[Script Info]
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[Events]
Format: Layer, Start, End, Style, Name, MarginL, MarginR, MarginV, Effect, Text
Dialogue: 0,0:00:07.55,0:00:09.89,Default,,0000,0000,0000,,How do we develop a new vaccine?
Dialogue: 0,0:00:09.89,0:00:14.39,Default,,0000,0000,0000,,After lots of laboratory work, how do we\Nknow it is ready to get tested in humans?
Dialogue: 0,0:00:14.70,0:00:17.00,Default,,0000,0000,0000,,And then, how do we know \Nwhether or not it works?
Dialogue: 0,0:00:17.64,0:00:22.95,Default,,0000,0000,0000,,We test new vaccines in clinical trials to\Ndetermine that they're both safe and effective
Dialogue: 0,0:00:22.95,0:00:25.25,Default,,0000,0000,0000,,before they get licensed in the US.
Dialogue: 0,0:00:25.59,0:00:27.90,Default,,0000,0000,0000,,Stick with us, this is going to be interesting.
Dialogue: 0,0:00:28.52,0:00:31.60,Default,,0000,0000,0000,,And, although this applies\Nto all kinds of drugs and vaccines,
Dialogue: 0,0:00:31.60,0:00:36.52,Default,,0000,0000,0000,,we're going to focus here on vaccines used for\Nprevention of a specific type of infection.
Dialogue: 0,0:00:37.29,0:00:41.15,Default,,0000,0000,0000,,The first thing to know is that a lot of\Ntesting is done before a vaccine
Dialogue: 0,0:00:41.15,0:00:42.89,Default,,0000,0000,0000,,ever gets tested in humans.
Dialogue: 0,0:00:42.89,0:00:45.78,Default,,0000,0000,0000,,There is a long process of development in\Na laboratory,
Dialogue: 0,0:00:45.78,0:00:49.60,Default,,0000,0000,0000,,and testing, both for safety and for \Nprotection, in animal studies.
Dialogue: 0,0:00:50.16,0:00:54.60,Default,,0000,0000,0000,,After we have a vaccine that looks both safe\Nand promising in preventing infection
Dialogue: 0,0:00:54.60,0:00:57.72,Default,,0000,0000,0000,,in a laboratory, we begin testing in humans.
Dialogue: 0,0:00:59.09,0:01:02.07,Default,,0000,0000,0000,,Because we don't know whether or not\Nthe vaccine will work,
Dialogue: 0,0:01:02.07,0:01:05.83,Default,,0000,0000,0000,,we begin a very structured set of studies\Ncalled clinical trials.
Dialogue: 0,0:01:05.83,0:01:10.80,Default,,0000,0000,0000,,These studies involve healthy volunteers,\Nwho are told in detail about how and why
Dialogue: 0,0:01:10.80,0:01:14.55,Default,,0000,0000,0000,,this vaccine is being tested, and about any\Npotential harm.
Dialogue: 0,0:01:15.39,0:01:19.54,Default,,0000,0000,0000,,This educational process is a process\Ncalled informed consent,
Dialogue: 0,0:01:19.54,0:01:22.28,Default,,0000,0000,0000,,and goes on before and during the trial.
Dialogue: 0,0:01:23.02,0:01:26.19,Default,,0000,0000,0000,,There's a continual discussion that happens\Nbetween the researchers
Dialogue: 0,0:01:26.19,0:01:27.78,Default,,0000,0000,0000,,and the study volunteers.
Dialogue: 0,0:01:27.78,0:01:31.92,Default,,0000,0000,0000,,Describing the study, informing the\Nvolunteers about any new information
Dialogue: 0,0:01:31.92,0:01:34.32,Default,,0000,0000,0000,,that happens at any time during the study,
Dialogue: 0,0:01:34.32,0:01:37.27,Default,,0000,0000,0000,,and answering all questions that\Nthe volunteers have.
Dialogue: 0,0:01:38.21,0:01:42.21,Default,,0000,0000,0000,,The study staff also determine whether\Nthe volunteer meets all the eligibility
Dialogue: 0,0:01:42.21,0:01:46.88,Default,,0000,0000,0000,,criteria to participate, which involves\Nphysical exams and blood tests.
Dialogue: 0,0:01:48.97,0:01:53.08,Default,,0000,0000,0000,,Next, we start what is called a ramdomized,\Ndouble-blinded clinical trial.
Dialogue: 0,0:01:53.08,0:01:57.44,Default,,0000,0000,0000,,What that means is that after volunteers\Nenrol in a study,
Dialogue: 0,0:01:57.44,0:02:00.79,Default,,0000,0000,0000,,a computer randomly decides whether they\Nwill get the vaccine
Dialogue: 0,0:02:00.79,0:02:02.83,Default,,0000,0000,0000,,or whether they will get the placebo,
Dialogue: 0,0:02:02.83,0:02:05.13,Default,,0000,0000,0000,,which is usually just salt water.
Dialogue: 0,0:02:05.52,0:02:09.46,Default,,0000,0000,0000,,We do this to be able to separate outside\Neffects that are due to the vaccine
Dialogue: 0,0:02:09.46,0:02:13.42,Default,,0000,0000,0000,,from those that are just happening to\Npeople in a community at the same time,
Dialogue: 0,0:02:13.50,0:02:16.40,Default,,0000,0000,0000,,like the rate of cold symptoms,\Nor headaches.
Dialogue: 0,0:02:17.30,0:02:21.93,Default,,0000,0000,0000,,And, we double-blind, meaning neither\Nthe participant nor the study staff
Dialogue: 0,0:02:21.93,0:02:24.85,Default,,0000,0000,0000,,know who is getting which type of injection.
