components that will be combined in a larger prime-boost protocol should the desired safety endpoints be obtained. Both components use a conformationally constrained gp120 that expresses epitopes recognized by broadly neutralizing antibodies. The priming immunogen will be the conformationally constrained gp120 gene delivered orally by live attenuated Salmonella typhi. The boosting immunogen will be a soluble subunit protein comprised solely of the conformationally constrained gp120. All participants in this study will receive the vaccine. Participants will be randomized to different vaccine doses. Participants will have eight study visits over 20 weeks. Study visits will include brief medical interview, physical exam, blood and urine tests, and counseling on avoiding HIV infection and pregnancy. Participants will be tested for HIV infection 3 times during the study.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HIV uninfected - Low risk sexual behavior - Negative for Hepatitis B surface antigen - Negative for Hepatitis C viral sequences and antibody - Availability for follow-up for planned duration of the study (12 months) - Acceptable methods of contraception Exclusion Criteria - Receipt of HIV vaccines or placebo in a previous HIV vaccine trial - History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications - History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure - Medical or psychiatric condition or occupational responsibilities which preclude compliance with the protocol - History of suicide attempts, recent suicidal ideation, or psychosis - High risk behavior for HIV infection as determined by screening questionnaire - History of injection drug use within 12 months of study entry - Live attenuated vaccines within 60 days of study entry. Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunizations. - Use of experimental agents within 30 days of study entry - Receipt of blood products or immunoglobulin within 6 months of study entry - Active syphilis - Active tuberculosis - History of anaphylaxis or serious adverse reactions to vaccines - History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension) - Pregnant or breastfeeding
Total Enrollment: 38
Location and Contact Information:
Overall Study Official:
GeorgeLewis, Principal Investigator, Univesity of Maryland
Institute of Human Virology
Baltimore, Maryland, 21201
United States
Additional Information:
Study ID Numbers: P01 AI47490;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062530
Other Hiv Infections Studies:
1. Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
2. A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers
3. Safety of and Immune Response to an HIV Vaccine (VRC-HIVDNA009-00-VP) Administered With Interleukin-2/Immunoglobulin (IL-2/Ig) DNA Adjuvant in Uninfected Adults
4. A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia in AIDS
5. A Study to See if Certain Antioxidants and Vitamins Will Keep Lactate Levels Down in Patients Taking Anti-HIV Drugs
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Safety of an Oral HIV Vaccine in HIV Uninfected Volunteers
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