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 range

18 Years – 50 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years – 50 Years

Sex

ALL

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