HVTN 042

This study is testing two vaccines: ALVAC and LIPO-5. Both vaccines are made by Aventis Pasteur.

The vaccines in this study are experimental. This means that they are not approved by the US Food and Drug Administration (FDA) for treating or preventing HIV infection. The FDA allows the use of these vaccines only in research. The vaccines are made according to FDA standards.

These vaccines are not produced from live HIV or from infected cells. There is no chance that they contains live (or dead) HIV virus. It is not possible to get HIV infection or AIDS from these vaccines.

Canarypox is a virus normally found in birds. The canarypox virus used in this study, called ALVAC-HIV (vCP1452), has small man-made parts of the HIV virus attached to it. The canarypox virus cannot grow in human cells and cannot cause disease in people. Researchers want to know if the body’s way of defending itself (immune system) will respond to the man-made pieces of HIV virus attached to the canarypox. This virus cannot cause infection with HIV.

The LIPO-5 vaccine used in this study is a mixture of 5 man-made proteins. The proteins are all very similar to proteins found in the HIV virus. These proteins cannot grow in human cells or cause an HIV infection.

HVTN 048

The purpose of this Phase I study is proposed to evaluate the safety and immunogenicity of EP HIV-1090 at 3 dose levels in healthy participants in a double-blinded, adjuvant-controlled, multicentered, dose-escalation clinical trial.  The primary goal is to establish, in healthy HIV-1 uninfected participants, the safety of the EP HIV-1090 vaccine administered at each of 3 dose levels.  The secondary goal is to evaluate the immunogenicity of EP HIV-1090, in terms of breadth and magnitude of HIV-1 specific CTL responses, at each of 3 dose levels and to determine the dose response relationships.  Participants will be sreened for HLA type prior to study enrollment.

HVTN 049

This study is testing 2 vaccines.

DNA vaccine: One vaccine is made of small pieces of DNA. DNA is a code used by cells to build proteins. The DNA is attached to tiny particles made of PLG (polylactide coglycolide). PLG is often used to make medicines, and the body can get rid of it easily. The particles were developed by scientists at Chiron Corporation. PLG carries the DNA and helps the body recognize it. Animal studies have shown that attaching the DNA to the outside of these very small PLG particles can improve the body’s response to the vaccine.

Protein vaccine: The second vaccine is made of protein (oligomeric gp140). The protein vaccine was developed by scientists at Chiron Corporation. The gp140 protein stimulates the body to make antibodies that fight HIV (antibodies are special proteins that can recognize and eliminate foreign or unwanted substances). The word oligomeric means the vaccine has several copies of the protein attached together. Oligomeric gp140 vaccine may help the body produce a type of antibody that is better than antibodies made by single-copy proteins of this type.

The protein vaccine is mixed with an adjuvant called MF59. An adjuvant helps the vaccine work better.

The vaccines in this study are experimental. The US Food and Drug Administration (FDA) allows the use of the vaccines only in research. The vaccines are made according to FDA standards and other international standards.

The vaccines are not produced from live HIV or from cells infected with HIV. There is no chance that the vaccines contain live (or dead) HIV virus. It is not possible to get HIV infection or AIDS from these vaccines.

Vaccines for HIV are designed to allow the body’s immune system to fight HIV before it sets in. The immune system is the body’s natural way of fighting infection. It does this using cells and antibodies.

Scientists believe that DNA vaccines like the one used in this study can instruct the body to make just enough specific HIV proteins to produce a response by the immune system

HVTN 052

This study is testing VRC-HIVDNA009-00-VP.

The vaccine in this study is experimental. This means that it is not approved by the US Food and Drug Administration (FDA) for treating or preventing HIV infection. The FDA allows the use of the vaccine only in research. The vaccine is made according to FDA standards.

This vaccine is not produced from live HIV or from infected cells. There is no chance that it contains live (or dead) HIV virus. It is not possible to get HIV infection or AIDS from this vaccine.

Vaccines are substances used by medical professionals to try to prevent infection and to fight or prevent disease. Most vaccines are made of proteins (natural substances that the body uses as building blocks) and are injected into the body. However, in this study the vaccine is made out of DNA. DNA is a code used by cells to build proteins.

