Safety of and Immune Response to a DNA HIV Vaccine Followed by an Adenoviral Vaccine Boost Given Three Different Ways to HIV Uninfected Adults

Not Applicable

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

• Registration Number: PER-008-07
• Lead Sponsor: ASOCIACION CIVIL SELVA AMAZONICA,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-26
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

1) Age: From 18 to 50 years old.
2) Access to a HVTU that participates in the study and a willingness to receive follow-up during the planned duration of the study.
3) Assessment of comprehension: Complete a questionnaire before the first vaccination; express that they have understood all the questions that were answered incorrectly.
4) Good disposition to receive the results of the HIV test
5) Informed Consent: Be able and willing to provide informed consent.
6) Health: Have a good general health.
7) Neutralizing titers of Ad5 ≥ 1:12.
8) Hemoglobin ≥ than the institutional normal lower limit.
9) Number of leukocytes = from 3,300 to 12,000 cells / mm3.
10) Total number of lymphocytes ≥ 800 cells / mm3.
11) The rest of the leukocyte formula within normal limits.
12) Thrombocytes: From 125,000 - 550,000 / mm3.
12) ALT: 1.25 times lower than the upper normal institutional limit.
13) Creatinine: Does not exceed the upper normal institutional limit.
14) Negative test result of HIV-1/2.
15) Negative result in the analysis of the surface antigen of hepatitis B (HBsAg).
16) Negative result in the analysis of the antibodies against the hepatitis C virus (against HCV), or in the PCR for the HCV in case the analysis against the HCV is positive.
17) Normal urine test.
18) Negative result in the pregnancy test of B-HCG in serum or urine.
19) Reproductive status: A female participant must agree to use contraception consistently, from at least 21 days before enrollment until the last protocol visit.

Exclusion Criteria

1) Vaccine (s) against HIV in a previous study of HIV vaccines.
2) Immunosuppressive drugs within 168 days before the first vaccination.
3) Blood products within 120 days before the first vaccination.
4) Immunoglobulin within 60 days before the first vaccination.
5) Attenuated vaccines within 30 days before the first vaccination.
6) Substances under investigation within 30 days before the first vaccination.
7) Vaccines of subunits or inactivated administered by medical indication.
8) Prevention or current treatment against tuberculosis: The participant suffers from a clinically significant disease, presents signs, clinically significant abnormalities are observed in the laboratory results, or has medical history with clinically significant sequelae for the current state of health.
9) Any medical, psychiatric, social or occupational disease or other situation that would interfere with, or be a contraindication to, adherence to the protocol, assessment of safety, reactogenicity, or the ability of a participant to give informed consent.
10) Serious adverse reactions to vaccines.
11) Autoimmune disease.
12) Immunodeficiency.
13) Infection by active syphilis.
14) Asthma.
15) Type I or type II diabetes, including cases controlled only with diet.
16) Thyroid disease or thyroidectomy that required medication during the last 12 months.
17) Angioedema in the last 3 years if the episodes are considered serious or have required medication during the last 2 years.
18) 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 has not been diagnosed with hypertension during the selection or before, exclude if he has a systolic blood pressure ≥ 150 mm Hg or diastolic ≥ 100 mm Hg in the inscription.
19) BMI ≥ 40 or BMI ≥ 35 plus one of the following: Age> 45 years, systolic blood pressure> 140 mm Hg, diastolic blood pressure> 90 mm Hg, known smoking or hyperlipidemia.
20) Haemorrhagic disorder diagnosed by a doctor.
21) Malignant neoplasm.
22) Convulsive disorder.
23) Asplenia.
24) Psychiatric illness that prevents compliance with the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Criterion 1: Clinical evaluation of the injection site: pain, sensitivity, erythema, induration / swelling / edema.<br>Criterion 2: Clinical evaluation of body temperature, discomfort and / or fatigue, myalgia, headache, chills, arthralgia, nausea, vomiting.<br>Criterion 3: Urine test, hematology panels and serum chemistry.<br>Criterion 4: Evaluation of adverse events based on the Table of Classification of the Severity of Adverse Events Adults and Pediatrics of the Division of AIDS Version 1.0.<br>Measure:Safety: 1) Signs and symptoms of local reactogenicity. 2) Signs and symptoms of systemic reactogenicity. 3) Safety measures in the laboratory. 4) Adverse events.<br>Timepoints:Criterion 1,2 and 4: After each injection and during the 12-month follow-up.<br>Criterion 2: Days 0, 14, 42, 70, 175 and 273.<br>