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1. Protein Dose-Sparing Effect of AS01B Adjuvant in a Randomized Preventive HIV Vaccine Trial of ALVAC-HIV (vCP2438) and Adjuvanted Bivalent Subtype C gp120.

Author

Chirenje, Zvavahera, Laher, Fatima, Dintwe, One, Muyoyeta, Monde, deCamp, Allan, He, Zonglin, Grunenberg, Nicole, Laher Omar, Faatima, Seaton, Kelly, Polakowski, Laura, Woodward Davis, Amanda, Maganga, Lucas, Baden, Lindsey, Mayer, Kenneth, Kalams, Spyros, Keefer, Michael, Edupuganti, Srilatha, Rodriguez, Benigno, Frank, Ian, Scott, Hyman, Stranix-Chibanda, Lynda, Gurunathan, Sanjay, Koutsoukos, Marguerite, Van Der Meeren, Olivier, DiazGranados, Carlos, Paez, Carmen, Andersen-Nissen, Erica, Kublin, James, Corey, Lawrence, Ferrari, Guido, Tomaras, Georgia, and McElrath, M

Subjects
HIV, adjuvant, dose, vaccine, Humans, Female, Adjuvants, Immunologic, AIDS Vaccines, Adult, Male, Young Adult, HIV Infections, HIV Envelope Protein gp120, Adolescent, Double-Blind Method, HIV Antibodies, Squalene, Polysorbates, HIV-1, Viral Vaccines
Abstract

BACKGROUND: HVTN 120 is a phase 1/2a randomized double-blind placebo-controlled human immunodeficiency virus (HIV) vaccine trial that evaluated the safety and immunogenicity of ALVAC-HIV (vCP2438) and MF59- or AS01B-adjuvanted bivalent subtype C gp120 Env protein at 2 dose levels in healthy HIV-uninfected adults. METHODS: Participants received ALVAC-HIV (vCP2438) alone or placebo at months 0 and 1. At months 3 and 6, participants received either placebo, ALVAC-HIV (vCP2438) with 200 μg of bivalent subtype C gp120 adjuvanted with MF59 or AS01B, or ALVAC-HIV (vCP2438) with 40 μg of bivalent subtype C gp120 adjuvanted with AS01B. Primary outcomes were safety and immune responses. RESULTS: We enrolled 160 participants, 55% women, 18-40 years old (median age 24 years) of whom 150 received vaccine and 10 placebo. Vaccines were generally safe and well tolerated. At months 6.5 and 12, CD4+ T-cell response rates and magnitudes were higher in the AS01B-adjuvanted groups than in the MF59-adjuvanted group. At month 12, HIV-specific Env-gp120 binding antibody response magnitudes in the 40 μg gp120/AS01B group were higher than in either of the 200 μg gp120 groups. CONCLUSIONS: The 40 μg dose gp120/AS01B regimen elicited the highest CD4+ T-cell and binding antibody responses. Clinical Trials Registration . NCT03122223.

Published
2024

2. Safety and immunogenicity of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120 vaccine boost adjuvanted with MF59 or alum in healthy adults without HIV (HVTN 107): A phase 1/2a randomized trial

Author

Moodie, Zoe, Andersen-Nissen, Erica, Grunenberg, Nicole, Dintwe, One B., Omar, Faatima Laher, Kee, Jia J., Bekker, Linda-Gail, Laher, Fatima, Naicker, Nivashnee, Jani, Ilesh, Mgodi, Nyaradzo M., Hunidzarira, Portia, Sebe, Modulakgota, Miner, Maurine D., Polakowski, Laura, Ramirez, Shelly, Nebergall, Michelle, Takuva, Simbarashe, Sikhosana, Lerato, Heptinstall, Jack, Seaton, Kelly E., De Rosa, Stephen, Diazgranados, Carlos A., Koutsoukos, Marguerite, Van Der Meeren, Olivier, Barnett, Susan W., Kanesa-thasan, Niranjan, Kublin, James G., Tomaras, Georgia D., McElrath, M. Juliana, Corey, Lawrence, Mngadi, Kathryn, and Goepfert, Paul

Subjects
United States. National Institutes of Health, HIV (Viruses) -- Comparative analysis -- Usage, Vaccination -- Usage -- Comparative analysis, Immune response -- Usage -- Comparative analysis, Immunoglobulin A -- Comparative analysis -- Usage, Clinical trials -- Usage -- Comparative analysis, Adults -- Comparative analysis -- Usage, Immunoglobulin G -- Usage -- Comparative analysis, AIDS vaccines -- Usage -- Product development, Biological sciences
Abstract

