Immunogenicity of an Extended Dose Interval for the Ad26.ZEBOV, MVA-BN-Filo Ebola Vaccine Regimen in Adults and Children in the Democratic Republic of the Congo

被引：0

作者：

Choi, Edward Man-Lik ^{[1
]}

Kasonia, Kambale ^{[1
]}

Kavunga-Membo, Hugo ^{[2
]}

Mukadi-Bamuleka, Daniel ^{[2
]}

Soumah, Aboubacar ^{[3
]}

Mossoko, Zephyrin ^{[2
]}

Edwards, Tansy ^{[4
,5
]}

Tetsa-Tata, Darius ^{[1
]}

Makarimi, Rockyath ^{[3
]}

Toure, Oumar ^{[3
]}

Mambula, Grace ^{[3
]}

Brindle, Hannah ^{[1
]}

Camacho, Anton ^{[3
]}

Connor, Nicholas E. ^{[1
]}

Mukadi, Pierre ^{[2
]}

McLean, Chelsea ^{[6
]}

Keshinro, Babajide ^{[6
]}

Gaddah, Auguste ^{[7
]}

Robinson, Cynthia ^{[6
]}

Luhn, Kerstin ^{[6
]}

Foster, Julie ^{[1
]}

Roberts, Chrissy H. ^{[1
]}

Johnson, John Emery ^{[8
]}

Imbault, Nathalie ^{[9
]}

Bausch, Daniel G. ^{[1
,10
]}

Grais, Rebecca F. ^{[3
]}

Watson-Jones, Deborah ^{[1
,11
]}

Muyembe-Tamfum, Jean Jacques ^{[2
]}

机构：

[1] London Sch Hyg & Trop Med, Dept Infect Dis Epidemiol, London WC1E 7HT, England

[2] Inst Natl Rech Biomed, POB 1192, Kinshasa, DEM REP CONGO

[3] Epicentre, F-75019 Paris, France

[4] London Sch Hyg & Trop Med, MRC Int Stat & Epidemiol Grp, Fac Epidemiol & Populat Hlth, London WC1E 7HT, England

[5] Nagasaki Univ, Sch Trop Med & Global Hlth, Nagasaki 8528523, Japan

[6] Janssen Vaccines & Prevent BV, NL-2333 CN Leiden, Netherlands

[7] Janssen Res & Dev, B-2340 Beerse, Belgium

[8] Med Sans Frontieres, F-75019 Paris, France

[9] Coalit Epidem Preparedness Innovat CEPI, N-0191 Oslo, Norway

[10] FIND, CH-1218 Geneva, Switzerland

[11] Natl Inst Med Res, Mwanza Intervent Trials Unit, POB 11936, Mwanza, Tanzania

来源：

VACCINES | 2024年 / 12卷 / 08期

关键词：

Ebola; outbreak; Democratic Republic of the Congo; DRC; vaccine; immunogenicity; interval; Ad26.ZEBOV; Zabdeno; MVA-BN-Filo; Mvabea; OPEN-LABEL; EFFICACY; SAFETY;

D O I：

10.3390/vaccines12080828

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

During the 2018-2020 Ebola virus disease outbreak in Democratic Republic of the Congo, a phase 3 trial of the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine (DRC-EB-001) commenced in Goma, with participants being offered the two-dose regimen given 56 days apart. Suspension of trial activities in 2020 due to the COVID-19 pandemic led to some participants receiving a late dose 2 outside the planned interval. Blood samples were collected from adults, adolescents, and children prior to their delayed dose 2 vaccination and 21 days after, and tested for IgG binding antibodies against Ebola virus glycoprotein using the Filovirus Animal Nonclinical Group (FANG) ELISA. Results from 133 participants showed a median two-dose interval of 9.3 months. The pre-dose 2 antibody geometric mean concentration (GMC) was 217 ELISA Units (EU)/mL (95% CI 157; 301) in adults, 378 EU/mL (281; 510) in adolescents, and 558 EU/mL (471; 661) in children. At 21 days post-dose 2, the GMC increased to 22,194 EU/mL (16,726; 29,449) in adults, 37,896 EU/mL (29,985; 47,893) in adolescents, and 34,652 EU/mL (27,906; 43,028) in children. Participants receiving a delayed dose 2 had a higher GMC at 21 days post-dose 2 than those who received a standard 56-day regimen in other African trials, but similar to those who received the regimen with an extended interval.

引用

页数：12

共 29 条

[1] Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trial [J].

Afolabi, Muhammed O. ;

Ishola, David ;

Manno, Daniela ;

Keshinro, Babajide ;

Bockstal, Viki ;

Rogers, Baimba ;

Owusu-Kyei, Kwabena ;

Serry-Bangura, Alimamy ;

Swaray, Ibrahim ;

Lowe, Brett ;

Kowuor, Dickens ;

Baiden, Frank ;

Mooney, Thomas ;

Smout, Elizabeth ;

Kohn, Brian ;

Otieno, Godfrey T. ;

Jusu, Morrison ;

Foster, Julie ;

Samai, Mohamed ;

Deen, Gibrilla Fadlu ;

Larson, Heidi ;

Lees, Shelley ;

Goldstein, Neil ;

Gallagher, Katherine E. ;

Gaddah, Auguste ;

Heerwegh, Dirk ;

Callendret, Benoit ;

Luhn, Kerstin ;

Robinson, Cynthia ;

Greenwood, Brian ;

Leyssen, Maarten ;

Douoguih, Macaya ;

Leigh, Bailah ;

Watson-Jones, Deborah .

LANCET INFECTIOUS DISEASES, 2022, 22 (01) :110-122

[2]

[Anonymous], 2020, Ebola outbreak 2018-2020- North Kivu-Ituri

[3]

[Anonymous], 2019, ERVEBO EBOLA ZAIRE V

[4]

[Anonymous], 2020, 10th Ebola outbreak in the Democratic Republic of the Congo declared over

[5]

Vigilance against flare-ups and support for survivors must continue

[6] Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in children and adolescents in Africa: A randomised, placebo-controlled, multicentre Phase II clinical trial [J].

Anywaine, Zacchaeus ;

Barry, Houreratou ;

Anzala, Omu ;

Mutua, Gaudensia ;

Sirima, Sodiomon B. ;

Eholie, Serge ;

Kibuuka, Hannah ;

Betard, Christine ;

Richert, Laura ;

Lacabaratz, Christine ;

McElrath, M. Juliana ;

De Rosa, Stephen C. ;

Cohen, Kristen W. ;

Shukarev, Georgi ;

Katwere, Michael ;

Robinson, Cynthia ;

Gaddah, Auguste ;

Heerwegh, Dirk ;

Bockstal, Viki ;

Luhn, Kerstin ;

Leyssen, Maarten ;

Thiebaut, Rodolphe ;

Douoguih, Macaya .

PLOS MEDICINE, 2022, 19 (01)

[7] Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in healthy and HIV-infected adults: A randomised, placebo-controlled Phase II clinical trial in Africa [J].

Barry, Houreratou ;

Mutua, Gaudensia ;

Kibuuka, Hannah ;

Anywaine, Zacchaeus ;

Sirima, Sodiomon B. ;

Meda, Nicolas ;

Anzala, Omu ;

Eholie, Serge ;

Betard, Christine ;

Richert, Laura ;

Lacabaratz, Christine ;

McElrath, M. Juliana ;

De Rosa, Stephen ;

Cohen, Kristen W. ;

Shukarev, Georgi ;

Robinson, Cynthia ;

Gaddah, Auguste ;

Heerwegh, Dirk ;

Bockstal, Viki ;

Luhn, Kerstin ;

Leyssen, Maarten ;

Douoguih, Macaya ;

Thiebaut, Rodolphe .

PLOS MEDICINE, 2021, 18 (10)

[8]

European Medicines Agency, 2020, Zabdeno Ebola Vaccine (Ad26.ZEBOV-GP Recombinant)

[9]

European Medicines Agency, 2020, Mvabea Ebola Vaccine (MVA-BN-Filo Recombinant)

[10] Modeling the effect of boost timing in murine irradiated sporozoite prime-boost vaccines [J].

Fernandez-Arias, Cristina ;

Arias, Clemente F. ;

Zhang, Min ;

Herrero, Miguel A. ;

Acosta, Francisco J. ;

Tsuji, Moriya .

PLOS ONE, 2018, 13 (01)

← 1 2 3 →