The study vaccine contains a piece of man-made DNA. This means the DNA used to make the vaccine was produced in a laboratory and did not come directly from HIV. Scientists believe that when the vaccine is injected into a muscle, it will tell the body to make small amounts of 4 different proteins normally made by HIV. Scientists will then see if the body makes immune responses to these HIV proteins. Immune responses protect your body from infections.

HVTN 056

This study is testing an experimental multi-epitope peptide HIV vaccine (MEP) made by Wyeth Vaccines Research.

This vaccine is not produced from live HIV or from infected cells. It does not contain live (or dead) HIV virus. It is impossible to get HIV infection or AIDS from this vaccine.

The MEP vaccine contains copies of 4 HIV peptides made in the lab. Peptides are small protein molecules. They can cause the immune system (the body’s way to fight diseases and infections) to react to them. This is the type of response we are looking for in an HIV vaccine.

The MEP vaccine will be given together with 1 or 2 adjuvants. Adjuvants are substances that improve immune responses (the body’s reaction to the vaccine). The adjuvants in this study are called RC529‑SE and GM-CSF.

RC529-SE is made by Corixa Corporation. Adjuvants similar to RC529-SE are used in various experimental vaccines against allergies and infectious diseases.

GM-CSF is a protein made by the body’s immune system and is often given to cancer patients on chemotherapy to help restore their blood cells. The GM-CSF used in the study is produced by Amgen. We are testing to see if adding GM-CSF to the vaccine stimulates the immune system to recognize and react to the MEP vaccine.

The MEP vaccine and RC529-SE adjuvant are experimental. They have not been approved by the US Food and Drug Administration (FDA) for treating or preventing HIV infection. The FDA allows their use in research only. GM-CSF has been approved for use with cancer patients, but it is still experimental in HIV research. All 3 study products are made according to FDA standards.

Merck 016

The purpose of this study is to test the safety of an experimental vaccine for HIV-1 and to see if the study vaccine can make your immune system respond against HIV-1 as tested in the laboratory.  The immune system of the body is what the body uses to protect itself from infection.

Two types of experimental study vaccine will be used for theis study.  One is called the MRK Ad5 HIV-1 gag/pol/nef vaccine and the other is callled the MRK Ad5 HIV-1 gag vaccine.  Both of these vaccines will be referred to as the "Study Vaccine".  Seven different doses of the study vaccine will be tested in this study.  The study vaccine will be compared to a placebo (a liquid that looks like the vaccine but does not contain active study vaccine).

Merck 018

The purpose of this study is to test the safety of an experimental vaccine for HIV-1 and to see if the study vaccine can make your immune system respond against HIV-1 as tested in the laboratory.  This research is funded by a grant from Merck & Co., Inc. and the US National Institutes of Health (NIH) to the Institution and doctor that are conducting this study.

The experimental study vaccine is calld MRK Adenovirus Serotype (MRK Ad5) HIV-1 gag vaccine.  Two different doses of the study vaccine will be tested in this study.  The study vaccine will be compared to a placebo. 

Merck 019

The purpose of this study is to see if two investigational HIV vaccines are safe when given to healthy, HIV-negative adults who previously received the MRK Ad5 vaccine, Ad5 vaccine, or placebo during participation in Merck Protocols 007.  HIV is the virus that causes AIDS.  Another important purpose is to study how the immune system responds to the vaccines in people already injected with the MRK Ad5 vaccine, Ad5 vaccine, or placebo.

Vaccines are given to people to try to resist infection or prevent a disease.  The experimental HIV vaccines in this study are called MRK Ad5 HIV-1 Gag Vaccine made by Merck & Co., Inc., and to people by injections in the upper arms.

Neither the MRK Ad5 HIV-1 Gag Vaccine nor the ALVAC-HIV (vCP205) Vaccine is made from live HIV.  Neither of the vaccines contain all of the parts needed to make HIV.  You cannot get HIV from these vaccines.

The MRK Ad5 HIV-1 Gag Vaccine and the ALVAC-HIV (vCP205) Vaccine are investigational.  This means they have not been approved by the US Food and Drug Administration (FDA).