Background Adjuvants are widely used to enhance and/or direct vaccine-induced immune responses yet rarely evaluated head-to-head. Our trial directly compared immune responses elicited by MF59 versus alum adjuvants in the RV144-like HIV vaccine regimen modified for the Southern African region. The RV144 trial of a recombinant canarypox vaccine vector expressing HIV env subtype B (ALVAC-HIV) prime followed by ALVAC-HIV plus a bivalent gp120 protein vaccine boost adjuvanted with alum is the only trial to have shown modest HIV vaccine efficacy. Data generated after RV144 suggested that use of MF59 adjuvant might allow lower protein doses to be used while maintaining robust immune responses. We evaluated safety and immunogenicity of an HIV recombinant canarypox vaccine vector expressing HIV env subtype C (ALVAC-HIV) prime followed by ALVAC-HIV plus a bivalent gp120 protein vaccine boost (gp120) adjuvanted with alum (ALVAC-HIV+gp120/alum) or MF59 (ALVAC-HIV+gp120/MF59) or unadjuvanted (ALVAC-HIV+gp120/no-adjuvant) and a regimen where ALVAC-HIV+gp120 adjuvanted with MF59 was used for the prime and boost (ALVAC-HIV+gp120/MF59 coadministration). Methods and findings Between June 19, 2017 and June 14, 2018, 132 healthy adults without HIV in South Africa, Zimbabwe, and Mozambique were randomized to receive intramuscularly: (1) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/MF59 (months 3, 6, and 12), n = 36; (2) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/alum (months 3, 6, and 12), n = 36; (3) 4 doses of ALVAC-HIV+gp120/MF59 coadministered (months 0, 1, 6, and 12), n = 36; or (4) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/no adjuvant (months 3, 6, and 12), n = 24. Primary outcomes were safety and occurrence and mean fluorescence intensity (MFI) of vaccine-induced gp120-specific IgG and IgA binding antibodies at month 6.5. All vaccinations were safe and well-tolerated; increased alanine aminotransferase was the most frequent related adverse event, occurring in 2 (1.5%) participants (1 severe, 1 mild). At month 6.5, vaccine-specific gp120 IgG binding antibodies were detected in 100% of vaccinees for all 4 vaccine groups. No significant differences were seen in the occurrence and net MFI of vaccine-specific IgA responses between the ALVAC-HIV+gp120/MF59-prime-boost and ALVAC-HIV+gp120/alum-prime-boost groups or between the ALVAC-HIV+gp120/MF59-prime-boost and ALVAC-HIV+gp120/MF59 coadministration groups. Limitations were the relatively small sample size per group and lack of evaluation of higher gp120 doses. Conclusions Although MF59 was expected to enhance immune responses, alum induced similar responses to MF59, suggesting that the choice between these adjuvants may not be critical for the ALVAC+gp120 regimen. Trial registration HVTN 107 was registered with the South African National Clinical Trials Registry (DOH-27-0715-4894) and ClinicalTrials.gov (NCT03284710)., Author(s): Zoe Moodie 1,*, Erica Andersen-Nissen 1,2, Nicole Grunenberg 1, One B. Dintwe 1,2, Faatima Laher Omar 2, Jia J. Kee 1, Linda-Gail Bekker 3, Fatima Laher 4, Nivashnee Naicker [...]

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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6. Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study

Author

Sridhar, Saranya, Joaquin, Arnel, Bonaparte, Matthew I, Bueso, Agustin, Chabanon, Anne-Laure, Chen, Aiying, Chicz, Roman M, Diemert, David, Essink, Brandon J, Fu, Bo, Grunenberg, Nicole A, Janosczyk, Helene, Keefer, Michael C, Rivera M, Doris M, Meng, Ya, Michael, Nelson L, Munsiff, Sonal S, Ogbuagu, Onyema, Raabe, Vanessa N, Severance, Randall, Rivas, Enrique, Romanyak, Natalya, Rouphael, Nadine G, Schuerman, Lode, Sher, Lawrence D, Walsh, Stephen R, White, Judith, von Barbier, Dalia, de Bruyn, Guy, Canter, Richard, Grillet, Marie-Helene, Keshtkar-Jahromi, Maryam, Koutsoukos, Marguerite, Lopez, Denise, Masotti, Roger, Mendoza, Sandra, Moreau, Catherine, Ceregido, Maria Angeles, Ramirez, Shelly, Said, Ansoyta, Tavares-Da-Silva, Fernanda, Shi, Jiayuan, Tong, Tina, Treanor, John, Diazgranados, Carlos A, and Savarino, Stephen

