2001;183:563C570. ELISpot assay reactions were 13% (95% CI: 21% to 26%) for recipients of vCP1452 only and 16% (95% CI: 2% to 29%) for recipients of vCP1452 plus rgp120. Conclusions Overall, the HIV-specific CD8+ cytotoxic T lymphocyte (CTL) response was not sufficient to be eligible the regimen for any subsequent trial designed to detect an immune correlate of safety requiring a minimum CD8+ CTL rate of recurrence of 30%. and encoding protease, a polynucleotide encompassing several human being and CTL epitopes, and sequences encoding the E3L and K3L vaccinia computer virus proteins (Sanofi Pasteur). The approximate titer was 107.26 median cells culture infective dose (TCID50) for each 1.0-mL dose. JNJ-28312141 The recombinant AIDSVAX? B/B gp120 subunit is derived from a clade B main isolate GNE8 sequence and HIV-1MN .14,15 Each dose consisted of 300 g/mL of MN rgp120 and 300 g/mL of GNE8 rgp120 in 1.2 mg of aluminum hydroxide adjuvant (VaxGen Inc., Brisbane, CA). PLACEBO-ALVAC (Sanofi Pasteur) contained computer virus stabilizer and freeze-drying medium, reconstituted with sterile 0.4% sodium chloride. AIDSVAX PLACEBO was a sterile suspension of aluminium hydroxide adjuvant. ALVAC vCP1452 or JNJ-28312141 placebo was given in the remaining arm and AIDSVAX B/B subunit or placebo was given in the right arm like a 1.0-mL intramuscular injection. Subjects The study enrolled healthy HIV-1Cuninfected adults aged 18 to 60 years. Risk for HIV illness was assessed at study entry based on a standardized interview of past and current sexual and drug use behaviors. All subjects were in good general health, HIV-seronegative, and were counseled to use birth control and prevent pregnancy throughout the program of the study. All participants provided written educated consent, JNJ-28312141 and each of the 10 trial sites acquired authorization for the study through their local institutional review boards. Study Design Eligible participants received injections at 4 time points (Table 1) and were monitored for 18 months for security and HIV-specific humoral and cellular immune responses. Local and systemic reactogenicity symptoms were graded according to the following criteria: (1) slight: transient or minimal symptoms, (2) moderate: symptoms requiring changes of activity, and (3) severe: incapacitating symptoms resulting in bed rest and/or loss of work or social activities. Serious adverse experiences (SAEs) were reported according to the Division of Acquired Defense Deficiency Syndrome (DAIDS) SAE reporting manual. Grade 3 or 4 4 AEs assessed as definitely, probably, or possibly related were also reported as SAEs. TABLE 1 Vaccine Trial Schema 0.05, and no adjustments were made for multiple comparisons. For CTLs and ELISpot assays, cumulative response rates on day time 98 or 182 were computed. Standard optimization techniques were used to obtain nonparametric maximum likelihood estimations (NPMLEs) of cumulative response rates.21 The study design was intended to provide a basis for any go/no-go decision regarding a phase 3 efficacy trial (HVTN 501). The decision criterion was based on the null hypothesis that the true response rate was not 30%, establishing the sample size at 120 vaccinees per routine to provide at least 90% power to distinguish response rates of 30% and 45%. Therefore, HVTN 203 JNJ-28312141 was individually designed to be eligible vCP1452 only and vCP1452 plus rgp120, the second option by pooling organizations TSPAN17 B and C, for potential effectiveness evaluation in HVTN 501. RESULTS Accrual and Demographic Data Three hundred 30 participants were enrolled at 10 sites in the United States between December 2000 JNJ-28312141 and August 2001 and were randomized to 1 1 of 4 organizations (see Table 1). Overall, 305 (92%) participants completed all.