None listed
Conditions
Interventions
PART 1. GROUP 1 Type of group
This group will be divided into 2 subgroups that will receive different treatment.
10 individuals will receive the Multiepitopic Recombinant Protein Vaccine EP-1043, which contains 0.05 mg of recombinant baculovirus expression protein adsorbed on Alhydrogel®, in 1 ml, IM in the same deltoid muscle, once in months 0, 1, 3 and 6.
2 individuals will receive the Multiepitopic Vaccine of Recombinant Protein EP-1043 Placebo, in 1 ml, IM in the same deltoid muscle, once in months 0, 1, 3 and 6.
This group will be divided into 2 subgroups that will receive different treatments.
30 individuals will receive the EP-DNA Multiepitopic HIV-1090 Vaccine, which contains 4 mg of DNA Plasmid in phosphate buffer saline containing 3.4% polyvinylpyrrolidone, in 2 ml, IM, in the vastus externus muscle, which can be injected into different thighs at each opportunity + Multiepitopic Recombinant Protein EP-1043 vaccine, which contains 0.2 mg of recombinant baculovirus expression protein adsorbed on A
Sponsors
National Health Institute(Division Sida),
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation to evaluate: 1) Signs and symptoms of local reactogenicity: At the site of injection, pain, tenderness, erythema, induration / swelling / edema. 2) Signs and symptoms of systemic reactogenicity: Body temperature, malaise and / or fatigue, myalgia, headache, chills, arthralgia, nausea, vomiting. 3) Safety measures in the laboratory: Urine test, hematology panels and serum chemistry. 4) Adverse events and severe adverse events: Their evaluation and classification will be based on the Severity Classification Table of Adverse Events Adults and Pediatrics of the Division of AIDS Version 1.0. Measure:Safety of treatment: 1) Signs and symptoms of local reactogenicity. 2) Signs and symptoms of systemic reactogenicity. 3) Safety measures in the laboratory. 4) Adverse events and severe adverse events. Timepoints:1) Signs and symptoms of local and systemic reactogenicity: Up to 3 days after the application of each vaccine. 2) Safety measures in the laboratory: Days 14, 42, 98, 182, 273 and 364. 4) Adverse events and severe adverse events: Days 98, 182, 273 and 364. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The ability of the vaccine to induce CD8 + and CD4 + T cell responses to specific epitopes will be evaluated by the following techniques: 1) ELISpot test for interferon gamma: Cryopreserved peripheral blood mononuclear cells stimulated during the night with synthetic peptide groups that group the proteins encoded by the recombinant DNA fragments of the vaccine will be used. The responses will be reported as number of staining cells (SFC) per 10-6 cells / good recognition of any specific peptide group. 2) Intracellular cytokine staining (ICS): Flow cytometry will be used to examine the responses of CD4 + and CD8 + T cells, after stimulation with synthetic HIV peptides that group the proteins encoded by the recombinant DNA fragments of the vaccine. Responses will be reported as a percentage of CD4 + or CD8 + T cells that recognize any specific peptide group. Measure:Immunogenicity: Specific cellular response to HIV. Timepoints:Two weeks after the visit of the fourth vaccine (day 168). ; Outcome name:All negative experiences or problems that the participant has experienced during their participation in this study will be evaluated. The following social impact will be monitored during the course of the study; social, travel, work, school, health care, life insurance, health insurance, housing, military service and any additional impact identified by a participant. Measure:Social impact. Timepoints:Days 84 and 68. | — |
Countries
Peru, United States
Outcome results
None listed