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7. Topical paromomycin for New World cutaneous leishmaniasis

Author

Sosa, Néstor, primary, Pascale, Juan Miguel, additional, Jiménez, Ana I., additional, Norwood, Jeanne A., additional, Kreishman-Detrick, Mara, additional, Weina, Peter J., additional, Lawrence, Kendra, additional, McCarthy, William F., additional, Adams, Ryan C., additional, Scott, Charles, additional, Ransom, Janet, additional, Tang, Douglas, additional, and Grogl, Max, additional

Published
2019
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10. Phase 1/2a Trial of Plasmodium vivax Malaria Vaccine Candidate VMP001/AS01B in Malaria-Naive Adults: Safety, Immunogenicity, and Efficacy

Author

Bennett, Jason W., primary, Yadava, Anjali, additional, Tosh, Donna, additional, Sattabongkot, Jetsumon, additional, Komisar, Jack, additional, Ware, Lisa A., additional, McCarthy, William F., additional, Cowden, Jessica J., additional, Regules, Jason, additional, Spring, Michele D., additional, Paolino, Kristopher, additional, Hartzell, Joshua D., additional, Cummings, James F., additional, Richie, Thomas L., additional, Lumsden, Joanne, additional, Kamau, Edwin, additional, Murphy, Jittawadee, additional, Lee, Cynthia, additional, Parekh, Falgunee, additional, Birkett, Ashley, additional, Cohen, Joe, additional, Ballou, W. Ripley, additional, Polhemus, Mark E., additional, Vanloubbeeck, Yannick F., additional, Vekemans, Johan, additional, and Ockenhouse, Christian F., additional

Published
2016
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12. Statement of William F. McCarthy, Ph.D.

Author

McCarthy, William F., McCarthy, William F., McCarthy, William F., and McCarthy, William F.

Abstract

(DLPS) 5571095.0452.035, http://name.umdl.umich.edu/5571095.0452.035, http://quod.lib.umich.edu/t/text/accesspolicy.html, Where applicable, subject to copyright. Other restrictions on distribution may apply. Please go to http://www.umdl.umich.edu/ for more information.

Published
1992

13. The Association Between Hydroxyurea Treatment and Pain Intensity, Analgesic Use, and Utilization in Ambulatory Sickle Cell Anemia Patients.

Author

Smith, Wally R, Ballas, Samir K, McCarthy, William F, Bauserman, Robert L, Swerdlow, Paul S, Steinberg, Martin H, Waclawiw, Myron A, Investigators of the Multicenter Study of Hydroxyurea in Sickle Cell Anemia, Smith, Wally R, Ballas, Samir K, McCarthy, William F, Bauserman, Robert L, Swerdlow, Paul S, Steinberg, Martin H, Waclawiw, Myron A, and Investigators of the Multicenter Study of Hydroxyurea in Sickle Cell Anemia

Abstract

Background. We compared daily pain, home analgesic use, and utilization among ambulatory adults in the randomized Multicenter Study of Hydroxyurea in Sickle Cell Anemia (MSH). We related the fetal hemoglobin (HbF) hydroxyurea response to these response variables. Methods. Patients rated their sickle cell pain intensity (0-9), use of analgesics, and visits for pain daily. Diaries were collected biweekly, and intensity was collapsed into single interval ratings. The interval proportions of days of analgesic use and medical visits for pain were also calculated. Group comparisons were made by intention to treat as well as by HbF change levels from baseline to 2 years of treatment (placebo and low, medium, high, or very high response). Results. A total of 134 (44.8%) enrollees completed 2 years of follow-up. Pain intensity correlated with analgesic use (r = 0.83, P > 0.0001) and utilization (r = 0.50, P < 0.0001). Pain intensity was lower for patients on hydroxyurea (2.51 ± 0.062 vs 2.82 ± 0.063 placebo, F(1,270) = 11.65, P = 0.0007). The difference, though small, appeared early and was sustained. Analgesic use and utilization were also slightly lower (analgesic use: F(1,270) = 11.97, P = 0.0006; utilization: F(1,270) = 32.0, P < 0.0001). Each was statistically significantly lower among hydroxyurea patients with higher HbF treatment responses to hydroxyurea. Conclusions. Hydroxyurea usage led to a small, statistically significant reduction in daily pain, analgesic use, and utilization in adults in MSH, corroborating previously shown larger reductions in crises and mortality. The degree of daily symptomatic reduction was related to the size of the HbF treatment response, further confirming HbF response as a useful laboratory correlate.

