Safety of and Immune Response to the Experimental Preventive HIV Vaccine, EP HIV-1090, in Healthy, HIV-1 Uninfected Adults

Not Applicable

Conditions: -Z21 Asymptomatic human immunodeficiency virus [HIV] infection status
Asymptomatic human immunodeficiency virus [HIV] infection status
Z21

Registration Number: PER-065-06

Lead Sponsor: ational Health Institute(Division Sida),

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1) Age: 18 to 50 years old.
2) Access to a HIV Vaccine Clinical Trials Unit that participates and the willingness to receive follow-up for the duration planned for the study.
3) Complete a questionnaire before the first vaccination, express that you have understood all the questions that were answered incorrectly.
4) Willingness to receive the results of the HIV analysis.
5) Informed consent: Have the possibility and willingness to give informed consent.
6) Hemoglobin ≥ institutional normal limit specific to sex and at least 11.0 g / dl for women. 12.5 g / dl for men.
7) WBC count = 3,300 to 12,000 cells / mm3.
8) Total lymphocyte count ≥ 800 cells / mm3.
9) The rest of the differential within the normal institutional limit or accompanied by the approval of the center´s doctor.
10) Platelets = 125,000 to 550,000 / mm3.
11) Chemistry panel: Part A: The values of ALT, AST, alkaline phosphatase and creatinine do not exceed the upper normal institutional limit and the CPK value does not exceed twice the higher institutional normal value. Part B: the values of ALT, AST and alkaline phosphatase do not exceed the upper normal institutional limit in 1.25 times; creatinine does not exceed the upper normal institutional limit.
12) Blood test negative for HIV.
13) Surface antigen for Hepatitis B (HBsAg) negative.
14) Antibodies to the hepatitis C virus (anti-HCV) negative, or PCT negative to HCV if the anti-HCV test is positive
15) Normal urine test.
16) Pregnancy test of B-HCG in serum or urine made on the day of the initial vaccination, before the same.
17) Reproductive status; a female participant must: a) Agree to use contraception consistently from a minimum of 21 days before enrollment until the last protocol visit. OR b) Not have reproductive capacity. c) Agree not to seek pregnancy by alternative methods such as artificial insemination or in vitro fertilization until the last visit of the protocol.

Exclusion Criteria

1) The participant has received one of the following substances: a) Vaccine (s) for HIV in a previous study. b) Immunosuppressive drugs in a period of 168 days before the first vaccination. c) Hemoderivates in a period of 120 before the first vaccination. d) Immunoglobulin in a period of 60 days before the first vaccination. e) Vaccines to live attenuated virus within 30 days before the first vaccination. f) Experimental research agents in a period of 30 days before the first vaccination. g) Vaccines of subunits or killed virus by medical indication. h) Prophylaxis or current anti-TB treatment.
2) The participant has a clinically significant medical condition, findings on the physical examination, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health.
3) Any medical, psychiatric or social or occupational or other liability that interferes with, or would be a contraindication to adherence to the protocol, the assessment of safety or reactogenicity, the ability of a participant to give informed consent.
4) Severe adverse reactions to vaccines.
5) Autoimmune disease.
6. Immunodeficiency.
7) Infection by active syphilis.
8) Asthma that is not mild or well controlled.
9) Diabetes mellitus type I or type II.
10) Thyroid disease or thyroidectomy that required medication during the last 12 months.
11) Angioedema within the last 3 years if the episodes are considered serious or have required medication during the past 2 years.
12) Hypertension: a) If a person has been diagnosed with hypertension during the screening or before, exclude those whose hypertension is not well controlled. b) If a person is NOT diagnosed with hypertension during selection or earlier, it will be excluded if: Systolic blood pressure ≥ 150 mm Hg at the time of enrollment OR Diastolic blood pressure ≥ 100 mm Hg at the time of enrollment.
13) BMI ≥ 40; or, BMI ≥ 35 with more than 1 of the following: age> 45, systolic blood pressure> 140 mm Hg, diastolic blood pressure> 90 mm Hg, smoking, known hyperlipidemia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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