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. 2023 Aug 2;11(8):1317.
doi: 10.3390/vaccines11081317.

The Effect of Previous Exposure to Malaria Infection and Clinical Malaria Episodes on the Immune Response to the Two-Dose Ad26.ZEBOV, MVA-BN-Filo Ebola Vaccine Regimen

Affiliations

The Effect of Previous Exposure to Malaria Infection and Clinical Malaria Episodes on the Immune Response to the Two-Dose Ad26.ZEBOV, MVA-BN-Filo Ebola Vaccine Regimen

Daniela Manno et al. Vaccines (Basel). .

Abstract

We assessed whether the immunogenicity of the two-dose Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen with a 56-day interval between doses was affected by exposure to malaria before dose 1 vaccination and by clinical episodes of malaria in the period immediately after dose 1 and after dose 2 vaccinations. Previous malaria exposure in participants in an Ebola vaccine trial in Sierra Leone (ClinicalTrials.gov: NCT02509494) was classified as low, intermediate, and high according to their antibody responses to a panel of Plasmodium falciparum antigens detected using a Luminex MAGPIX platform. Clinical malaria episodes after vaccinations were recorded as part of the trial safety monitoring. Binding antibody responses against the Ebola virus (EBOV) glycoprotein (GP) were measured 57 days post dose 1 and 21 days post dose 2 by ELISA and summarized as Geometric Mean Concentrations (GMCs). Geometric Mean Ratios (GMRs) were used to compare groups with different levels of exposure to malaria. Overall, 587 participants, comprising 188 (32%) adults (aged ≥ 18 years) and 399 (68%) children (aged 1-3, 4-11, and 12-17 years), were included in the analysis. There was no evidence that the anti-EBOV-GP antibody GMCs post dose 1 and post dose 2 differed between categories of previous malaria exposure. There was weak evidence that the GMC at 57 days post dose 1 was lower in participants who had had at least one episode of clinical malaria post dose 1 compared to participants with no diagnosed clinical malaria in the same period (GMR = 0.82, 95% CI: 0.69-0.98, p-value = 0.02). However, GMC post dose 2 was not reduced in participants who experienced clinical malaria post-dose 1 and/or post-dose 2 vaccinations. In conclusion, the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen is immunogenic in individuals with previous exposure to malaria and in those who experience clinical malaria after vaccination. This vaccine regimen is suitable for prophylaxis against Ebola virus disease in malaria-endemic regions.

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

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Conflict of interest statement

A.G., B.K. (Babajide Keshinro) and C.R. are full-time employees of Janssen, Pharmaceutical Companies of Johnson & Johnson. A.G. and C.R. report ownership of shares in Janssen, Pharmaceutical Companies of Johnson & Johnson. All other authors declare funding from the IMI 2 Joint Undertaking. The funders (IMI) had no role in the design of the study; in the collection, analysis, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1
Figure 1
Malaria study conceptual framework. Note: the potential effect of malaria infection on vaccine immunogenicity was considered in three ways: (1) exposure to malaria before vaccination, (2) exposure to malaria at the time of vaccination, described previously [18], and (3) exposure to malaria after vaccination. Assessment of vaccine immunogenicity post dose 1 was evaluated on Day 57. Assessment of vaccine immunogenicity post dose 2 (a measure of the overall immunogenicity of the vaccine regimen), was evaluated on Day 78 (21 days after dose 2 vaccination).
Figure 2
Figure 2
Study flow diagram showing the recruitment process and sample availability for laboratory analysis.

References

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