Poly(sodium 4-styrene sulfonate): evaluation of a topical microbicide gel against herpes simplex virus type 2 and Chlamydia trachomatis infections in mice

Bourne, Nigel; Zaneveld, L. J. D.; Ward, J. A.; Ireland, James; Stanberry, Lawrence R.

doi:10.1046/j.1469-0691.2003.00659.x

Cited by 23 publications

(16 citation statements)

References 29 publications

(37 reference statements)

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“…In summary, when used as topical microbicides, zinc salt solutions may provide significant protection against HSV-2 infection in a mouse model, albeit at levels lower than those seen previously with some other topical microbicide candidates in this model (2)(3)(4). However, at a protective concentration, the salts produced vaginal epithelial disruption.…”

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confidence: 69%

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Efficacy and Toxicity of Zinc Salts as Candidate Topical Microbicides against Vaginal Herpes Simplex Virus Type 2 Infection

Bourne

Stegall

Montano

et al. 2005

Antimicrob Agents Chemother

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Zinc salt solutions administered as topical microbicides provided significant protection against herpes simplex virus type 2 infection in a mouse vaginal challenge model. However, at the therapeutic concentration, the salt solutions caused sloughing of sheets of vaginal epithelial cells. These observations limit the utility of zinc salts as microbicides and suggest that the application of zinc solutions to mucosal surfaces has the potential to cause damage that might increase susceptibility to secondary infections at a later time.

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confidence: 69%

“…We have used this model previously for the evaluation of other candidate topical microbicides, including a number that are currently undergoing clinical evaluation (2)(3)(4). Briefly, female Swiss Webster mice (weight, 18 to 21 g; Harlan, Houston, Tex.)…”

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confidence: 99%

Efficacy and Toxicity of Zinc Salts as Candidate Topical Microbicides against Vaginal Herpes Simplex Virus Type 2 Infection

Bourne

Stegall

Montano

et al. 2005

Antimicrob Agents Chemother

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“…The active ingredient of VivaGel® is SPL7013 which belongs to the class of macromolecules called dendrimers, characterized by a highly branched three-dimensional architecture [4]. In vitro and in vivo studies of this compound have shown that SPL7013 is a potent inhibitor of HSV-2 and HIV [5]–[8]. SPL7013 is believed to prevent the attachment of HIV to human T-cells by binding glycoprotein-120 and analogously prevent the attachment of HSV-2 to epithelial cells by binding glycoprotein-B.…”

Section: Introductionmentioning

confidence: 99%

A Phase I Randomized Placebo Controlled Trial of the Safety of 3% SPL7013 Gel (VivaGel®) in Healthy Young Women Administered Twice Daily for 14 Days

et al. 2011

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ObjectiveTo assess the safety of VivaGel® used vaginally twice daily for 14 days among healthy, sexually-abstinent women, aged 18–24 years in the USA and Kenya.DesignRandomized placebo controlled trial.MethodsParticipants were randomized 2∶1, VivaGel to placebo. Safety was assessed by comparing genitourinary (GU) adverse events (AEs), colposcopy findings, vaginal lactobacilli and laboratory abnormalities by arm.ResultsFifty-four women were enrolled; 35 in the VivaGel arm and 19 in the placebo arm. Twenty-six (74%) and 10 (53%) women reported taking all doses of VivaGel and placebo, respectively. No grade 3 or 4 AEs, or serious AEs occurred. Twenty-five (71%) participants in the VivaGel arm compared to 10 (53%) participants in the placebo arm had at least one grade 1 or 2 GU AE associated with product use (RR = 1.4, 95% CI 0.8-2.2). All seven grade 2 GU AEs associated with product use occurred among four women in the VivaGel arm. Vulvar and cervical erythema, cervical lesions, symptomatic BV, urinary frequency and metrorrhagia were more common in the VivaGel arm than the placebo arm. Twenty-nine (83%) participants in the VivaGel arm had a colposcopic finding compared to 10 (53%) participants in the placebo arm (RR = 1.6, 95%CI = 1.0-2.5). Two women in the VivaGel arm prematurely discontinued product use themselves due to a reported GU AE. Persistence of H2O2-producing and non-producing lactobacilli did not differ by study arm.ConclusionsGU AEs and colposcopic findings consistent with mild epithelial irritation and inflammation occurred more commonly among women in the VivaGel arm.Trial RegistrationClinicalTrials.gov NCT003311032

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“…With full UTMB IACUC approval, 18–21g female Swiss Webster mice (Harlan, Indianapolis, IN, USA) were pre-treated either with the candidate microbicide or with the PBS vehicle and then challenged intravaginally with 15uL of an inoculum containing 10 4 IFU of C. muridarum strain Nigg II (Bourne et al, 2003). Vaginal swab samples were collected 3 and 6d post-inoculation (PI) into 1mL SPG medium and then stored at −80° C. CT ascending into the upper genital tract was detected from animals sacrificed 10d PI.…”

Section: Methodsmentioning

confidence: 99%

High-throughput multistrain polymerase chain reaction quantification of Chlamydia trachomatis from clinical and preclinical urogenital specimens

McGowin

Whitlock

Pyles

2009

Diagnostic Microbiology and Infectious Disease

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Chlamydia trachomatis (CT) is the most prevalent sexually transmitted bacterial pathogen worldwide and causes severe reproductive tract infections. Currently, nucleic acid amplification tests (NAATs) are the gold standard for clinical diagnosis but most NAATs are labor intensive and limited to specific CT serovars. We developed and validated a quantitative PCR assay that reproducibly detected CT serovars D, E, F, Ia and C. muridarum over a linear range of 2log10 to 10log10 genomes with low coefficients of variation (CV) from both experimental and human urine samples. CT DNA loads from human vaginal, endocervical and male urethral swabs correlated well with the BD ProbeTec ET assay run in parallel. In a preclinical microbicide evaluation, C. muridarum DNA loads in mouse swabs and tissues correlated well with an immunofluorescence assay. The optimized qPCR system provided enhanced sensitivity and facilitated the quantitative evaluation of clinical and experimental preclinical samples for anti-CT therapeutic and microbicide evaluation.

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Poly(sodium 4-styrene sulfonate): evaluation of a topical microbicide gel against herpes simplex virus type 2 and Chlamydia trachomatis infections in mice

Abstract: T-PSS gel formulations have promising in vivo activity as topical microbicides.

Cited by 23 publications

References 29 publications

Efficacy and Toxicity of Zinc Salts as Candidate Topical Microbicides against Vaginal Herpes Simplex Virus Type 2 Infection

Efficacy and Toxicity of Zinc Salts as Candidate Topical Microbicides against Vaginal Herpes Simplex Virus Type 2 Infection

A Phase I Randomized Placebo Controlled Trial of the Safety of 3% SPL7013 Gel (VivaGel®) in Healthy Young Women Administered Twice Daily for 14 Days

High-throughput multistrain polymerase chain reaction quantification of Chlamydia trachomatis from clinical and preclinical urogenital specimens

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