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1. Safety and immunogenicity of the live attenuated intranasal pertussis vaccine BPZE1: a phase 1b, double-blind, randomised, placebo-controlled dose-escalation study

Author

Dager, Lena, Ekholm, Nina, Gustafsson, Margareta, Linde, Åsa, Lång, Cecilia, Nastase, Maria, Reinholdsson, Inga-Lill, Sigurdardottir, Erla, Wahlberg, Anneli, Zarea, Izabella, Aktas, Teodora, Andersson, Ingrid, Hanson Pihlainen, Eva, Ljungman, Margaretha, Ringman, Maj, Tecleab, Teghesti, Wehlin, Lena, Allais, Florence, Assuied, Alex, Chêne, Geneviève, Gilbert, Camille, Jean, Delphine, Le Marec, Fabien, Moinot, Laetitia, Reboud, Philippe, Rousseau, Emilie, Roy, Céline, Schwimmer, Christine, Taïeb, Ludivine, Wallet, Cédrick, Derocle, Gabrielle, Gueguen, Sonia, Lévy-Marchal, Claire, Esperou, Hélène, Debrie, Anne-Sophie, Raze, Dominique, Coutte, Loïc, Diallo, Alpha, Mercier, Noémie, Jahnmatz, Maja, Richert, Laura, al-Tawil, Nabil, Storsaeter, Jann, Colin, Céline, Bauduin, Claire, Thalen, Marcel, Solovay, Ken, Rubin, Keith, Mielcarek, Nathalie, Thorstensson, Rigmor, and Locht, Camille

Published
2020
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3. Randomized Trial of Vaccines for Zaire Ebola Virus Disease

Author

Kieh, Mark, Richert, Laura, Beavogui, Abdoul H., Grund, Birgit, Leigh, Bailah, D’ortenzio, Eric, Doumbia, Seydou, Lhomme, Edouard, Sow, Samba, Vatrinet, Renaud, Roy, Céline, Kennedy, Stephen B., Faye, Sylvain, Lees, Shelley, Millimouno, Niouma P., Camara, Alseny M., Samai, Mohamed, Deen, Gibrilla F., Doumbia, Moussa, Espérou, Hélène, Pierson, Jerome, Watson-Jones, Deborah, Diallo, Alpha, Wentworth, Deborah, Mclean, Chelsea, Simon, Jakub, Wiedemann, Aurélie, Dighero-Kemp, Bonnie, Hensley, Lisa, Lane, Clifford, Levy, Yves, Piot, Peter, Greenwood, Brian, Chêne, Geneviève, Neaton, James, Yazdanpanah, Yazdan, CHU de Bordeaux Pellegrin [Bordeaux], Statistics In System biology and Translational Medicine (SISTM), Inria Bordeaux - Sud-Ouest, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)- Bordeaux population health (BPH), and Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
[SDV]Life Sciences [q-bio], General Medicine
Abstract

Questions remain concerning the rapidity of immune responses and the durability and safety of vaccines used to prevent Zaire Ebola virus disease.We conducted two randomized, placebo-controlled trials - one involving adults and one involving children - to evaluate the safety and immune responses of three vaccine regimens against Zaire Ebola virus disease: Ad26.ZEBOV followed by MVA-BN-Filo 56 days later (the Ad26-MVA group), rVSVΔG-ZEBOV-GP followed by placebo 56 days later (the rVSV group), and rVSVΔG-ZEBOV-GP followed by rVSVΔG-ZEBOV-GP 56 days later (the rVSV-booster group). The primary end point was antibody response at 12 months, defined as having both a 12-month antibody concentration of at least 200 enzyme-linked immunosorbent assay units (EU) per milliliter and an increase from baseline in the antibody concentration by at least a factor of 4.A total of 1400 adults and 1401 children underwent randomization. Among both adults and children, the incidence of injection-site reactions and symptoms (e.g., feverishness and headache) was higher in the week after receipt of the primary and second or booster vaccinations than after receipt of placebo but not at later time points. These events were largely low-grade. At month 12, a total of 41% of adults (titer, 401 EU per milliliter) and 78% of children (titer, 828 EU per milliliter) had a response in the Ad26-MVA group; 76% (titer, 992 EU per milliliter) and 87% (titer, 1415 EU per milliliter), respectively, had a response in the rVSV group; 81% (titer, 1037 EU per milliliter) and 93% (titer, 1745 EU per milliliter), respectively, had a response in the rVSV-booster group; and 3% (titer, 93 EU per milliliter) and 4% (titer, 67 EU per milliliter), respectively, had a response in the placebo group (P0.001 for all comparisons of vaccine with placebo). In both adults and children, antibody responses with vaccine differed from those with placebo beginning on day 14.No safety concerns were identified in this trial. With all three vaccine regimens, immune responses were seen from day 14 through month 12. (Funded by the National Institutes of Health and others; PREVAC ClinicalTrials.gov number, NCT02876328; EudraCT numbers, 2017-001798-18 and 2017-001798-18/3rd; and Pan African Clinical Trials Registry number, PACTR201712002760250.).

