Safety and Effectiveness of an HIV DNA Vaccine Followed by an HIV Adenoviral Vector Vaccine for Prevention of HIV Infection in the Americas and Africa

Not Applicable

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-060-07
• Lead Sponsor: ASOCIACION CIVIL IMPACTA, SALUD Y EDUCACION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-07
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Men or women, ≥18 and ≤45 years of age who, within the 24-week period prior to randomization, and met one or more of the risk criteria for HIV infection.
2. Ability and willingness to grant informed consent and to be available for follow-up for the duration of the study.
3. Willingness to undergo HIV testing, counseling about HIV and receiving the results of HIV tests.
4. If a woman of childbearing age agrees to use a contraceptive method from a minimum of 3 weeks before randomization until at least 4 weeks after receiving the last injection of the study and undergo pregnancy tests as specified in the schedule of the protocol.
5. Persons not infected with HIV.
6. Negative result in a pregnancy test of a woman of childbearing age carried out within 24 hours prior to randomization.

Exclusion Criteria

1. Women who are breastfeeding a baby under 24 weeks of age or who plan to become pregnant during the period that begins at randomization and ends 4 weeks after receiving the last injection of the study.
2. Participation in a clinical trial of another experimental product in the previous 12 weeks.
3. Contraindicated intramuscular injections, history of bleeding disorders or treatment with anticoagulants during the 4 weeks prior to randomization.
4. Have previously received an experimental vaccine against HIV.
5. History of severe systemic or local reactogenicity to vaccines or severe allergic reactions or recurrent urticaria of unknown origin in the last 5 years.
6. Have received an inactivated vaccine in the previous 2 weeks.
7. Have received any blood product or any immunomodulator in the previous 12 weeks.
8. History of malignant tumors.
9. History of a clinically significant autoimmune disease or of an immunodeficiency syndrome at any time or the use of immunosuppressants in the previous 24 weeks.
10. Other seizure disorder other than: A) Febrile convulsions in children under two years of age. B) Seizures secondary to alcohol withdrawal more than 3 years ago. C) A single seizure more than 3 years ago that has not been repeated or needed treatment in the last 3 years.
11. Any disease that would alter the performance of the study or, together with participation in the study, would endanger the health of the subject.
12. Any acute illness that must be evaluated, treated and resolved before the randomization of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Criterion 1: The diagnosis of HIV-1 will be made through blood samples processed with the Genetic Systems HIV-1 / HIV-2 PLUS OR EIA (Bio-Rad HIV-1/2 + 0), approved by the FDA.<br>Criterion 2: PCR in peripheral blood to detect RNA with the Roche Amplicor HIV-1 MONITOR Test ultrasensitive, version 1.5.<br>Measure:1) Contagiousness of HIV-1 infection. 2) Average of the two measurements of plasma viral load of HIV-1 RNA in log10.<br>Timepoints:Criterion 1: 26 weeks or more after randomization.<br>Criterion 2: After detecting HIV-1 infection.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Criterion 1: Evaluation of local adverse events such as pain, redness and inflammation in the injection area.<br>Criterion 2: Evaluation of non-local adverse events that occur after injection.<br>Criterion 3: Clinical evaluation of any unfavorable or unintentional change in body structure, body functioning or laboratory results temporarily associated with the use of the study medication.<br>Measure:Safety: 1. Signs and symptoms of local reactogenicity. 2) Signs and symptoms of systemic reactogenicity. 3) Adverse events.<br>Timepoints:During the 3 days after the administration of each injection of the study.<br>