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9 results on '"Myra Happe"'

1. Heterologous cAd3-Ebola and MVA-EbolaZ vaccines are safe and immunogenic in US and Uganda phase 1/1b trials

Author

Myra Happe, Amelia R. Hofstetter, Jing Wang, Galina V. Yamshchikov, LaSonji A. Holman, Laura Novik, Larisa Strom, Francis Kiweewa, Salim Wakabi, Monica Millard, Colleen F. Kelley, Sarah Kabbani, Srilatha Edupuganti, Allison Beck, Florence Kaltovich, Tamar Murray, Susanna Tsukerman, Derick Carr, Carl Ashman, Daphne A. Stanley, Aurélie Ploquin, Robert T. Bailer, Richard Schwartz, Fatim Cham, Allan Tindikahwa, Zonghui Hu, Ingelise J. Gordon, Nadine Rouphael, Katherine V. Houser, Emily E. Coates, Barney S. Graham, Richard A. Koup, John R. Mascola, Nancy J. Sullivan, Merlin L. Robb, Julie A. Ake, Kirsten E. Lyke, Mark J. Mulligan, Julie E. Ledgerwood, Hannah Kibuuka, and the VRC 208 and RV 422 study team

Subjects
Immunologic diseases. Allergy, RC581-607, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Ebola virus disease (EVD) is a filoviral infection caused by virus species of the Ebolavirus genus including Zaire ebolavirus (EBOV) and Sudan ebolavirus (SUDV). We investigated the safety and immunogenicity of a heterologous prime-boost regimen involving a chimpanzee adenovirus 3 vectored Ebola vaccine [either monovalent (cAd3-EBOZ) or bivalent (cAd3-EBO)] prime followed by a recombinant modified vaccinia virus Ankara EBOV vaccine (MVA-EbolaZ) boost in two phase 1/1b randomized open-label clinical trials in healthy adults in the United States (US) and Uganda (UG). Trial US (NCT02408913) enrolled 140 participants, including 26 EVD vaccine-naïve and 114 cAd3-Ebola-experienced participants (April-November 2015). Trial UG (NCT02354404) enrolled 90 participants, including 60 EVD vaccine-naïve and 30 DNA Ebola vaccine-experienced participants (February-April 2015). All tested vaccines and regimens were safe and well tolerated with no serious adverse events reported related to study products. Solicited local and systemic reactogenicity was mostly mild to moderate in severity. The heterologous prime-boost regimen was immunogenic, including induction of durable antibody responses which peaked as early as two weeks and persisted up to one year after each vaccination. Different prime-boost intervals impacted the magnitude of humoral and cellular immune responses. The results from these studies demonstrate promising implications for use of these vaccines in both prophylactic and outbreak settings.

Published
2024
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2. Safety and immunogenicity of an HIV-1 prefusion-stabilized envelope trimer (Trimer 4571) vaccine in healthy adults: A first-in-human open-label, randomized, dose-escalation, phase 1 clinical trial

Author

Katherine V. Houser, Martin R. Gaudinski, Myra Happe, Sandeep Narpala, Raffaello Verardi, Edward K. Sarfo, Angela R. Corrigan, Richard Wu, Ro Shauna Rothwell, Laura Novik, Cynthia S. Hendel, Ingelise J. Gordon, Nina M. Berkowitz, Cora Trelles Cartagena, Alicia T. Widge, Emily E. Coates, Larisa Strom, Somia Hickman, Michelle Conan-Cibotti, Sandra Vazquez, Olga Trofymenko, Sarah Plummer, Judy Stein, Christopher L. Case, Martha Nason, Andrea Biju, Danealle K. Parchment, Anita Changela, Cheng Cheng, Hongying Duan, Hui Geng, I-Ting Teng, Tongqing Zhou, Sarah O'Connell, Chris Barry, Kevin Carlton, Jason G. Gall, Britta Flach, Nicole A. Doria-Rose, Barney S. Graham, Richard A. Koup, Adrian B. McDermott, John R. Mascola, Peter D. Kwong, and Julie E. Ledgerwood