Published
2022
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7. Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: interim results of a randomised, placebo-controlled, phase 1–2, dose-ranging study

Author

Goepfert, Paul A, Fu, Bo, Chabanon, Anne-Laure, Bonaparte, Matthew I, Davis, Matthew G, Essink, Brandon J, Frank, Ian, Haney, Owen, Janosczyk, Helene, Keefer, Michael C, Koutsoukos, Marguerite, Kimmel, Murray A, Masotti, Roger, Savarino, Stephen J, Schuerman, Lode, Schwartz, Howard, Sher, Lawrence D, Smith, Jon, Tavares-Da-Silva, Fernanda, Gurunathan, Sanjay, DiazGranados, Carlos A, and de Bruyn, Guy

Published
2021
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8. Immunogenicity and safety of simplified vaccination schedules for the CYD-TDV dengue vaccine in healthy individuals aged 9–50 years (CYD65): a randomised, controlled, phase 2, non-inferiority study

Author

Coronel-MartÍnez, Diana Leticia, Park, Juliana, López-Medina, Eduardo, Capeding, María Rosario, Cadena Bonfanti, Andrés Angelo, Montalbán, María Cecilia, Ramírez, Isabel, Gonzales, María Liza Antoinette, DiazGranados, Carlos A, Zambrano, Betzana, Dayan, Gustavo, Savarino, Stephen, Chen, Zhenghong, Wang, Hao, Sun, Sunny, Bonaparte, Matthew, Rojas, Andrey, Ramírez, Jenny Carolina, Verdan, Mae Ann, and Noriega, Fernando

Published
2021
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10. A phase 1b randomized study of the safety and immunological responses to vaccination with H4:IC31, H56:IC31, and BCG revaccination in Mycobacterium tuberculosis-uninfected adolescents in Cape Town, South Africa

Author

Bekker, Linda-Gail, Dintwe, One, Fiore-Gartland, Andrew, Middelkoop, Keren, Hutter, Julia, Williams, Anthony, Randhawa, April K., Ruhwald, Morten, Kromann, Ingrid, Andersen, Peter L., DiazGranados, Carlos A., Rutkowski, Kathryn T., Tait, Dereck, Miner, Maurine D., Andersen-Nissen, Erica, De Rosa, Stephen C., Seaton, Kelly E., Tomaras, Georgia D., McElrath, M. Juliana, Ginsberg, Ann, and Kublin, James G.

Published
2020
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11. Late boosting of the RV144 regimen with AIDSVAX B/E and ALVAC-HIV in HIV-uninfected Thai volunteers: a double-blind, randomised controlled trial

Author

Pitisuthitham, Arom, Sabmee, Yupa, Sirisopana, Narongrid, Eamsila, Chirapa, Savaraj, Prapaporn, Labwech, Wanlaya, Teerachia, Siriluck, Chotirosniramit, Nuntisa, Supindham, Taweewat, Pruenglampoo, Boonlure, Sugandhavesa, Patcharaphan, Kosashunhanan, Natthapol, Kaewthip, Oranitcha, Sroysuwan, Piyathida, Jarujareet, Pawinee, Ratto-Kim, Silvia, Molnar, Sebastian, Schoen, Jesse, Churikanont, Nampueng, Getchalarat, Saowanit, Sangnoi, Nongluck, Nuntapinit, Bessara, Phramtong, Anant, Grandin, Pornsuk V., Madnote, Sirinan, Rittiroongrad, Surawach, Kaewboon, Boot, Trichavaroj, Rapee, Puangkaew, Jiraporn, Chantakulkij, Somsak, Rakyat, Phiromrat, Panjapornsuk, Pornchanok, Tragonlugsana, Nipattra, Chuenarom, Weerawan, de Souza, Mark, Ngauy, Viseth, Phanuphak, Nittaya, Chomchey, Nitiya, Saengtawan, Puttachard, Teeratakulpisarn, Nipat, Rerknimitr, Rungsun, Kroon, Eugene, Lee, Carter A., Chinaworapong, Suchada, Pitisuttithum, Punnee, Nitayaphan, Sorachai, Chariyalertsak, Suwat, Kaewkungwal, Jaranit, Dawson, Peter, Dhitavat, Jittima, Phonrat, Benjaluck, Akapirat, Siriwat, Karasavvas, Nicos, Wieczorek, Lindsay, Polonis, Victoria, Eller, Michael A, Pegu, Poonam, Kim, Dohoon, Schuetz, Alexandra, Jongrakthaitae, Surat, Zhou, Yingjun, Sinangil, Faruk, Phogat, Sanjay, Diazgranados, Carlos A, Tartaglia, James, Heger, Elizabeth, Smith, Kirsten, Michael, Nelson L, Excler, Jean-Louis, Robb, Merlin L, Kim, Jerome H, O'Connell, Robert J, and Vasan, Sandhya

