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1. Switch to long-acting cabotegravir and rilpivirine in virologically suppressed adults with HIV in Africa (CARES): week 48 results from a randomised, multicentre, open-label, non-inferiority trial

Author

Mugerwa, Henry, Tamale, William, Yiga, Joshua, Asaasira, Susan Esther, Kinyera, Nigel, Nambi, Christine, Nakiboneka, Dridah Luyirika, Kabatana, Rose, Kiyimba, Winfred, Ategeka, Gilbert, Yawe, Ibrahim, Alinaitwe, Adolf, Zawedde, Aidah, Wasswa, George, Arinda, Allan, Rweyora, Angela, Kangah, Mary Goretti, Cresswell, Fiona, Castelnuovo, Barbara, Kaimal, Arvind, Ogwal, Patience, Muhumuza, Neville, Okwero, Max, Ayebare, Peruth, Nakate, Vivian, Asienzo, Jesca, Mayanja, Hamza, Laker, Eva, Shah, Reena, Riunga, Felix, Onyango, Peter Odhiambo, Wanja, Josephine, Sayed, Shaheen, Gohil, Jaimini, Mungathia, Isaiah, Githuka, Alfred Mburu, Kibwage, Haron, Siika, Abraham Mosigisi, Wambui, Charity Kanyoro, Kirui, Viola Cherotich, Kipyego, Jairus, Sang, Natalie, Mokaya, Martha Mokeira Bisieri, Chepkorir, Consolata, Mboya, Chris Sande, Tonui, Ronald, Njulu, Florence, Kaziga, Hilda, Kosgei, Josphat, Sawe, Fredrick, Omol, Magdaline Adhiambo, Riziki, Faith, Daud, Ibrahim, Kimetto, Leelgo, Okumu, Billy Omalla, Lipuku, Francis, Sokhela, Simiso, Venter, Francois, Moller, Karlien, Nzuza, Nompumelelo, Ramela, Gontse, Tom, Noxolo, Nyamuzihwa, Tsitsi, Macholo, Philadelphia, Macebele, Hlamulani, Akpomiemie, Godspower, Naidoo, Logashvari, Jeenarain, Nitesha, Hurbans, Nivriti, Reddy, Mayuri, Mphisa, Gerald Thsepo, Kityo, Cissy, Paton, Nicholas, Mambule, Ivan Kiggundu, Opiyo, Kimton, Musaazi, Joseph, Otike, Caroline, Kabanyoro, Ritah, Sekajja, Francis, Nantumbwe, Sandra, Sekabira, Harriet, Ocitti, Paul, Ouma, Benson, Nankya, Immaculate, Ainembabazi, Pamela, Lötter, Melissa, Mohamed, Saeeda, Herbst, Madel, Peters, Tarryn, Mehta, Heena, Khan, Shaguftha, Kruger, Marlien, van Rein-van der Horst, Willemijn, Addo Boateng, Fafa, Van Solingen, Rodica, Vandermeulen, Kati, Van Eygen, Veerle, Crauwels, Herta, Luo, Donghan, Votto, Donna, Idahosa, Awhonukeh, Mwendia, Fridah, Klasko-Foster, Lynne, Bondal, Malavika, Eshun-Wilsonova, Ingrid, Mohammed, Perry, Spreen, William, D'Amico, Ronald, Kaleebu, Pontiano, Ojoo, Sylvia, Katana, Milly, Moosa, Yunus, Phiri, Sam, Munderi, Paula, Hill, Andrew, Mambule, Ivan K, Siika, Abraham, Möller, Karlien, Wambui, Charity, and Paton, Nicholas I

Published
2024
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3. Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, parallel, randomised, modified double-blind, placebo-controlled trial

Author

Abalos, Karina, Accini, Jose, Aloysia, Naveena, Amuasi, John Humphrey, Ansah, Nana Akosua, Benkeser, David, Berge, Aude, Beyko, Hanna, Bilotkach, Oleksandra, Breuer, Thomas, Bonfanti, Alberto Cadena, Bukusi, Elisabeth, Canter, Richard, Carrillo, Jaime Augusto, Chansinghakul, Danaya, Coux, Florence, Das, Chandan, Das, Santa Kumar, Devlin, Louis, Espinoza, Luis, Fay, Michael, Follmann, Dean, Frago, Carina, Garinga, Agnes, Gilbert, Peter B, Gonzalez, Claudia, Granados, Maria Angelica, Guillery, Lea, Huang, Ying, Hudzina, Kathy, Jain, Manish, Kanodia, Piush, Khandelwal, Nitin, Mutuluuza, Cissy Kityo, Kiweewa, Francis, Kiwanuka, Noah, Kosolsak, Chalit, Kukian, Darshna, Kushwaha, Jitendra Singh, Laot, Thelma, Lopez-Medina, Eduardo, Macareno Arroyo, Hugo, Mandaliya, Kishorchandra, Mamod, Stephanie, Mangarule, Somnath, Martínez, Javier, McClelland, Scott, Menard, Lisa, Mendoza, Sandra, Mohapatra, Satyajit, Moreau, Catherine, Mugo, Nelly, Nduba, Videlis, Noriega, Fernando, Ntege, Patricia Nahirya, Okech, Brenda, Otero, Maria, Ouma, Samuel Gurrion, Oyieko, Janet, Paredes, Mercedes, Pardo, Erwin, Postol, Svitlana, Pekala, David, Peng, Penny, Py, Marie-Laure, Rivas, Enrique, Rivero, Rafael, Rodriguez, Edith, Saleh, Mansoor, Sánchez, Pedro, Sater, Nessryne, Shah, Jinen, Shrestha, Rajeev, Siika, Abraham, Singh, Chandramani, Singh, Veer Bahadur, Tamrakar, Dipesh, Tavares Da-Silva, Fernanda, Otieno Tina, Lucas, Velasquez, Hector, Wabwire, Deo, Wajja, Anne, Zaworski, Elodie, Zhang, Nianxian, Dayan, Gustavo H, Rouphael, Nadine, Walsh, Stephen R, Chen, Aiying, Grunenberg, Nicole, Allen, Mary, Antony, Johannes, Asante, Kwaku Poku, Bhate, Amit Suresh, Beresnev, Tatiana, Bonaparte, Matthew I, Celle, Médéric, Ceregido, Maria Angeles, Corey, Lawrence, Dobrianskyi, Dmytro, Fu, Bo, Grillet, Marie-Helene, Keshtkar-Jahromi, Maryam, Juraska, Michal, Kee, Jia Jin, Kibuuka, Hannah, Koutsoukos, Marguerite, Masotti, Roger, Michael, Nelson L, Neuzil, Kathleen M, Reynales, Humberto, Robb, Merlin L, Villagómez Martínez, Sandra M, Sawe, Fredrick, Schuerman, Lode, Tong, Tina, Treanor, John, Wartel, T Anh, Diazgranados, Carlos A, Chicz, Roman M, Gurunathan, Sanjay, Savarino, Stephen, and Sridhar, Saranya

Published
2023
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4. Efficacy of a monovalent (D614) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, multi-country study

