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SCIENTIFIC STRATERGY
Several vaccine candidates are being tested simultaneously in India to accelerate the process of finding an effective AIDS vaccine. Several vaccine candidates have been identified as suitable for testing in India by a panel of national and international experts convened by ICMR.
- A conservative estimate is that it may take between eight to ten years before a final product is ready for industrial manufacturing.
- India has a critical role to play in the global efforts for AIDS vaccine research and development. This initiative helped in strengthening the existing research infrastructures at the trial sites, respectively the National AIDS Research Institute (NARI), Pune, and Tuberculosis Research Center (TRC), Chennai. It also contributed to building capacity of the Indian research staff and scientists involved in clinical trials to ensure compliance with national and international ethical and scientific standards.
- TRC and NARI have been strengthened as global centres of excellence for clinical evaluation of AIDS vaccines in India.
- Capacity building activities involved the renovation and equipment of the Vaccine Trial Centre (clinic, counseling unit, pharmacy and data management unit) and the Safety, Immunology and Virology laboratories. The laboratories are quality controlled and have been audited.
- At both centres, clinical, laboratory and administrative staffs were hired and have undergone an intensive training. The laboratory staff has been trained in Good Clinical Laboratory Practices at the IAVI Core Laboratory in London, UK , CLS in South Africa, and at the NARI and TRC laboratories. The clinical trial staff has been trained in Good Clinical Practices by an expert team from the John Hopkins University Bloomberg School of Public Health and IAVI and has been sensitised to gender-related issues.
- Two vaccine candidates were prioritised for Phase I clinical trials in India:
tgAAC09, an Adeno-Associated Virus (AAV)-based vaccine,
and TBC-M4, a Modified Vaccinia Ankara (MVA) based vaccine.
Indian scientists have been involved in the research and development of both these candidates.
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| TBC-M4 (MVA) |
tgAAC09 (AAV) |
Designed with the participation of an Indian scientist, and manufactured in the US by Therion Biologics, Cambridge, Massachusetts |
Designed and manufactured in the US by Targeted Genetics Corporation, Seattle, Washington |
Derived from Vaccinia virus
A highly attenuated (weakened) form of Vaccinia virus
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Natural infection
A non-pathogenic virus often found in people infected with adenoviruses
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Not known to replicate in human cells |
Not capable of replication |
Used as a vehicle for six HIV-1 subtype C genes (Subtype C is the most prevalent subtype of HIV in India) |
Used as a vehicle for gag, protease and part of the reverse transcriptase genes of HIV-1 Subtype C |
Multigenic (a large number of genes can be accommodated in MVA) |
Limited number of genes can be accommodated in AAV. Several AAV vectors would be needed to accommodate additional genes. |
MVA vector known to be safe in humans |
Safe and well tolerated as tested in Belgium and Germany
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Several injections needed
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Single injection, however booster may be needed
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Prime-boost immunisation schedule possible |
Prime-boost immunisation schedule possible
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- A Phase I trial of tgAAC09 was initiated on February 7, 2005 at the National AIDS Research Institute (NARI), Pune and was completed in December 2006.
- Volunteers were enrolled in the low, mid and high-dosage groups. After each group was enrolled, the data was reviewed by an independent international Safety Review Board (SRB) who gave authorisation to start enrollment for the next dosage group. The vaccine was found to be safe, well tolerated and moderately immunogenic.
- The Phase I trial of TBC-M4- Modified Vaccinia Ankara (MVA) candidate is currently ongoing at the Tuberculosis Research Centre (TRC), Chennai.
- The regulatory approval process for the MVA vaccine was identical to that followed for the AAV vaccine. Prior to the trial initiation, approvals were obtained from the Institutional Scientific Committee, Institutional Ethics Committee, the Drug Controller General of India, the Genetic Engineering Approval Committee, the Central Ethics Committee, and the Health Ministry's Screening Committee.
- The communication and advocacy for community mobilisation and recruitment of volunteers and processes related to informed consent and care and treatment of trial participants were implemented at both sites.
- All volunteers received their vaccination regimens and are being followed up. Only one volunteer withdrew from the TBC-M4 trial at TRC for personal reasons
- Expanding on the results of the previous trials in India, a new Phase I trial is being considered.
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