PregInPoxVac | MATERNAL AND INFANT SAFETY AND IMMUNOGENICITY IN A PHASE 3, OPEN-LABEL, RANDOMISED, VACCINE TRIAL OF A TWO-DOSE MPOX VACCINE

Summary
Mpox can cause severe complications in vulnerable groups such as pregnant women and children, necessitating targeted public health interventions and vaccine trials in these populations. Limited data suggest the MVA-BN vaccine is safe for pregnant women and likely poses no risk to breastfed infants, but comprehensive human data are lacking. Trials in endemic areas are crucial for evaluating the vaccine's safety and efficacy in real-world settings.

Vaccine hesitancy, exacerbated by misinformation and distrust in healthcare systems, poses a significant challenge, especially in the Democratic Republic of the Congo. Pregnant women are particularly affected by concerns about vaccine safety, which influences their willingness to vaccinate. Addressing these concerns through targeted communication and community engagement is vital.

A proposed phase 3, randomized trial will assess the safety and immunogenicity of the MVA-BN vaccine in healthy pregnant and postpartum women and in infants/children (6-24 months old). Additionally, a qualitative study on vaccine hesitancy will inform the trial design and implementation, aiming to enhance vaccination uptake in these high-risk groups.
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More information & hyperlinks
Web resources: https://cordis.europa.eu/project/id/101195533
Start date: 01-08-2024
End date: 31-07-2027
Total budget - Public funding: 1 599 327,50 Euro - 1 599 327,00 Euro
Cordis data

Original description

Mpox can cause severe complications in vulnerable groups such as pregnant women and children, necessitating targeted public health interventions and vaccine trials in these populations. Limited data suggest the MVA-BN vaccine is safe for pregnant women and likely poses no risk to breastfed infants, but comprehensive human data are lacking. Trials in endemic areas are crucial for evaluating the vaccine's safety and efficacy in real-world settings.

Vaccine hesitancy, exacerbated by misinformation and distrust in healthcare systems, poses a significant challenge, especially in the Democratic Republic of the Congo. Pregnant women are particularly affected by concerns about vaccine safety, which influences their willingness to vaccinate. Addressing these concerns through targeted communication and community engagement is vital.

A proposed phase 3, randomized trial will assess the safety and immunogenicity of the MVA-BN vaccine in healthy pregnant and postpartum women and in infants/children (6-24 months old). Additionally, a qualitative study on vaccine hesitancy will inform the trial design and implementation, aiming to enhance vaccination uptake in these high-risk groups.

Status

SIGNED

Call topic

HORIZON-JU-GH-EDCTP3-2024-Mpox

Update Date

06-11-2024
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Horizon Europe
HORIZON.2 Global Challenges and European Industrial Competitiveness
HORIZON.2.1 Health
HORIZON.2.1.0 Cross-cutting call topics
HORIZON-JU-GH-EDCTP3-2024-Mpox Mobilisation of Emergency funding for Mpox outbreak research response