Author

Abalos, Karina, Adams, Michael, Allaw, Mohamed, Aloysia, Naveena, Amuasi, John Humphrey, Ansah, Nana Akosua, Asante, Kwaku Poku, Benkeser, David, Berge, Aude, Breuer, Thomas, Briesemeister, Liz, Broder, Gail, Bonfanti, Alberto Cadena, Calinescu, Cornell, Canter, Richard, Carrillo, Jaime Augusto, Chansinghakul, Danaya, Coux, Florence, Das, Chandan, Davies, Matthew, Devlin, Louis, Fay, Michael, Follmann, Dean, Frago, Carina, Fukase, Hiroyuki, Garinga, Agnes, Gilbert, Peter B., Gonzalez, Claudia, Granados, Maria Angelica, Greiwe, Cathy, Guillery, Lea, Hall, Jessicalee, Henderson, Jeffrey, Huang, Ying, Hudzina, Kathy, Hural, John, Hutchens, Mark, Jain, Manish, Jennings, William, Kanodia, Piush, Kimmel, Murray, Kirby, William, Khandelwal, Nitin, Kopp, James, Kosolsak, Chalit, Kublin, Jim, Kukian, Darshna, Kushwaha, Jitendra Singh, Laot, Thelma, Lopez-Medina, Eduardo, Arroyo, Hugo Macareno, Mamod, Stephanie, Mangarule, Somnath, Martin, Troy, Menard, Lisa, Mendoza, Sandra, Meyer, Robert, Middleton, Randle, Miracle, Jill, Mizuyama, Kazuyuki, Mohapatra, Satyajit, Moreau, Catherine, Murray, Linda, Nagamatsu, Shinya, Newberg, Joseph, Noriega, Fernando, Nugent, Paul, Peake-Andrasik, Michele, Pekala, David, Peng, Penny, Py, Marie-Laure, Ramirez, Shelly, Reddy, Chinthaparthi Prabhakar, Reynolds, Michelle, Rivas, Enrique, Sater, Nessryne, Shah, Jinen, Sher, Lawrence, Sieger, Silva, Singh, Chandramani, Singh, Veer Bahadur, Sirisuphmitr, Nuchra, Starkey, Thomas, Suzuki, Kazuo, Tamrakar, Dipesh, Tangemen, Cayce, Da-Silva, Fernanda Tavares, Taylor, David, Tharenos, Leslie, Wartel, T. Anh, Zaworski, Elodie, Zhang, Nianxian, Dayan, Gustavo H., Rouphael, Nadine, Walsh, Stephen R., Chen, Aiying, Grunenberg, Nicole, Allen, Mary, Antony, Johannes, Bhate, Amit Suresh, Beresnev, Tatiana, Bonaparte, Matthew I., Celle, Médéric, Ceregido, Maria Angeles, Corey, Lawrence, Fu, Bo, Grillet, Marie-Helene, Keshtkar-Jahromi, Maryam, Juraska, Michal, Kee, Jia Jin, Kaali, Seyram, Koutsoukos, Marguerite, Masotti, Roger, Michael, Nelson L., Neuzil, Kathleen M., Reynales, Humberto, Robb, Merlin L., Uchiyama, Akiyoshi, Sawe, Fredrick, Schuerman, Lode, Shrestha, Rajeev, Tong, Tina, Treanor, John, Diazgranados, Carlos A., Chicz, Roman M., Gurunathan, Sanjay, Savarino, Stephen, and Sridhar, Saranya

Published
2023
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5. Effect of the relationship between anaemia and systemic inflammation on the risk of incident tuberculosis and death in people with advanced HIV: a sub-analysis of the REMEMBER trial

Author

Araújo-Pereira, Mariana, Krishnan, Sonya, Salgame, Padmini, Manabe, Yukari C., Hosseinipour, Mina C., Bisson, Gregory, Severe, Damocles Patrice, Rouzier, Vanessa, Leong, Samantha, Mave, Vidya, Sawe, Fredrick Kipyego, Siika, Abraham M., Kanyama, Cecilia, Dadabhai, Sufia S., Lama, Javier R., Valencia-Huamani, Javier, Badal-Faesen, Sharlaa, Lalloo, Umesh Gangaram, Naidoo, Kogieleum, Mohapi, Lerato, Kityo, Cissy, Andrade, Bruno B., and Gupta, Amita

Published
2023
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6. Switch to long-acting cabotegravir and rilpivirine in virologically suppressed adults with HIV in Africa (CARES): week 48 results from a randomised, multicentre, open-label, non-inferiority trial

Author

Kityo, Cissy, primary, Mambule, Ivan K, additional, Musaazi, Joseph, additional, Sokhela, Simiso, additional, Mugerwa, Henry, additional, Ategeka, Gilbert, additional, Cresswell, Fiona, additional, Siika, Abraham, additional, Kosgei, Josphat, additional, Shah, Reena, additional, Naidoo, Logashvari, additional, Opiyo, Kimton, additional, Otike, Caroline, additional, Möller, Karlien, additional, Kaimal, Arvind, additional, Wambui, Charity, additional, Van Eygen, Veerle, additional, Mohammed, Perry, additional, Addo Boateng, Fafa, additional, Paton, Nicholas I, additional, Tamale, William, additional, Yiga, Joshua, additional, Asaasira, Susan Esther, additional, Kinyera, Nigel, additional, Nambi, Christine, additional, Nakiboneka, Dridah Luyirika, additional, Kabatana, Rose, additional, Kiyimba, Winfred, additional, Yawe, Ibrahim, additional, Alinaitwe, Adolf, additional, Zawedde, Aidah, additional, Wasswa, George, additional, Arinda, Allan, additional, Rweyora, Angela, additional, Kangah, Mary Goretti, additional, Castelnuovo, Barbara, additional, Ogwal, Patience, additional, Muhumuza, Neville, additional, Okwero, Max, additional, Ayebare, Peruth, additional, Nakate, Vivian, additional, Asienzo, Jesca, additional, Mayanja, Hamza, additional, Laker, Eva, additional, Riunga, Felix, additional, Onyango, Peter Odhiambo, additional, Wanja, Josephine, additional, Sayed, Shaheen, additional, Gohil, Jaimini, additional, Mungathia, Isaiah, additional, Githuka, Alfred Mburu, additional, Kibwage, Haron, additional, Siika, Abraham Mosigisi, additional, Wambui, Charity Kanyoro, additional, Kirui, Viola Cherotich, additional, Kipyego, Jairus, additional, Sang, Natalie, additional, Mokaya, Martha Mokeira Bisieri, additional, Chepkorir, Consolata, additional, Mboya, Chris Sande, additional, Tonui, Ronald, additional, Njulu, Florence, additional, Kaziga, Hilda, additional, Sawe, Fredrick, additional, Omol, Magdaline Adhiambo, additional, Riziki, Faith, additional, Daud, Ibrahim, additional, Kimetto, Leelgo, additional, Okumu, Billy Omalla, additional, Lipuku, Francis, additional, Venter, Francois, additional, Moller, Karlien, additional, Nzuza, Nompumelelo, additional, Ramela, Gontse, additional, Tom, Noxolo, additional, Nyamuzihwa, Tsitsi, additional, Macholo, Philadelphia, additional, Macebele, Hlamulani, additional, Akpomiemie, Godspower, additional, Jeenarain, Nitesha, additional, Hurbans, Nivriti, additional, Reddy, Mayuri, additional, Mphisa, Gerald Thsepo, additional, Kityo, Cissy, additional, Paton, Nicholas, additional, Mambule, Ivan Kiggundu, additional, Kabanyoro, Ritah, additional, Sekajja, Francis, additional, Nantumbwe, Sandra, additional, Sekabira, Harriet, additional, Ocitti, Paul, additional, Ouma, Benson, additional, Nankya, Immaculate, additional, Ainembabazi, Pamela, additional, Lötter, Melissa, additional, Mohamed, Saeeda, additional, Herbst, Madel, additional, Peters, Tarryn, additional, Mehta, Heena, additional, Khan, Shaguftha, additional, Kruger, Marlien, additional, van Rein-van der Horst, Willemijn, additional, Van Solingen, Rodica, additional, Vandermeulen, Kati, additional, Crauwels, Herta, additional, Luo, Donghan, additional, Votto, Donna, additional, Idahosa, Awhonukeh, additional, Mwendia, Fridah, additional, Klasko-Foster, Lynne, additional, Bondal, Malavika, additional, Eshun-Wilsonova, Ingrid, additional, Spreen, William, additional, D'Amico, Ronald, additional, Kaleebu, Pontiano, additional, Ojoo, Sylvia, additional, Katana, Milly, additional, Moosa, Yunus, additional, Phiri, Sam, additional, Munderi, Paula, additional, and Hill, Andrew, additional