Published
2020
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12. 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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13. Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial

Author

Bekker, Linda-Gail, Moodie, Zoe, Grunenberg, Nicole, Laher, Fatima, Tomaras, Georgia D, Cohen, Kristen W, Allen, Mary, Malahleha, Mookho, Mngadi, Kathryn, Daniels, Brodie, Innes, Craig, Bentley, Carter, Frahm, Nicole, Morris, Daryl E, Morris, Lynn, Mkhize, Nonhlanhla N, Montefiori, David C, Sarzotti-Kelsoe, Marcella, Grant, Shannon, Yu, Chenchen, Mehra, Vijay L, Pensiero, Michael N, Phogat, Sanjay, DiazGranados, Carlos A, Barnett, Susan W, Kanesa-thasan, Niranjan, Koutsoukos, Marguerite, Michael, Nelson L, Robb, Merlin L, Kublin, James G, Gilbert, Peter B, Corey, Lawrence, Gray, Glenda E, and McElrath, M Juliana

Published
2018
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15. Randomized, Double-Blind Evaluation of Late Boost Strategies for HIV-Uninfected Vaccine Recipients in the RV 144 HIV Vaccine Efficacy Trial

Author

RV305 Study Team, Rerks-Ngarm, Supachai, Pitisuttithum, Punnee, Excler, Jean-Louis, Nitayaphan, Sorachai, Kaewkungwal, Jaranit, Premsri, Nakorn, Kunasol, Prayura, Karasavvas, Nicos, Schuetz, Alexandra, Ngauy, Viseth, Sinangil, Faruk, Dawson, Peter, deCamp, Allan C., Phogat, Sanjay, Garunathan, Sanjay, Tartaglia, James, DiazGranados, Carlos, Ratto-Kim, Silvia, Pegu, Poonam, Eller, Michael, Karnasuta, Chitraporn, Montefiori, David C., Sawant, Sheetal, Vandergrift, Nathan, Wills, Saintedym, Tomaras, Georgia D., Robb, Merlin L., Michael, Nelson L., Kim, Jerome H., Vasan, Sandhya, and O'Connell, Robert J.

Published
2017

16. Protein Dose-Sparing Effect of AS01B Adjuvant in a Randomized Preventive HIV Vaccine Trial of ALVAC-HIV (vCP2438) and Adjuvanted Bivalent Subtype C gp120

Author

Chirenje, Zvavahera Mike, primary, Laher, Fatima, additional, Dintwe, One, additional, Muyoyeta, Monde, additional, deCamp, Allan C, additional, He, Zonglin, additional, Grunenberg, Nicole, additional, Laher Omar, Faatima, additional, Seaton, Kelly E, additional, Polakowski, Laura, additional, Woodward Davis, Amanda S, additional, Maganga, Lucas, additional, Baden, Lindsey R, additional, Mayer, Kenneth, additional, Kalams, Spyros, additional, Keefer, Michael, additional, Edupuganti, Srilatha, additional, Rodriguez, Benigno, additional, Frank, Ian, additional, Scott, Hyman, additional, Stranix-Chibanda, Lynda, additional, Gurunathan, Sanjay, additional, Koutsoukos, Marguerite, additional, Van Der Meeren, Olivier, additional, DiazGranados, Carlos A, additional, Paez, Carmen, additional, Andersen-Nissen, Erica, additional, Kublin, James, additional, Corey, Lawrence, additional, Ferrari, Guido, additional, Tomaras, Georgia, additional, and McElrath, M Juliana, additional

Published
2023
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17. 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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18. Immune Response Persistence and Safety of a Booster Dose of the Tetravalent Dengue Vaccine in Adolescents and Adults Who Previously Completed the 3-dose Schedule 4–5 Years Earlier in Latin America: A Randomized Placebo-controlled Trial