Published
2022

7. Correction to: Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries

Author

Badio, Moses, Lhomme, Edouard, Kieh, Mark, Beavogui, Abdoul Habib, Kennedy, Stephen B, Doumbia, Seydou, Leigh, Bailah, Sow, Samba O, Diallo, Alpha, Fusco, Daniela, Kirchoff, Matthew, Termote, Monique, Vatrinet, Renaud, Wentworth, Deborah, Esperou, Helène, Lane, H Clifford, Pierson, Jerome, Watson-Jones, Deborah, Roy, Céline, D'Ortenzio, Eric, Greenwood, Brian, Chêne, Genevieve, Richer, Laura, Neaton, James D, Yazdanpanah, Yazdan, and PREVAC study team

Abstract

Following the publication of the original article [1], we were notified of an error in the affiliation of 3 authors of the article: Celine Roy, Laura Richert and Genevieve Chene. Their affiliation was initially mentioned as: “Partnership for Research on Ebola Virus in Liberia (PREVAIL), Monrovia, Liberia” However, their correct affiliation is: Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.tp.

Published
2021

9. Additional file 1 of Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries

Author

Badio, Moses, Lhomme, Edouard, Kieh, Mark, Beavogui, Abdoul Habib, Kennedy, Stephen B., Seydou Doumbia, Bailah Leigh, Samba O. Sow, Diallo, Alpha, Fusco, Daniela, Kirchoff, Matthew, Termote, Monique, Vatrinet, Renaud, Wentworth, Deborah, Helène Esperou, H. Clifford Lane, Pierson, Jerome, Watson-Jones, Deborah, Roy, Céline, D’Ortenzio, Eric, Greenwood, Brian, Chêne, Genevieve, Richert, Laura, Neaton, James D., and Yazdan Yazdanpanah

Abstract

Additional file 1: Appendix 1. Secondary objectives. Appendix 2. Sample size considerations and statistical analysis. Appendix 3. PREVAC study team. Appendix 4. Trial organization. Appendix 5. Assent and consent forms. Appendix 6. Participants in the PREVAC trial. Appendix 7. Enrollment of the participants in the PREVAC trial. Appendix 8. Baseline antibody data.

Published
2021
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11. Safety and immunogenicity of the live attenuated intranasal pertussis vaccine BPZE1: a phase 1b, double-blind, randomised, placebo-controlled dose-escalation study

Author

Jahnmatz, Maja, primary, Richert, Laura, additional, al-Tawil, Nabil, additional, Storsaeter, Jann, additional, Colin, Céline, additional, Bauduin, Claire, additional, Thalen, Marcel, additional, Solovay, Ken, additional, Rubin, Keith, additional, Mielcarek, Nathalie, additional, Thorstensson, Rigmor, additional, Locht, Camille, additional, Dager, Lena, additional, Ekholm, Nina, additional, Gustafsson, Margareta, additional, Linde, Åsa, additional, Lång, Cecilia, additional, Nastase, Maria, additional, Reinholdsson, Inga-Lill, additional, Sigurdardottir, Erla, additional, Wahlberg, Anneli, additional, Zarea, Izabella, additional, Aktas, Teodora, additional, Andersson, Ingrid, additional, Hanson Pihlainen, Eva, additional, Ljungman, Margaretha, additional, Ringman, Maj, additional, Tecleab, Teghesti, additional, Wehlin, Lena, additional, Allais, Florence, additional, Assuied, Alex, additional, Chêne, Geneviève, additional, Gilbert, Camille, additional, Jean, Delphine, additional, Le Marec, Fabien, additional, Moinot, Laetitia, additional, Reboud, Philippe, additional, Rousseau, Emilie, additional, Roy, Céline, additional, Schwimmer, Christine, additional, Taïeb, Ludivine, additional, Wallet, Cédrick, additional, Derocle, Gabrielle, additional, Gueguen, Sonia, additional, Lévy-Marchal, Claire, additional, Esperou, Hélène, additional, Debrie, Anne-Sophie, additional, Raze, Dominique, additional, Coutte, Loïc, additional, Diallo, Alpha, additional, and Mercier, Noémie, additional

