PER-036-01
Completed
未知
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.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- -B23 Human immunodeficiency virus [HIV] disease resulting in other conditions
- Sponsor
- FRED HUTCHINSON CANCER RESEARCH CENTER,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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%
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Not specified
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