Dialogue: 0,0:02:25.61,0:02:30.28,Default,,0000,0000,0000,,That prevents both the volunteers and the\Nstaff from over or under reporting symptoms.
Dialogue: 0,0:02:30.28,0:02:34.16,Default,,0000,0000,0000,,We advise participants to tell us about\Neverything that is happening to them.
Dialogue: 0,0:02:35.04,0:02:39.25,Default,,0000,0000,0000,,Before a vaccine is licensed by the\NUS food and drug administration,
Dialogue: 0,0:02:39.25,0:02:42.41,Default,,0000,0000,0000,,it usually goes through 3 phases of\Nclinical trials,
Dialogue: 0,0:02:42.41,0:02:44.74,Default,,0000,0000,0000,,each of which has a specific purpose.
Dialogue: 0,0:02:45.83,0:02:48.78,Default,,0000,0000,0000,,Phase 1 trials, which can last up to 2 years,
Dialogue: 0,0:02:48.78,0:02:52.84,Default,,0000,0000,0000,,compare the safety - does the vaccine\Ncause any side effects,
Dialogue: 0,0:02:52.84,0:02:57.71,Default,,0000,0000,0000,,and tolerability - does the injection hurt,\Nand for how long?
Dialogue: 0,0:02:58.21,0:03:02.26,Default,,0000,0000,0000,,In this phase of studies, scientists are\Nalso gathering information about
Dialogue: 0,0:03:02.28,0:03:04.82,Default,,0000,0000,0000,,the body's immune response to the vaccine,
Dialogue: 0,0:03:04.83,0:03:09.07,Default,,0000,0000,0000,,to see whether it is a promising approach\Nto preventing this specific infection.
Dialogue: 0,0:03:09.62,0:03:14.56,Default,,0000,0000,0000,,Phase 1 trials do not determine whether\Nor not the study product is actually doing
Dialogue: 0,0:03:14.56,0:03:15.73,Default,,0000,0000,0000,,what we hope it will do.
Dialogue: 0,0:03:16.98,0:03:20.30,Default,,0000,0000,0000,,Phase 2 trials, which can last\Nlonger than 2 years,
Dialogue: 0,0:03:20.30,0:03:23.84,Default,,0000,0000,0000,,will confirm the safety in a larger group\Nof volunteers,
Dialogue: 0,0:03:23.84,0:03:28.10,Default,,0000,0000,0000,,and focus on the best dose and the best\Ntiming of vaccinations to produce
Dialogue: 0,0:03:28.10,0:03:29.90,Default,,0000,0000,0000,,the strongest immune response.
Dialogue: 0,0:03:31.44,0:03:35.44,Default,,0000,0000,0000,,Promising vaccines that are safe and\Ngenerate a strong immune response
Dialogue: 0,0:03:35.44,0:03:37.72,Default,,0000,0000,0000,,move into phase 3 trials.
Dialogue: 0,0:03:37.72,0:03:42.59,Default,,0000,0000,0000,,These are the largest trials, and compare\Nthe rate of infection in the vaccine and
Dialogue: 0,0:03:42.59,0:03:43.68,Default,,0000,0000,0000,,placebo groups.
Dialogue: 0,0:03:44.61,0:03:47.45,Default,,0000,0000,0000,,This will tell us whether the vaccine is\Nable to prevent infection,
Dialogue: 0,0:03:47.45,0:03:53.22,Default,,0000,0000,0000,,and, if so, if it is effective in all of\Nthe volunteers, or only a sub-group,
Dialogue: 0,0:03:53.22,0:03:55.49,Default,,0000,0000,0000,,like younger volunteers, or women.
Dialogue: 0,0:03:56.80,0:04:01.17,Default,,0000,0000,0000,,Along with the safety data that is collected\Nin all phases of vaccine studies,
Dialogue: 0,0:04:01.17,0:04:07.05,Default,,0000,0000,0000,,this efficacy data is used by the FDA to\Ndecide if the vaccine should be licensed,
Dialogue: 0,0:04:07.05,0:04:09.94,Default,,0000,0000,0000,,and, if so, for whom it is recommended.
Dialogue: 0,0:04:11.96,0:04:16.55,Default,,0000,0000,0000,,In the best case scenario, it could take\N6-10 years for a promising vaccine to move
Dialogue: 0,0:04:16.55,0:04:20.04,Default,,0000,0000,0000,,from phase 1 testing\Nto real world distribution.
Dialogue: 0,0:04:20.04,0:04:21.89,Default,,0000,0000,0000,,Often it takes longer.
Dialogue: 0,0:04:22.90,0:04:26.34,Default,,0000,0000,0000,,The clinical trials are absolutely \Nnecessary to determine that a vaccine
Dialogue: 0,0:04:26.34,0:04:29.51,Default,,0000,0000,0000,,is safe and effective in preventing \Nnew infections.
Dialogue: 0,0:04:31.21,0:04:35.03,Default,,0000,0000,0000,,This video has been provided to you by\NYoureka science, in collaboration with
Dialogue: 0,0:04:35.03,0:04:36.33,Default,,0000,0000,0000,,BridgeHIV.
Dialogue: 0,0:04:36.33,0:04:39.15,Default,,0000,0000,0000,,To stay in touch with Youreka science,\Nlike us on Facebook,
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Dialogue: 0,0:04:42.89,0:04:44.40,Default,,0000,0000,0000,,YourekaScience.org
Dialogue: 0,0:04:44.40,0:04:45.43,Default,,0000,0000,0000,,Thank you for watching!