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2. Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design

Author

Horwitz, Leora I., primary, Thaweethai, Tanayott, additional, Brosnahan, Shari B., additional, Cicek, Mine S., additional, Fitzgerald, Megan L., additional, Goldman, Jason D., additional, Hess, Rachel, additional, Hodder, S. L., additional, Jacoby, Vanessa L., additional, Jordan, Michael R., additional, Krishnan, Jerry A., additional, Laiyemo, Adeyinka O., additional, Metz, Torri D., additional, Nichols, Lauren, additional, Patzer, Rachel E., additional, Sekar, Anisha, additional, Singer, Nora G., additional, Stiles, Lauren E., additional, Taylor, Barbara S., additional, Ahmed, Shifa, additional, Algren, Heather A., additional, Anglin, Khamal, additional, Aponte-Soto, Lisa, additional, Ashktorab, Hassan, additional, Bassett, Ingrid V., additional, Bedi, Brahmchetna, additional, Bhadelia, Nahid, additional, Bime, Christian, additional, Bind, Marie-Abele C., additional, Black, Lora J., additional, Blomkalns, Andra L., additional, Brim, Hassan, additional, Castro, Mario, additional, Chan, James, additional, Charney, Alexander W., additional, Chen, Benjamin K., additional, Chen, Li Qing, additional, Chen, Peter, additional, Chestek, David, additional, Chibnik, Lori B., additional, Chow, Dominic C., additional, Chu, Helen Y., additional, Clifton, Rebecca G., additional, Collins, Shelby, additional, Costantine, Maged M., additional, Cribbs, Sushma K., additional, Deeks, Steven G., additional, Dickinson, John D., additional, Donohue, Sarah E., additional, Durstenfeld, Matthew S., additional, Emery, Ivette F., additional, Erlandson, Kristine M., additional, Facelli, Julio C., additional, Farah-Abraham, Rachael, additional, Finn, Aloke V., additional, Fischer, Melinda S., additional, Flaherman, Valerie J., additional, Fleurimont, Judes, additional, Fonseca, Vivian, additional, Gallagher, Emily J., additional, Gander, Jennifer C., additional, Gennaro, Maria Laura, additional, Gibson, Kelly S., additional, Go, Minjoung, additional, Goodman, Steven N., additional, Granger, Joey P., additional, Greenway, Frank L., additional, Hafner, John W., additional, Han, Jenny E., additional, Harkins, Michelle S., additional, Hauser, Kristine S. P., additional, Heath, James R., additional, Hernandez, Carla R., additional, Ho, On, additional, Hoffman, Matthew K., additional, Hoover, Susan E., additional, Horowitz, Carol R., additional, Hsu, Harvey, additional, Hsue, Priscilla Y., additional, Hughes, Brenna L., additional, Jagannathan, Prasanna, additional, James, Judith A., additional, John, Janice, additional, Jolley, Sarah, additional, Judd, S. E., additional, Juskowich, Joy J., additional, Kanjilal, Diane G., additional, Karlson, Elizabeth W., additional, Katz, Stuart D., additional, Kelly, J. Daniel, additional, Kelly, Sara W., additional, Kim, Arthur Y., additional, Kirwan, John P., additional, Knox, Kenneth S., additional, Kumar, Andre, additional, Lamendola-Essel, Michelle F., additional, Lanca, Margaret, additional, Lee-lannotti, Joyce K., additional, Lefebvre, R. Craig, additional, Levy, Bruce D., additional, Lin, Janet