VAC52150EBL4006

Prospective, Multi-country, Non-interventional, Case-control with Test- negative Controls to Estimate the Effectiveness of the Ad26.ZEBOV, MVA-BN-Filo Vaccine Regimen Against Ebola Virus Disease in Real-world Setting (v2.0, 23 January 2024)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202409720685028

Enrollment

840

Registered

2024-09-02

Start date

2025-01-05

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ebola

Interventions

Ad26 ZEBOV MVA BN Filo vaccine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Must have suspected EVD according to the WHO case definition refer to Section 3.1.2.1). 2. Must have PCR test planned to be performed. 3. Must have informed consent planned to be collected (ie, individual consent, community- or country-based group consent, refer to Section 7.1) Matching Methods for Alternative Control Group 1. Must be healthy or have medically stable chronic diseases 2. Must have same age (range ±5 years), occupation, and geographic location (to be defined in each country) 3. Must not have suspected EVD 4. Must have informed consent planned to be collected

Exclusion criteria

Exclusion criteria: Not Applicable

Design outcomes

Primary

Measure	Time frame
PCR-confirmed diagnostic of EVD in suspected EVD cases received at ETU - To estimate the vaccine effectiveness of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen (given =42 days apart, with the second dose administered =3 weeks and =2 years [ie, 730 days] before presenting at the ETU) or a booster dose ofAd26.ZEBOV (given =7 days and =2 years [i.e., 730 days] before presenting at the ETU) against polymerase chain reaction (PCR)-confirmed EVD in adults and children	—

Measure

Time frame

PCR-confirmed diagnostic of EVD in suspected EVD cases received at ETU - To estimate the vaccine effectiveness of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen (given =42 days apart, with the second dose administered =3 weeks and =2 years [ie, 730 days] before presenting at the ETU) or a booster dose ofAd26.ZEBOV (given =7 days and =2 years [i.e., 730 days] before presenting at the ETU) against polymerase chain reaction (PCR)-confirmed EVD in adults and children

—

Secondary

Measure	Time frame
1) To estimate the vaccine effectiveness of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen (given =42 days apart, with the second dose administered =3 weeks and =2 years [ie, 730 days] before presenting at the ETU) or a booster dose of Ad26.ZEBOV (given =7 days and =2 years [ie, 730 days] before presenting at the ETU) against PCR-confirmed EVD in adults and children in terms of: a) Death related to EVD b) Presence of complications in PCR-confirmed EVD c) Supplemental oxygen given d) Intravenous fluid resuscitation required 2) To estimate the vaccine effectiveness of the Ad26.ZEBOV vaccine (given =3 weeks and =1 year [ie, 365 days] before presenting at an ETU) against PCR-confirmed EVD in adults and children vaccinated with Ad26.ZEBOV only	—

Measure

Time frame

1) To estimate the vaccine effectiveness of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen (given =42 days apart, with the second dose administered =3 weeks and =2 years [ie, 730 days] before presenting at the ETU) or a booster dose of Ad26.ZEBOV (given =7 days and =2 years [ie, 730 days] before presenting at the ETU) against PCR-confirmed EVD in adults and children in terms of: a) Death related to EVD b) Presence of complications in PCR-confirmed EVD c) Supplemental oxygen given d) Intravenous fluid resuscitation required 2) To estimate the vaccine effectiveness of the Ad26.ZEBOV vaccine (given =3 weeks and =1 year [ie, 365 days] before presenting at an ETU) against PCR-confirmed EVD in adults and children vaccinated with Ad26.ZEBOV only

—

Countries

Congo, Guinea, Rwanda, Sierra Leone, Uganda

Contacts

Public ContactHugo Kavunga Membo

Principal Investigator

hugokavunga@gmail.com+243993549796

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026