Subjects
HIV-1, Vaccine, Trimer 4571, BG505 DS-SOSIP.664, Phase 1 clinical trial, NIH, Medicine (General), R5-920
Abstract

Background: Advances in therapeutic drugs have increased life-expectancies for HIV-infected individuals, but the need for an effective vaccine remains. We assessed safety and immunogenicity of HIV-1 vaccine, Trimer 4571 (BG505 DS-SOSIP.664) adjuvanted with aluminum hydroxide (alum), in HIV-negative adults. Methods: We conducted a phase I, randomized, open-label, dose-escalation trial at the National Institutes of Health Clinical Center in Bethesda, MD, USA. Eligible participants were HIV-negative, healthy adults between 18-50 years. Participants were randomized 1:1 to receive Trimer 4571 adjuvanted with 500 mcg alum by either the subcutaneous (SC) or intramuscular (IM) route at weeks 0, 8, and 20 in escalating doses of 100 mcg or 500 mcg. The primary objectives were to evaluate the safety and tolerability of Trimer 4571 with a secondary objective of evaluating vaccine-induced antibody responses. The primary and safety endpoints were evaluated in all participants who received at least one dose of Trimer 4571. Trial results were summarized using descriptive statistics. This trial is registered at ClinicalTrials.gov, NCT03783130. Findings: Between March 7 and September 11, 2019, 16 HIV-negative participants were enrolled, including six (38%) males and ten (62%) females. All participants received three doses of Trimer 4571. Solicited reactogenicity was mild to moderate in severity, with one isolated instance of severe injection site redness (6%) following a third 500 mcg SC administration. The most commonly reported solicited symptoms included mild injection site tenderness in 14 (88%) and mild myalgia in six (38%) participants. The most frequent unsolicited adverse event attributed to vaccination was mild injection site pruritus in six (38%) participants. Vaccine-induced seropositivity occurred in seven (44%) participants and resolved in all but one (6%). No serious adverse events occurred. Trimer 4571-specific binding antibodies were detected in all groups two weeks after regimen completion, primarily focused on the glycan-free trimer base. Neutralizing antibody activity was limited to the 500 mcg dose groups. Interpretation: Trimer 4571 was safe, well tolerated, and immunogenic in this first-in-human trial. While this phase 1 trial is limited in size, our results inform and support further evaluation of prefusion-stabilized HIV-1 envelope trimers as a component of vaccine design strategies to generate broadly neutralizing antibodies against HIV-1. Funding: Intramural Research Program of the Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health.

Published
2022
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3. Low-dose intravenous and subcutaneous CIS43LS monoclonal antibody for protection against malaria (VRC 612 Part C): a phase 1, adaptive trial

Author

Kirsten E Lyke, Andrea A Berry, Kaitlin Mason, Azza H Idris, Mark O'Callahan, Myra Happe, Larisa Strom, Nina M Berkowitz, Mercy Guech, Zonghui Hu, Mike Castro, Manjula Basappa, Lu Wang, Kwang Low, LaSonji A Holman, Floreliz Mendoza, Ingelise J Gordon, Sarah H Plummer, Olga Trofymenko, Kathleen S Strauss, Sudhaunshu Joshi, Biraj Shrestha, Matthew Adams, Andrezza Campos Chagas, Jittawadee R Murphy, Judy Stein, Somia Hickman, Andrew McDougal, Bob Lin, Sandeep R Narpala, Sandra Vazquez, Leonid Serebryannyy, Adrian McDermott, Martin R Gaudinski, Edmund V Capparelli, Emily E Coates, Richard L Wu, Julie E Ledgerwood, Lesia K Dropulic, Robert A Seder, Cheryl Young, Colleen Boyce, Jennifer Winkler, Susan Holian, Nancy Greenberg, Shirley George, Alyson Kwon, Brenda Dorsey, Ana Raquel Da Costa, William Witt, Daryl Grays, Arren Gapasin, Paula Bernal, Jeffrey Floyd, Eric Goldstein, Leslie Howe, Myounghee Lee, Jennifer Marron, Kelly Brooks, Lisa Turek, Patricia Farley, Shantel Frels, Delores Booth, Jason Gall, Kevin Carlton, Gabriela Albright, Nadia Amharref, Kandace Atallah, Sashikanth Banappagari, Niutish Bastani, Daniel Blackstock, Bobby Boonyaratanakornkit, Elizabeth Carey, Adam Charlton, Rajoshi Chaudhuri, Alegria M. Caringal, Mingzhong Chen, Peifeng Chen, Wei Cheng, Daniel Gowetski, Krishana Gulla, Erica Hastings, Joe Horwitz, Vera Ivleva, Dan Kordella, Lisa A. Kueltzo, Sara Lagler, Matt Le, James Lee, Paula Lei, Yile Li, Attila Nagy, Aakash Patel, Peyi Runsewe, Will Shadrick, Shamitha Shetty, Hairong Wang, Calvin Webber, Farah Vejzagic, and Yoo-Jung Yang

