Safety and Immune Response to a Prime-Boost Vaccination Schedule in HIV-infected Patients
Status:
Completed
Trial end date:
2009-06-25
Target enrollment:
Participant gender:
Summary
Study Design: This is a Phase I, randomized, placebo-controlled, double-blinded study to
examine safety, tolerability and immune response of a prime-boost vaccination regimen for
treatment of HIV infection. The vaccination schedule consists of three injections of a
multiclade HIV plasmid DNA vaccine followed by one injection of a multiclade recombinant
adenoviral vector vaccine (rAd), in HIV-infected adults. The hypothesis is that this
vaccination regimen will be safe and elicit an immune response in HIV-infected subjects. The
primary objectives are related to evaluating the safety and tolerability of the vaccination
regimen and assessing the effect of vaccination on humoral and cellular immune responses to
vaccine-specific HIV antigens.
Product Description: VRC-HIVDNA016-00-VP is composed of 6 closed, circular DNA plasmids that
are each 16.67% (by weight) of the vaccine. Each of the 6 plasmids in this vaccine expresses
a single gene product. Plasmids VRC 4401, VRC 4409 and VRC 4404 are designed to express clade
B HIV-1 Gag, Pol and Nef, respectively. VRC 5736, VRC 5737, and VRC 5738 are designed to
express HIV-1 Env glycoprotein from clade A, clade B, and clade C, respectively. Each DNA
vaccination will be 1 mL of vaccine administered intramuscularly (IM) using the Biojector
2000 Needle-Free Injection Management System. Phosphate buffered saline (PBS) will be used as
the placebo for the DNA vaccine.
VRC-HIVADV014-00-VP (rAd) is a recombinant product composed of 4 adenoviral vectors (Ad) (in
a 3:1:1:1 ratio) that encode the HIV-1 Gag/Pol polyprotein from clade B and HIV-1 Env
glycoproteins from clades A, B, and C, respectively. Injections of 10(10) PU will be
administered IM by needle and syringe. The final formulation buffer (FFB) will be used as the
placebo for the rAd vaccine.
Subjects: HIV-infected adult volunteers (18-50 years old) on stable highly active
antiretroviral therapy (HAART) therapy who have a CD4+ cell count greater than 350 cells/mm3
and have had a viral load (VL) less than 400 copies/mL for at least six months and a viral
load of less than 50 copies/mL within 4 weeks prior to enrollment.
Study Plan: Fifteen volunteers will be enrolled and randomized in a 2:1 ratio to
vaccine:control (10 DNA prime with rAd boost:5 PBS with FFB placebo). A Data and Safety
Monitoring Board (DSMB) will review the study every 6 months. Subjects will be evaluated for
safety and immunogenicity for 48 weeks, which is 24 weeks after the target date for the
booster vaccination.
Study Duration: Subjects will be followed for 48 weeks after enrollment into the study.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)