NAPWA

About this trial

This is a studyA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. of a vaccine with the potential to prevent HIV infection. Unlike other studies listed on this site it is only open to people who are HIV negative.

This is an early-stage study. It is not aiming to prove that the vaccine will prevent HIV in large numbers of people, but rather that it (1) is safe and well-tolerated and (2) may provide some evidence that it EITHER reduces the number of people who acquire HIV or can prevent people from developing any illness resulting from exposure to HIV.

The experimental(Of a drug) Not licensed for use in humans, or as a treatment for a particular condition. Experimental drugs are studied in clinical trials to determine their safety and efficacy, and are sometimes made available via Special Access Schemes prior to their approval. HIV vaccine will be tested against a placeboA dummy medical treatment, designed to have no pharmacological effect, administered to the control group of a clinical trial. or 'dummy pill'. Both are administered by injection so people in the study will not know whether they are receiving the vaccine or not.

Background information

Most vaccines are designed to prevent you from actually becoming infected with a particular virus or bacteriaA microscopic organism composed of a single cell. Many bacteria can cause disease in humans.. They are designed so that the immune system attacks the invading virus or bacteria, and 'neutralises' it so it cannot infect your body. This sort of vaccination has proven extremely hard to develop in HIV and so an alternative approach has been developed. 

The vaccine in this study uses synthetic or 'manufactured' parts of HIV's genetic material and introduces them into the body's cells by 'piggybacking' them on a completely different, harmless virus. The theory is that this will stimulate the body to produce an army of killer T-cells which will seek out and destroy any cells infected with these HIV genesThe most basic unit of genetic information.. The body would then 'remember' its response so that later, if a person did actually get exposed to HIV, the body would have a planned response and be ready to eliminate any of the cells infected with HIV.

There is an important limitation to this experimental(Of a drug) Not licensed for use in humans, or as a treatment for a particular condition. Experimental drugs are studied in clinical trials to determine their safety and efficacy, and are sometimes made available via Special Access Schemes prior to their approval. approach. It is possible that it will not prevent people from becoming infected with HIV but will assist the immune system to keep HIV under control over the longer term so that it cannot go on to cause disease. The point of this trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. is to see if this is so.

There is no guarantee in this trial that you will be receiving the vaccine or that the vaccine can prevent you from getting HIV.

NAPWA commentary

There are very serious issues to consider when entering a placebo-controlledA method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition. vaccine study. Most important is to understand that there is no guarantee that this vaccine will either prevent you from getting HIV or prevent HIV from being able to cause illness if you do become infected.

The trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. has been approved because there is so far good evidence that the vaccine may either prevent HIV or delay or prevent HIV-related illness, but this has not been proven. This study is part of the process of collecting the evidence.

At least one vaccine using a similar approach has already been trialed in Sydney and did not produce the immune responses which would be needed for an effective vaccine of this sort. There is some evidence that this current vaccine may be effective but this is not known. It is also important to realise that you may be randomisedA method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit to the participant to receive the placeboA dummy medical treatment, designed to have no pharmacological effect, administered to the control group of a clinical trial. or 'dummy' injections.

If you are accepted into this study, it is because you, your doctor and the trial organisers have agreed that, because of your current life circumstances or behaviours, you are at high risk of exposure to HIV.

The definition used to work out whether you are at 'high risk' has been made using current Australian research about risk of HIV transmission. The definition includes: Women and men who have an HIV positive regular sexual partner; Women and men who have ever taken non-occupational PEP (post-exposure prophylaxis); Men who have had unprotected anal sex in the last six months; and Men who have had an anal sexually transmissible infection in the last year.

You should not make decisions about your HIV risk or behave differently on the assumption that you will be 'vaccinated' or 'protected' against HIV during or after this trial.

HIV infection can be prevented by always using condoms and lubricant when having anal or vaginal sex and by always using new equipment when injecting drugs. For further information about preventing HIV contact your local AIDS council or PLWHAPerson (or People) Living with HIV/AIDS. group.

This study will also collect further information about the safety of the experimental(Of a drug) Not licensed for use in humans, or as a treatment for a particular condition. Experimental drugs are studied in clinical trials to determine their safety and efficacy, and are sometimes made available via Special Access Schemes prior to their approval. vaccine. There may be other, non-HIV related risks from taking this vaccine, which may include: pain, swelling or reactions at the injection site, headache, or a range of immune responses common to many vaccines, including fluA highly contagious and relatively common viral infection of the respiratory system, transmitted by infected droplets of moisture which may be spread through coughing and sneezing. Most people with flu recover but some go on to develop secondary infections such as pneumonia which may be fatal.-like illness, joint pain or swelling, fever and diarrhoea.