Subjects
Infectious Diseases
Published
2023
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4. Safety, tolerability, and immunogenicity of the chimpanzee adenovirus type 3-vectored Marburg virus (cAd3-Marburg) vaccine in healthy adults in the USA: a first-in-human, phase 1, open-label, dose-escalation trial

Author

Melinda J Hamer, Katherine V Houser, Amelia R Hofstetter, Ana M Ortega-Villa, Christine Lee, Anne Preston, Brooke Augustine, Charla Andrews, Galina V Yamshchikov, Somia Hickman, Steven Schech, Jack N Hutter, Paul T Scott, Paige E Waterman, Mihret F Amare, Victoria Kioko, Casey Storme, Kayvon Modjarrad, Melanie D McCauley, Merlin L Robb, Martin R Gaudinski, Ingelise J Gordon, LaSonji A Holman, Alicia T Widge, Larisa Strom, Myra Happe, Josephine H Cox, Sandra Vazquez, Daphne A Stanley, Tamar Murray, Caitlyn N M Dulan, Ruth Hunegnaw, Sandeep R Narpala, Phillip A Swanson, Manjula Basappa, Jagada Thillainathan, Marcelino Padilla, Britta Flach, Sarah O’Connell, Olga Trofymenko, Patricia Morgan, Emily E Coates, Jason G Gall, Adrian B McDermott, Richard A Koup, John R Mascola, Aurélie Ploquin, Nancy J Sullivan, Julie A Ake, Julie E Ledgerwood, Rebecca Lampley, Brenda Larkin, Pamela Costner, Hope Wilson, and Mike Read

Subjects
General Medicine
Published
2023
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6. Low-Dose Subcutaneous or Intravenous Monoclonal Antibody to Prevent Malaria

Author

Richard L, Wu, Azza H, Idris, Nina M, Berkowitz, Myra, Happe, Martin R, Gaudinski, Christian, Buettner, Larisa, Strom, Seemal F, Awan, LaSonji A, Holman, Floreliz, Mendoza, Ingelise J, Gordon, Zonghui, Hu, Andrezza, Campos Chagas, Lawrence T, Wang, Lais, Da Silva Pereira, Joseph R, Francica, Neville K, Kisalu, Barbara J, Flynn, Wei, Shi, Wing-Pui, Kong, Sarah, O'Connell, Sarah H, Plummer, Allison, Beck, Adrian, McDermott, Sandeep R, Narpala, Leonid, Serebryannyy, Mike, Castro, Rosa, Silva, Marjaan, Imam, Iris, Pittman, Somia P, Hickman, Andrew J, McDougal, Ashly E, Lukoskie, Jittawadee R, Murphy, Jason G, Gall, Kevin, Carlton, Patricia, Morgan, Ellie, Seo, Judy A, Stein, Sandra, Vazquez, Shinyi, Telscher, Edmund V, Capparelli, Emily E, Coates, John R, Mascola, Julie E, Ledgerwood, Lesia K, Dropulic, Robert A, Seder, and Benjamin, Clarkson

