India is today a strong global partner in the international effort of finding a safe and effective AIDS vaccine for the world. Indian scientists are collaborating with international partners to develop a safe, affordable and preventive AIDS vaccine. The first vaccine being researched has been specifically designed for HIV-1 subtype C, the most prevalent HIV subtype in India, and this has been done using genes from Indian strains of the virus. (One day, it may make sense to test vaccines developed elsewhere – and checked by Indian scientists – but researchers need to know if a vaccine that looks promising in another country will also work against the type of HIV found in India and amongst Indians). Development and deployment of an AIDS vaccine for India would require participation by the people in testing out the vaccine.

Much of the development and deployment of an AIDS vaccine for India is being carried out under the aegis of a Memorandum of Understanding between the Indian government and the International AIDS Vaccine Initiative (there are some other vaccine development programmes in India but all are under strict government control). Before any vaccine trial in India can start, it will have to be approved by the Indian Council of Medical Research, the National AIDS Control Organisation and the office of the Drugs Controller General of India (which approves all clinical research with unlicensed medicines or vaccines).

Individuals who express interest in participating in the trial will be invited to attend a series of information seminars. They will be provided information on the trial and all questions will be answered. All of this will take place in local languages and in a manner which is understood by the volunteers. Locally appropriate and acceptable methods will be used to ensure that individuals have understood all the risks and requirements of the trial. For those who have successfully understood the process, an appointment will be made for a screening visit.

Informed consent means that a volunteer who decides to participate in a clinical trial agrees that it is her/ his free will to participate. It requires that the volunteer understands what participating in the trial involves and what the potential risks and benefits are. It is the responsibility of the research team to ensure that the participants have access to all information in their mother tongue, including people- friendly medical and legal issues (this is especially important for non-literate people or those with low levels of education). Only after the volunteer has understood all the details of the trial can s/he give informed consent. A researcher who is not involved in running the trial must test this understanding. This happens before entering a trial and before any procedures are carried out. However, giving consent does not mean that a volunteer is bound to stay in the trial. A volunteer can decide to leave the trial any time without having to explain the reasons.

India has been hit hard by HIV/AIDS. It is estimated that 3.97 million Indians are HIV-infected. While effective HIV/AIDS prevention and care strategies such as education, risk reduction counselling and condom promotion have helped reverse the tide in certain pockets of the country, a vaccine is also needed to complement existing strategies. Drugs that are available to treat people with HIV/ AIDS do not cure or stop the spread of HIV. The only real hope to stop the spread of HIV is a safe and effective preventive vaccine. The development of such a vaccine requires the participation of human volunteers. Volunteers in other countries say that their main motivation for taking part has been a desire to protect the next generation and their children by finding something, which can stop the ravage of HIV/AIDS.

The first trial that will be conducted in India is a Phase I trial. To participate in this trial, individuals must be:

men and women between 18 and 55 years of age
in good health
HIV negative
residents of India and those planning to live in India, near the trial site, for the next 18 months
willing to take part in many follow-up visits designed to monitor intensively the effects of the vaccine.

Women who are pregnant, lactating, or planning to become pregnant in the next year are not eligible to volunteer for the trial.

After giving informed consent, a counsellor will provide volunteers with more information about the screening, including HIV-testing. Later a complete medical history will be taken and physical examinations will be performed. Blood for routine tests, including HIV, will be obtained. After that, the volunteer will be given an appointment to come back for review of the results and enrolment, if s/he fulfils the enrolment criteria. If an individual is found to be HIV-positive at the screening, s/he will not be enrolled in the trial. S/he will be given information on where to access appropriate counselling and medical care and support.

The blood will be used in the laboratory to find out whether the vaccine causes any changes in the way an individual’s organs (such as kidneys or liver) function and what the effects of the vaccine on the immune system are. Through laboratory tests, it will be seen whether the vaccine can stimulate the immune responses that might fight against HIV/AIDS. The volunteer will not be exposed to HIV/AIDS at any point. Some back-up tests will be performed at a laboratory outside the country, which has been specifically designed to compare the results of Indian trials with trials in other parts of the world. The laboratories will never know the identity of the volunteer from whom the specific specimen has been taken.

No one knows – this is why early tests are in a small, intensively monitored group. However, the vaccines which are being researched for possible trials in India are from a class of vaccines with a good track record of safety in human beings. It is likely that some participants may experience pain, tenderness, redness or swelling at the injection site, or mild flu-like symptoms such as headache and fever. Some participants, however, may experience no side effects at all. Volunteers 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. Although the tests in animals indicate that the vaccine is safe, there always remains a small risk of unexpected adverse events.

No, individuals may react differently to a vaccine. There is room for potential side effects that the vaccine may have on an individual’s immune system. Both genders, male and female, must participate in the vaccine trials to ensure that there are no important differences in the way men and women react to the vaccine.

No. The design of the trial includes a control group. Individuals in the control group will be given a placebo, which is an inactive harmless substance (for example, saline) that is administered in the same way as the candidate vaccine.

Neither the volunteer nor the study team will know if the individual has received the vaccine or the placebo. This is called blinding. Blinding is necessary to be able to appropriately assess whether a potential side effect is caused by the vaccine or not and to evaluate the immune response in order to avoid any bias in the interpretation of the results. The blinding is maintained until the end of the trial. The assignment of volunteers to either the vaccine group or the placebo group will be made automatically by a computer. This process is called randomisation. It resembles the tossing of a coin.

The research team will not inform anybody about a volunteer’s participation in the trial. At the time of seeking consent, all volunteers 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 volunteers’ identity will never be disclosed. However, it is entirely up to the individual whether s/he wants to inform anybody about his or her decision to participate in the trial.

• receive compensation for time, transportation, food, housing if any, and other inconvenience for participation in the trials;
• have regular and supportive contact with healthcare workers and counsellors throughout the course of the trial;
• receive information regarding HIV transmission and how it can be prevented;
• have access to pre-agreed care and treatment package for HIV/AIDS if they become HIV-infected while enrolled in the trial;
• develop protective immunity to HIV if the vaccine is effective