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Clinical Trial
. 2024 Dec 31;20(1):2327747.
doi: 10.1080/21645515.2024.2327747. Epub 2024 Mar 24.

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

Neil Goldstein  1 , Chelsea McLean  1 , Auguste Gaddah  2 , Joachim Doua  2 , Babajide Keshinro  1 , Linda Bus-Jacobs  1 , Jenny Hendriks  1 , Kerstin Luhn  1 , Cynthia Robinson  1 , Macaya Douoguih  1
Affiliations
Clinical Trial

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

Neil Goldstein et al. Hum Vaccin Immunother. .

Abstract

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.

Keywords: Ad26.ZEBOV; Ebola; MVA-BN-Filo; clinical trial; immunogenicity; vaccine.

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Conflict of interest statement

NG, JD, and MD were employees of Janssen at the time the study was conducted. CM, AG, BK, LB-J, JH, KL, and CR are current employees of Janssen. All authors are stockholders of Johnson & Johnson.

Figures

Figure 1.
Figure 1.
Participant disposition.
Figure 2.
Figure 2.
Anti-EBOV GP–binding antibody responses (PP-immunogenicity subset).
See this image and copyright information in PMC

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