Subjects
Adult, Child, Preschool, Plasmodium falciparum, Animals, Antibodies, Monoclonal, Humans, Administration, Intravenous, General Medicine, Malaria, Falciparum, Administration, Cutaneous, Child, Parasitemia, Malaria
Abstract

New approaches for the prevention and elimination of malaria, a leading cause of illness and death among infants and young children globally, are needed.We conducted a phase 1 clinical trial to assess the safety and pharmacokinetics of L9LS, a next-generation antimalarial monoclonal antibody, and its protective efficacy against controlled human malaria infection in healthy adults who had never had malaria or received a vaccine for malaria. The participants received L9LS either intravenously or subcutaneously at a dose of 1 mg, 5 mg, or 20 mg per kilogram of body weight. Within 2 to 6 weeks after the administration of L9LS, both the participants who received L9LS and the control participants underwent controlled human malaria infection in which they were exposed to mosquitoes carryingNo safety concerns were identified. L9LS had an estimated half-life of 56 days, and it had dose linearity, with the highest mean (±SD) maximum serum concentration (CIn this small trial, L9LS administered intravenously or subcutaneously protected recipients against malaria after controlled infection, without evident safety concerns. (Funded by the National Institute of Allergy and Infectious Diseases; VRC 614 ClinicalTrials.gov number, NCT05019729.).

Published
2023

7. Vaccines

Author

Katherine V. Houser, Myra Happe, Rachel Bean, and Emily E. Coates

Published
2023
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8. Optimization of the CIS43LS Malarial Monoclonal Antibody and Protection Against Malaria

Author

Kirsten E. Lyke, Andrea A. Berry, Kaitlin Mason, Azza A. Idris, Mark O'Callahan, Myra Happe, Larisa Strom, Nina M. Berkowitz, Mercy Guech, Zonghui Hu, Mike Castro, Manjula Basappa, Lu Wang, Muhammed Naqvi, Kwang Low, LaSonji A. Holman, Floreliz Mendoza, Ingelize J. Gordon, Sarah H. Plummer, Olga Trofymenko, Kathleen S. Strauss, Sudhaunshu Joshi, Biraj Shrestha, Matthew Adams, Andrezza Campos Chagas, Jittawadee R. Murphy, Judy A. Stein, Somia P. Hickman, Andrew J. McDougal, Bob Lin, Sandeep Narparla, Sandra Vazquez, Leonid Serebryannyy, Adrian McDermott, Martin R. Gaudinski, Edmund V. Capparelli, Emily E. Coates, Richard L. Wu, Julie E. Ledgerwood, Lesia K. Dropulic, and Robert A. Seder

Published
2022
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9. Safety and immunogenicity of a trivalent virus-like particle vaccine against western, eastern, and Venezuelan equine encephalitis viruses: a phase 1, open-label, dose-escalation, randomised clinical trial

Author

Emily E Coates, Srilatha Edupuganti, Grace L Chen, Myra Happe, Larisa Strom, Alicia Widge, Maria Burgos Florez, Josephine H Cox, Ingelise Gordon, Sarah Plummer, Abidemi Ola, Galina Yamshchikov, Charla Andrews, Sharon Curate-Ingram, Patricia Morgan, Shashi Nagar, Matthew H Collins, Amy Bray, Thuy Nguyen, Judy Stein, Christopher L Case, Florence Kaltovich, Diane Wycuff, C Jason Liang, Kevin Carlton, Sandra Vazquez, John R Mascola, Julie E Ledgerwood, Ellie Butler, Jean Winter, Jianguo Xu, Amy Sherman, Colleen Kelley, Rameses Fredrick, Nadine Rouphael, Varun Phadke, Cynthia Whitney, Alicarmen Alvarez, Renata Dennis, Rebecca Fineman, Pamela Lankford-Turner, Sha Yi, Lilin Lai, Gena Burch, Shanker Gupta, Nina Berkowitz, Cristina Carter, Allison Beck, Brenda Larkin, Stephanie Taylor, Mandy Alger, Jessica Bahorich, Amy Lynch Chamberlain, Ya-chen Chang, Rajoshi Chaudhuri, Jonathan Cooper, Jacob Demirji, Fan Yang, Alissa Fernald, Deepika Gollapudi, Janel Holland-Linn, Lisa Kueltzo, James Lee, Jie Liu, Xun Liu, Rachel Mowery, Sarah O'Connell, Erwin Rosales-Zavala, Jason Sands, Xin Wang, Shaojie Weng, and Sara Witter