Published
2024
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7. Safety and Immunogenicity of Accelerated Heterologous 2-Dose Ebola Vaccine Regimens in Adults With and Without HIV in Africa.

Author

Mwesigwa, Betty, Sawe, Fredrick, Oyieko, Janet, Mwakisisile, Joel, Viegas, Edna, Akintunde, Gideon Akindiran, Kosgei, Josphat, Kokogho, Afoke, Ntinginya, Nyanda, Jani, Ilesh, Shukarev, Georgi, Hooper, Jay W, Kwilas, Steven A, Ward, Lucy A, Rusnak, Janice, Bounds, Callie, Overman, Rachel, Badorrek, Christopher S, Eller, Leigh Anne, and Eller, Michael A

Subjects
*PATIENT safety, *DRUG side effects, *RESEARCH funding, *VACCINE effectiveness, *HIV-positive persons, *STATISTICAL sampling, *BLIND experiment, *CD4 lymphocyte count, *ENZYME-linked immunosorbent assay, *RANDOMIZED controlled trials, *DESCRIPTIVE statistics, *VACCINE immunogenicity, *VIRAL vaccines, *EBOLA virus, *DRUG tolerance, *EVALUATION
Abstract

Background Shorter prophylactic vaccine schedules may offer more rapid protection against Ebola in resource-limited settings. Methods This randomized, observer-blind, placebo-controlled, phase 2 trial conducted in 5 sub-Saharan African countries included people without human immunodeficiency virus (HIV) (PWOH, n = 249) and people with HIV (PWH, n = 250). Adult participants received 1 of 2 accelerated Ebola vaccine regimens (MVA-BN-Filo, Ad26.ZEBOV administered 14 days apart [n = 79] or Ad26.ZEBOV, MVA-BN-Filo administered 28 days apart [n = 322]) or saline/placebo (n = 98). The primary endpoints were safety (adverse events [AEs]) and immunogenicity (Ebola virus [EBOV] glycoprotein–specific binding antibody responses). Binding antibody responders were defined as participants with a >2.5-fold increase from baseline or the lower limit of quantification if negative at baseline. Results The mean age was 33.4 years, 52% of participants were female, and among PWH, the median CD4+ cell count was 560.0 (interquartile range, 418.0–752.0) cells/μL. AEs were generally mild/moderate with no vaccine-related serious AEs or remarkable safety profile differences by HIV status. At 21 days post–dose 2, EBOV glycoprotein–specific binding antibody response rates in vaccine recipients were 99% for the 14-day regimen (geometric mean concentrations [GMCs]: 5168 enzyme-linked immunosorbent assay units [EU]/mL in PWOH; 2509 EU/mL in PWH) and 98% for the 28-day regimen (GMCs: 6037 EU/mL in PWOH; 2939 EU/mL in PWH). At 12 months post–dose 2, GMCs in PWOH and PWH were 635 and 514 EU/mL, respectively, for the 14-day regimen and 331 and 360 EU/mL, respectively, for the 28-day regimen. Conclusions Accelerated 14- and 28-day Ebola vaccine regimens were safe and immunogenic in PWOH and PWH in Africa. Clinical Trials Registration.  NCT02598388. [ABSTRACT FROM AUTHOR]

Published
2024
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8. Cardiovascular Disease Risk Factors in HIV-Infected Women After Initiation of Lopinavir/Ritonavir- and Nevirapine-Based Antiretroviral Therapy in Sub-Saharan Africa

Author

Shaffer, Douglas, Hughes, Michael D, Sawe, Fredrick, Bao, Yajing, Moses, Agnes, Hogg, Evelyn, Lockman, Shahin, and Currier, Judith

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, HIV/AIDS, Infectious Diseases, Sexually Transmitted Infections, Prevention, Cardiovascular, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adenine, Adult, Africa South of the Sahara, Anti-HIV Agents, Antiretroviral Therapy, Highly Active, Blood Pressure, Body Mass Index, CD4-Positive T-Lymphocytes, Cardiovascular Diseases, Cholesterol, HDL, Cholesterol, LDL, Deoxycytidine, Emtricitabine, Endpoint Determination, Female, HIV Infections, HIV-1, Humans, Linear Models, Logistic Models, Lopinavir, Multivariate Analysis, Nevirapine, Organophosphonates, Prospective Studies, RNA, Viral, Risk Factors, Ritonavir, Tenofovir, Triglycerides, women, Africa, nevirapine, lopinavir, ritonavir, cardiovascular disease risk factors, Public Health and Health Services, Virology, Clinical sciences, Epidemiology, Public health
Abstract

BackgroundLimited comparative, prospective data exist regarding cardiovascular risk factors in HIV-infected women starting antiretroviral therapy in Africa.MethodsIn 7 African countries, 741 women with CD4

Published
2014

9. Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, parallel, randomised, modified double-blind, placebo-controlled trial