Y., additional, Logarbo, Brian P., additional, Logue, Jennifer K., additional, Longo, Michele T., additional, Luciano, Carlos A., additional, Lutrick, Karen, additional, Malakooti, Shahdi K., additional, Mallett, Gail, additional, Maranga, Gabrielle, additional, Marathe, Jai G., additional, Marconi, Vincent C., additional, Marshall, Gailen D., additional, Martin, Christopher F., additional, Martin, Jeffrey N., additional, May, Heidi T., additional, McComsey, Grace A., additional, McDonald, Dylan, additional, Mendez-Figueroa, Hector, additional, Miele, Lucio, additional, Mittleman, Murray A., additional, Mohandas, Sindhu, additional, Mouchati, Christian, additional, Mullington, Janet M., additional, Nadkarni, Girish N., additional, Nahin, Erica R., additional, Neuman, Robert B., additional, Newman, Lisa T., additional, Nguyen, Amber, additional, Nikolich, Janko Z., additional, Ofotokun, Igho, additional, Ogbogu, Princess U., additional, Palatnik, Anna, additional, Palomares, Kristy T. S., additional, Parimon, Tanyalak, additional, Parry, Samuel, additional, Parthasarathy, Sairam, additional, Patterson, Thomas F., additional, Pearman, Ann, additional, Peluso, Michael J., additional, Pemu, Priscilla, additional, Pettker, Christian M., additional, Plunkett, Beth A., additional, Pogreba-Brown, Kristen, additional, Poppas, Athena, additional, Porterfield, J. Zachary, additional, Quigley, John G., additional, Quinn, Davin K., additional, Raissy, Hengameh, additional, Rebello, Candida J., additional, Reddy, Uma M., additional, Reece, Rebecca, additional, Reeder, Harrison T., additional, Rischard, Franz P., additional, Rosas, Johana M., additional, Rosen, Clifford J., additional, Rouphael, Nadine G., additional, Rouse, Dwight J., additional, Ruff, Adam M., additional, Saint Jean, Christina, additional, Sandoval, Grecio J., additional, Santana, Jorge L., additional, Schlater, Shannon M., additional, Sciurba, Frank C., additional, Selvaggi, Caitlin, additional, Seshadri, Sudha, additional, Sesso, Howard D., additional, Shah, Dimpy P., additional, Shemesh, Eyal, additional, Sherif, Zaki A., additional, Shinnick, Daniel J., additional, Simhan, Hyagriv N., additional, Singh, Upinder, additional, Sowles, Amber, additional, Subbian, Vignesh, additional, Sun, Jun, additional, Suthar, Mehul S., additional, Teunis, Larissa J., additional, Thorp, John M., additional, Ticotsky, Amberly, additional, Tita, Alan T. N., additional, Tragus, Robin, additional, Tuttle, Katherine R., additional, Urdaneta, Alfredo E., additional, Utz, P. J., additional, VanWagoner, Timothy M., additional, Vasey, Andrew, additional, Vernon, Suzanne D., additional, Vidal, Crystal, additional, Walker, Tiffany, additional, Ward, Honorine D., additional, Warren, David E., additional, Weeks, Ryan M., additional, Weiner, Steven J., additional, Weyer, Jordan C., additional, Wheeler, Jennifer L., additional, Whiteheart, Sidney W., additional, Wiley, Zanthia, additional, Williams, Natasha J., additional, Wisnivesky, Juan P., additional, Wood, John C., additional, Yee, Lynn M., additional, Young, Natalie M., additional, Zisis, Sokratis N., additional, and Foulkes, Andrea S., additional

