Fatigue is a frequent symptom reported by persons living with HIV disease and one that affects all aspects of quality of life. To improve quality of care of persons with HIV disease, it is important to address all factors that contribute to fatigue. The purpose of this study was to determine the associations of physiological, psychological, and sociological factors with fatigue in an HIV-infected population. With Piper's integrated fatigue model guiding selection, factors examined in this study were hemoglobin, hematocrit, CD4+ cell count, HIV-RNA viral load, total sleep time, sleep quality, daytime sleepiness, HIV-related symptoms, anxiety, depression, and perceived stress. The sample (N = 79) for this descriptive correlational study was recruited from a primary health care association in South Carolina and consisted of 42 (53.2%) HIV-infected women and 37 (46.8%) HIV-infected men between the ages of 24 and 63 years (x = 39.9, s = 7.9). Of the participants, 70 (90%) were African American, 5 (6%) were Caucasian, and 3 (4%) were Hispanic. Using Pearson's r, significant relationships were observed between fatigue and sleep quality, daytime sleepiness, HIV-related symptoms, state anxiety, trait anxiety, depression, and perceived stress. Sleep quality (F5,65 = 12.02, P = 0.0009), state anxiety (F5,65 = 8.28, P = 0.0054), HIV-related symptoms (F5,65 = 4.87, P = 0.0308), and depression (F5,65 = 7.31, P = 0.0087) retained significance in a 3-step, backward stepwise elimination model and accounted for 67% of the variance in fatigue. These findings underscore the need for addressing psychosocial stressors and sleep quality in developing effective care for HIV-infected individuals who experience fatigue.

RTS,S/AS01 is an advanced pre-erythrocytic malaria vaccine candidate with demonstrated vaccine efficacy up to 86.7% in controlled human malaria infection (CHMI) studies; however, reproducible immune correlates of protection (CoP) are elusive. To identify candidates of humoral correlates of vaccine mediated protection, we measured antibody magnitude, subclass, and avidity for Plasmodium falciparum (Pf) circumsporozoite protein (CSP) by multiplex assays in two CHMI studies with varying RTS,S/AS01B vaccine dose and timing regimens. Central repeat (NANP6) IgG1 magnitude correlated best with protection status in univariate analyses and was the most predictive for protection in a multivariate model. NANP6 IgG3 magnitude, CSP IgG1 magnitude, and total serum antibody dissociation phase area-under-the-curve for NANP6, CSP, NPNA3, and N-interface binding were also associated with protection status in the regimen adjusted univariate analysis. Identification of multiple immune response features that associate with protection status, such as antibody subclasses, fine specificity and avidity reported here may accelerate development of highly efficacious vaccines against P. falciparum.

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The outcome of the recent Antibody Mediated Prevention (AMP) trials that tested infusion of the broadly neutralizing antibody (bnAb) VRC01 provides proof of concept for blocking infection from sensitive HIV-1 strains. These results also open up the possibility that triple combinations of bnAbs such as PGT121, PGDM1400, as well as long-lasting LS variants such as VRC07-523 LS, have immunoprophylactic potential. PGT121 and PGDM1400 target the HIV-1 V3 and V2 glycan regions of the gp120 envelope protein, respectively, while VRC07-523LS targets the HIV-1 CD4 binding site. These bnAbs demonstrate neutralization potency and complementary breadth of HIV-1 strain coverage. An important clinical trial outcome is the accurate measurement of in vivo concentrations of passively infused bnAbs to determine effective doses for therapy and/or prevention. Standardization and validation of this testing method is a key element for clinical studies as is the ability to simultaneously detect multiple bnAbs in a specific manner. Here we report the development of a sensitive, specific, accurate, and precise multiplexed microsphere-based assay that simultaneously quantifies the respective physiological concentrations of passively infused bnAbs in human serum to ultimately define the threshold needed for protection from HIV-1 infection.

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