Author

Coronel, Diana, García-Rivera, Enid J., Rivera, Doris Maribel, Arredondo-García, José Luis, Dietze, Reynaldo, Perroud, Ana Paula, Cortés, Margarita, Bonaparte, Matthew, Wang, Hao, Pagnon, Anke, Jantet-Blaudez, Frédérique, Peñalosa, Luis Andrey Rojas, Dayan, Gustavo, Zambrano, Betzana, DiazGranados, Carlos A., and Noriega, Fernando

Published
2020
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19. Selection of HIV vaccine candidates for concurrent testing in an efficacy trial

Author

Huang, Ying, DiazGranados, Carlos, Janes, Holly, Huang, Yunda, deCamp, Allan C, Metch, Barbara, Grant, Shannon, Sanchez, Brittany, Phogat, Sanjay, Koutsoukos, Marguerite, Kanesa-Thasan, Niranjan, Bourguignon, Patricia, Collard, Alix, Buchbinder, Susan, Tomaras, Georgia D, McElrath, Julie, Gray, Glenda, Kublin, James G, Corey, Lawrence, and Gilbert, Peter B

Published
2016
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20. Reply to Skowronski et al

Author

DiazGranados, Carlos A., Dunning, Andrew J., Robertson, Corwin A., Talbot, H. Keipp, Landolfi, Victoria, and Greenberg, David P.

Published
2016

33. Analysis of the HIV Vaccine Trials Network 702 Phase 2b–3 HIV-1 Vaccine Trial in South Africa Assessing RV144 Antibody and T-Cell Correlates of HIV-1 Acquisition Risk

Author

Moodie, Zoe, primary, Dintwe, One, additional, Sawant, Sheetal, additional, Grove, Doug, additional, Huang, Yunda, additional, Janes, Holly, additional, Heptinstall, Jack, additional, Omar, Faatima Laher, additional, Cohen, Kristen, additional, De Rosa, Stephen C, additional, Zhang, Lu, additional, Yates, Nicole L, additional, Sarzotti-Kelsoe, Marcella, additional, Seaton, Kelly E, additional, Laher, Fatima, additional, Bekker, Linda Gail, additional, Malahleha, Mookho, additional, Innes, Craig, additional, Kassim, Sheetal, additional, Naicker, Nivashnee, additional, Govender, Vaneshree, additional, Sebe, Modulakgotla, additional, Singh, Nishanta, additional, Kotze, Philip, additional, Lazarus, Erica, additional, Nchabeleng, Maphoshane, additional, Ward, Amy M, additional, Brumskine, William, additional, Dubula, Thozama, additional, Randhawa, April K, additional, Grunenberg, Nicole, additional, Hural, John, additional, Kee, Jia Jin, additional, Benkeser, David, additional, Jin, Yutong, additional, Carpp, Lindsay N, additional, Allen, Mary, additional, D’Souza, Patricia, additional, Tartaglia, James, additional, DiazGranados, Carlos A, additional, Koutsoukos, Marguerite, additional, Gilbert, Peter B, additional, Kublin, James G, additional, Corey, Lawrence, additional, Andersen-Nissen, Erica, additional, Gray, Glenda E, additional, Tomaras, Georgia D, additional, and McElrath, M Juliana, additional

Published
2022
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38. Safety and immunogenicity of a SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in healthy adults: interim findings from a phase 2, randomised, dose-finding, multi-centre study

Author

Sridhar, Saranya, primary, Joaquin, Arnel, additional, Bonaparte, Matthew I, additional, Bueso, Agustin, additional, Chabanon, Anne-Laure, additional, Chen, Aiying, additional, Chicz, Roman M., additional, Diemert, David, additional, Essink, Brandon J, additional, Fu, Bo, additional, Grunenberg, Nicole A, additional, Janosczyk, Helene, additional, Keefer, Michael C, additional, Rivera M, Doris M, additional, Meng, Ya, additional, Michael, Nelson L., additional, Munsiff, Sonal S, additional, Ogbuagu, Onyema, additional, Raabe, Vanessa N, additional, Severance, Randall, additional, Rivas, Enrique, additional, Romanyak, Natalya, additional, Rouphael, Nadine G, additional, Schuerman, Lode, additional, Sher, Lawrence D, additional, Walsh, Stephen R, additional, White, Judith, additional, von Barbier, Dalia, additional, de Bruyn, Guy, additional, Canter, Richard, additional, Grillet, Marie-Helene, additional, Keshtkar-Jahromi, Maryam, additional, Koutsoukos, Marguerite, additional, Lopez, Denise, additional, Masotti, Roger, additional, Mendoza, Sandra, additional, Moreau, Catherine, additional, Ceregido, Maria Angeles, additional, Ramirez, Shelly, additional, Said, Ansoyta, additional, Tavares-Da-Silva, Fernanda, additional, Shi, Jiayuan, additional, Tong, Tina, additional, Treanor, John, additional, Diazgranados, Carlos A, additional, and Savarino, Stephen, additional