Author

Dayan, Gustavo H, primary, Rouphael, Nadine, additional, Walsh, Stephen R, additional, Chen, Aiying, additional, Grunenberg, Nicole, additional, Allen, Mary, additional, Antony, Johannes, additional, Asante, Kwaku Poku, additional, Bhate, Amit Suresh, additional, Beresnev, Tatiana, additional, Bonaparte, Matthew I, additional, Celle, Médéric, additional, Ceregido, Maria Angeles, additional, Corey, Lawrence, additional, Dobrianskyi, Dmytro, additional, Fu, Bo, additional, Grillet, Marie-Helene, additional, Keshtkar-Jahromi, Maryam, additional, Juraska, Michal, additional, Kee, Jia Jin, additional, Kibuuka, Hannah, additional, Koutsoukos, Marguerite, additional, Masotti, Roger, additional, Michael, Nelson L, additional, Neuzil, Kathleen M, additional, Reynales, Humberto, additional, Robb, Merlin L, additional, Villagómez Martínez, Sandra M, additional, Sawe, Fredrick, additional, Schuerman, Lode, additional, Tong, Tina, additional, Treanor, John, additional, Wartel, T Anh, additional, Diazgranados, Carlos A, additional, Chicz, Roman M, additional, Gurunathan, Sanjay, additional, Savarino, Stephen, additional, Sridhar, Saranya, additional, Abalos, Karina, additional, Accini, Jose, additional, Aloysia, Naveena, additional, Amuasi, John Humphrey, additional, Ansah, Nana Akosua, additional, Benkeser, David, additional, Berge, Aude, additional, Beyko, Hanna, additional, Bilotkach, Oleksandra, additional, Breuer, Thomas, additional, Bonfanti, Alberto Cadena, additional, Bukusi, Elisabeth, additional, Canter, Richard, additional, Carrillo, Jaime Augusto, additional, Chansinghakul, Danaya, additional, Coux, Florence, additional, Das, Chandan, additional, Das, Santa Kumar, additional, Devlin, Louis, additional, Espinoza, Luis, additional, Fay, Michael, additional, Follmann, Dean, additional, Frago, Carina, additional, Garinga, Agnes, additional, Gilbert, Peter B, additional, Gonzalez, Claudia, additional, Granados, Maria Angelica, additional, Guillery, Lea, additional, Huang, Ying, additional, Hudzina, Kathy, additional, Jain, Manish, additional, Kanodia, Piush, additional, Khandelwal, Nitin, additional, Mutuluuza, Cissy Kityo, additional, Kiweewa, Francis, additional, Kiwanuka, Noah, additional, Kosolsak, Chalit, additional, Kukian, Darshna, additional, Kushwaha, Jitendra Singh, additional, Laot, Thelma, additional, Lopez-Medina, Eduardo, additional, Macareno Arroyo, Hugo, additional, Mandaliya, Kishorchandra, additional, Mamod, Stephanie, additional, Mangarule, Somnath, additional, Martínez, Javier, additional, McClelland, Scott, additional, Menard, Lisa, additional, Mendoza, Sandra, additional, Mohapatra, Satyajit, additional, Moreau, Catherine, additional, Mugo, Nelly, additional, Nduba, Videlis, additional, Noriega, Fernando, additional, Ntege, Patricia Nahirya, additional, Okech, Brenda, additional, Otero, Maria, additional, Ouma, Samuel Gurrion, additional, Oyieko, Janet, additional, Paredes, Mercedes, additional, Pardo, Erwin, additional, Postol, Svitlana, additional, Pekala, David, additional, Peng, Penny, additional, Py, Marie-Laure, additional, Rivas, Enrique, additional, Rivero, Rafael, additional, Rodriguez, Edith, additional, Saleh, Mansoor, additional, Sánchez, Pedro, additional, Sater, Nessryne, additional, Shah, Jinen, additional, Shrestha, Rajeev, additional, Siika, Abraham, additional, Singh, Chandramani, additional, Singh, Veer Bahadur, additional, Tamrakar, Dipesh, additional, Tavares Da-Silva, Fernanda, additional, Otieno Tina, Lucas, additional, Velasquez, Hector, additional, Wabwire, Deo, additional, Wajja, Anne, additional, Zaworski, Elodie, additional, and Zhang, Nianxian, additional

Published
2023
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10. Safety and Immunogenicity of PENNVAX-G DNA Prime Administered by Biojector 2000 or CELLECTRA Electroporation Device With Modified Vaccinia Ankara-CMDR Boost

Author

Ake, Julie A., Schuetz, Alexandra, Pegu, Poonam, Wieczorek, Lindsay, Eller, Michael A., Kibuuka, Hannah, Sawe, Fredrick, Maboko, Leonard, Polonis, Victoria, Karasavva, Nicos, Weiner, David, Sekiziyivu, Arthur, Kosgei, Josphat, Missanga, Marco, Kroidl, Arne, Mann, Philipp, Ratto-Kim, Silvia, Eller, Leigh Anne, Earl, Patricia, Moss, Bernard, Dorsey-Spitz, Julie, Milazzo, Mark, Ouedraogo, G. Laissa, Rizvi, Farrukh, Yan, Jian, Khan, Amir S., Peel, Sheila, Sardesai, Niranjan Y., Michael, Nelson L., Ngauy, Viseth, Marovich, Mary, and Robb, Merlin L.

Published
2017

11. Efficacy of a monovalent (D614) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, multi-country study

Author

Dayan, Gustavo H., primary, Rouphael, Nadine, additional, Walsh, Stephen R., additional, Chen, Aiying, additional, Grunenberg, Nicole, additional, Allen, Mary, additional, Antony, Johannes, additional, Bhate, Amit Suresh, additional, Beresnev, Tatiana, additional, Bonaparte, Matthew I., additional, Celle, Médéric, additional, Ceregido, Maria Angeles, additional, Corey, Lawrence, additional, Fu, Bo, additional, Grillet, Marie-Helene, additional, Keshtkar-Jahromi, Maryam, additional, Juraska, Michal, additional, Kee, Jia Jin, additional, Kaali, Seyram, additional, Koutsoukos, Marguerite, additional, Masotti, Roger, additional, Michael, Nelson L., additional, Neuzil, Kathleen M., additional, Reynales, Humberto, additional, Robb, Merlin L., additional, Uchiyama, Akiyoshi, additional, Sawe, Fredrick, additional, Schuerman, Lode, additional, Shrestha, Rajeev, additional, Tong, Tina, additional, Treanor, John, additional, Diazgranados, Carlos A., additional, Chicz, Roman M., additional, Gurunathan, Sanjay, additional, Savarino, Stephen, additional, Sridhar, Saranya, additional, Abalos, Karina, additional, Adams, Michael, additional, Allaw, Mohamed, additional, Aloysia, Naveena, additional, Amuasi, John Humphrey, additional, Ansah, Nana Akosua, additional, Asante, Kwaku Poku, additional, Benkeser, David, additional, Berge, Aude, additional, Breuer, Thomas, additional, Briesemeister, Liz, additional, Broder, Gail, additional, Bonfanti, Alberto Cadena, additional, Calinescu, Cornell, additional, Canter, Richard, additional, Carrillo, Jaime Augusto, additional, Chansinghakul, Danaya, additional, Coux, Florence, additional, Das, Chandan, additional, Davies, Matthew, additional, Devlin, Louis, additional, Fay, Michael, additional, Follmann, Dean, additional, Frago, Carina, additional, Fukase, Hiroyuki, additional, Garinga, Agnes, additional, Gilbert, Peter B., additional, Gonzalez, Claudia, additional, Granados, Maria Angelica, additional, Greiwe, Cathy, additional, Guillery, Lea, additional, Hall, Jessicalee, additional, Henderson, Jeffrey, additional, Huang, Ying, additional, Hudzina, Kathy, additional, Hural, John, additional, Hutchens, Mark, additional, Jain, Manish, additional, Jennings, William, additional, Kanodia, Piush, additional, Kimmel, Murray, additional, Kirby, William, additional, Khandelwal, Nitin, additional, Kopp, James, additional, Kosolsak, Chalit, additional, Kublin, Jim, additional, Kukian, Darshna, additional, Kushwaha, Jitendra Singh, additional, Laot, Thelma, additional, Lopez-Medina, Eduardo, additional, Arroyo, Hugo Macareno, additional, Mamod, Stephanie, additional, Mangarule, Somnath, additional, Martin, Troy, additional, Menard, Lisa, additional, Mendoza, Sandra, additional, Meyer, Robert, additional, Middleton, Randle, additional, Miracle, Jill, additional, Mizuyama, Kazuyuki, additional, Mohapatra, Satyajit, additional, Moreau, Catherine, additional, Murray, Linda, additional, Nagamatsu, Shinya, additional, Newberg, Joseph, additional, Noriega, Fernando, additional, Nugent, Paul, additional, Peake-Andrasik, Michele, additional, Pekala, David, additional, Peng, Penny, additional, Py, Marie-Laure, additional, Ramirez, Shelly, additional, Reddy, Chinthaparthi Prabhakar, additional, Reynolds, Michelle, additional, Rivas, Enrique, additional, Sater, Nessryne, additional, Shah, Jinen, additional, Sher, Lawrence, additional, Sieger, Silva, additional, Singh, Chandramani, additional, Singh, Veer Bahadur, additional, Sirisuphmitr, Nuchra, additional, Starkey, Thomas, additional, Suzuki, Kazuo, additional, Tamrakar, Dipesh, additional, Tangemen, Cayce, additional, Da-Silva, Fernanda Tavares, additional, Taylor, David, additional, Tharenos, Leslie, additional, Wartel, T. Anh, additional, Zaworski, Elodie, additional, and Zhang, Nianxian, additional