Published
2020
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12. Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries

Author

Badio, Moses, primary, Lhomme, Edouard, additional, Kieh, Mark, additional, Beavogui, Abdoul Habib, additional, Kennedy, Stephen B, additional, Doumbia, Seydou, additional, Leigh, Bailah, additional, Sow, Samba O, additional, Diallo, Alpha, additional, Fusco, Daniela, additional, Kirchoff, Matthew, additional, Termote, Monique, additional, Vatrinet, Renaud, additional, Wentworth, Deborah, additional, Esperou, Helène, additional, Lane, H Clifford, additional, Pierson, Jerome, additional, Watson-Jones, Deborah, additional, Roy, Céline, additional, D'Ortenzio, Eric, additional, Greenwood, Brian, additional, Chêne, Genevieve, additional, Richert, Laura, additional, Neaton, James D, additional, and Yazdanpanah, Yazdan, additional

Published
2020
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13. Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries.

Author

Badio, Moses, Lhomme, Edouard, Kieh, Mark, Beavogui, Abdoul Habib, Kennedy, Stephen B., Doumbia, Seydou, Leigh, Bailah, Sow, Samba O., Diallo, Alpha, Fusco, Daniela, Kirchoff, Matthew, Termote, Monique, Vatrinet, Renaud, Wentworth, Deborah, Esperou, Helène, Lane, H. Clifford, Pierson, Jerome, Watson-Jones, Deborah, Roy, Céline, and D'Ortenzio, Eric

Abstract

Introduction: The Ebola virus disease (EVD) outbreak in 2014–2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preventative vaccine. Multiple questions regarding the safety, immunogenicity, and efficacy of EVD vaccines remain unanswered. To address these gaps in the evidence base, the Partnership for Research on Ebola Vaccines (PREVAC) trial was designed. This paper describes the design, methods, and baseline results of the PREVAC trial and discusses challenges that led to different protocol amendments. Methods: This is a randomized, double-blind, placebo-controlled phase 2 clinical trial of three vaccine strategies against the Ebola virus in healthy volunteers 1 year of age and above. The three vaccine strategies being studied are the rVSVΔG-ZEBOV-GP vaccine, with and without a booster dose at 56 days, and the Ad26.ZEBOV,MVA-FN-Filo vaccine regimen with Ad26.ZEBOV given as the first dose and the MVA-FN-Filo vaccination given 56 days later. There have been 4 versions of the protocol with those enrolled in Version 4.0 comprising the primary analysis cohort. The primary endpoint is based on the antibody titer against the Ebola virus surface glycoprotein measured 12 months following the final injection. Results: From April 2017 to December 2018, a total of 5002 volunteers were screened and 4789 enrolled. Participants were enrolled at 6 sites in four countries (Guinea, Liberia, Sierra Leone, and Mali). Of the 4789 participants, 2560 (53%) were adults and 2229 (47%) were children. Those < 18 years of age included 549 (12%) aged 1 to 4 years, 750 (16%) 5 to 11 years, and 930 (19%) aged 12–17 years. At baseline, the median (25th, 75th percentile) antibody titer to Ebola virus glycoprotein for 1090 participants was 72 (50, 116) EU/mL. Discussion: The PREVAC trial is evaluating—placebo-controlled—two promising Ebola candidate vaccines in advanced stages of development. The results will address unanswered questions related to short- and long-term safety and immunogenicity for three vaccine strategies in adults and children. Trial registration: ClinicalTrials.gov NCT02876328. Registered on 23 August 2016. [ABSTRACT FROM AUTHOR]

Published
2021
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20. Pesticide determination in rose concrete and rose absolute using dispersive-solid phase extraction followed by gas chromatographytandem mass spectrometry.

