Individuals can participate in this Phase I clinical trial if they are……

• men or women between 18-50 years of age;
• in good health;
• HIV-uninfected;
• persons who stand a very low chance of contracting HIV;
• residents of India and are planning to live close to the trial site for the entire duration of the Phase I trial;
• able to understand the process of the trial and give their signed informed consent to participate
• willing to come for all scheduled visits for clinical examination and blood draws. These visits are designed to intensively monitor the effects of the vaccine.

Women who are pregnant, lactating or planning to become pregnant within four months after the vaccination do not qualify to participate in a Phase I clinical trial.

Although the researchers have a person's informed consent, the individual is free to leave the trial at any stage without having to explain the reasons. It is also the individual's right to ask for any information s/he may require at any time during the clinical trial. However, the person will only be told whether s/he received the vaccine or placebo (see FAQ 4 below) at the end of the trial.

All participants in a Phase I clinical trial will not receive the vaccine. Some participants will receive an inactive and harmless substance called a placebo. This is typical to any research design where scientists need to be able to differentiate between effects related to the vaccine and those due to other extraneous factors. The assignment to receive the vaccine or placebo is made by a computer in order to avoid any bias in judgment. This procedure is called “randomisation”. It is very useful because it helps the research team compare the vaccine group and the placebo group to find out whether a potential side effect is caused by the vaccine or not and to evaluate the immune response of trial participants without any bias in the interpretation of the results. Neither the trial team nor the volunteer will know whether the vaccine or placebo has been administered. Since both parties are ‘blind’ to this information, it is called a “double-blind” study. The blinding is maintained until the end of the trial.

Other than the research team, nobody will be informed about volunteers’ participation in the trials. At the time of seeking consent, they will be assured of complete privacy and confidentiality. The entire team is bound to keep all medical information collected from participants confidential. This means that a volunteer's identity will never be disclosed and his/her records will only have a code number without the name. However, it is entirely up to the person whether s/he wants to inform anybody about his/her decision to participate in the trial.

There is no risk at all of getting infected with HIV due to this vaccine because the virus is never used in its natural, active and infectious form to make the vaccine. Scientists create synthetic copies of a small part of HIV's genetic material in the lab and use them for the vaccine. It is impossible for the experimental vaccine to cause HIV infection or AIDS.

The vaccine is a new substance given to the body and for it to be effective, the body must recognise it. This process of recognition may cause some reaction in the body. Additionally, individuals may react differently to the same vaccine. It is likely that some participants may experience side effects such as tenderness, swelling or redness at the injection site, or mild flu-like symptoms such as headache and fever. All participants will be asked to come to the clinic to review any side effects. They will also be given telephone numbers to call in case there are any problems.

A participant may test false ‘HIV positive’ after vaccination. This does not mean that s/he is HIV-infected. This just means that s/he has developed antibodies as a response to the vaccine. The most commonly used test to check for HIV is the HIV antibody test. This test looks for the antibodies produced by the immune system in response to HIV. The vaccine, however, also stimulates the immune system to produce HIV antibodies and can therefore potentially show a positive result in the HIV antibody test.

To check whether a participant is testing ‘HIV positive’ due to the vaccination and the antibodies it induces, or due to true HIV infection, a different kind of test that looks for the virus itself is needed. This is sometimes called an antigen test and can pick up the actual presence of HIV in the body.

False HIV seropositivity will most probably be a very transient condition. Upon request, the investigator can provide participants with a letter mentioning that their HIV positive status is related to the vaccine received and that they are not HIV-infected.

As mentioned previously, the AIDS vaccine on its own cannot cause HIV infection. All participants will be counselled on prevention of HIV infection at every visit to the clinic and they will be repeatedly tested for HIV during the trial. Should a participant get infected with HIV from another source, for example, unprotected sexual intercourse or unsafe sharing of needles during drug use, s/he will receive counselling and will be referred by the trial team for free HIV care and treatment in keeping with the Government of India (NACO) guidelines.

Yes, participants can and should continue with their normal daily life. Only healthy individuals are selected to participate. They can continue with a normal sexual life but they will be counselled to practise safe sex and use condoms, a general precaution applicable to all, whether people are participating in this clinical trial or not.

• receive information regarding HIV transmission and how it can be prevented;
• receive compensation for time, transportation, food, and other inconveniences caused due to your participation in the trial;
• have regular and supportive contact with healthcare workers and counsellors throughout the course of the trial;
• receive regular information about their ‘health status’ and the results of their blood tests, free of charge;
• have access to a pre-agreed care and treatment package for HIV/AIDS if they become HIV-infected for any reason, including any behaviour that puts them at risk of HIV infection while enrolled in the trial (such as blood transfusion without appropriate screening);
• receive free medical insurance that will cover any medical costs for illnesses not related to participation in the vaccine trial (such as pneumonia);
• receive free treatment for any adverse effects they might experience as a result of participating in the trial.

Ethics are sets of guidelines to ensure the protection of basic human rights of participants in biomedical research. These guidelines define the information that people have a right to and the choices people have the right to make in the context of the clinical trial. Before any trial can begin, the relevant ethics committees must approve the protocol in order to verify that international guidelines are respected and that the confidentiality, safety and liberty of the participants in the trial are not compromised. It has been ensured that this clinical trial has been approved by the national regulatory agencies in India and all the required ethics committees.

The trial will be conducted by research scientists who are well trained in Good Clinical Practice and ethical conduct of research. Both NARI and TRC are government institutes with many years of experience of conducting clinical research that conforms to highest international ethical and scientific standards. Similarly, IAVI has sponsored and supported AIDS vaccine development and trials in several countries in the world.

An appropriate written informed consent will be obtained after providing detailed information about study participation including the benefits and risks of participation and compensation. Participation will be entirely voluntary and the investigators will be available for discussion with the participant or his/her family members when required. The investigators will maintain confidentiality regarding the participant’s identification details. Efforts will be made to provide best possible medical care during the trial period.