[Email Exchange between Mary Lou Clements and Bruce Weniger]

Weniger, Bruce
From: Mary Lou Clements-Mann, MD, MPH [[email protected]]
Sent: 19-Mar-98 12:22
To: Weniger, Bruce
Subject: Re: Lyme and Rotavirus precedents
bruce,
even tho the lyme vaccines had evidence of possible immune correlates
before the field trials, I found out from Mike Brennan at the FDA that
those correlates did not hold up in the trials--that is people who did not
develop those antibodies to ops A were still protected. Thus, as I
understand it SKB has an effective vaccine but does not know the correlates
of protective immunity for humans. Nonetheless, the vaccine will probably
be licensed and widely used.
so much for correlates--by the way, I am writing up a piece on the myths
about immune correlates for Aids and human retrovirus june issue (to be
distributed to the Int AIDS conference).
all the best,
Mary lou
At 11:20 AM 3/19/98 -0500, you wrote:
>Dear Jonathan,
> Perhaps Mary Lou has already plied you with
>her reprint files on rotavirus and Lyme disease vaccines.
>But just in case, since you are using these precedents
>for comparisons with AIDS vaccines, I thought you might
>find useful some additional technical background on these
>other vaccines, in case further questions come up.
> So I am faxing you right now an excellent overview
>on the development of the rotavirus vaccines by Timo
>Vesikari, as well as some scattered abstracts on Lyme
>disease vaccine.
> Although it is clear that the rotavirus vaccines lack
>known correlates of immunity, especially before the
>efficacy trials began, this was not the case for Lyme disease,
>which had some reassuring animal models.
> To me, a key lesson of Lyme disease vaccine was that
>two private companies (without NIH funding) were able to
>recruit >10,000 subjects for each of their vaccine efficacy trials.
>In contrast, the 1994 ARAC committee agonized that it would
>be too difficult and expensive to recruit such numbers for an
>AIDS vaccine field trial (www.hsph.harvard.edu/Organizations/
>hai/vaccines/1994arac2.html).
> I'm hearing from respected people in this effort, praising
>you as a "true public health advocate" and for "doing a
>great service here."
> Thanks and best regards,
> Bruce
Vacn aeyadDvlpetAtvt

> Vaccine Safety and Development Activity
> National Immunization Program, CDC (E-61)
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