Author

Tascone, Oriane, Roy, Céline, and Meierhenrich, Uwe J.

Subjects
*PESTICIDE research, *PLANT extracts, *DAMASK rose, *SOLID phase extraction, *EXTRACTION (Chemistry), *GAS chromatography/Mass spectrometry (GC-MS)
Abstract

The rose species Rosa damascena and Rosa centifolia are cultivated for their use as perfume raw materials. The solvent extract of rose petals provides the concrete that is further transformed into the absolute. Both, concrete and absolute contain a variety of organic molecules. As a result of the lack of an adequate analytical procedure and the complexity of the matrices, the accurate quantification of pesticides in concrete and absolute remains challenging. Here we describe the first analytical method to quantify 57 pesticide residues in rose concrete and 56 pesticide residues in rose absolute. The method uses a multistep dispersive-solid phase extraction (d-SPE) cleanup followed by injection in a gas chromatography-tandem mass spectrometer. Sample preparation includes the extraction of analytes from the matrix using acetonitrile and a mixture of salts and a double clean-up step using sorbents in the form of primary and secondary amines (PSA), magnesium sulphate, C18 and graphitized carbon black (GCB). Two fortification levels, 0.025 to 0.15 and 0.5mg/kg, were assessed. For 56 pesticides, the obtained recoveries were within the range of 70% to 120 % with a relative standard deviation (RSD) lower than 20% at each spiked level. The validation parameters proved that the developed method can be used for the quantification of 57 pesticide residues in rose concrete and 56 pesticide residues in rose absolute with a limit of quantification (LOQ) ranging from 0.025 to 0.1mg/kg in concrete and from0.05 to 0.15mg/kg in absolute, depending on the active substance. [ABSTRACT FROM AUTHOR]

Published
2016
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22. Transmitted drug resistance in French HIV-2-infected patients

Author

Charpentier, Charlotte, Visseaux, Benoit, Bénard, Antoine, Peytavin, Gilles, Damond, Florence, Roy, Céline, Taieb, Audrey, Chêne, Geneviève, Matheron, Sophie, Brun-Vézinet, Francoise, Descamps, Diane, Michelet, Christian, Laboratoire de Virologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Epidémiologie et Biostatistique [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de pharmacie, Service des maladies infectieuses et tropicales, Université Paris Diderot - Paris 7 (UPD7)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), ANRS CO5 HIV-2 Cohort, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris]-Université Paris Diderot - Paris 7 (UPD7), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), and Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )

Subjects
medicine.medical_treatment, Immunology, Human immunodeficiency virus (HIV), HIV Infections, Drug resistance, medicine.disease_cause, 03 medical and health sciences, 0302 clinical medicine, Drug Resistance, Viral, Prevalence, medicine, Humans, Immunology and Allergy, 030212 general & internal medicine, 0303 health sciences, Protease, 030306 microbiology, business.industry, Survey research, HIV Protease Inhibitors, Virology, Reverse transcriptase, Confidence interval, 3. Good health, Infectious Diseases, [SDV.TOX]Life Sciences [q-bio]/Toxicology, HIV-2, Cohort, RNA, Viral, Reverse Transcriptase Inhibitors, France, business
Abstract

International audience; We report the first transmitted drug resistance survey study in HIV-2-infected patients living in France. The prevalence of transmitted drug resistance was 5.0% (95% confidence interval, 0.1-9.9) with mutations detected only in protease, not in reverse transcriptase. In this series, 10% of patients displayed X4/dual-mixed viruses. These findings classified the rate of transmitted drug resistance in the HIV-2 French Cohort as low prevalence.

23. Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries

Author

Badio, Moses, Lhomme, Edouard, Kieh, Mark, Beavogui, Abdoul Habib, Kennedy, Stephen B., Doumbia, Seydou, Leigh, Bailah, Sow, Samba O., Diallo, Alpha, Fusco, Daniela, Kirchoff, Matthew, Termote, Monique, Vatrinet, Renaud, Wentworth, Deborah, Esperou, Helène, Lane, H. Clifford, Pierson, Jerome, Watson-Jones, Deborah, Roy, Céline, D’Ortenzio, Eric, Greenwood, Brian, Chêne, Genevieve, Richert, Laura, Neaton, James D., Yazdanpanah, Yazdan, Abdoulaye, Coulibaly, Aboulhab, Jamilia, Akoo, Pauline, Akpa, Esther, Akpata, Robert, Albert, Sara, Ale, Boni Maxime, C. Andrews, Benetta, Anoma, Stephane, Assiandi, Saw-San, Augier, Augustin, Awuondo, Ken, Bagayoko, Aminata, Bakare, Nyasha, Balde, Abby, Bangura, Lamin Molecule, Barrington, Kesha, Barte de Saint Fare, Eric, Baseler, Beth, Bauder, Ali, Bauduin, Claire, Bawo, Luke, Habib Beavogui, Abdoul, Belson, Michael, Bererd, Marion, Beyslow, Teedoh, Binachon, Blandine, Blie, Julie, Bockstal, Viki, Boire, Youba, Boison, Patricia, Bolay, Fatorma, Boly, Aliou, Gael Borg, Anne, Bowers, Donna, Browne, Sarah, Cagniard, Barbara, Cahill, Kelly, Abdoulaye Camara, Aissata, Camara, Keira, Camara, Modet, Campion, Cécilia, Cash, Jennifer, Pin Chai, Siew, Chambelin, Francois, Chieck, Keita, Chêne, Geneviève, Ciancia, Séverine, Ndiaga Cisse, Papa, Clide, Elfrida, Colin, Céline, Coller, Beth-Ann, Siaka Conde, Djélikan, Cone, Katherine, Connor, Laurie, Connor, Nicholas, Boye Cooper, Joseph, Couffin-Cardiergues, Sandrine, Coulibaly, Fatoumata, Coulibaly, Mariam, Dabakuyo-Yonli, Sandrine, Dabitao, Djeneba, Damerval, Thierry, Davis, Bionca, Fadlu Deen, Gibrilla, Dekeyster, Eline, Delfraissy, Jean-François, Delmas, Christelle, Dembele, Rokia, Diakite, Mahamadou, Saliou Diallo, Mamadou, Diarra, Ayouba, Diawara, Oualy, Dighero-kemp, Bonnie, Diop, Samba, Diouf, Waly, Doepel, Laurie, Moise Doumbia, Moussa, Douoguih, Macaya, DuChêne, Alain, Duvenhage, Michael, Eckes, Risa Eckes, Egan, Avril, Enria, Luisa, Espérou, Hélène, Etienne, Cécile, Eyler, Allison, Faye, Sylvain, Fernandez, José, Fleck, Suzanne, Fofana, Vemy, Franklin, Kokulo, Gaddah, Auguste, Gaignet, Marylène, Gallagher, Katherine, Garcia Gozalbes, Julia, Grandits, Greg, Gray, Maima, Greijer, Astrid, Grue, Louis, Grund, Birgit, Guindo, Oumar, Gupta, Swati, Haidara, Fadima, Hamze, Benjamin, Hancox, Emma, Hart, Gavin, Hébert, Jean-Christophe, Heijnen, Esther, Hensley, Patricia, Hensley, Lisa, Higgs, Elisabeth, Hilton, Trudi, Holley, Preston, Hoover, Marie, Howard, Natasha, Hughes, Melissa, Ilo, Dicko, Imes, Jen, Irvine, Skip, Ishola, David, Jacob, Will, Jato, Yvonne, Johnson, Melvin, Jusu, Morrison, Sidiki Kaba, Aboubacar, Kante, Myriam, Katoudi, Judith, Keita, Sakoba, Kennedy, Stephen, Jide