Published
2023
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15. HIV-1 infections with multiple founders associate with the development of neutralization breadth

Author

Lewitus, Eric, primary, Townsley, Samantha M., additional, Li, Yifan, additional, Donofrio, Gina C., additional, Dearlove, Bethany L., additional, Bai, Hongjun, additional, Sanders-Buell, Eric, additional, O’Sullivan, Anne Marie, additional, Bose, Meera, additional, Kibuuka, Hannah, additional, Maganga, Lucas, additional, Nitayaphan, Sorachai, additional, Sawe, Fredrick K., additional, Eller, Leigh Anne, additional, Michael, Nelson L., additional, Polonis, Victoria R., additional, Ake, Julie A., additional, Vasan, Sandhya, additional, Robb, Merlin L., additional, Tovanabutra, Sodsai, additional, Krebs, Shelly J., additional, and Rolland, Morgane, additional

Published
2022
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16. 1049. Minimal Transient HIV-1 Viremia Following Vaccination Regimens Containing AD26. ZEBOV and MVA-BN-Filo in ART-Suppressed People Living with HIV

Author

Custer, Benjamin L, primary, Mwesigwa, Betty, additional, Sawe, Fredrick, additional, Oyieko, Janet, additional, Ntinginya, Nyanda, additional, Jani, Ilesh, additional, Iroezindu, Michael, additional, Hutter, Jack, additional, Jagodzinski, Linda, additional, Shukarev, Georgi, additional, Eller, Leigh Anne, additional, Ward, Lucy, additional, Overman, Rachel, additional, Rusnak, Janice M, additional, Bounds, Callie, additional, Badorrek, Christopher, additional, Polyak, Christina, additional, Esber, Allahna L, additional, Moodley, Amber D, additional, Tran, Chi, additional, Gaddah, Auguste, additional, Luhn, Kerstin, additional, Douoguih, Macaya, additional, Robinson, Cynthia, additional, and Ake, Julie A, additional

Published
2021
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19. Attaining 95-95-95 through Implementation Science: 15 Years of Insights and Best Practices from the Walter Reed Army Institute of Research’s Implementation of the U.S. President’s Emergency Plan for AIDS Relief

Author

Lee, Elizabeth H., primary, Ganesan, Kavitha, additional, Khamadi, Samoel A., additional, Meribe, Stanley C., additional, Njeru, Dorothy, additional, Adamu, Yakubu, additional, Magala, Fred, additional, Crowell, Trevor A., additional, Akom, Eniko, additional, Agaba, Patricia, additional, Desai, Priyanka, additional, Hamm, Tiffany, additional, Teyhen, Deydre, additional, Ake, Julie A., additional, Polyak, Christina S., additional, Shaffer, Douglas, additional, Sawe, Fredrick, additional, and Hickey, Patrick W., additional

Published
2021
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21. Association of the US President’s Emergency Plan for AIDS Relief’s Funding With Prevention of Mother-to-Child Transmission of HIV in Kenya

Author

Barnhart, Dale A., primary, Tsikhutsu, Isaac, additional, Kirui, Duncan, additional, Sawe, Fredrick, additional, Muli, Jane, additional, Sugut, William, additional, Abboud, Nareen, additional, Birx, Deborah, additional, Hamm, Tiffany, additional, Coakley, Peter, additional, Hickey, Patrick W., additional, Wolfman, Vanessa, additional, Lee, Elizabeth, additional, and Spiegelman, Donna, additional

Published
2019
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22. Prospective International Study of Incidence and Predictors of Immune Reconstitution Inflammatory Syndrome and Death in People Living With Human Immunodeficiency Virus and Severe Lymphopenia

Author

Sereti, Irini, primary, Sheikh, Virginia, additional, Shaffer, Douglas, additional, Phanuphak, Nittaya, additional, Gabriel, Erin, additional, Wang, Jing, additional, Nason, Martha C, additional, Roby, Gregg, additional, Ngeno, Hellen, additional, Kirui, Fredrick, additional, Pau, Alice, additional, Mican, Joann M, additional, Rupert, Adam, additional, Bishop, Rachel, additional, Agan, Brian, additional, Chomchey, Nitiya, additional, Teeratakulpisarn, Nipat, additional, Tansuphaswadikul, Somsit, additional, Langat, Deborah, additional, Kosgei, Josphat, additional, French, Martyn, additional, Ananworanich, Jintanat, additional, and Sawe, Fredrick, additional

Published
2019
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23. Do the socioeconomic impacts of antiretroviral therapy vary by gender? A longitudinal study of Kenyan agricultural worker employment outcomes

Author

Sigei Carolyne, Bii Margret, Rosen Sydney, Fox Mathew P, Larson Bruce A, Shaffer Douglas, Sawe Fredrick, McCoy Kelly, Wasunna Monique, and Simon Jonathan L

Subjects
Public aspects of medicine, RA1-1270
Abstract

Abstract Background As access to antiretroviral therapy (ART) has grown in Africa, attention has turned to evaluating the socio-economic impacts of ART. One key issue is the extent to which improvements in health resulting from ART allows individuals to return to work and earn income. Improvements in health from ART may also be associated with reduced impaired presenteeism, which is the loss of productivity when an ill or disabled individual attends work but accomplishes less at his or her usual tasks or shifts to other, possibly less valuable, tasks. Methods Longitudinal data for this analysis come from company payroll records for 97 HIV-infected tea estate workers (the index group, 56 women, 41 men) and a comparison group of all workers assigned to the same work teams (n = 2485, 1691 men, 794 women) for a 37-month period covering two years before and one year after initiating ART. We used nearest neighbour matching methods to estimate the impacts of HIV/AIDS and ART on three monthly employment outcomes for tea estate workers in Kenya – days plucking tea, days assigned to non-plucking assignments, and kilograms harvested when plucking. Results The female index group worked 30% fewer days plucking tea monthly than the matched female comparison group during the final 9 months pre-ART. They also worked 87% more days on non-plucking assignments. While the monthly gap between the two groups narrowed after beginning ART, the female index group worked 30% fewer days plucking tea and about 100% more days on non-plucking tasks than the comparison group after one year on ART. The male index group was able to maintain a similar pattern of work as their comparison group except during the initial five months on therapy. Conclusion Significant impaired presenteeism continued to exist among the female index group after one year on ART. Future research needs to explore further the socio-economic implications of HIV-infected female workers on ART being less productive than the general female workforce over sustained periods of time.

