WithdrawnPhase 1

Evaluating the Safety and Immune Response to Two HIV Vaccine Regimens in Healthy, HIV-Uninfected Adults in the United States and South Africa

Plain-language summary

The purpose of this study is to evaluate the safety and immune response to two different HIV vaccine regimens in healthy, HIV-uninfected people in the United States and South Africa.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Negative urine glucose, and
✓. Negative or trace urine protein, and
✓. Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range).

Exclusion criteria

✕. If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. More information on this criterion can be found in the protocol.
✕. If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure greater than or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or equal to 100 mm Hg at enrollment.

What they're measuring

Frequency of severe local and systemic reactogenicity signs and symptoms

Timeframe: Measured within the initial 7-day period following each vaccination visit and followed until resolution

Frequency of adverse events (AEs)

Timeframe: Measured through participants' last study visit at Month 12

Reports of serious adverse events (SAEs) throughout the active surveillance period

Timeframe: Measured through the end of participants' 3-year follow-up period

Measurements of laboratory measures of safety

Timeframe: Measured through participants' last study visit at Month 12

Magnitude and breadth of HIV-specific binding antibody responses as assessed by multiplex assay

Timeframe: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection

HIV-specific CD4+ and CD8+ T-cell response rates

Timeframe: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection

Magnitude of HIV-specific CD4+ and CD8+ T-cell responses

Timeframe: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection

Trial details

NCT IDNCT01927835

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2017-01

View on ClinicalTrials.gov More HIV Infections trials

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Negative urine glucose, and
✓. Negative or trace urine protein, and
✓. Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range).

Exclusion criteria

✕. If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. More information on this criterion can be found in the protocol.
✕. If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure greater than or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or equal to 100 mm Hg at enrollment.

What they're measuring

Frequency of severe local and systemic reactogenicity signs and symptoms

Timeframe: Measured within the initial 7-day period following each vaccination visit and followed until resolution

Frequency of adverse events (AEs)

Timeframe: Measured through participants' last study visit at Month 12

Reports of serious adverse events (SAEs) throughout the active surveillance period

Timeframe: Measured through the end of participants' 3-year follow-up period

Measurements of laboratory measures of safety

Timeframe: Measured through participants' last study visit at Month 12

Magnitude and breadth of HIV-specific binding antibody responses as assessed by multiplex assay

Timeframe: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection

HIV-specific CD4+ and CD8+ T-cell response rates

Timeframe: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection

Magnitude of HIV-specific CD4+ and CD8+ T-cell responses

Timeframe: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection