This form comprises of two parts:
- An information sheet - this contains relevant information regarding the research and the expectations of participants.
- Certificate of Consent this is purposely for signature confirming your consent to participation in the research.
- Participants will be issued with full copies of the consent forms.
Part I: Information Sheet
HIV Trials Network is an organization geared towards the elimination of Acquired Immune Deficiency Syndrome in all populations across the world. It is our vision to see a healthy world free of HIV and the saddening situations of the death of family members and friends alike. As an organization we have been on a constant research program that aims at finding a cure for AIDS, it has been a continuous journey and by the day we are getting improvement on our drug trials.
It is critical that you understand that the success of the quest against AIDS involves the experimentation on volunteers. It is important that we study the effects of our clinically approved drugs in order to find out the potential of the newly improved drugs. It is imperative for you as a participant to understand that the key objectives of the research are to find a lasting cure for AIDS. You are free to consult with your partner, parent or guardian before consenting to these trial. It is highly important that you should be consciously aware of your consent. It is highly important that you should go through this information sheet carefully before consent.
In the case of medical lingo that you do not understand, we will be available round the clock to answer all your questions. You dont have to hold yourself back whenever you have any inquiries or need for clarification. In the course of the clinical trials, we will take the time to explain to you the purpose of every stage of the research study. Your consent is of great value to us and the success of the research project. It is expected of you to follow the instructions of the research at all times; you should adhere to the stated rules of the research, and your compliance is much needed for the success of the research program. If you have questions, you should be free to ask me, the study doctor or any of the members leading the clinical trials.
Purpose of Research
HIV AIDS is a killer disease that has brought the death of a great many people globally. Since its discovery, no medical interventions have been able to suppress the effects of this disease. The HIV virus causes a reduction of the overall immunity of the body. The disease infects human beings, and it has been noticed in some species of primates. The disease predisposes the body to attacks from any disease; this predisposition places an individual at the risk of any disease attack. In many scenarios, individuals have succumbed to death by diseases such as Malaria, Tuberculosis, Dysentery and other curable illnesses. Their deaths can be attributed to the weakened body defense system. In South Africa statistics indicate that three people out of ten are HIV positive. It is then imperative that medical interventions be formulated in a bid to fight against this disease.
Recent medical research has brought forth new drugs that have been proven to reduce the effects of HIV. The reason for conducting this research is to test the ability of the drug to improve the immune system of patients with HIV. The results of this research are highly important in order to develop conclusions on the potential of these discoveries.
The HIV Vaccine Trials Network seeks to test the latest HIV vaccine combination. The research is expected to be undertaken with 252 patients from multiple locations of South Africa. This study is going to be payed for by the US National Institutes of Health. It is imperative to note that this research intends to know if these drugs are safe for use by people. It is our mandate to know if you as a participant is comfortable with undertaking the research. Finally, we would like to study how your immune system is going to be affected after the intake of HIV vaccines. Your immune system is a part of the body that protects you from contracting diseases. The primary purpose of this research study is to find a drug that will prevent the contraction of HIV & AIDS in the first place. The research is expected to run consistently for a period of two years. The drugs that will be administered are:
ALVAC-HIV (vCP2438) as a lyophilized vaccine.
Much More clear descriptions of the drugs, their effects, and their immune benefits will be discussed in the other parts of the information sheet.
Type of Research Intervention
The research is an intervention that seeks to prevent the contraction of HIV AIDS. The people selected for the research will be of any gender whatsoever, selection will be done on a randomized procedure. It is important that you understand that we conduct these trials in a bid to help people to avoid acquiring HIV virus in the near future.
Your consent for participating in the research should be 100% voluntary. You have a choice to take part in the researchs clinical trials or not. If you have been receiving any medical assistance from your current clinic, there will not be any interruptions curbing you from receiving drugs upon your cancellation of your participation in the clinical trials.
It is important for you to understand the course of the research and if you feel uncomfortable participating in the research you can opt out at any time. All that we request from you is discretion and your utmost consistency in the program. Your freedom will not be restrained in any manner.