Published
2009
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26. Additional file 4: of The Enhanced Mentor Mother ProgrAm (EMMA) for the prevention of mother-to-child transmission of HIV in Kenya: study protocol for a cluster randomized controlled trial

Author

Larson, Bruce, Bii, Margaret, Tsikhutsu, Isaac, Halim, Nafisa, Wolfman, Vanessa, Coakley, Peter, Sugut, William, and Sawe, Fredrick

Subjects
virus diseases
Abstract

EMMA CRFs (Mother visit data extraction form; mother-infant data extraction form; Mentor-Mother/patient visit record form). (PDF 176 kb)

Published
2018
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27. Additional file 1: of The Enhanced Mentor Mother ProgrAm (EMMA) for the prevention of mother-to-child transmission of HIV in Kenya: study protocol for a cluster randomized controlled trial

Author

Larson, Bruce, Bii, Margaret, Tsikhutsu, Isaac, Halim, Nafisa, Wolfman, Vanessa, Coakley, Peter, Sugut, William, and Sawe, Fredrick

Abstract

SPIRIT Checklist. Checklist of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. (DOCX 66 kb)

Published
2018
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29. ART treatment costs and retention in care in Kenya: a cohort study in three rural outpatient clinics

Author

Larson, Bruce A., Bii, Margaret, Henly-Thomas, Sarah, McCoy, Kelly, Sawe, Fredrick, Shaffer, Douglas, and Rosen, Sydney

Subjects
Medical care, Cost of -- Economic aspects, Highly active antiretroviral therapy -- Economic aspects, AIDS treatment -- Economic aspects, Health
Abstract

Introduction: After almost 10 years of PEPFAR funding for antiretroviral therapy (ART) treatment programmes in Kenya, little is known about the cost of care provided to HIV-positive patients receiving ART. With some 430,000 ART patients, understanding and managing costs is essential to treatment programme sustainability. Methods: Using patient-level data from medical records (n =120/site), we estimated the cost of providing ART at three treatment sites in the Rift Valley Province of Kenya (a clinic at a government hospital, a hospital run by a large agricultural company and a mission hospital). Costs included ARV and non-ARV drugs, laboratory tests, salaries to personnel providing patient care, and infrastructure and other fixed costs. We report the average cost per patient during the first 12 months after ART initiation, stratified by site, and the average cost per patient achieving the primary outcome, retention in care 12 months after treatment initiation. Results: The cost per patient initiated on ART was $206, $252 and $213 at Sites 1, 2 and 3, respectively. The proportion of patients remaining in care at 12 months was similar across all sites (0.82, 0.80 and 0.84). Average costs for the subset of patients who remained in care at 12 months was also similar (Site 1, $229; Site 2, $287; Site 3, $237). Patients not retained in care cost substantially less (Site 1, $104; Site 2, $113; Site 3, $88). For the subset of patients who remained in care at 12 months, ART medications accounted for 51%, 44% and 50% of the costs, with the remaining costs split between non-ART medications (15%, 11%, 10%), laboratory tests (14%, 15%, 15%), salaries to personnel providing patient care (9%, 11%, 12%) and fixed costs (11%, 18%, 13%). Conclusions: At all three sites, 12-month retention in care compared favourably to retention rates reported in the literature from other low-income African countries. The cost of providing treatment was very low, averaging $224 in the first year, less than $20/month. The cost of antiretroviral medications, roughly $120 per year, accounted for approximately half of the total costs per patient retained in care after 12 months. Keywords: HIV; Kenya; antiretroviral therapy; cost analysis; retent., Introduction Almost 10 years after public sector provision of antiretroviral therapy (ART) began in many African countries, better information on the costs to healthcare providers for delivering medical care to [...]

Published
2013
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31. Diagnosis disclosure to adolescents living with HIV in rural Kenya improves antiretroviral therapy adherence and immunologic outcomes: A retrospective cohort study

Author

Montalto, Gregg Joseph, primary, Sawe, Fredrick K., additional, Miruka, Argwings, additional, Maswai, Jonah, additional, Kiptoo, Ignatius, additional, Aoko, Appolonia, additional, Oreyo, Chrispine, additional, Obiero, Eunice, additional, Korir, Sheila, additional, Bii, Stephen K., additional, Song, Katherine X., additional, and Kunz, Anjali N., additional

Published
2017
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32. Cardiovascular disease risk factors in HIV-infected women after initiation of lopinavir/ritonavir- and nevirapine-based antiretroviral therapy in Sub-Saharan Africa: A5208 (OCTANE)

Author

Shaffer, Douglas, Hughes, Michael D, Sawe, Fredrick, Bao, Yajing, Moses, Agnes, Hogg, Evelyn, Lockman, Shahin, and Currier, Judith

Subjects
CD4-Positive T-Lymphocytes, cardiovascular disease risk factors, nevirapine, HIV Infections, Blood Pressure, Cardiovascular, Deoxycytidine, Lopinavir, Body Mass Index, Risk Factors, Emtricitabine, Viral, Prospective Studies, ritonavir, Cholesterol, Infectious Diseases, Cardiovascular Diseases, 6.1 Pharmaceuticals, Public Health and Health Services, HIV/AIDS, Female, women, Infection, Adult, HDL, Anti-HIV Agents, Endpoint Determination, Clinical Sciences, Organophosphonates, Antiretroviral Therapy, LDL, Clinical Research, Virology, Humans, Highly Active, Nevirapine, Tenofovir, Triglycerides, Africa South of the Sahara, Ritonavir, Adenine, Evaluation of treatments and therapeutic interventions, lopinavir, Logistic Models, Good Health and Well Being, Multivariate Analysis, Africa, HIV-1, Linear Models, RNA
Abstract

BackgroundLimited comparative, prospective data exist regarding cardiovascular risk factors in HIV-infected women starting antiretroviral therapy in Africa.MethodsIn 7 African countries, 741 women with CD4

Published
2014

33. Excellent retention, virologic and clinical outcomes after transitioning from an antiretroviral treatment clinical trial to locally-provided care and treatment in Africa

Author

Sawe, Fredrick, primary, Hughes, Michael D., additional, Bao, Yajing, additional, Hogg, Evelyn, additional, Shaffer, Douglas, additional, Phulusa, Jacob, additional, Kakhu, Tebogo, additional, Conradie, Francesca, additional, Kasaro, Margaret, additional, Mngqbisa, Rosie, additional, Siika, Abraham, additional, Atwiine, Diana, additional, Chipato, Tsungai, additional, McIntyre, James, additional, Currier, Judith, additional, and Lockmand, Shahin, additional

Published
2017
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34. Kericho CLinic-Based ART Diagnostic Evaluation (CLADE): Design, Accrual, and Baseline Characteristics of a Randomized Controlled Trial Conducted in Predominately Rural, District-Level, HIV Clinics of Kenya

Author

Sawe, Fredrick K., primary, Obiero, Eunice, additional, Yegon, Peter, additional, Langat, Rither C., additional, Aoko, Appolonia, additional, Tarus, Jemutai, additional, Kiptoo, Ignatius, additional, Langat, Raphael K., additional, Maswai, Jonah, additional, Bii, Margaret, additional, Khamadi, Samoel, additional, Shikuku, Kibet P., additional, Close, Nicole, additional, Sinei, Samuel, additional, and Shaffer, Douglas N., additional

Published
2015
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38. Contraceptive Use in Women Enrolled into Preventive HIV Vaccine Trials: Experience from a Phase I/II Trial in East Africa

Author

Kibuuka, Hannah, primary, Guwatudde, David, additional, Kimutai, Robert, additional, Maganga, Lucas, additional, Maboko, Leonard, additional, Watyema, Cecilia, additional, Sawe, Fredrick, additional, Shaffer, Douglas, additional, Matsiko, Dickson, additional, Millard, Monica, additional, Michael, Nelson, additional, Wabwire-Mangen, Fred, additional, and Robb, Merlin, additional

Published
2009
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39. Do the socioeconomic impacts of antiretroviral therapy vary bygender? A longitudinal study of Kenyan agricultural workeremployment outcomes.

