4 ms·

You are misunderstanding the point of this study. This is a Phase 1 study designed to show that the vaccine itself doesn't directly make people sick and to meas

You are misunderstanding the point of this study. This is a Phase 1 study designed to show that the vaccine itself doesn't directly make people sick and to measure their antibody responses via blood tests. The on-going Phase 2/3 trials in the UK, South Africa and Brazil are designed to establish the efficacy of the vaccine under viral challenge. The idea is that you vaccinate a bunch of people (and an equally-sized control group) and wait around until a subset of them test positive for the virus. Then you unblind the groups and make sure that the people who got sick were in the control group. You also check for ADE (antibody dependent enhancement) to make sure the vaccine doesn't amplify the strength of the virus. All your questions are valid, but this study doesn't claim to answer them. Those results are still forthcoming. Additionally, the risk of ADE is well understood and carefully considered in the design of these trials. (Disclaimer - I'm a participant in the UK Phase 2/3 trial)

yomly 6y ago
Thank you for participating and for sharing these details!
capkutay 6y ago
It's still good to see such questions being raised in the community, especially when someone knowledgeable on the matter (such as yourself) has an educated response.
lbeltrame 6y ago
It is slightly different than a regular Phase 1 study because there's a control arm. I suspect they want to use the data as a complement to the Phase 2/3 results in the unfortunate case the volounteers end up positive for the virus.
drited 6y ago
The OP was critiquing the media reporting on the study not the study itself so I think your suggestion that the OP misunderstood the point of the study is off base. The OP did not claim that the study sought to answer the questions posed. The article does answer the question 'Is it safe?' with the word 'Yes' so I believe you are actually in agreement with the OP and the OP did understand that it is really early to say that, hence the critique.
- IgorPartola 6y ago
  > Although this virus has killed many, the risk factor for it is nowhere near high enough to warrant an emergency vaccine. Sure reads to me like the OP is attacking the idea of developing a vaccine, not the media coverage.
  - glial 6y ago
    To me, it seems like OP is attacking the idea of releasing the vaccine to the general public without due diligence. That’s different than developing it.
    - addHocker 6y ago
      Lets not forget the dengue debacle.
anticensor 6y ago
> (Disclaimer - I'm a participant in the UK Phase 2/3 trial) I have always thought those medical trials are conducted under an NDA against the patient, meaning you do not only not know what group you are in, you are not even allowed to tell you are being observed in such a study (to prevent accidental unblinding).
- throwanem 6y ago
  How would you expect to obtain informed consent without the patient knowing they're in the study?
  - 1_over_n 6y ago
    Being in a trial does not guarantee you get the investigative candidate because many trials have control arms without an intervention (hence a double-blind randomised controlled trial). Neither you or the doctor know which arm you are in during a double-blinded trial because placebo effects are very well known and have to be accounted for during the drug development process. This very much depends on the study design and phase of the study. Informed consent will take a patient through these factors, but it does not mean they are guaranteed to get the intervention. There are studies which have been stopped before the trial hit its end-points as it was deemed unethical not to give patients in the control arm the intervention because it proved so effective.
    - narag 6y ago
      Nothing indicates that the commenter knows if he's in the placebo group or the real thing group. He just said he is participating in the study, that could mean he's in either group.
      - anticensor 6y ago
        The thing is someone else participating in that same study may read that and experience an unintended placebo/nocebo/antidote effect. You are not supposed to dicslose you are in such a clinical trial. The ancestrals misunderstood that as not telling the test subject that he is being tested. You could also neutralise that consent effect by making the group of consent broader than the group of study, by adding two more controls such that one group (reverse intervention group) takes a drug that acually worsens the disease (I see the possible objections, but this alone will make the study complete faster), and one takes just nothing (neutral group-those would be sent back by telling them they are diagnosed negative, but actual diagnosis will be recorded in their files), in addition to a placebo group.

yomly 6y ago

Thank you for participating and for sharing these details!

capkutay 6y ago

It's still good to see such questions being raised in the community, especially when someone knowledgeable on the matter (such as yourself) has an educated response.

lbeltrame 6y ago

It is slightly different than a regular Phase 1 study because there's a control arm. I suspect they want to use the data as a complement to the Phase 2/3 results in the unfortunate case the volounteers end up positive for the virus.

drited 6y ago

The OP was critiquing the media reporting on the study not the study itself so I think your suggestion that the OP misunderstood the point of the study is off base. The OP did not claim that the study sought to answer the questions posed. The article does answer the question 'Is it safe?' with the word 'Yes' so I believe you are actually in agreement with the OP and the OP did understand that it is really early to say that, hence the critique.

IgorPartola 6y ago
> Although this virus has killed many, the risk factor for it is nowhere near high enough to warrant an emergency vaccine. Sure reads to me like the OP is attacking the idea of developing a vaccine, not the media coverage.
- glial 6y ago
  To me, it seems like OP is attacking the idea of releasing the vaccine to the general public without due diligence. That’s different than developing it.
  - addHocker 6y ago
    Lets not forget the dengue debacle.

anticensor 6y ago

> (Disclaimer - I'm a participant in the UK Phase 2/3 trial) I have always thought those medical trials are conducted under an NDA against the patient, meaning you do not only not know what group you are in, you are not even allowed to tell you are being observed in such a study (to prevent accidental unblinding).

throwanem 6y ago
How would you expect to obtain informed consent without the patient knowing they're in the study?
- 1_over_n 6y ago
  Being in a trial does not guarantee you get the investigative candidate because many trials have control arms without an intervention (hence a double-blind randomised controlled trial). Neither you or the doctor know which arm you are in during a double-blinded trial because placebo effects are very well known and have to be accounted for during the drug development process. This very much depends on the study design and phase of the study. Informed consent will take a patient through these factors, but it does not mean they are guaranteed to get the intervention. There are studies which have been stopped before the trial hit its end-points as it was deemed unethical not to give patients in the control arm the intervention because it proved so effective.
  - narag 6y ago
    Nothing indicates that the commenter knows if he's in the placebo group or the real thing group. He just said he is participating in the study, that could mean he's in either group.
    - anticensor 6y ago
      The thing is someone else participating in that same study may read that and experience an unintended placebo/nocebo/antidote effect. You are not supposed to dicslose you are in such a clinical trial. The ancestrals misunderstood that as not telling the test subject that he is being tested. You could also neutralise that consent effect by making the group of consent broader than the group of study, by adding two more controls such that one group (reverse intervention group) takes a drug that acually worsens the disease (I see the possible objections, but this alone will make the study complete faster), and one takes just nothing (neutral group-those would be sent back by telling them they are diagnosed negative, but actual diagnosis will be recorded in their files), in addition to a placebo group.