Published
2023
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3. Safety, acceptability, and pharmacokinetics of a monoclonal antibody-based vaginal multipurpose prevention film (MB66): A Phase I randomized trial

Author

Politch, Joseph A., Cu-Uvin, Susan, Moench, Thomas R., Tashima, Karen T., Marathe, Jai G., Guthrie, Kate M., Cabral, Howard, Nyhuis, Tara, Brennan, Miles, Zeitlin, Larry, Spiegel, Hans M. L., Mayer, Kenneth H., Whaley, Kevin J., and Anderson, Deborah J.

Subjects
Pharmacokinetics -- Research, Pharmacology, Experimental, Sexually transmitted diseases -- Prevention, Herpes -- Prevention, Monoclonal antibodies -- Dosage and administration, Vagina, Medication by -- Dosage and administration, Herpesvirus diseases -- Prevention, HIV infection -- Prevention, Biological sciences
Abstract

Background MB66 film is a multipurpose prevention technology (MPT) product with monoclonal antibodies (mAbs) against HIV-1 (VRC01-N) and HSV-1 and 2 (HSV8-N). The mAbs were produced by transient expression in Nicotiana benthamiana (N). We conducted a Phase I clinical trial to assess the safety, pharmacokinetics (PK), and ex vivo efficacy of single and repeated doses of MB66 when used intravaginally. Methods and findings The clinical trial enrolled healthy reproductive-aged, sexually abstinent women. In Segment A, 9 women received a single MB66 film which was inserted into the vaginal posterior fornix by a clinician. In Segment B, 29 women were randomly assigned to MB66 (Active) or Placebo film groups and were instructed to insert 1 film vaginally for 7 consecutive days. Visits and clinical sampling occurred predose and at various time points after single and repeated film doses. The primary endpoint was number of adverse events (AEs) Grade 2 or higher related to product use. Secondary endpoints included film dissolution rate, Nugent score (a Gram stain scoring system to diagnose bacterial vaginosis), vaginal pH, post-use survey results, cytokine concentrations in cervicovaginal lavage (CVL) specimens (assessed by Luminex assay), mAb concentrations in vaginal fluid collected from 4 sites (assessed by ELISA), and HIV and HSV neutralization activity of CVL samples ex vivo (assessed by TZM-bl and plaque reduction assay, respectively). The product was generally safe and well tolerated, with no serious AEs recorded in either segment. The AEs in this study were primarily genitourinary in nature with the most commonly reported AE being asymptomatic microscopic hematuria. There were no differences in vaginal pH or Nugent scores or significant increases in levels of proinflammatory cytokines for up to 7 days after film insertion in either segment or between Active and Placebo groups. Acceptability and willingness to use the product were judged to be high by post-use surveys. Concentrations of VRC01-N and HSV8-N in vaginal secretions were assessed over time to generate pharmacokinetic curves. Antibody levels peaked 1 hour postdosing with Active film (median: 35 [mu]g/mL) and remained significantly elevated at 24 hours post first and seventh film (median: 1.8 [mu]g/mL). Correcting for sample dilution (1:20), VRC01-N concentrations ranged from 36 to 700 [mu]g/mL at the 24-hour time point, greater than 100-fold the IC.sub.50 for VRC01 (0.32 [mu]g/mL); HSV8-N concentrations ranged from 80 to 601 [mu]g/mL, well above the IC.sub.50 of 0.1 [mu]g/m. CVL samples collected 24 hours after MB66 insertion significantly neutralized both HIV-1 and HSV-2 ex vivo. Study limitations include the small size of the study cohort, and the fact that no samples were collected between 24 hours and 7 days for pharmacokinetic evaluation. Conclusions Single and repeated intravaginal applications of MB66 film were safe, well tolerated, and acceptable. Concentrations and ex vivo bioactivity of both mAbs in vaginal secretions were significantly elevated and thus could provide protection for at least 24 hours postdose. However, further research is needed to evaluate the efficacy of MB66 film in women at risk for HIV and HSV infection. Additional antibodies could be added to this platform to provide protection against other sexually transmitted infections (STIs) and contraception. Trial registration ClinicalTrials.gov NCT02579083., Author(s): Joseph A. Politch 1,*, Susan Cu-Uvin 2, Thomas R. Moench 3, Karen T. Tashima 4, Jai G. Marathe 1, Kate M. Guthrie 5, Howard Cabral 6, Tara Nyhuis 3, [...]

