A5232
Optimizing
Vaccine Responsiveness in HIV-1 and HCV Infections
and Identifying Determinants of Responsiveness: A
Pilot Study
Purpose of this Study: To
evaluate whether baseline DC, B-cell, or T-cell function
in HCV-infection, HIV-1-infection, and HCV/HIV-1 coinfection
predicts neoantigen or recall antigen responsiveness
at week 8, as determined by vaccine-induced T-cell
response and B-cell humoral immune response.
Requirements to Enter Study:
- Men and women age 18-65 who are hepatitis A
antibody negative, hepatitis B surface antibody
negative, hepatitis B surface antigen negative,
and tetanus antibody positive will be eligible.
Participants will be divided into the following
arms based on their HCV/HIV-1 status:
- Arm A: Twenty-two participants with
chronic HCV infection defined as PCR positive
without previous HCV based therapy and without
the presence of Child's B or C cirrhosis.
These participants will be HIV-1 seronegative.
- Arm B: Twenty-two antiretroviral
treatment naive subjects (< 7 days of antiretroviral
therapy) with chronic HIV-1 infection (as
defined in section 4.1.1), CD4+ T-cell count
> 300 cells/mm3, no prior or current opportunistic
infection, and with no indication for or the
need for HIV-1 therapy. These participants
will be HCV seronegative.
- Arm C: Twenty-two participants with
HCV/HIV-1 co-infection as defined above in
Arms A and B.
Treatment: .Participants in each
arm will be immunized with diphtheria/tetanus toxoid
on day 0, and with combined hepatitis A-hepatitis
B vaccine (Twinrix: recombinant HBV at 20 µg,
HAV at 720 ELU, and aluminum at 0.45 mg) on days 0,
7, and 21 (accelerated vaccination protocol).
Duration of Study: Participants
will be on study for a total of 24 weeks.
For
more information contact:
Study
Contacts
Kathryn
Maffei, RN (215) 349-8092