Keshinro, Babajide, Khon, Brian, Kiawu, Hassan, Kirchoff, Matt, Kodio, Mamoudou, Koivogui, Lamine, Kombi, Tania, Kopka, Stacy, Kowuors, Dickens, Lacabaratz, Christine, Lacarra, Boris, Lambert, Laurie, Lane, Cliff, Lee, Shona, Lees, Shelley, Lefevre, Annabelle, Lemarcis, Frederic, Lévy, Yves, Levy-Marchal, Claire, Lewally, Jemilla, Leyssen, Maarten, Liu, Ken, Lowe, Brett, Lysander, Julia, Madelaine, Claire, Mahamadou, Ibrah, Manno, Daniela, Marchand, Johnathan, Marynissen, Siegfried, Massaquoi, Moses B.F., Masson, Laure, Matard, Charly, Matthew, Onorato, McCullough, John, Mercier, Noemie, Michavila, Pauline, Miller, Tracey, Miranda, Alejandra, Mohamed, Soumaya, Mooney, Tom, Morsch, Hans, Muamba, Dally, Lukoo Ndamenyaa, Rita, Neaton, James, Neboua, Désiré, Nelson, Micki, Newell, Kevin, Nguyen, Vinh-kim, Nielsen, Leslie, Niouma, Millimouno, Offergeld, Kim, Onorato, Matthew, Onwuchekwa, Uma, Orsega, Susan, Ortega-Perez, Inmaculada, Osborne, Cynthia, Otieno, Tuda, Patel, Sushma, Peiffer-Smadj, Nathan, Phillips, Robert, Piot, Peter, Piziali, Micheal, Pong, Stephany, Proffitt, Calvin, Quach, Alexandre, Ramers-verhoeven, Corina, Randunu, Nadeeka, Rivière, Priscille, Robinson, Cynthia, Van Roey, Griet, Falk Russell, Amy, Samai, Sibiry Samake, Mohamed, Sangare, Ballan, Sanogo, Ibrahim, Sadio Sarro, Yeya, Sarro, Sadio, Saville, Mélanie, Sawadogo, Serge, Schvartz, Maxime, Schwimmer, Christine, Secka, Fatou, Seraphin, Jacques, Shelley, Denise, Siddiqui, Sophia, Simon, Jakub, Simpson, Shelly, Muyisa Sivahera, Billy, Skip, Irvine, Slater, Karen, Smolskis, Mary, Smout, Elizabeth, Snowden, Emily, Soutthiphong, Anne-Aygline, Sow, Samba, Sow, Ydrissa, Splinter, Daniel, Spreng, Simone, Stapleton, Helen, Stoop, Jeroen, Sweeney, Mary, Tamba, Sienneh, Tapia, Mili, Tegli, Jemee, Thiebaut, Rodolphe, Thompson, Greg, Tierney, John, Touré, Abdoulaye, Traina, Stacey, Traore, Awa, Traore, Moussa, Tyee, Tijili, Vallée, David, Van Der Donck, Katrien V, Verbruggen, Nadia, Vincent, Corine, Vogel, Susan, Wallet, Cedrick, Wesseh, Cecelia, Whitworth, Jimmy, Wiedemann, Aurelie, Willems, Wouter, Williams, Julian, Wilson, Barthalomew, Wissedi, Njoh, Wolf, Jayanthi, Woods, Ian, Wurie, Alie, Yamadjako, Delphine, Yaradouno, Marcel, Zeggani, Zara, Statistics In System biology and Translational Medicine (SISTM), Inria Bordeaux - Sud-Ouest, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)- Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), PREVAIL, Centre National de Formation et de Recherche en Santé Rurale [Maférinyah, Guinée] (CNFRSR), Malaria Research and Training Center [Bamako, Mali], Université de Bamako, University of Sierra Leone (USL), Institut National de Santé Publique [Bamako] = National Institute of Research on Public Health (INSP), ANRS - Maladies infectieuses émergentes (ANRS - MIE), Institut National de la Santé et de la Recherche Médicale (INSERM), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Minnesota [Twin Cities] (UMN), University of Minnesota System, Pôle de Recherche Clinique [Paris] (PRC), National Institute of Allergy and Infectious Diseases [Bethesda] (NIAID-NIH), National Institutes of Health [Bethesda] (NIH), and London School of Hygiene and Tropical Medicine (LSHTM)