Author

Larson, Bruce A., Fox, Mathew P., Rosen, Sydney, Bii, Margret, Sigei, Carolyne, Shaffer, Douglas, Sawe, Fredrick, McCoy, Kelly, Wasunna, Monique, and Simon, Jonathan L.

Subjects
ANTIRETROVIRAL agents, LONGITUDINAL method, HIV, AIDS
Abstract

Background: As access to antiretroviral therapy (ART) has grown in Africa, attention has turned to evaluating the socio-economic impacts of ART. One key issue is the extent to which improvements in health resulting from ART allows individuals to return to work and earn income. Improvements in health from ART may also be associated with reduced impaired presenteeism, which is the loss of productivity when an ill or disabled individual attends work but accomplishes less at his or her usual tasks or shifts to other, possibly less valuable, tasks. Methods: Longitudinal data for this analysis come from company payroll records for 97 HIV-infected tea estate workers (the index group, 56 women, 41 men) and a comparison group of all workers assigned to the same work teams (n = 2485, 1691 men, 794 women) for a 37-month period covering two years before and one year after initiating ART. We used nearest neighbour matching methods to estimate the impacts of HIV/AIDS and ART on three monthly employment outcomes for tea estate workers in Kenya - days plucking tea, days assigned to non-plucking assignments, and kilograms harvested when plucking. Results: The female index group worked 30% fewer days plucking tea monthly than the matched female comparison group during the final 9 months pre-ART. They also worked 87% more days on non-plucking assignments. While the monthly gap between the two groups narrowed after beginning ART, the female index group worked 30% fewer days plucking tea and about 100% more days on non-plucking tasks than the comparison group after one year on ART. The male index group was able to maintain a similar pattern of work as their comparison group except during the initial five months on therapy. Conclusion: Significant impaired presenteeism continued to exist among the female index group after one year on ART. Future research needs to explore further the socio-economic implications of HIV-infected female workers on ART being less productive than the general female workforce over sustained periods of time. [ABSTRACT FROM AUTHOR]

Published
2009
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40. Phase 1 Trial of the Safety and Immunogenicity of PENNVAX®-G DNA Prime Administered by Biojector® 2000 or CELLECTRA® EP Device with MVA-CMDR Boost.

Author

Ratto-Kim, Silvia, Schuetz, Alexandra, Wieczorek, Lindsay, Nguay, Viseth, Kibuuka, Hannah, Sawe, Fredrick, Maboko, Leonard, Polonis, Victoria, Weiner, David, DeSouza, Mark, Sekiziyivu, Arthur, Kosgei, Josphat, Missanga, Marco, Kroidl, Arne, Earl, Patricia, Moss, Bernard, Adams, Elizabeth, Martinez, Ana, Rizvi, Farrukh, and Khan, Amir

Abstract

An abstract of the article "Phase 1 Trial of the Safety and Immunogenicity of PENNVAX®-G DNA Prime Administered by Biojector® 2000 or CELLECTRA® EP Device with MVA-CMDR Boost" by Julie Ake and colleagues is presented.

Published
2014
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41. Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 Protein Vaccine.

Author

Dayan GH, Rouphael N, Walsh SR, Chen A, Grunenberg N, Allen M, Antony J, Asante KP, Bhate AS, Beresnev T, Bonaparte MI, Ceregido MA, Dobrianskyi D, Fu B, Grillet MH, Keshtkar-Jahromi M, Juraska M, Kee JJ, Kibuuka H, Koutsoukos M, Masotti R, Michael NL, Reynales H, Robb ML, Villagómez Martínez SM, Sawe F, Schuerman L, Tong T, Treanor J, Wartel TA, Diazgranados CA, Chicz RM, Gurunathan S, Savarino S, and Sridhar S

Abstract

Background: COVID-19 vaccines with alternative strain compositions are needed to provide broad protection against newly emergent SARS-CoV-2 variants of concern., Methods: We conducted a global Phase 3, multi-stage efficacy study (NCT04904549) among adults aged ≥18 years. Participants were randomized 1:1 to receive two intramuscular injections 21 days apart of a bivalent SARS-CoV-2 recombinant protein vaccine with AS03-adjuvant (5 μg of ancestral (D614) and 5 μg of B.1.351 [beta] variant spike protein) or placebo. Symptomatic COVID-19 was defined as laboratory-confirmed COVID-19 with COVID-19-like illness (CLI) symptoms. The primary efficacy endpoint was the prevention of symptomatic COVID-19 ≥14 days after the second injection (post-dose 2 [PD2])., Results: Between 19 Oct 2021 and 15 Feb 2022, 12,924 participants received ≥1 study injection. 75% of participants were SARS-CoV-2 non-naïve. 11,416 participants received both study injections (efficacy-evaluable population [vaccine, n=5,736; placebo, n=5,680]). Up to 15 March 2022, 121 symptomatic COVID-19 cases were reported (32 in the vaccine group and 89 in the placebo group) ≥14 days PD2 with a vaccine efficacy (VE) of 64.7% (95% confidence interval [CI] 46.6; 77.2%). VE was 75.1% (95% CI 56.3; 86.6%) in non-naïve and 30.9% (95% CI -39.3; 66.7%) in naïve participants. Viral genome sequencing identified the infecting strain in 68 cases (Omicron [BA.1 and BA.2 subvariants]: 63; Delta: 4; Omicron and Delta: 1). The vaccine was well-tolerated and had an acceptable safety profile., Conclusions: A bivalent vaccine conferred heterologous protection against symptomatic infection with newly emergent Omicron (BA.1 and BA.2) in non-naïve adults 18-59 years of age., Competing Interests: Declaration of interests GHD, MIB, BF, M-HG, CAG, RMC, SS are Sanofi employees. MIB, BF, M-HG, CAG, RMC, SS hold stock or stock options in Sanofi. SS hold patents pending on COVID-19 vaccine. RMC has Received institutional funding from BARDA for the present study; has received support for attending meetings and/or travel from Sanofi; and holds patents planned, issued or pending from Sanofi. M-HG has received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Sanofi. NR has received institutional funding from the National Institutes of Health; and institutional grants or contracts from Merck, Sanofi, Quidel, Pfizer and Lilly. SRW has received institutional funding from Sanofi and the National Institute of Allergy and Immunology/National Institutes of Health; and institutional grants or contracts from Janssen Vaccines/Johnson & Johnson, Moderna Tx, Vir Biotechnology and Worcester HIV vaccine; has participated on data safety monitoring or advisory boards for Janssen Vaccines/Johnson & Johnson; and his spouse holds stock/stock options in Regeneron Pharmaceuticals. NG has received institutional funding from Sanofi, GSK and the National Institute of Allergy and Immunology/National Institutes of Health; and is in receipt of grants or contracts from the NIH/NIAID/DAIDS. MA is an employee of the NIAID, which funded aspects of the current study. MAC and MK are employees of GSK and owns shares in the GSK group of companies. LS is an employee of the GSK group of companies. MJ and JJK have received institutional support from Sanofi and the NIAID/NIH with respect to this study. MLR has received institutional support/contracts for the present manuscript from WRAIR IPA and the US Medical Research and Development Command. MA is an employee of the NIAID, which funded aspects of the current study; The NIAID provides grant funding to the HIV Vaccine Trials Network (HVTN) Leadership and Operations Center (UM1 AI 68614HVTN), the Statistics and Data Management Center (UM1 AI 68635), the HVTN Laboratory Center (UM1 AI 68618), the HIV Prevention Trials Network Leadership and Operations Center (UM1 AI 68619), the AIDS Clinical Trials Group Leadership and Operations Center (UM1 AI 68636), and the Infectious Diseases Clinical Research Consortium leadership group 5 (UM1 AI 148684-03). SSa was a Sanofi employee at the time of study conduct; and holds patents planned, issued of pending on COVID-19 vaccines. AC, JA KPA, ASB, TB, DD, MKJ, HK, RM, NM, HR, SMVM, FS, JT, TAW, SG have no interests to declare.