Published
2011

14. Early detection of response to hydroxyurea therapy in patients with sickle cell anemia.

Author

Ballas, Samir K., McCarthy, William F., Guo, Nan, Brugnara, Carlo, Kling, Gail, Bauserman, Robert L., Waclawiw, Myron A., Ballas, Samir K., McCarthy, William F., Guo, Nan, Brugnara, Carlo, Kling, Gail, Bauserman, Robert L., and Waclawiw, Myron A.

Abstract

Red blood cells (RBC) and reticulocyte parameters were determined on peripheral blood from a subset of patients enrolled in the multicenter study of hydroxyuea (HU) in sickle cell anemia. Multiple blood samples were obtained every 2 weeks. Cellular indices were measured by flow cytometry. Generalized linear models were used to determine the relationship between the longitudinal trajectories of RBC and reticulocyte indices and HU usage. There was a significant relationship between HU usage and most of the RBC and reticulocyte indices. Hydroxyurea produced higher value trajectories than those generated by placebo usage for the hemoglobin (Hb) content of both the RBCs and reticulocytes and for the mean corpuscular volume (MCV) of reticulocytes. These changes were first detected 10 weeks after starting HU and before the increase in Hb F levels. The data suggest that subtle and early markers of response to HU reside in the hemogram.

Published
2010

16. Randomized, Double-Blinded, Phase 2 Trial of WR 279,396 (Paromomycin and Gentamicin) for Cutaneous Leishmaniasis in Panama

Author

Sosa, Néstor, primary, Capitán, Zeuz, additional, Nieto, Javier, additional, Nieto, Melissa, additional, Calzada, José, additional, Paz, Hector, additional, Spadafora, Carmenza, additional, Kreishman-Deitrick, Mara, additional, Kopydlowski, Karen, additional, Ullman, Diane, additional, McCarthy, William F., additional, Ransom, Janet, additional, Berman, Jonathan, additional, Scott, Charles, additional, and Grogl, Max, additional

Published
2013
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22. Phase 1/2a Trial of Plasmodium vivax Malaria Vaccine Candidate VMP001/AS01B in Malaria-Naive Adults: Safety, Immunogenicity, and Efficacy.

Author

Bennett, Jason W., Yadava, Anjali, Tosh, Donna, Sattabongkot, Jetsumon, Komisar, Jack, Ware, Lisa A., McCarthy, William F., Cowden, Jessica J., Regules, Jason, Spring, Michele D., Paolino, Kristopher, Hartzell, Joshua D., Cummings, James F., Richie, Thomas L., Lumsden, Joanne, Kamau, Edwin, Murphy, Jittawadee, Lee, Cynthia, Parekh, Falgunee, and Birkett, Ashley

Subjects
MALARIA vaccines, PLASMODIUM vivax, MALARIA treatment, CIRCUMSPOROZOITE protein, IMMUNE response, PARASITEMIA
Abstract

Background: A vaccine to prevent infection and disease caused by Plasmodium vivax is needed both to reduce the morbidity caused by this parasite and as a key component in efforts to eradicate malaria worldwide. Vivax malaria protein 1 (VMP001), a novel chimeric protein that incorporates the amino- and carboxy- terminal regions of the circumsporozoite protein (CSP) and a truncated repeat region that contains repeat sequences from both the VK210 (type 1) and the VK247 (type 2) parasites, was developed as a vaccine candidate for global use. Methods: We conducted a first-in-human Phase 1 dose escalation vaccine study with controlled human malaria infection (CHMI) of VMP001 formulated in the GSK Adjuvant System AS01B. A total of 30 volunteers divided into 3 groups (10 per group) were given 3 intramuscular injections of 15μg, 30μg, or 60μg respectively of VMP001, all formulated in 500μL of AS01B at each immunization. All vaccinated volunteers participated in a P. vivax CHMI 14 days following the third immunization. Six non-vaccinated subjects served as infectivity controls. Results: The vaccine was shown to be well tolerated and immunogenic. All volunteers generated robust humoral and cellular immune responses to the vaccine antigen. Vaccination did not induce sterile protection; however, a small but significant delay in time to parasitemia was seen in 59% of vaccinated subjects compared to the control group. An association was identified between levels of anti-type 1 repeat antibodies and prepatent period. Significance: This trial was the first to assess the efficacy of a P. vivax CSP vaccine candidate by CHMI. The association of type 1 repeat-specific antibody responses with delay in the prepatency period suggests that augmenting the immune responses to this domain may improve strain-specific vaccine efficacy. The availability of a P. vivax CHMI model will accelerate the process of P. vivax vaccine development, allowing better selection of candidate vaccines for advancement to field trials. [ABSTRACT FROM AUTHOR]