Subjects
Adult, Male, Pain, Alphavirus, Middle Aged, Antibodies, Viral, Antibodies, Neutralizing, Encephalitis Virus, Venezuelan Equine, Young Adult, Infectious Diseases, Immunogenicity, Vaccine, Adjuvants, Immunologic, Double-Blind Method, Animals, Humans, Female, Horses, Vaccines, Virus-Like Particle
Abstract

Western (WEEV), eastern (EEEV), and Venezuelan (VEEV) equine encephalitis viruses are mosquito-borne pathogens classified as potential biological warfare agents for which there are currently no approved human vaccines or therapies. We aimed to evaluate the safety, tolerability, and immunogenicity of an investigational trivalent virus-like particle (VLP) vaccine, western, eastern, and Venezuelan equine encephalitis (WEVEE) VLP, composed of WEEV, EEEV, and VEEV VLPs.The WEVEE VLP vaccine was evaluated in a phase 1, randomised, open-label, dose-escalation trial at the Hope Clinic of the Emory Vaccine Center at Emory University, Atlanta, GA, USA. Eligible participants were healthy adults aged 18-50 years with no previous vaccination history with an investigational alphavirus vaccine. Participants were assigned to a dose group of 6 μg, 30 μg, or 60 μg vaccine product and were randomly assigned (1:1) to receive the WEVEE VLP vaccine with or without aluminium hydroxide suspension (alum) adjuvant by intramuscular injection at study day 0 and at week 8. The primary outcomes were the safety and tolerability of the vaccine (assessed in all participants who received at least one administration of study product) and the secondary outcome was immune response measured as neutralising titres by plaque reduction neutralisation test (PRNT) 4 weeks after the second vaccination. This trial is registered at ClinicalTrials.gov, NCT03879603.Between April 2, 2019, and June 13, 2019, 30 trial participants were enrolled (mean age 32 years, range 21-48; 16 [53%] female participants and 14 [47%] male participants). Six groups of five participants each received 6 μg, 30 μg, or 60 μg vaccine doses with or without adjuvant, and all 30 participants completed study follow-up. Vaccinations were safe and well tolerated. The most frequently reported symptoms were mild injection-site pain and tenderness (22 [73%] of 30) and malaise (15 [50%] of 30). Dose-dependent differences in the frequency of pain and tenderness were found between the 6 μg, 30 μg, and 60 μg groups (p=0·0217). No significant differences were observed between dosing groups for any other reactogenicity symptom. Two adverse events (mild elevated blood pressure and moderate asymptomatic neutropenia) were assessed as possibly related to the study product in one trial participant (60 μg dose with alum); both resolved without clinical sequelae. 4 weeks after second vaccine administration, neutralising antibodies were induced in all study groups with the highest response seen against all three vaccine antigens in the 30 μg plus alum group (PRNTThe favourable safety profile and neutralising antibody responses, along with pressing public health need, support further evaluation of the WEVEE VLP vaccine in advanced-phase clinical trials.The Vaccine Research Center of the National Institute of Allergy and Infectious Diseases, National Institutes of Health funded the clinical trial. The US Department of Defense contributed funding for manufacturing of the study product.

Published
2021

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