3 ms·

What isn’t it saying?

by laurencerowe 4y ago

mrslave 4y ago
The probability of them acquiring HIV within 6 months without the vaccine under trial.
- bruce511 4y ago
  They're not testing for efficacy, but rather safety. Looking for side effects etc... Efficacy won't be proved by this trial, although potentially disproved.
barry-cotter 4y ago
If those 18 people are randomly selected all they’re doing is testing for safety, phase 1. If they expect to get anything about efficacy out of it the only population where there’s a sliver of a chance of getting signal given base rates of infection is one of the populations that get HIV a lot. Those are men who have sex with men and sex workers. I presume they were trying to gesture at the first but 18 is just too small to get anything worthwhile unless you’re doing a human challenge trial. Choosing 18 people who have lots of unprotected sex and don’t use PREP would not pass a sane person trying to be good. It certainly wouldn’t pass any plausible IRB. IRBs wouldn’t approve fire if it was new.
- mikeyouse 4y ago
  We don't have to guess.. it's literally in the article. This is a Phase 1 trial purely to test safety and immunogenicity. More details: > The IAVI-sponsored trial, IAVI G003, builds on progress in HIV vaccine research. Recent findings from the Phase I clinical trial IAVI G001 showed that vaccination with the HIV immunogen eOD-GT8 60mer as a recombinant protein safely induced the targeted immune responses in 97% of recipients (healthy U.S. adults). The immune response — targeting and expanding a specific class of B cells — is needed to start the process of developing broadly neutralizing antibodies (bnAbs). The induction of bnAbs is widely considered to be a goal of an efficacious HIV vaccine, and this B-cell activation is the first step in that process. IAVI G003 is designed to test the hypothesis that vaccination with eOD-GT8 60mer, developed by scientific teams at IAVI and Scripps Research, delivered via Moderna’s mRNA platform, can induce similar immune responses in African populations as was seen for IAVI G001.

What isn’t it saying?

mrslave 4y ago

The probability of them acquiring HIV within 6 months without the vaccine under trial.

bruce511 4y ago
They're not testing for efficacy, but rather safety. Looking for side effects etc... Efficacy won't be proved by this trial, although potentially disproved.

barry-cotter 4y ago

If those 18 people are randomly selected all they’re doing is testing for safety, phase 1. If they expect to get anything about efficacy out of it the only population where there’s a sliver of a chance of getting signal given base rates of infection is one of the populations that get HIV a lot. Those are men who have sex with men and sex workers. I presume they were trying to gesture at the first but 18 is just too small to get anything worthwhile unless you’re doing a human challenge trial. Choosing 18 people who have lots of unprotected sex and don’t use PREP would not pass a sane person trying to be good. It certainly wouldn’t pass any plausible IRB. IRBs wouldn’t approve fire if it was new.

mikeyouse 4y ago
We don't have to guess.. it's literally in the article. This is a Phase 1 trial purely to test safety and immunogenicity. More details: > The IAVI-sponsored trial, IAVI G003, builds on progress in HIV vaccine research. Recent findings from the Phase I clinical trial IAVI G001 showed that vaccination with the HIV immunogen eOD-GT8 60mer as a recombinant protein safely induced the targeted immune responses in 97% of recipients (healthy U.S. adults). The immune response — targeting and expanding a specific class of B cells — is needed to start the process of developing broadly neutralizing antibodies (bnAbs). The induction of bnAbs is widely considered to be a goal of an efficacious HIV vaccine, and this B-cell activation is the first step in that process. IAVI G003 is designed to test the hypothesis that vaccination with eOD-GT8 60mer, developed by scientific teams at IAVI and Scripps Research, delivered via Moderna’s mRNA platform, can induce similar immune responses in African populations as was seen for IAVI G001.