Phase II Multicenter Clinical Trial to evaluate the immune response generation capacity and the safety of the ALVAC-HIVVCP1452 Vaccine administered alone and in combination with the MN rpg 120 / HIV-1 vaccine in humans from Brazil, Haiti, Peru and Trinidad and Tobago.
- Conditions
- -B23 Human immunodeficiency virus [HIV] disease resulting in other conditionsB23Human immunodeficiency virus [HIV] disease resulting in other conditions
- Registration Number
- PER-036-01
- Lead Sponsor
- FRED HUTCHINSON CANCER RESEARCH CENTER,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Age: Between 18 and 60 years [No more than 10% of the volunteers must be over 50 years of age]
• Sex: Men and Women [For women, it is necessary that they have a negative pregnancy test at the time of the initial evaluation and in the three days prior to the initial immunization, as well as, ensure the use of appropriate methods of contraception that they must be used from one month prior to the initial immunization and during the entire duration of the immunization period (7 months)].
• Not having been diagnosed with a sexually transmitted disease in the last six months (syphilis, gonorrhea, first episode of genital herpes, pelvic inflammatory disease, trichomoniasis, chancroid, chlamydia, venereal iinfogtanuloma, mucous purulent cervicitis, acute epididymitis, acute proctitis or non-gonococcal urethritis).
• Not having had more than one sexual partner in the last six months.
• Not having used intravenous drugs or cocaine in the last six months.
• Not have had sex in exchange for money or drugs in the last six months.
• Have availability to meet the follow-up period of 18 months after the initial Immunization.
• Have a normal medical evaluation.
• Have a normal hematological evaluation, defined by a:
• Hematocrit 30%
• Leukocyte count 3,500 cells / mm3 and 15,000 cells / mm3 with a differential distribution within the limit of normal or approved by the physician responsible for the clinical evaluation.
• Total lymphocyte count 800 cells / mm3.
• Absolute CD4 lymphocyte count 400 cells / mml
• Platelet count 125,000 / mm3 and 550,000 / mm3
• Have a normal serum alanine-lysine transferase value (3 times the upper value of the institutional limit) and a normal serum creatinine value (1.6 mg / dl).
• Have a negative colorimetric evaluation of the presence of proteins, glucose or blood in urine (a test that indicates protein traces or 1+ is acceptable if the serum creatinine value is normal).
• A negative serum test for the presence of HeDatitis B Virus Surface Antigen (HBsAg).
• A negative serum test for infection with Human T-lymphotrophic Virus 1 (HTLV-1).
• A negative serum test of RPR or FTA-ABS (syphilis).
• A negative test for the presence of sickle cell anemia (those with presence of falciformism traits may be eligible).
• Negative ELISA tests for HIV and RNA PCR for HIV in blood samples obtained within 8 weeks prior to the initial immunization.
• Have been able to establish EBV-induced cell lines from mononuclear peripheral blood cells and that are viable at the time of the first immunization (ie, confirmation by the Central Laboratory of HIVNET of the development of sufficiently mature cell lines is necessary of analysis of cytotoxic T lymphocytes).
• History of some type of immunodeficiency, chronic disease, malignancy, autoimmune disease or use of immunosuppressive medication. Individuals with a prior history of cancer will be excluded, unless they have undergone excisional surgery followed by a sufficient observation period to guarantee a reasonable chance of cure.
• Have any medical condition, psychiatric condition or job responsibility, which does not allow the volunteer to comply with the requirements of the protocol.
• Have a sexual partner with a known diagnosis of HIV infection, unless they have practiced abstinence or have consistently used the condom in the past 6 months.
• Having a sexual partner at high risk of becoming infected with HIV (defined as having had multiple sexual partners in the last 6 months, diagnosis of STDs - syphilis, gonorrhea, first episode of genital herpes, pelvic inflammatory disease, trichomoniasis, chancroid, chlamydiasis, lymphogranuloma venereum, mucous purulent cervicitis, acute epididymitis, acute proctitis, non-gonococcal urethritis or Hepatitis B- in the last 6 months or have been a user of intravenous drugs or cocaine in the last 6 months.
• Have received some type of vaccine composed of live attenuated microorganisms [Vaccines composed of killed microorganisms or vaccines composed of subunits (such as influenza, pneumococcus) prescribed for medical reasons, should be administered in a period greater than at least 2 weeks before or after immunizations against HIV],
• Have received some type of medication in the experimentation stage in the 60 days prior to the planned vaccination day.
• Have received products of blood derivatives or immunoglobulin in the last six months.
• Have active tuberculosis [NOTE: Volunteers with a positive PPD test and a chest x-ray that shows no evidence of active disease and do not require prophylaxis with isoniazid will be eligible.
• Have a previous history of anaphylaxis or previous history of serious adverse reactions after the administration of vaccines.
• Have a previous history of a serious allergic reaction to any substance, which required hospitalization or emergency medical attention (such as the development of Stevens-Johnson Syndrome, bronchospasm or hypotension).
• Have received any type of experimental vaccine to prevent infection with HIV-1 or placebo within any previous clinical trial.
• To be a woman who is pregnant or breastfeeding.
• Allergy to egg products, thimerosol or neomycin (used in the preparation of ALVAC vaccines).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Registry of severe local and systemic adverse reactions<br>Measure:Occurrence of severe local and systemic adverse reactions<br>Timepoints:During the study<br>;<br>Outcome name:The final point of overall evaluation of the immune response generating capacity will be the binary indicator of the response of cytotoxic CD8 + T lymphocytes to at least one of the mentioned proteins at any specific time point.<br>Measure:The response of cytotoxic TCD8+ lymphocytes against HIV-1 gag and env proteins<br>Timepoints:On visits of 6 and 12 months of follow-up.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Blood tests<br>Measure:Antibodies that block the binding of giicoprotelna gp120 to CD4 + T lymphocytes<br>Timepoints:In the visits of 6 and 12 months of follow-up<br>;<br>Outcome name:Blood tests<br>Measure:Antibody-dependent cellular cytotoxicity measurements<br>Timepoints:At the end of treatment<br>;<br>Outcome name:Blood tests<br>Measure:Cross-neutralizing antibodies against HIV-1 strains other than HIV-1 MN and SF-2 strains<br>Timepoints:At the end of treatment<br>;<br>Outcome name:Blood tests<br>Measure:Antibodies that bind to antigens of MN strains of HIV-1<br>Timepoints:In the visits of 6 and 12 months of follow-up<br>