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PHASE I TRIAL OF AN AIDS VACCINE FOR INDIA
This is a Phase-I trial of a newly developed experimental AIDS vaccine


Objective of the trial: To evaluate the safety of the vaccine and its ability to generate immune response in HIV-uninfected, healthy volunteers.
This international multi-centric trial is being conducted by the National AIDS Research Institute, Pune, under the joint auspices of the National AIDS Control Organization (Ministry of Health and Family Welfare, Government of India), the Indian Council of Medical Research (ICMR) and sponsored by the International AIDS Vaccine Initiative (IAVI).

THE TRIAL VACCINE
The vaccine being tested is called tgAAC09.
The vaccine does not contain HIV virus. Therefore the volunteers cannot get infected with HIV from this vaccine. This is a preventive vaccine intended for people who are not infected with HIV and not for persons living with HIV. It is not a drug for AIDS.
This particular vaccine has been tested in animals prior to this trial. Data from animal and pre-clinical studies indicate that the vaccine was safe and was well tolerated, allowing testing in human beings.
This Phase-I trial is currently ongoing in two European countries, Belgium and Germany where fifty volunteers have already received this vaccine in whom it was found to be safe.
This vaccine will be tested for the first time in human beings in India at NARI in Pune. Three groups of volunteers will receive three different doses of vaccine (low, medium and high) and the volunteer may be in any one of these groups. The vaccine will be given intramuscularly in the upper arm.

Who can participate in this trial?
30 volunteers will participate in this clinical trial. Volunteers must fulfill the following criteria to be able to participate in the trial:
Men or women between 18 and 50 years of age
Healthy, HIV-uninfected and at low risk for HIV infection
People living in and around Pune and available for all visits scheduled during the study
Literate, who can give written informed consent
Willing to avoid pregnancy from screening until four months after the vaccination
Who cannot participate?
Persons with the following conditions will not be able to participate in the trial
HIV- infected or practicing high risk behaviour for HIV infection
Pregnant or lactating women
Presence of chronic disease, mental disorders and physical disability
Recently received vaccine, blood or blood products
History of allergic reactions to vaccination
How will this trial be conducted?
The 30 volunteers will be assigned to one of three dosage groups (low, medium or high dosage). Each group will include 10 volunteers, of which 8 will receive the vaccine and 2 will receive the placebo. Placebo is a substance that looks similar to the experimental vaccine but has no active ingredient. Participants will have to agree to vaccine either the vaccine or the placebo.
Neither the volunteer nor the researchers will know who has received the placebo or the vaccine until the end of the trial. This is called double blinding.

Study procedures
Screening, Enrollment & Follow up visits

Screening:
Signing informed consent for screening, tests and evaluation.
Medical history & physical examination
Blood tests including HIV test, Urine examination
Enrollment:
Informed consent for enrollment
A test to assess the adequacy of comprehension (Multiple choice test)
Vaccination: Single injection of the trial vaccine in the arm.

Follow-up:
Follow up for 12 months
10 visits to clinic as per schedule and 2 additional contacts by phone or home visit
HIV test at 3 of these visits
Blood will be collected at 6 of these visits
Possible risks and discomforts

As after any injection, participants may experience some mild or moderate reaction at the injection site (redness, swelling, pain and tenderness, and in very rare cases, the formation of a scab and skin discoloration), reactions that will only be temporary.
Participants may also experience mild fever, chills, headache, nausea, fatigue, vomiting, malaise, mild muscular pain and joint pain. Participants may not experience any of them.
Like any new drug or vaccine, there is a possibility of a totally unexpected side effect, although previous testing with other vaccines in other countries indicates that this vaccine is quite safe.
This clinical trial is not designed to study whether tgAAC09 can protect against HIV infection (efficacy). Therefore participants must avoid any behaviour that may put them at risk of contracting HIV. Participants should not consider themselves protected from HIV after receiving the injection
It is not known what effect/s the test vaccine might have on an unborn child. Therefore women participating in the trial should use a reliable form of contraception until four months after the injection. Participating men are also advised to use condoms.

Some important features:
Study approved by:
Ethics committee (NARI and ICMR)
Drug Controller General of India
Health Ministry Govt. of India)
Monitoring according to international standards.
Special efforts to protect the rights of the volunteers.
Complete confidentiality regarding participant related information.
Compensations for transport expenses and loss of wages at every visit.
Full treatment for Trial related injuries free of charge.
Medical insurance for trial unrelated medical events requiring hospitalization.
Contact details:
For any questions or to know more about the trial, the volunteers may contact Dr. Sanjay Mehendale (Principal Investigator) at:

AIDS Vaccine Trial Unit
National AIDS Research Institute,
P.O.Box 1895,
Bhosari, Pune, India.
Tel: 020-27121342/43,
Fax: 020-27121071


Community Office at Prashant Society, Plot No. 17, Paud Road, Pune 411029
Tel: 020-25458117

Email: smehendale@nariindia.org
Website: www.nari-icmr.res.in

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