Vaccine
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| 1. Why we need HIV-1 vaccine ? |
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- The Human toll of AIDS is staggering. More than 25 million
men, women and children have died from AIDS. More than
40 million people are living with HIV and this number
is ever increasing.
- Prevention programs-including education, condom and
and peer counseling-have slowed the spread of HIV, but
have not stopped it.
- Treatment advances have yielded important new AIDS therapies,
but the cost and complexity of their use are limiting
factors for most people in the developing countries. In
industrialized nations where drugs are more readily available,
side effects and increased rates of viral resistance have
raised concerns about their long-term use.
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2. Is HIV-1 vaccine currently available ? |
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No.
But there are many experimental vaccine preparations, which
are being tested in phase I, some in phase II and one vaccine
is in phase III trial. |
3. What is phase I, II, III vaccine trial ? |
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The
vaccine, which is showing good results in animal experiments,
is further tested in three phases before its large-scale use.
- Phase I vaccine trial: It is the first
human tests of a candidate vaccine, generally conducted
on small numbers (10-30) of healthy adult volunteers who
are not at risk for the disease. The main goal is evaluation
of safety, and to a lesser extent, analysis of the immune
responses evoked by the vaccine. A Phase I trial usually
takes 8-12 months to complete.
- Phase II vaccine trial: It involves
a larger number of volunteers (50-500), usually a mixture
of low-risk people and higher-risk individuals from the
population where Phase III (vaccine efficacy) trials will
eventually be conducted. Phase II trials generate additional
safety data as well as information for refining the dosage
and immunization schedule. Although not set up to determine
whether the vaccine actually works, Phase II trials are
sometimes large enough to yield preliminary indications
of efficacy. These trials generally take 18-24 months.
- Phase III vaccine trial: Phase III
trials are the definitive test of whether a vaccine is
effective in preventing disease. Using thousands of volunteers
from high-risk populations in geographic regions where
HIV is circulating, the incidence of HIV in vaccinated
people is compared to that in people who receive a placebo.
Successful demonstration of efficacy in a Phase III trial
can then lead to an application for licensure of the vaccine.
Phase III trials of AIDS vaccines are generally expected
to require a minimum of three years for enrollment, immunizations,
and assessments of efficacy.
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| 4. How many vaccines are in phase I, II and III ? |
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Currently
there is only one vaccine in phase III. Two are in phase II
and more than twenty are in phase I.
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| 5. Is there any vaccine trial undergoing in India ? |
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First phase I trial will be conducted atin India in year.
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| 6. Why scientists believe that effective anti-HIV-1 vaccine can be prepared ? |
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The
scientific consensus is that an AIDS vaccine is possible.
This is because
- Experimental AIDS vaccines have protected non-human
primates (monkeys).
- It has been found that there are rare individuals who
exhibit an exceptional ability to tame the virus. Analysis
of what is different about immune system of these individuals
is yielding idea for vaccine development. For example,
some female sex workers have remained HIV uninfected for
years, despite repeated exposure to HIV. Researchers are
building and testing vaccines designed to induce similar
immune response as shown by these women.
- Vaccines have controlled other infectious diseases such
as small pox, Polio and Measles.
- Advances in molecular biology and basic HIV research
have led to the development of promising strategies for
effective AIDS vaccines.
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| 7. What are major obstacles in preparation of HIV-1 vaccine ? |
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The
major obstacle in HIV vaccine preparation is that, the virus
continuously changes its surface makeup and evolves to escape
defending mechanism against it.
There are nine different subtypes of HIV across the globe
and there is large variation within each subtype making vaccine
preparation a difficult task.
HIV infects immune cells needed to fight disease and also
develops reservoirs of virus by integrating into the host
DNA.
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| 8. How soon will a vaccine against HIV/AIDS be available ? |
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Recently,
there have been promising breakthroughs in research on vaccines
that reduce viral load, thereby decreasing chances of transmission
from someone who is HIV positive to someone who is not. A
preventative HIV vaccine, however, may still be years away.
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| 9. What is mean by prime-boost vaccine approach? |
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Priming is to give one type of vaccine dose to induce certain kind of immune response, to be followed by or together with a second type of vaccine (booster). A prime-boost combination may induce different types of immune responses and/or enhance overall responses beyond those seen with only one type of vaccine.
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| 10. What is mean by randomized trial? and blinded vaccine trial ? |
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In
randomized trial participants are assigned by chance to experimental
or control arm of the trial. Randomization minimizes the differences
among groups by equally distributing people with particular
characteristics among all the trial arms.
In blinded vaccine trial participants are unaware whether
they are in the experimental or control arm of study. A clinical
trial in which neither the study staff nor the participants
know which participants are receiving the experimental vaccine
and which are receiving placebo is called double-blind study.
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