Hope on trial

Aparna Shrotri looks very busy as she glances through consent forms and questionnaires stacked neatly in different folders. Barely has she a...

Written by Anuradha Mascarenhas

Pune | February 13, 2005 12:00 AM IST

4 min read

Aparna Shrotri looks very busy as she glances through consent forms and questionnaires stacked neatly in different folders. Barely has she adjusted her doctor8217;s coat that the office attendant announces the arrival of a volunteer.

As the country8217;s begins its first human clinical trial to prevent AIDS, history is being created at Pune8217;s National AIDS Research Institute. Specially created within the space at NARI for the vaccine trial, a small clinic is abuzz with friendly counsellors and community coordinators.

Above in his office, the principal investigator of the trial8212;Dr Sanjay Mehendale8217;s phone does not stop ringing. 8216;8216;We are extremely busy,8217;8217; he apologises but revels in the fact that 8216;8216;they are on the right track and the schedule is just fine.8217;8217; The first batch of ten volunteers will be given the study injection by the end of the month.

So what is this vaccine? Called tgAACO9 recombinant adeno-associated viral vector rAAV and designed by Seattle-based Targeted Genetics Corp, the vaccine candidate is modelled after subtype C of HIV that accounts for most infections worldwide. tgAACO9 consists of an artificially made copy of HIV8217;s genetic material. It does not cause HIV infection or AIDS, says Mehendale.

There are 30 volunteers who have enrolled for Phase 1 of the trial. During Phase 1, some volunteers will receive an injection of tgAACO9 while others will receive an inactive substance called a placebo. What8217;s important is that neither the volunteers nor the clinicians working with them will know who received tgAACO9 and who received the placebo until after the study is over.

For the selection procedure, community coordinators and counsellors have played an important role. As Shrotri, Dr Seema Sahay, Ashish Tribhuvan and their team screen the participants, what is emphasised is their physical fitness. 8216;8216;We need healthy individuals,8217;8217; says Mehendale.

Each player has a defined role at the Vaccine Trial Clinic. Separate rooms are created for screening, counselling and testing the volunteer. Once the screening to test the participant8217;s eligibility is over, the counsellor takes charge and makes the volunteer feel at ease. Private and confidential conversations take place in the counsellor8217;s room. After the study injection is given, there will be a review period of three weeks. Then the second batch of ten volunteers will be given the study injection, with a higher dose. This entire process during the first phase may take 15 months to be completed.

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Volunteers will be monitored for their medical fitness and tested for any abnormal reactions. 8216;8216;What is really amazing is the level of participation here,8217;8217; says Dr Ramesh Paranjape, officer-in-charge of NARI. Each volunteer has given us the time and date when they can be contacted. So far the schedule is going just right, says Mehendale.

Volunteers will return to the trial site frequently for check-ups and samples of their blood will be analysed for safety. The blood samples will be analysed to collect preliminary data on whether the vaccine candidate elicits immune responses that may play a role in preventing HIV infection. The first phase of the trial is comparing a low, medium and high vaccine dose. So far the Phase 1 trial using the same vaccine has shown good 8216;safety8217; results in Belgium and Germany.

The tension here is palpable but hope is constant as the race against AIDS hots up at this small clinic in Pune.

Anuradha Mascarenhas

Anuradha Mascarenhas is a Senior Editor at The Indian Express, based in Pune. With a career spanning three decades, she is one of the most respected voices in Indian journalism regarding healthcare, science and environment and research developments. She also takes a keen interest in covering women's issues . Professional Background Education: A gold medalist in Communication and Journalism from Savitribai Phule Pune University and a Master’s degree in Literature. Author: She authored the biography At The Wheel Of Research, which chronicles the life and work of Dr. Soumya Swaminathan, the former Chief Scientist at the WHO. Key Focus: She combines scientific accuracy with storytelling, translating complex medical research into compelling public and human-interest narratives. Awards and Recognition Anuradha has won several awards including the Press Council of India's national award for excellence in journalism under the gender based reporting category in 2019 and the Laadli Media award (gender sensitivity -2024). A recipient of the Lokmat journalism award (gender category-2022), she was also shortlisted for the RedInk awards for excellence in journalism-2021. Her debut book At The Wheel Of Research, an exclusive biography of Dr Soumya Swaminathan the inaugural chief scientist of World Health Organisation was also nominated in the Popular Choice Category of JK Paper AUTHER awards. She has also secured competitive fellowships including the Laadli Media Fellowship (2022), the Survivors Against TB – New Research in TB Media Fellowship (2023) and is part of the prestigious 2025 India Cohort of the WomenLift Health Leadership Journey.” Recent Notable Articles (Late 2025) 1. Cancer & Specialized Medical Care "Tata Memorial finds way to kill drug-resistant cancer cells" (Nov 26, 2025): Reporting on a breakthrough for triple-negative breast cancer, one of the most aggressive forms of the disease. Discipline, diet and purpose; How a 97-year-old professor defies ageing'' (Nov 15, 2025) Report about Prof Gururaj Mutalik, the first Head of Department at Pune's B J Government Medical College who at 97 credits his longevity to healthy habits and a strong sense of purpose. 2. Environmental Health (The "Breathless Pune" Series) Long-term exposure even to 'moderate' air leads to chronic heart, lung, kidney issues" (Nov 26, 2025): Part of an investigative series highlighting that even "safe" pollution levels are damaging to vital organs. "For every 10 µg/m3 increase in PM2.5 level, there was 6-8% jump in medicine sales" (Nov 23, 2025): Using commercial data to prove the direct link between air quality and respiratory illnesses in Pune. 3. Lifestyle & Wellness News "They didn't let cancer, diabetes and heart disease stop them from travelling" (Dec 22, 2025): A collaborative piece featuring survivors who share practical tips for traveling with chronic conditions. At 17, his BP shot up to 200/120 mmHG; Lancet study flags why child and teen hypertension doubled between 2000 and 2020'' (Nov 12,2025)--A report that focusses on 17-year-old-boy's hypertensive crisis and reflects the rising global trend of high blood pressure among children and adolescents. 4. Scientific Recognition & Infrastructure For promoting sci-comm, gender diversity: IUCAA woman prof highlighted in Nature" (Nov 25, 2025): Covering the global recognition of Indian women scientists in gender studies and physics. Pune researchers find a spiral galaxy like the Milky Way from early universe'' (December 3, 2025)- A report on how Indian researchers discovered a massive galaxy that existed when the universe was just 1.5 billion years old , one of the earliest to have been observed so far. Signature Beat: Health, Science & Women in Leadership Anuradha is known for her COVID-19 reportage, where she was one of the first journalists to provide detailed insights into the Covishield and Covaxin trials. She has a dedicated interest in gender diversity in health and science, often profiling women researchers who are breaking the "leaky pipeline" in STEM fields. Her writing style is scrupulous, often featuring interviews with top-tier scientists and health experts from various institutions. ... Read More

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