CompletedPhase 1

Safety and Immune Response to a Prime-Boost Vaccination Schedule in HIV-infected Patients

United States17 participantsStarted 2005-12-21

Plain-language summary

Study Design: This is a Phase I, randomized, placebo-controlled, double-blinded study to examine safety, tolerability and immune response of a prime-boost vaccination regimen for treatment of HIV infection. The vaccination schedule consists of three injections of a multiclade HIV plasmid DNA vaccine followed by one injection of a multiclade recombinant adenoviral vector vaccine (rAd), in HIV-infected adults. The hypothesis is that this vaccination regimen will be safe and elicit an immune response in HIV-infected subjects. The primary objectives are related to evaluating the safety and tolerability of the vaccination regimen and assessing the effect of vaccination on humoral and cellular immune responses to vaccine-specific HIV antigens. Product Description: VRC-HIVDNA016-00-VP is composed of 6 closed, circular DNA plasmids that are each 16.67% (by weight) of the vaccine. Each of the 6 plasmids in this vaccine expresses a single gene product. Plasmids VRC 4401, VRC 4409 and VRC 4404 are designed to express clade B HIV-1 Gag, Pol and Nef, respectively. VRC 5736, VRC 5737, and VRC 5738 are designed to express HIV-1 Env glycoprotein from clade A, clade B, and clade C, respectively. Each DNA vaccination will be 1 mL of vaccine administered intramuscularly (IM) using the Biojector 2000 Needle-Free Injection Management System. Phosphate buffered saline (PBS) will be used as the placebo for the DNA vaccine. VRC-HIVADV014-00-VP (rAd) is a recombinant product composed of 4 adenoviral vectors (Ad) (in a 3:1:1:1 ratio) that encode the HIV-1 Gag/Pol polyprotein from clade B and HIV-1 Env glycoproteins from clades A, B, and C, respectively. Injections of 10(10) PU will be administered IM by needle and syringe. The final formulation buffer (FFB) will be used as the placebo for the rAd vaccine. Subjects: HIV-infected adult volunteers (18-50 years old) on stable highly active antiretroviral therapy (HAART) therapy who have a CD4+ cell count greater than 350 cells/mm3 and have had a viral load (VL) less than 400 copies/mL for at least six months and a viral load of less than 50 copies/mL within 4 weeks prior to enrollment. Study Plan: Fifteen volunteers will be enrolled and randomized in a 2:1 ratio to vaccine:control (10 DNA prime with rAd boost:5 PBS with FFB placebo). A Data and Safety Monitoring Board (DSMB) will review the study every 6 months. Subjects will be evaluated for safety and immunogenicity for 48 weeks, which is 24 weeks after the target date for the booster vaccination. Study Duration: Subjects will be followed for 48 weeks after enrollment into the study.

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

. HIV-1 infection defined as documented by any approved ELISA test kit and confirmed with a Western blot at any time prior to study entry.
. On stable highly active antiretroviral therapy (HAART), as defined by the Department of Health and Human Services (http://www.aidsinfo.nih.gov/other/cbrochure/english/04\_en.pdf), with no change in the drugs included in the treatment regimen for a minimum of 8 weeks prior to enrollment.
. CD4+ cell count greater than 350 cells/mm(3) at 2 different time points that meet the following criteria: The first result must be from between 4 weeks to 36 weeks prior to enrollment obtained at any laboratory used by a health care facility. The second result must be obtained at the NIH Clinical Center within 28 days prior to enrollment. There must be at least 28 days between the two tests used for eligibility.
. HIV-1 RNA viral load (VL) consistently less than 400 copies/mL for six months or longer prior to enrollment (as reported by the subject). Documentation must include the following: at least one documented HIV RNA PCR result showing VL less than 400 copies/mL obtained between 12-36 weeks prior to enrollment at any laboratory used by a health care facility and another VL less than 50 copies/mL that must be obtained at the NIH Clinical Center within 28 days prior to study entry.

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.

Trial details

NCT IDNCT00270465

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2009-06-25

View on ClinicalTrials.gov More HIV trials

Plain-language summary

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

. HIV-1 infection defined as documented by any approved ELISA test kit and confirmed with a Western blot at any time prior to study entry.
. On stable highly active antiretroviral therapy (HAART), as defined by the Department of Health and Human Services (http://www.aidsinfo.nih.gov/other/cbrochure/english/04\_en.pdf), with no change in the drugs included in the treatment regimen for a minimum of 8 weeks prior to enrollment.
. CD4+ cell count greater than 350 cells/mm(3) at 2 different time points that meet the following criteria: The first result must be from between 4 weeks to 36 weeks prior to enrollment obtained at any laboratory used by a health care facility. The second result must be obtained at the NIH Clinical Center within 28 days prior to enrollment. There must be at least 28 days between the two tests used for eligibility.
. HIV-1 RNA viral load (VL) consistently less than 400 copies/mL for six months or longer prior to enrollment (as reported by the subject). Documentation must include the following: at least one documented HIV RNA PCR result showing VL less than 400 copies/mL obtained between 12-36 weeks prior to enrollment at any laboratory used by a health care facility and another VL less than 50 copies/mL that must be obtained at the NIH Clinical Center within 28 days prior to study entry.

Safety and Immune Response to a Prime-Boost Vaccination Schedule in HIV-infected Patients

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

Trial details

Safety and Immune Response to a Prime-Boost Vaccination Schedule in HIV-infected Patients

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

Trial details

Exclusion criteria