Trial Outcomes & Findings for Assessment of Safety Profile of MVA-BN Vaccine in the PALM-007 Study in DRC (NCT NCT05734508)
NCT ID: NCT05734508
Last Updated: 2026-02-12
Results Overview
Number of participants with an SAE up to 14 days after dose
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
500 participants
Primary outcome timeframe
Within 14 days of first vaccine dose
Results posted on
2026-02-12
Participant Flow
Participants were recruited at three sites from March 2023 to June 2024. The first two sites were Tunda and Kole General Hospitals, in Maniema and Sankuru provinces, DRC (the two sites where participants with mpox were enrolled in the PALM 007 therapeutic RCT). The third site subsequently opened at the INRB main campus in Kinshasa, DRC. Adult participants (≥18 years) were recruited from PALM 007 study staff, although it was not mandatory for staff to be vaccinated or participate in the trial.
Participant milestones
| Measure |
MVA-BN Mpox Vaccine
This arm, which includes all participants in this observational safety study, received the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine, an attenuated, live, non-replicating virus, administered in two doses separated by at least 28 days.
|
|---|---|
|
Overall Study
STARTED
|
500
|
|
Overall Study
Received First Vaccine Dose
|
500
|
|
Overall Study
Received Second Vaccine Dose
|
494
|
|
Overall Study
COMPLETED
|
494
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
MVA-BN Mpox Vaccine
This arm, which includes all participants in this observational safety study, received the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine, an attenuated, live, non-replicating virus, administered in two doses separated by at least 28 days.
|
|---|---|
|
Overall Study
Pregnancy
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MVA-BN Mpox Vaccine
n=500 Participants
This arm, which includes all participants in this observational safety study, received the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine, an attenuated, live, non-replicating virus, administered in two doses separated by at least 28 days.
|
|---|---|
|
Age, Continuous
|
34.3 Years
STANDARD_DEVIATION 11.4 • n=500 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=500 Participants
|
|
Sex: Female, Male
Male
|
391 Participants
n=500 Participants
|
PRIMARY outcome
Timeframe: Within 14 days of first vaccine doseNumber of participants with an SAE up to 14 days after dose
Outcome measures
| Measure |
MVA-BN Mpox Vaccine
n=500 Participants
This arm, which includes all participants in this observational safety study, received the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine, an attenuated, live, non-replicating virus, administered in two doses separated by at least 28 days.
|
|---|---|
|
Frequency of SAEs After First Dose of MVA-BN Vaccine
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 14 days of second vaccine doseNumber of participants with an SAE up to 14 days after dose
Outcome measures
| Measure |
MVA-BN Mpox Vaccine
n=494 Participants
This arm, which includes all participants in this observational safety study, received the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine, an attenuated, live, non-replicating virus, administered in two doses separated by at least 28 days.
|
|---|---|
|
Frequency of SAEs After Second Dose of MVA-BN Vaccine
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 14 days of first vaccine doseNumber of participants with an AE within 14 days of first vaccine dose
Outcome measures
| Measure |
MVA-BN Mpox Vaccine
n=500 Participants
This arm, which includes all participants in this observational safety study, received the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine, an attenuated, live, non-replicating virus, administered in two doses separated by at least 28 days.
|
|---|---|
|
Frequency of AEs After First Dose of MVA-BN Vaccine
|
219 Participants
|
PRIMARY outcome
Timeframe: Within 28 days of second vaccine doseNumber of participants with an AE up to 28 days after second vaccine dose
Outcome measures
| Measure |
MVA-BN Mpox Vaccine
n=494 Participants
This arm, which includes all participants in this observational safety study, received the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine, an attenuated, live, non-replicating virus, administered in two doses separated by at least 28 days.
|
|---|---|
|
Frequency of AEs After Second MVA-BN Vaccine Dose
|
102 Participants
|
Adverse Events
MVA-BN Mpox Vaccine
Serious events: 0 serious events
Other events: 281 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MVA-BN Mpox Vaccine
n=500 participants at risk
This arm, which includes all participants in this observational safety study, received the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine, an attenuated, live, non-replicating virus, administered in two doses separated by at least 28 days.
|
|---|---|
|
General disorders and administration site conditions
Pyrexia
|
13.4%
67/500 • Number of events 67 • From enrollment until the end of follow-up, up to 28 days after receipt of the second vaccine dose
|
|
General disorders and administration site conditions
Vaccination site pain
|
32.8%
164/500 • Number of events 164 • From enrollment until the end of follow-up, up to 28 days after receipt of the second vaccine dose
|
|
Nervous system disorders
Headache
|
14.4%
72/500 • Number of events 72 • From enrollment until the end of follow-up, up to 28 days after receipt of the second vaccine dose
|
Additional Information
Nsengi Ntamabyaliro
National Institute of Biomedical Research, Democratic Republic of the Congo
Phone: +243815171991
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place