Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRC

PHASE3RecruitingINTERVENTIONAL
Enrollment

359

Participants

Timeline

Start Date

June 23, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

May 31, 2027

Conditions
NeonateMaternal TransmissionMpoxVaccinationImmunogenicitySafetyPregnancyPostpartum
Interventions
BIOLOGICAL

MVA-BN standard regimen

The MVA-BN vaccine, with the active ingredient: Modified Vaccinia Ankara-Bavarian Nordic, will be administered as a standard two-dose regimen at 1x10\^8 TCID50 Inf.U./0.5 mL. The doses will be given 28 days apart (±3 days) via subcutaneous injection into the deltoid muscle, preferably in the non-dominant arm.

BIOLOGICAL

MVA-BN standard regimen (Administered as PEP)

"MVA-BN. Post Exposure Prophylaxis (PEP)~The MVA-BN vaccine, with the active ingredient: Modified Vaccinia Ankara-Bavarian Nordic, will be administered as a standard two-dose regimen at 1x10\^8 TCID50 Inf.U./0.5 mL. The doses will be given 28 days apart (±3 days) via subcutaneous injection into the deltoid muscle, preferably in the non-dominant arm.~For Maternal Group 3, MVA-Bn will be administered as PEP as soon as possible after exposure, preferably within 4 days after exposure. However, as per WHO guidelines, PEP will be offered up to 14 days after exposure if the pregnant woman has not yet developed symptoms."

Trial Locations (1)

Unknown

RECRUITING

Boende Hôpital Général de Référence, Boende

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PENTA Foundation

NETWORK

collaborator

Ace Africa

OTHER

collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

collaborator

Bavarian Nordic

INDUSTRY

collaborator

University of Kinshasa

OTHER

lead

Jean-Pierre Van geertruyden

OTHER

NCT06844500 - Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRC | Biotech Hunter | Biotech Hunter