Phase 3
N=4,005
A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects
Smallpox
Bottom Line
View on ClinicalTrials.gov: NCT01144637 ↗Enrolled (actual)
4,005
Serious AEs
0.8%
Results posted
Jan 2019
Primary outcome: Primary: PRNT GMT — 110.7; 100.5; 117.2; 1.0 Titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IMVAMUNE® (Biological); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bavarian Nordic
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PRNT GMT |
110.7; 100.5; 117.2; 1.0 | — |
| SECONDARY ELISA GMT |
901.0; 794.4; 946.7; 1.2 | — |
| SECONDARY PRNT Seroconversion Rate |
99.8; 99.7; 99.8; 1.4 | — |
| SECONDARY ELISA Seroconversion Rate |
99.7; 99.5; 100.0; 2.0 | — |
| SECONDARY Correlation PRNT vs ELISA Titers |
0.581; 0.620; 0.612; 0.486 | — |
| SECONDARY Serious Adverse Events |
11; 7; 7; 8; 8; 6 | — |
| SECONDARY Cardiac Signs or Symptoms |
2; 5; 1; 1; 0; 0 | — |
| SECONDARY Related Grade >=3 Adverse Events |
58; 57; 53; 27 | — |
| SECONDARY Unsolicited Non-serious AEs: Intensity |
288; 350; 320; 280; 190; 236 | — |
| SECONDARY Unsolicited Non-serious AEs: Relationship to Vaccination |
187; 218; 181; 189; 40; 56 | — |
| SECONDARY Solicited Local AEs |
846; 823; 830; 187; 76; 66 | — |
| SECONDARY Solicited General AEs |
17; 19; 14; 9; 13; 15 | — |
Summary
A randomized, double-blind, placebo-controlled Phase III trial to evaluate immunogenicity and safety of three consecutive production lots of IMVAMUNE® (MVA-BN®) smallpox vaccine in healthy, vaccinia-naïve subjects.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects, 18 to 40 years of age
- The subject has read, signed and dated the informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject and prior to performance of any trial specific procedures
- BMI ≥ 18.5 and 60 ml/min as estimated by the Cockcroft-Gault equation:
- For men: (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dl x 72) = CrCl (ml/min)
- For women: multiply the result by 0.85 = CrCl (ml/min).
- Adequate hepatic function defined as:
- a. Total bilirubin ≤ 1.5 x ULN in the absence of other evidence of significant liver disease
- b. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤ 1.5 x ULN
- Troponin I 5 mg prednisone (or equivalent)/day or any other immune-modifying drugs during a period starting from three months prior to administration of the vaccine and ending at last physical trial visit (V5)
- Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy
- Administration or planned administration of immunoglobulins and/or any blood products during a period starting from three months prior to administration of the vaccine and ending at last physical trial visit (V5)
- Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the first dose of the trial vaccine, or planned administration of such a drug during the trial period
- Trial personnel
Data sourced from ClinicalTrials.gov (NCT01144637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.