Published
2023
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42. Prospective International Study of Incidence and Predictors of Immune Reconstitution Inflammatory Syndrome and Death in People Living With Human Immunodeficiency Virus and Severe Lymphopenia.

Author

Sereti I, Sheikh V, Shaffer D, Phanuphak N, Gabriel E, Wang J, Nason MC, Roby G, Ngeno H, Kirui F, Pau A, Mican JM, Rupert A, Bishop R, Agan B, Chomchey N, Teeratakulpisarn N, Tansuphaswadikul S, Langat D, Kosgei J, French M, Ananworanich J, and Sawe F

Subjects
Adult, CD4 Lymphocyte Count, Female, HIV, Humans, Incidence, Kenya, Male, Prospective Studies, Thailand, HIV Infections complications, HIV Infections drug therapy, Immune Reconstitution Inflammatory Syndrome epidemiology, Lymphopenia epidemiology
Abstract

Background: Patients living with human immunodeficiency virus (PLWH) with low CD4 counts are at high risk for immune reconstitution inflammatory syndrome (IRIS) and death at antiretroviral therapy (ART) initiation., Methods: We investigated the clinical impact of IRIS in PLWH and CD4 counts <100 cells/μL starting ART in an international, prospective study in the United States, Thailand, and Kenya. An independent review committee adjudicated IRIS events. We assessed associations between baseline biomarkers, IRIS, immune recovery at week 48, and death by week 48 with Cox models., Results: We enrolled 506 participants (39.3% were women). Median age was 37 years, and CD4 count was 29 cells/μL. Within 6 months of ART, 97 (19.2%) participants developed IRIS and 31 (6.5%) died. Participants with lower hemoglobin at baseline were at higher IRIS risk (hazard ratio [HR], 1.2; P = .004). IRIS was independently associated with increased risk of death after adjustment for known risk factors (HR, 3.2; P = .031). Being female (P = .004) and having a lower body mass index (BMI; P = .003), higher white blood cell count (P = .005), and higher D-dimer levels (P = .044) were also significantly associated with increased risk of death. Decision-tree analysis identified hemoglobin <8.5 g/dL as predictive of IRIS and C-reactive protein (CRP) >106 μg/mL and BMI <15.6 kg/m2 as predictive of death., Conclusions: For PLWH with severe immunosuppression initiating ART, baseline low BMI and hemoglobin and high CRP and D-dimer levels may be clinically useful predictors of IRIS and death risk., (Published by Oxford University Press for the Infectious Diseases Society of America 2019.)

Published
2020
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43. Cardiovascular disease risk factors in HIV-infected women after initiation of lopinavir/ritonavir- and nevirapine-based antiretroviral therapy in Sub-Saharan Africa: A5208 (OCTANE).

Author

Shaffer D, Hughes MD, Sawe F, Bao Y, Moses A, Hogg E, Lockman S, and Currier J

Subjects
Adenine adverse effects, Adenine analogs & derivatives, Adenine therapeutic use, Adult, Africa South of the Sahara, Anti-HIV Agents adverse effects, Anti-HIV Agents therapeutic use, Antiretroviral Therapy, Highly Active adverse effects, Blood Pressure drug effects, Body Mass Index, CD4-Positive T-Lymphocytes, Cholesterol, HDL blood, Cholesterol, LDL blood, Deoxycytidine adverse effects, Deoxycytidine analogs & derivatives, Deoxycytidine therapeutic use, Emtricitabine, Endpoint Determination, Female, HIV Infections complications, HIV-1 growth & development, HIV-1 isolation & purification, Humans, Linear Models, Logistic Models, Lopinavir therapeutic use, Multivariate Analysis, Nevirapine therapeutic use, Organophosphonates adverse effects, Organophosphonates therapeutic use, Prospective Studies, RNA, Viral isolation & purification, Risk Factors, Ritonavir therapeutic use, Tenofovir, Triglycerides blood, Cardiovascular Diseases epidemiology, HIV Infections drug therapy, Lopinavir adverse effects, Nevirapine adverse effects, Ritonavir adverse effects
Abstract

Background: Limited comparative, prospective data exist regarding cardiovascular risk factors in HIV-infected women starting antiretroviral therapy in Africa., Methods: In 7 African countries, 741 women with CD4 <200 cells/mm were randomized to tenofovir/emtricitabine (TDF/FTC) plus either nevirapine (NVP, n = 370) or lopinavir/ritonavir (LPV/r, n = 371). Lipids and blood pressure (BP) were evaluated at entry, 48, 96, and 144 weeks. Multivariable linear and logistic regression models were used to evaluate mean risk factor changes and clinically relevant risk factor changes., Results: At entry, both NVP and LPV/r groups were similar regarding age [mean = 33.5 (SD = 7.1) years], CD4 [129 (67) cells/mm], and HIV-1 RNA [5.1 (0.6) log10 copies/mL]. Nearly, all women had normal lipids and BP except for high-density lipoprotein (HDL)-cholesterol. Over 144 weeks, the LPV/r compared with NVP group had significantly greater mean lipid increases (eg, non-HDL: +29 vs. +13 mg/dL) and smaller HDL increases (+12 vs. +21 mg/dL). In contrast, the NVP compared with LPV/r group had greater mean increases in BP (eg, diastolic BP: +5 vs. -0.5 mm Hg). Significantly, more women assigned LPV/r had week 144 "abnormal" lipid levels (eg, HDL 29.7% vs. 14.8% and triglycerides 28.6% vs. 8.2%), and significantly, more women assigned NVP had "abnormal" BP (eg, diastolic BP 22.7% vs. 6.5%). Most differences remained significant when adjusted for baseline risk factor, age, CD4, and HIV-1 RNA., Conclusions: In HIV-infected women initiating antiretroviral therapy in Africa, LPV/r + TDF/FTC was associated with less favorable changes in lipids, and use of NVP + TDF/FTC was associated with less favorable changes in BP.

Published
2014
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45. Community engagement and investment in biomedical HIV prevention research for youth: rationale, challenges, and approaches.

Author

Ellen JM, Wallace M, Sawe FK, and Fisher K

Subjects
Adolescent, Child, Clinical Trials as Topic methods, Humans, South Africa, United States, Young Adult, Community Participation methods, HIV Infections prevention & control
Abstract

There has been a growing awareness of the importance of engaging communities in the development, testing, and eventual dissemination of biomedical strategies. Community engagement offers many benefits but comes with many challenges. This article will discuss these benefits and challenges and describe two examples of community engagement, Connect to Protect in the United States, and the South African Studies on HIV in Adolescents Project in South Africa, that represent investment in community engagement as preparation for biomedical HIV prevention clinical trials for youth.

Published
2010
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