Published
2021
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7. Production and characterization of a human antisperm monoclonal antibody against CD52g for topical contraception in women

Author

Baldeon-Vaca, Gabriela, primary, Marathe, Jai G., additional, Politch, Joseph A., additional, Mausser, Emilie, additional, Pudney, Jeffrey, additional, Doud, James, additional, Nador, Ellena, additional, Zeitlin, Larry, additional, Pauly, Michael, additional, Moench, Thomas R., additional, Brennan, Miles, additional, Whaley, Kevin J., additional, and Anderson, Deborah J., additional

Published
2021
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8. Time to SARS-CoV-2 PCR Clearance in Immunocompromising Conditions: Is Test-Based Removal From Isolation Necessary in Severely Immunocompromised Individuals?

Author

Epstein, Rachel L, primary, Sperring, Heather, additional, Hofman, Melissa, additional, Lodi, Sara, additional, White, Laura F, additional, Barocas, Joshua A, additional, Bouton, Tara C, additional, Xiao, Yian, additional, Hsu, Heather E, additional, Miller, Nancy S, additional, Linas, Benjamin P, additional, and Marathe, Jai G, additional

Published
2021
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11. Is gene therapy a good therapeutic approach for HIV-positive patients?

Author

Marathe, Jai G and Wooley, Dawn P

Subjects
Review
Abstract

Despite advances and options available in gene therapy for HIV-1 infection, its application in the clinical setting has been challenging. Although published data from HIV-1 clinical trials show safety and proof of principle for gene therapy, positive clinical outcomes for infected patients have yet to be demonstrated. The cause for this slow progress may arise from the fact that HIV is a complex multi-organ system infection. There is uncertainty regarding the types of cells to target by gene therapy and there are issues regarding insufficient transduction of cells and long-term expression. This paper discusses state-of-the-art molecular approaches against HIV-1 and the application of these treatments in current and ongoing clinical trials.

Published
2007

12. Syntaxin 3 is necessary for cAMP- and cGMP-regulated exocytosis of CFTR: implications for enterotoxigenic diarrhea.

Author

Collaco A, Marathe J, Kohnke H, Kravstov D, and Ameen N

Subjects
Animals, Caco-2 Cells, Diarrhea microbiology, HEK293 Cells, Humans, Jejunum metabolism, Mice, Mice, Inbred BALB C, Qa-SNARE Proteins analysis, Rats, Rats, Sprague-Dawley, Cyclic AMP metabolism, Cyclic GMP metabolism, Cystic Fibrosis Transmembrane Conductance Regulator metabolism, Diarrhea metabolism, Enterotoxins metabolism, Exocytosis, Qa-SNARE Proteins metabolism
Abstract

Enterotoxins elaborated by Vibrio cholerae and Escherichia coli cannot elicit fluid secretion in the absence of functional cystic fibrosis transmembrane conductance regulator (CFTR) chloride channels. After enterotoxin exposure, CFTR channels are rapidly recruited from endosomes and undergo exocytic insertion into the apical plasma membrane of enterocytes to increase the number of channels on the cell surface by at least fourfold. However, the molecular machinery that orchestrates exocytic insertion of CFTR into the plasma membrane is largely unknown. The present study used immunofluorescence, immunoblotting, surface biotinylation, glutathione S-transferase (GST) pulldown assays, and immunoprecipitation to identify components of the exocytic soluble N-ethylmaleimide (NEM)-sensitive factor attachment receptor (SNARE) vesicle fusion machinery in cyclic nucleotide-activated exocytosis of CFTR in rat jejunum and polarized intestinal Caco-2(BB)e cells. Syntaxin 3, an intestine-specific SNARE, colocalized with CFTR on the apical domain of enterocytes in rat jejunum and polarized Caco-2(BB)e cells. Coimmunoprecipitation and GST binding studies confirmed that syntaxin 3 interacts with CFTR in vivo. Moreover, heat-stable enterotoxin (STa) activated exocytosis of both CFTR and syntaxin 3 to the surface of rat jejunum. Silencing of syntaxin 3 by short hairpin RNA (shRNA) interference abrogated cyclic nucleotide-stimulated exocytosis of CFTR in cells. These observations reveal a new and important role for syntaxin 3 in the pathophysiology of enterotoxin-elicited diarrhea.

Published
2010
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