Published
2021
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44. Analysis of Hospitalized and Severe Dengue Cases Over the 6 years of Follow-up of the Tetravalent Dengue Vaccine (CYD-TDV) Efficacy Trials in Asia and Latin America

Author

Forrat, Rémi, primary, Dayan, Gustavo H, additional, DiazGranados, Carlos A, additional, Bonaparte, Matthew, additional, Laot, Thelma, additional, Capeding, Maria Rosario, additional, Sanchez, Leilani, additional, Coronel, Diana Leticia, additional, Reynales, Humberto, additional, Chansinghakul, Danaya, additional, Hadinegoro, Sri Rezeki S, additional, Perroud, Ana Paula, additional, Frago, Carina, additional, Zambrano, Betzana, additional, Machabert, Tifany, additional, Wu, Yukun, additional, Luedtke, Alexander, additional, Price, Brenda, additional, Vigne, Claire, additional, Haney, Owen, additional, Savarino, Stephen J, additional, Bouckenooghe, Alain, additional, and Noriega, Fernando, additional

Published
2021
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46. Transmission of West Nile virus from an organ donor to four transplant recipients

Author

Iwamoto, Martha, Hellinger, Walter C., DiazGranados, Carlos A., Goodman, Jesse L., Jernigan, Daniel B., Pham, Si M., Winquist, Andrea G., Marfin, Anthony A., Guasch, Antonio, Zaki, Sherif, Perlino, Carl A., Chamberland, Mary E., Trepka, Mary Jo, Lanciotti, Robert S., Wiersma, Steven, Peterson, Lyle R., Blackmore, Carina G., Lance-Parker, Susan E., and Hillyer, Krista L.

Subjects
Organ transplant recipients -- Research, Organ donors -- Research, West Nile virus -- Research, West Nile virus -- Care and treatment
Abstract

Suspicion of transmission of West Nile virus through organ transplantation is reviewed by identification of associated blood components in persons who donated blood to the organ donor. It is concluded that organ recipients receiving immunosuppressive drugs may be at high risk for severe disease after West Nile virus infection with blood transfusion being the probable source of the West Nile virus viremia in the organ donor.

Published
2003

47. Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: a randomised, placebo-controlled, dose-ranging study

Author

Goepfert, Paul A, primary, Fu, Bo, additional, Chabanon, Anne-Laure, additional, Bonaparte, Matthew I, additional, Davis, Matthew G, additional, Essink, Brandon J, additional, Frank, Ian, additional, Haney, Owen, additional, Janosczyk, Helene, additional, Keefer, Michael C, additional, Koutsoukos, Marguerite, additional, Kimmel, Murray A, additional, Masotti, Roger, additional, Savarino, Stephen J, additional, Schuerman, Lode, additional, Schwartz, Howard, additional, Sher, Lawrence D, additional, Smith, Jon, additional, Tavares-Da-Silva, Fernanda, additional, Gurunathan, Sanjay, additional, DiazGranados, Carlos A, additional, and De Bruyn, Guy, additional

Published
2021
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48. Zika and Dengue Interactions in the Context of a Large Dengue Vaccine Clinical Trial in Latin America

Author

Zambrano, Betzana, primary, Noriega, Fernando, additional, Dayan, Gustavo H., additional, Rivera, Doris Maribel, additional, Arredondo, José Luis, additional, Reynales, Humberto, additional, Luz, Kleber, additional, Deseda, Carmen, additional, Bonaparte, Matthew I., additional, Langevin, Edith, additional, Wu, Yukun, additional, Cortés, Margarita, additional, Savarino, Stephen, additional, and DiazGranados, Carlos A., additional

Published
2021
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50. Immunobridging efficacy of a tetravalent dengue vaccine against dengue and against hospitalized dengue from children/adolescents to adults in highly endemic countries

Author

Huang, Ying, primary, Moodie, Zoe, additional, Juraska, Michal, additional, Fong, Youyi, additional, Carpp, Lindsay N, additional, Chambonneau, Laurent, additional, Coronel, Diana L, additional, Dayan, Gustavo H, additional, DiazGranados, Carlos A, additional, and Gilbert, Peter B, additional

Published
2020
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