Published
2016
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25. Don't blow it

Author

McCarthy, William F. and Quigley, Robert C.

Subjects
Bomb threats -- Safety and security measures, Bombings -- Prevention, Business, Engineering and manufacturing industries, Law
Abstract

BECAUSE SECURITY PROFESSIONals in the United States rarely experience an actual explosion or confirm the existence of an improvised explosive device, they have been lulled to sleep when it comes [...]

Published
1992

27. Gender and Acute Myocardial Infarction: Is There a Different Response to Thrombolysis?

Author

Woodfield, Scott L., primary, Lundergan, Conor F., additional, Reiner, Jonathan S., additional, Thompson, Mark A., additional, Rohrbeck, Steven C., additional, Deychak, Yuri, additional, Smith, James O., additional, Burton, Jeffrey R., additional, McCarthy, William F., additional, Califf, Robert M., additional, White, Harvey D., additional, Weaver, W.Douglas, additional, Topol, Eric J., additional, and Ross, Allan M., additional

Published
1997
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28. A retrospective analysis of the protective efficacy of tafenoquine and mefloquine as prophylactic antimalarials in non-immune individuals during deployment to a malaria-endemic area.

Author

Dow, Geoffrey S., McCarthy, William F., Reid, Mark, Smith, Bryan, Tang, Douglas, and Shanks, G. Dennis

Subjects
*MEFLOQUINE, *ANTIMALARIALS, *MALARIA prevention, *ARMED forces
Abstract

Background In 2000/2001, the Australian Defense Forces (ADF), in collaboration with SmithKline Beecham and the United States Army, conducted a field trial to evaluate the safety, tolerability and efficacy of tafenoquine and mefloquine/primaquine for the prophylaxis of malaria amongst non-immune Australian soldiers deployed to East Timor (now called Timor Leste) for peacekeeping operations. The lack of a concurrent placebo control arm prevented an internal estimate of the malaria attack rate and so the protective efficacy of the study regimens was not determined at the time. Methods In a retrospective analysis of the trial results, the all species malaria attack rate was estimated for the prophylactic phase of the study which was defined as the period between administration of the first prophylactic dose and the first dose of post-deployment medication. First, the Plasmodium vivax attack rate was estimated during the prophylactic phase of the deployment by adjusting the observed P. vivax relapse rate during postdeployment to account for the known anti-relapse efficacies (or effectiveness) of the study medications (determined from prior studies). The all species malaria attack rate (P. vivax and Plasmodium falciparum) was then determined by adjusting the P. vivax attack rate based on the ratio of P. falciparum to P. vivax observed during prior ADF deployments to Timor Leste. This estimated all species malaria attack rate was then used as the 'constant estimated attack rate' in the calculation of the protective efficacy of tafenoquine and mefloquine during the prophylactic phase of the deployment. Results The estimated attack rate during the prophylactic phase of the study was determined to be 7.88%. The protective efficacies of tafenoquine and mefloquine, with corresponding 95% confidence intervals (95% CI), were determined to be 100% (93%-100%) and 100% (79%- 100%) respectively. Conclusions The protective efficacy of tafenoquine (200 mg per day for three days, followed by weekly 200 mg maintenance doses) is similar to that of the weekly standard of care (mefloquine, 250 mg). [ABSTRACT FROM AUTHOR]

Published
2014
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