Subjects
[SDV]Life Sciences [q-bio]
Abstract

International audience; Abstract Introduction The Ebola virus disease (EVD) outbreak in 2014–2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preventative vaccine. Multiple questions regarding the safety, immunogenicity, and efficacy of EVD vaccines remain unanswered. To address these gaps in the evidence base, the Partnership for Research on Ebola Vaccines (PREVAC) trial was designed. This paper describes the design, methods, and baseline results of the PREVAC trial and discusses challenges that led to different protocol amendments. Methods This is a randomized, double-blind, placebo-controlled phase 2 clinical trial of three vaccine strategies against the Ebola virus in healthy volunteers 1 year of age and above. The three vaccine strategies being studied are the rVSVΔG-ZEBOV-GP vaccine, with and without a booster dose at 56 days, and the Ad26.ZEBOV,MVA-FN-Filo vaccine regimen with Ad26.ZEBOV given as the first dose and the MVA-FN-Filo vaccination given 56 days later. There have been 4 versions of the protocol with those enrolled in Version 4.0 comprising the primary analysis cohort. The primary endpoint is based on the antibody titer against the Ebola virus surface glycoprotein measured 12 months following the final injection. Results From April 2017 to December 2018, a total of 5002 volunteers were screened and 4789 enrolled. Participants were enrolled at 6 sites in four countries (Guinea, Liberia, Sierra Leone, and Mali). Of the 4789 participants, 2560 (53%) were adults and 2229 (47%) were children. Those

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24. Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults.

Author

Lee AW, Liu K, Lhomme E, Blie J, McCullough J, Onorato MT, Connor L, Simon JK, Dubey S, VanRheenen S, Deutsch J, Owens A, Morgan A, Welebob C, Hyatt D, Nair S, Hamzé B, Guindo O, Sow SO, Beavogui AH, Leigh B, Samai M, Akoo P, Serry-Bangura A, Fleck S, Secka F, Lowe B, Watson-Jones D, Roy C, Hensley LE, Kieh M, and Coller BG

Subjects
Adult, Child, Humans, Antibodies, Viral, Viral Envelope Proteins, Vaccines, Synthetic, Vaccination methods, Vaccines, Attenuated, Immunogenicity, Vaccine, Hemorrhagic Fever, Ebola, Ebola Vaccines, Ebolavirus
Abstract

Background: The rVSVΔG-ZEBOV-GP vaccine (ERVEBO®) is a single-dose, live-attenuated, recombinant vesicular stomatitis virus vaccine indicated for the prevention of Ebola virus disease (EVD) caused by Zaire ebolavirus in individuals 12 months of age and older., Methods: The Partnership for Research on Ebola VACcination (PREVAC) is a multicenter, phase 2, randomized, double-blind, placebo-controlled trial of 3 vaccine strategies in healthy children (ages 1-17) and adults, with projected 5 years of follow-up (NCT02876328). Using validated assays (GP-ELISA and PRNT), we measured antibody responses after 1-dose rVSVΔG-ZEBOV-GP, 2-dose rVSVΔG-ZEBOV-GP (given on Day 0 and Day 56), or placebo. Furthermore, we quantified vaccine virus shedding in a subset of children's saliva using RT-PCR., Results: In total, 819 children and 783 adults were randomized to receive rVSVΔG-ZEBOV-GP (1 or 2 doses) or placebo. A single dose of rVSVΔG-ZEBOV-GP increased antibody responses by Day 28 that were sustained through Month 12. A second dose of rVSVΔG-ZEBOV-GP given on Day 56 transiently boosted antibody concentrations. In vaccinated children, GP-ELISA titers were superior to placebo and non-inferior to vaccinated adults. Vaccine virus shedding was observed in 31.7% of children, peaking by Day 7, with no shedding observed after Day 28 post-dose 1 or any time post-dose 2., Conclusions: A single dose of rVSVΔG-ZEBOV-GP induced robust antibody responses in children that was non-inferior to the responses induced in vaccinated adults. Vaccine virus shedding in children was time-limited and only observed after the first dose. Overall, these data support the use of rVSVΔG-ZEBOV-GP for the prevention of EVD in at-risk children. Clinical Trials Registration. The study is registered at ClinicalTrials.gov (NCT02876328), the Pan African Clinical Trials Registry (PACTR201712002760250), and the European Clinical Trials Register (EudraCT number: 2017-001798-18)., Competing Interests: Potential conflicts of interest. K. L., M. T. O., L. C., S. D., S. V., A. O., C. W., D .H., S. N., and B.-A. C. G. are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ USA, who may own stock and/or hold stock options in Merck & Co., Inc., Rahway, NJ, USA. A. W. L., J. K. S., J. D., and A. M. were employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and may own/have owned stock and/or hold/held stock options in Merck & Co., Inc., Rahway, NJ, USA at the time the study was conducted. E. L., B. H., and C. R. report provision of vaccines from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA to the academic sponsors for the PREVAC trial, but no funding directly to themselves or their institution. J. M. reports provision of sample collection kits for the study sites, provision and support of lab software, technical support and supervision of lab activities, and lab data management. S. O. S. reports payments from Leidos to his institution. P. A. reports support for attending meetings and/or travel including Air tickets and accommodations for attending study related meetings during the conduct of the study. D. W.-J reports funding from Innovative Medicines Initiative 2 Joint Undertaking, additionally D. W.-J. reports funding and donations of an HPV vaccine (Gardasil®) from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA for another unrelated study. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Published
2024
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25. Randomized Trial of Vaccines for Zaire Ebola Virus Disease.

