Trial Outcomes & Findings for Special Access Program IMVAMUNE® (NCT NCT03472014)

Results Overview

Seropositivity rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seropositivity is defined as antibody titers ≥ detection limit (50). Percentages based on number of subjects with data available.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

22 participants

Primary outcome timeframe

up to Week 7

Results posted on

2020-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	MVA-BN Two s.c. vaccinations with 0.5 ml MVA-BN® vaccine containing 1 x 10E8 TCID50 / dose
Overall Study STARTED	22
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	MVA-BN Two s.c. vaccinations with 0.5 ml MVA-BN® vaccine containing 1 x 10E8 TCID50 / dose
Overall Study Lost to Follow-up	4

Baseline Characteristics

Special Access Program IMVAMUNE®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MVA-BN n=22 Participants Two s.c. vaccinations with 0.5 ml MVA-BN® vaccine containing 1 x 10E8 TCID50 / dose
Age, Continuous	34.36 years STANDARD_DEVIATION 8.83 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: up to Week 7

Population: Full Analysis Set

Seropositivity rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seropositivity is defined as antibody titers ≥ detection limit (50). Percentages based on number of subjects with data available.

Outcome measures

Outcome measures
Measure	MVA-BN n=22 Participants Two s.c. vaccinations with 0.5 ml MVA-BN® vaccine containing 1 x 10E8 TCID50 / dose
ELISA Seropositivity Rate Screening	40.9 percentage of subjects Interval 20.7 to 63.7
ELISA Seropositivity Rate Week 7	100.0 percentage of subjects Interval 84.6 to 100.0

SECONDARY outcome

Timeframe: Week 7

Population: Full Analysis Set

Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to the Screening titer for initially seropositive subjects. Percentages based on number of subjects with data available.

Outcome measures

Outcome measures
Measure	MVA-BN n=22 Participants Two s.c. vaccinations with 0.5 ml MVA-BN® vaccine containing 1 x 10E8 TCID50 / dose
ELISA Seroconversion Rate	90.9 percentage of subjects Interval 70.8 to 98.9

SECONDARY outcome

Timeframe: up to Week 7

Population: Full Analysis Set

Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.

Outcome measures

Outcome measures
Measure	MVA-BN n=22 Participants Two s.c. vaccinations with 0.5 ml MVA-BN® vaccine containing 1 x 10E8 TCID50 / dose
ELISA GMT Screening	370.08 Titer Interval 166.3 to 823.5
ELISA GMT Week 7	14961.54 Titer Interval 11163.8 to 20051.1

SECONDARY outcome

Timeframe: up to 32 weeks

Population: Full Analysis Set

Incidence, relationship and intensity of any Serious Adverse Event (SAE).

Outcome measures

Outcome measures
Measure	MVA-BN n=22 Participants Two s.c. vaccinations with 0.5 ml MVA-BN® vaccine containing 1 x 10E8 TCID50 / dose
Serious Adverse Events	0 Participants

SECONDARY outcome

Timeframe: within 29 days after any vaccination

Population: Full Analysis Set

Incidence of any Grade \>=3 Adverse Events possibly, probably or definitely related to the trial vaccine

Outcome measures

Outcome measures
Measure	MVA-BN n=22 Participants Two s.c. vaccinations with 0.5 ml MVA-BN® vaccine containing 1 x 10E8 TCID50 / dose
Related Grade >=3 Adverse Events	1 Participants

SECONDARY outcome

Timeframe: within 29 days after any vaccination

Population: Full Analysis Set

Incidence of non-serious AEs

Outcome measures

Outcome measures
Measure	MVA-BN n=22 Participants Two s.c. vaccinations with 0.5 ml MVA-BN® vaccine containing 1 x 10E8 TCID50 / dose
Non-serious AEs	19 Participants

Adverse Events

MVA-BN

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MVA-BN n=22 participants at risk Two s.c. vaccinations with 0.5 ml MVA-BN® vaccine containing 1 x 10E8 TCID50 / dose
General disorders Fatigue	18.2% 4/22 • up to 32 weeks
General disorders Injection site erythema	36.4% 8/22 • up to 32 weeks
General disorders Injection site induration	27.3% 6/22 • up to 32 weeks
General disorders Injection site pain	68.2% 15/22 • up to 32 weeks
General disorders Injection site pruritis	18.2% 4/22 • up to 32 weeks
General disorders Injection site swelling	36.4% 8/22 • up to 32 weeks
Musculoskeletal and connective tissue disorders Myalgia	9.1% 2/22 • up to 32 weeks
Nervous system disorders Headache	18.2% 4/22 • up to 32 weeks

Additional Information

Program Lead, Clinical Operations

Bavarian Nordic A/S

Phone: +45 3326

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place