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

Not Applicable

• Conditions: Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases; -B20 Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases; B20

• Registration Number: PER-052-06
• Lead Sponsor: INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-25
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Age: 18 to 50 years.
2) Access to a participating HIV Vaccine Trial Unit and willingness to be followed for the planned duration of the study.
3) Assessment of understanding: Complete a questionnaire prior to first vaccination; verbalize understanding of all questions answered incorrectly.
4) Willingness to receive HIV test results.
5) Informed consent: Be able and willing to provide informed consent
6) Health: Be in good general health as shown by medical history, physical exam, and screening laboratory tests performed within 56 days of enrollment.
7) Hemoglobin: ≥ sex-specificc institutional lower limit of normal and at least 11.0 g/dL for women, 12.5 g/dL for men.
8) WBC count = 3,300 to 12,000 cells/mm3.
9) Total lymphocyte count > 800 cells/mm3.
10) Remaining differential either within institutional normal range or accompanied by site physician approval.
11) Platelets = 125,000 to 550,000/mm3.
12) Chemlstry panel: Part A: ALT, AST, alkaline phosphatase, and creatinine values do not exceed institutional upper limit of normal, and CPK value does not exceed 2 times the institutional upper limit of normal; Part B: ALT, AST, and alkaline phosphatase do not exceed 1.25 times the institutional upper limit of normal; creatinine does not exceed institutional upper limit of normal.
13) Negative HIV blood test. US participants must have a negative FDA-approved ELISA test. Non-US sites will use locally available and locally approved assays.
14) Negative Hepatitis B surface antigen (HBsAg).
15) Negative anti-HepatitIs C virus antibodies, or negative HCV PCR if the anti-HCV is positive
16) Normal urine test.
17) Negative serum or urine B-HCG pregnancy test performed on the day of initial vaccination prior to vaccination
18) Reproductive status: a female participant must: a) Agree to consistently use contraception for at least 21 days prior to enrollment until the last protocol visit. b) Not be of reproductive potential, such as having reached menopause or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation. c) Agree not to seek pregnancy through altemative methods such as artificial insemination or in vitro fertilization until last protocol visit.

Exclusion Criteria

1) Age: 18 to 50 years.
2) Access to a participating HIV Vaccine Trial Unit and willingness to be followed for the planned duration of the study.
3) Assessment of understanding: Complete a questionnaire prior to first vaccination; verbalize understanding of all questions answered incorrectly.
4) Willingness to receive HIV test results.
5) Informed consent: Be able and willing to provide informed consent
6) Health: Be in good general health as shown by medical history, physical exam, and screening laboratory tests performed within 56 days of enrollment.
7) Hemoglobin: ≥ sex-specificc institutional lower limit of normal and at least 11.0 g/dL for women, 12.5 g/dL for men.
8) WBC count = 3,300 to 12,000 cells/mm3.
9) Total lymphocyte count > 800 cells/mm3.
10) Remaining differential either within institutional normal range or accompanied by site physician approval.
11) Platelets = 125,000 to 550,000/mm3.
12) Chemlstry panel: Part A: ALT, AST, alkaline phosphatase, and creatinine values do not exceed institutional upper limit of normal, and CPK value does not exceed 2 times the institutional upper limit of normal; Part B: ALT, AST, and alkaline phosphatase do not exceed 1.25 times the institutional upper limit of normal; creatinine does not exceed institutional upper limit of normal.
13) Negative HIV blood test. US participants must have a negative FDA-approved ELISA test. Non-US sites will use locally available and locally approved assays.
14) Negative Hepatitis B surface antigen (HBsAg).
15) Negative anti-HepatitIs C virus antibodies, or negative HCV PCR if the anti-HCV is positive
16) Normal urine test.
17) Negative serum or urine B-HCG pregnancy test performed on the day of initial vaccination prior to vaccination
18) Reproductive status: a female participant must: a) Agree to consistently use contraception for at least 21 days prior to enrollment until the last protocol visit. b) Not be of reproductive potential, such as having reached menopause or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation. c) Agree not to seek pregnancy through altemative methods such as artificial insemination or in vitro fertilization until last protocol visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified