Lot-to-lot consistency, immunogenicity, and safety of the Ad26.ZEBOV, MVA-BN-Filo Ebola virus vaccine regimen: A phase 3, randomized, double-blind, placebo-controlled trial
This phase-3, double-blind, placebo-controlled study (NCT04228783) evaluated lot-to-lot consistency of the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen. Participants were randomized (6:6:6:1) to receive the two-dose regimen from three consecutively manufactured lots of Ad26.ZEBOV on Day 1 paired wi...
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Taylor & Francis Group
2024-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2024.2327747 |
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| author | Neil Goldstein Chelsea McLean Auguste Gaddah Joachim Doua Babajide Keshinro Linda Bus-Jacobs Jenny Hendriks Kerstin Luhn Cynthia Robinson Macaya Douoguih |
| author_facet | Neil Goldstein Chelsea McLean Auguste Gaddah Joachim Doua Babajide Keshinro Linda Bus-Jacobs Jenny Hendriks Kerstin Luhn Cynthia Robinson Macaya Douoguih |
| author_sort | Neil Goldstein |
| collection | DOAJ |
| description | This phase-3, double-blind, placebo-controlled study (NCT04228783) evaluated lot-to-lot consistency of the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen. Participants were randomized (6:6:6:1) to receive the two-dose regimen from three consecutively manufactured lots of Ad26.ZEBOV on Day 1 paired with three consecutively manufactured lots of MVA-BN-Filo on Day 57 (Groups 1–3) or two doses of placebo (Group 4). An additional cohort also received an Ad26.ZEBOV booster or placebo 4 months post-dose 2. Equivalence of the immunogenicity at 21 days post-dose 2 between any two groups was demonstrated if the 95% confidence interval (CI) of the Ebola virus glycoprotein (EBOV GP)–binding antibody geometric mean concentration (GMC) ratio was entirely within the prespecified margin of 0.5–2.0. Lot-to-lot consistency (i.e., consecutive lots can be consistently manufactured) was accomplished if equivalence was shown for all three pairwise comparisons. Results showed that the primary objective in the per-protocol immunogenicity subset (n = 549) was established for each pairwise comparison (Group 1 vs 2: GMC ratio = 0.9 [95% CI: 0.8, 1.1], Group 1 vs 3: 0.9 [0.8, 1.1], Group 2 vs 3: 1.0 [0.9, 1.2]). Equivalence of the three groups for the Ad26.ZEBOV component only was also demonstrated at 56 days post-dose 1. EBOV GP–binding antibody responses (post-vaccination concentrations >2.5-fold from baseline) were observed in 419/421 (99.5%) vaccine recipients at 21 days post-dose 2 and 445/460 (96.7%) at 56 days post-dose 1. In the booster cohort (n = 39), GMCs increased 9.0- and 11.8-fold at 7 and 21 days post-booster, respectively, versus pre-booster. Ad26.ZEBOV, MVA-BN-Filo was well tolerated, and no safety issues were identified. |
| format | Article |
| id | doaj-art-65e3268d9a954502879e597a8bb39643 |
| institution | OA Journals |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
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| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-65e3268d9a954502879e597a8bb396432025-08-20T02:16:46ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2024-12-0120110.1080/21645515.2024.2327747Lot-to-lot consistency, immunogenicity, and safety of the Ad26.ZEBOV, MVA-BN-Filo Ebola virus vaccine regimen: A phase 3, randomized, double-blind, placebo-controlled trialNeil Goldstein0Chelsea McLean1Auguste Gaddah2Joachim Doua3Babajide Keshinro4Linda Bus-Jacobs5Jenny Hendriks6Kerstin Luhn7Cynthia Robinson8Macaya Douoguih9Janssen Vaccines & Prevention B.V, Leiden, The NetherlandsJanssen Vaccines & Prevention B.V, Leiden, The NetherlandsJanssen Research & Development, Beerse, BelgiumJanssen Research & Development, Beerse, BelgiumJanssen Vaccines & Prevention B.V, Leiden, The NetherlandsJanssen Vaccines & Prevention B.V, Leiden, The