Eight persons from five institutions in different countries carried out polymerizations of aniline following the same preparation protocol. In a "standard" procedure, aniline hydrochloride was oxidized with ammonium peroxydisulfate in aqueous medium at ambient temperature. The yield of polyaniline was higher than 90 % in all cases. The electrical conductivity of polyaniline hydrochloride thus prepared was 4.4 ± 1.7 S cm-1 (average of 59 samples), measured at room temperature. A product with defined electrical properties could be obtained in various laboratories by following the same synthetic procedure. The influence of reduced reaction temperature and increased acidity of the polymerization medium on polyaniline conductivity were also addressed. The conductivity changes occurring during the storage of polyaniline were monitored. The density of polyaniline hydrochloride was 1.329 g cm-3. The average conductivity of corresponding polyaniline bases was 1.4 x108 S cm-1, the density being 1.245 g cm-1. Additional changes in the conductivity take place during storage. Aging is more pronounced in powders than in compressed samples. As far as aging effects are concerned, their assessment is relative. The observed reduction in the conductivity by ~10 % after more than one-year storage is large but, compared with the low conductivity of corresponding polyaniline (PANI) base, such a change is negligible. For most applications, an acceptable level of conductivity may be maintained throughout the expected lifetime.
Anti-HIV-1 broadly neutralizing antibodies (bnAbs) have been developed as potential agents for prevention of HIV-1 infection. The HIV Vaccine Trials Network and the HIV Prevention Trials Network are conducting the Antibody Mediated Prevention (AMP) trials to assess whether, and how, intravenous infusion of the anti-CD4 binding site bnAb, VRC01, prevents HIV-1 infection. These are the first test-of-concept studies to assess HIV-1 bnAb prevention efficacy in humans.
The AMP trials are two parallel phase 2b HIV-1 prevention efficacy trials conducted in two cohorts: 2700 HIV-uninfected men and transgender persons who have sex with men in the United States, Peru, Brazil, and Switzerland; and 1500 HIV-uninfected sexually active women in seven countries in sub-Saharan Africa. Participants are randomized 1:1:1 to receive an intravenous infusion of 10 mg/kg VRC01, 30 mg/kg VRC01, or a control preparation every 8 weeks for a total of 10 infusions. Each trial is designed (1) to assess overall prevention efficacy (PE) pooled over the two VRC01 dose groups vs. control and (2) to assess VRC01 dose and laboratory markers as correlates of protection (CoPs) against overall and genotype- and phenotype-specific infection.
Each AMP trial is designed to have 90 % power to detect PE > 0 % if PE is ≥ 60 %. The AMP trials are also designed to identify VRC01 properties (i. e., concentration and effector functions) that correlate with protection and to provide insight into mechanistic CoPs. CoPs are assessed using data from breakthrough HIV-1 infections, including genetic sequences and sensitivities to VRC01-mediated neutralization and Fc effector functions.
The AMP trials test whether VRC01 can prevent HIV-1 infection in two study populations. If affirmative, they will provide information for estimating the optimal dosage of VRC01 (or subsequent derivatives) and identify threshold levels of neutralization and Fc effector functions associated with high-level protection, setting a benchmark for future vaccine evaluation and constituting a bridge to other bnAb approaches for HIV-1 prevention.