Author

Kieh M, Richert L, Beavogui AH, Grund B, Leigh B, D'Ortenzio E, Doumbia S, Lhomme E, Sow S, Vatrinet R, Roy C, Kennedy SB, Faye S, Lees S, Millimouno NP, Camara AM, Samai M, Deen GF, Doumbia M, Espérou H, Pierson J, Watson-Jones D, Diallo A, Wentworth D, McLean C, Simon J, Wiedemann A, Dighero-Kemp B, Hensley L, Lane HC, Levy Y, Piot P, Greenwood B, Chêne G, Neaton J, and Yazdanpanah Y

Subjects
Adult, Child, Humans, Antibodies, Viral, Democratic Republic of the Congo, Ebola Vaccines therapeutic use, Ebolavirus, Hemorrhagic Fever, Ebola prevention & control
Abstract

Background: Questions remain concerning the rapidity of immune responses and the durability and safety of vaccines used to prevent Zaire Ebola virus disease., Methods: We conducted two randomized, placebo-controlled trials - one involving adults and one involving children - to evaluate the safety and immune responses of three vaccine regimens against Zaire Ebola virus disease: Ad26.ZEBOV followed by MVA-BN-Filo 56 days later (the Ad26-MVA group), rVSVΔG-ZEBOV-GP followed by placebo 56 days later (the rVSV group), and rVSVΔG-ZEBOV-GP followed by rVSVΔG-ZEBOV-GP 56 days later (the rVSV-booster group). The primary end point was antibody response at 12 months, defined as having both a 12-month antibody concentration of at least 200 enzyme-linked immunosorbent assay units (EU) per milliliter and an increase from baseline in the antibody concentration by at least a factor of 4., Results: A total of 1400 adults and 1401 children underwent randomization. Among both adults and children, the incidence of injection-site reactions and symptoms (e.g., feverishness and headache) was higher in the week after receipt of the primary and second or booster vaccinations than after receipt of placebo but not at later time points. These events were largely low-grade. At month 12, a total of 41% of adults (titer, 401 EU per milliliter) and 78% of children (titer, 828 EU per milliliter) had a response in the Ad26-MVA group; 76% (titer, 992 EU per milliliter) and 87% (titer, 1415 EU per milliliter), respectively, had a response in the rVSV group; 81% (titer, 1037 EU per milliliter) and 93% (titer, 1745 EU per milliliter), respectively, had a response in the rVSV-booster group; and 3% (titer, 93 EU per milliliter) and 4% (titer, 67 EU per milliliter), respectively, had a response in the placebo group (P<0.001 for all comparisons of vaccine with placebo). In both adults and children, antibody responses with vaccine differed from those with placebo beginning on day 14., Conclusions: No safety concerns were identified in this trial. With all three vaccine regimens, immune responses were seen from day 14 through month 12. (Funded by the National Institutes of Health and others; PREVAC ClinicalTrials.gov number, NCT02876328; EudraCT numbers, 2017-001798-18 and 2017-001798-18/3rd; and Pan African Clinical Trials Registry number, PACTR201712002760250.)., (Copyright © 2022 Massachusetts Medical Society.)

Published
2022
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26. Correction to: Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries.

Author

Badio M, Lhomme E, Kieh M, Beavogui AH, Kennedy SB, Doumbia S, Leigh B, Sow SO, Diallo A, Fusco D, Kirchoff M, Termote M, Vatrinet R, Wentworth D, Esperou H, Lane HC, Pierson J, Watson-Jones D, Roy C, D'Ortenzio E, Greenwood B, Chêne G, Richer L, Neaton JD, and Yazdanpanah Y

Published
2021
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