NetherlandsJanssen Vaccines & Prevention B.V, Leiden, The NetherlandsJanssen Vaccines & Prevention B.V, Leiden, The NetherlandsJanssen Vaccines & Prevention B.V, Leiden, The NetherlandsJanssen Vaccines & Prevention B.V, Leiden, The NetherlandsThis phase-3, double-blind, placebo-controlled study (NCT04228783) evaluated lot-to-lot consistency of the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen. Participants were randomized (6:6:6:1) to receive the two-dose regimen from three consecutively manufactured lots of Ad26.ZEBOV on Day 1 paired with three consecutively manufactured lots of MVA-BN-Filo on Day 57 (Groups 1–3) or two doses of placebo (Group 4). An additional cohort also received an Ad26.ZEBOV booster or placebo 4 months post-dose 2. Equivalence of the immunogenicity at 21 days post-dose 2 between any two groups was demonstrated if the 95% confidence interval (CI) of the Ebola virus glycoprotein (EBOV GP)–binding antibody geometric mean concentration (GMC) ratio was entirely within the prespecified margin of 0.5–2.0. Lot-to-lot consistency (i.e., consecutive lots can be consistently manufactured) was accomplished if equivalence was shown for all three pairwise comparisons. Results showed that the primary objective in the per-protocol immunogenicity subset (n = 549) was established for each pairwise comparison (Group 1 vs 2: GMC ratio = 0.9 [95% CI: 0.8, 1.1], Group 1 vs 3: 0.9 [0.8, 1.1], Group 2 vs 3: 1.0 [0.9, 1.2]). Equivalence of the three groups for the Ad26.ZEBOV component only was also demonstrated at 56 days post-dose 1. EBOV GP–binding antibody responses (post-vaccination concentrations >2.5-fold from baseline) were observed in 419/421 (99.5%) vaccine recipients at 21 days post-dose 2 and 445/460 (96.7%) at 56 days post-dose 1. In the booster cohort (n = 39), GMCs increased 9.0- and 11.8-fold at 7 and 21 days post-booster, respectively, versus pre-booster. Ad26.ZEBOV, MVA-BN-Filo was well tolerated, and no safety issues were identified.https://www.tandfonline.com/doi/10.1080/21645515.2024.2327747EbolaAd26.ZEBOVMVA-BN-Filovaccineimmunogenicityclinical trial |
| spellingShingle | Neil Goldstein Chelsea McLean Auguste Gaddah Joachim Doua Babajide Keshinro Linda Bus-Jacobs Jenny Hendriks Kerstin Luhn Cynthia Robinson Macaya Douoguih Lot-to-lot consistency, immunogenicity, and safety of the Ad26.ZEBOV, MVA-BN-Filo Ebola virus vaccine regimen: A phase 3, randomized, double-blind, placebo-controlled trial Human Vaccines & Immunotherapeutics Ebola Ad26.ZEBOV MVA-BN-Filo vaccine immunogenicity clinical trial |
| title | Lot-to-lot consistency, immunogenicity, and safety of the Ad26.ZEBOV, MVA-BN-Filo Ebola virus vaccine regimen: A phase 3, randomized, double-blind, placebo-controlled trial |
| title_full | Lot-to-lot consistency, immunogenicity, and safety of the Ad26.ZEBOV, MVA-BN-Filo Ebola virus vaccine regimen: A phase 3, randomized, double-blind, placebo-controlled trial |
| title_fullStr | Lot-to-lot consistency, immunogenicity, and safety of the Ad26.ZEBOV, MVA-BN-Filo Ebola virus vaccine regimen: A phase 3, randomized, double-blind, placebo-controlled trial |
| title_full_unstemmed | Lot-to-lot consistency, immunogenicity, and safety of the Ad26.ZEBOV, MVA-BN-Filo Ebola virus vaccine regimen: A phase 3, randomized, double-blind, placebo-controlled trial |
| title_short | Lot-to-lot consistency, immunogenicity, and safety of the Ad26.ZEBOV, MVA-BN-Filo Ebola virus vaccine regimen: A phase 3, randomized, double-blind, placebo-controlled trial |
| title_sort | lot to lot consistency immunogenicity and safety of the ad26 zebov mva bn filo ebola virus vaccine regimen a phase 3 randomized double blind placebo controlled trial |
| topic | Ebola Ad26.ZEBOV MVA-BN-Filo vaccine immunogenicity clinical trial |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2327747 |
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