Here are a few questions to elucidate your understanding
should you decide to be involved with this research, are you aware of the options at your disposal?
Are you aware that this research is undertaken purely voluntarily?
What questions linger in your mind?
Information regarding the Drug Trials
This research trials will be dwelled on the usability of two drugs to human beings as preventive drugs for HIV &AIDS, namely; ALVAC-HIV (vCP2438) Placebo and Bivalent gp 120/MF59 Placebo. The research is going to take place within a time span of two years. It is important to know that these above-mentioned drugs are experimental drugs, and we are not sure if these drugs are safe for human beings to use. We are also not sure if these drugs are able to prevent the contraction of HIV and AIDS in human beings. You should realize that these drugs are used in experimental studies only. It is good to be aware that drugs are not approved for prevention of HIV &AIDS yet but they are used as experimental drugs which can be improved. The improvement of these drugs depends on the statistics collected from the current clinical trial.
It is imperative that we enlighten you about the AVAC vaccine before you agree or disagree on joining the clinical trials. The AVAC vaccine is experimentally made out of the Canarypox virus. Canarypox virus usually infects birds, there is no medical account of its growth in the human body. The virus has been genetically modified, and some small bits of man-made DNA have been inserted in it. The DNA is a natural substance that is found in all living creatures on the planet; including people, animal, and even viruses. Canarypox virus is very instrumental in this context in that it helps in getting the DNA into the body cells. The DNA that has been inserted into the body then is able to instruct the body to make a small amount of protein cells that resemble that of the HIV.
You should know that a similar research is being currently conducted in South Africa using the ALVAC vaccine, the project has already admitted 80 individuals who signed up voluntarily. Till present, there has not been any occurrence of individuals with serious health problems. I cannot assure you of the safety of these drugs because at their current state they are experimental drugs. I would advise that you should be 100% sure before you sign up into the clinical trials.
It isof great importance that the protein vaccine has laboratory made pieces of proteins that are found on the outer walls of HIV. Through the use of an adjuvant mixed with protein MF59, the vaccine is made. An adjuvant is an element that is usually added to the vaccine in order to trigger the immune system to work much better. You should know that protein MF59 has been previously been administered to over 50,000 people in various clinical trials, no serious medical and health problems have been noticed since.
A practice such as this, the combination of study vaccines has never been conducted before; you will be among the first people globally to have gone through such as a clinical trial. However, you should know that in many other case studies, the ALVAC vaccine and the protein vaccines have been issued to more than 10,000 people in various clinical trials. No case of serious health problems has been reported since. It is of value to you as a participant to know that over 300 people initially received the same combination of ALVAC and protein vaccine with the use of MF59 as an adjuvant in clinical trials conducted without any adverse health problems. This clinical trial will consist of 251 other people inclusive of you to give a total number of 252 people from different parts of South Africa. You will be expected to show up to clinics 14 times over a time span of 18 months.
Procedures and Protocol
Considering that you have signed up for the clinical trials, because we are not sure if the vaccines that will be administered will have any effects on the reduction of HIV virus or the buildup of immunity against HIV virus, it will be important to let you know that tests will be conducted over the days of the research. In order to measure the disparities of each and every individual, all the participants will be injected with the ALVAC-HIV vaccine and a Placebo. The participants will be divided into two groups; this is for the purposes of having one group use the experimental drug while the other group would use placebos as a control aspect of the experiment. The selection of people who are going to be administered the drug, and those who will be issued with placebos will be done in a randomized manner. It is important that even us we should not be aware of the details of individuals using placebos and those that do not use the placebos in order to experiment without the biased preconceived ideas.
The ALVAC vaccine is the man-made vaccine that we informed you earlier about; it is formed out of Canarypox virus. The ALVAC vaccine will be administered a lyophilized vaccine injection at a viral titer. This vaccine will then be mixed with sodium chloride commonly known as common salt, for an injection in the muscle areas (arms). Later a bivalent Subtype C gp120/MF59 consisting of 2 monomeric proteins will be administered...
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