SmallpoxPhase 2NCT00189956
Dose-finding Study to Evaluate Immunogenicity of Three Different Dose Levels of the IMVAMUNE (MVA-BN) Smallpox Vaccine.
A Phase 2 study testing IMVAMUNE (MVA-BN) in people with Smallpox, run by Bavarian Nordic at 1 site in Switzerland.
Trial summary
The objective of the study is to find the optimal dose for the smallpox candidate vaccine IMVAMUNE (MVA-BN). For this purpose the study compares IMVAMUNE (MVA-BN) administered at three different dose levels. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox
- What is being tested?
- IMVAMUNE (MVA-BN)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2003to Dec 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects, aged 18 - 30 years
- Signed informed consent after being advised of the risks and benefits of the study in a language able to understand, and prior to performance of any study specific procedure.
- Free of obvious health problems with acceptable medical history by screening evaluation and physical examination.
- Subject of not of child-bearing potential or all of the following: A urine/serum ß-HCG pregnancy test gives a negative result, use of adequate contraceptive precautions for 30 days before first vaccination.
Who cannot join
- Known or suspected history of smallpox vaccination or typical vaccinia scar.
- Positive test result in MVA specific ELISA or PRNT at screening.
- Positive result in HIV or HCV antibody test at screening.
- HbsAG positive at screening.
- Pregnancy or breast-feeding.
- Uncontrolled serious infection i.e. not responding to antimicrobial therapy
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- History of any serious medical condition, which in the opinion of the investigator, would compromise the safety of the subject.
- History of autoimmune disease
- History of malignancy.
- History of chronic alcohol abuse and/or intravenous drug abuse.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- History of anaphylaxis or severe allergic reaction.
- Acute disease (a moderate or severe illness with or without a fever) at the time of enrolment.
- Any vaccinations within a period starting 30 days prior to administration of the vaccine and ending at study conclusion.
- Chronic administration of immuno-suppressants or other immune-modifying drugs.
- Administration or planned administration of immunoglobulins and/or any blood products during the study period.
- Use of any investigational or non-registered drug or vaccine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II, Double-blind, Randomised, Dose-finding Study to Evaluate the Immunogenicity of Three Different Doses of MVA-BN Smallpox Vaccine in 18-30 Year Old Smallpox naïve Healthy Subjects
The objective of the study is to find the optimal dose for the smallpox candidate vaccine IMVAMUNE (MVA-BN). For this purpose the study compares IMVAMUNE (MVA-BN) administered at three different dose levels.
- Conditions
- Smallpox
- Being tested
- IMVAMUNE (MVA-BN)
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMVAMUNE (MVA-BN)Biological
Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | healthy, vaccinia naïve subjects 2 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous Receives: Biological: IMVAMUNE (MVA-BN) |
| Group 2 | Active comparator | healthy, vaccinia naïve subjects 5 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous Receives: Biological: IMVAMUNE (MVA-BN) |
| Group 3 | Active comparator | healthy, vaccinia naïve subjects
1 x 10E8 TCID50 IMVAMUNE (MVA-BN), subcutaneous Receives: Biological: IMVAMUNE (MVA-BN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ELISA seroconversion rate
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Measured: Day 42
Secondary outcomes (9)
ELISA seroconversion rate
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Measured: Days 28, 84
ELISA GMT
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'.
Measured: Days 28, 42, 84
PRNT seroconversion rate
Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Measured: Days 28, 42, 84
PRNT GMT
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
Measured: Days 28, 42, 84
Cytotoxic T-Lymphocyte response
The Cytotoxic T-Lymphocyte (CTL) response was determined by measuring IFNγ producing cells by Intracellular cytokine staining (ICS)
Measured: Days 28, 42, 84
Serious Adverse Events
Incidence, relationship and intensity of any Serious Adverse Event (SAE)
Measured: within 12 weeks
Solicited Local Adverse Events
Incidence and intensity of solicited local AEs. Percentages based on subjects with at least one completed diary card.
Measured: within 8 days after any vaccination
Solicited General Adverse Events
Incidence of solicited general AEs: Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.
Measured: within 8 days after any vaccination
Unsolicited Non-serious Adverse Events
Occurrence of unsolicited non-serious AEs: Intensity and relationship to vaccination
Measured: within 31 days after any vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionNov 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmallpoxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rolf Pokorny, M.D., Principal investigator, Swiss Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189956
- Sponsor's protocol ID
- POX-MVA-004
- Status last verified
- Dec 2018
- First submitted
- 11 Sep 2005
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
von Krempelhuber A, Vollmar J, Pokorny R, Rapp P, Wulff N, Petzold B, Handley A, Mateo L, Siersbol H, Kollaritsch H, Chaplin P. A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE. Vaccine. 2010 Feb 3;28(5):1209-16. doi: 10.1016/j.vaccine.2009.11.030. Epub 2009 Nov 25.
PubMed 19944151
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Double-blind, Randomised, Dose-finding Study to Evaluate the Immunogenicity of Three Different Doses of MVA-BN Smallpox Vaccine in 18-30 Year Old Smallpox naïve Healthy Subjects
- ClinicalTrials.gov ID
- NCT00189956
- Acronym / sponsor ID
- POX-MVA-004
- Conditions
- Smallpox
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Apr 2003
- Primary completion
- Nov 2003 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to find the optimal dose for the smallpox candidate vaccine IMVAMUNE (MVA-BN). For this purpose the study compares IMVAMUNE (MVA-BN) administered at three different dose levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: IMVAMUNE (MVA-BN)healthy, vaccinia naïve subjects 2 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous |
| Group 2 | Active comparator | Biological: IMVAMUNE (MVA-BN)healthy, vaccinia naïve subjects 5 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous |
| Group 3 | Active comparator | Biological: IMVAMUNE (MVA-BN)healthy, vaccinia naïve subjects 1 x 10E8 TCID50 IMVAMUNE (MVA-BN), subcutaneous |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects, aged 18 - 30 years
- Signed informed consent after being advised of the risks and benefits of the study in a language able to understand, and prior to performance of any study specific procedure.
- Free of obvious health problems with acceptable medical history by screening evaluation and physical examination.
- Subject of not of child-bearing potential or all of the following: A urine/serum ß-HCG pregnancy test gives a negative result, use of adequate contraceptive precautions for 30 days before first vaccination.
Key exclusion criteria (17 listed)
- Known or suspected history of smallpox vaccination or typical vaccinia scar.
- Positive test result in MVA specific ELISA or PRNT at screening.
- Positive result in HIV or HCV antibody test at screening.
- HbsAG positive at screening.
- Pregnancy or breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMVAMUNE (MVA-BN)Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval. | Biological | Group 1, Group 2, Group 3 |
Primary outcome
ELISA seroconversion rate
Time frame: Day 42
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
9 secondary outcomes
ELISA seroconversion rate
Time frame: Days 28, 84
ELISA GMT
Time frame: Days 28, 42, 84
PRNT seroconversion rate
Time frame: Days 28, 42, 84
PRNT GMT
Time frame: Days 28, 42, 84
Cytotoxic T-Lymphocyte response
Time frame: Days 28, 42, 84
Serious Adverse Events
Time frame: within 12 weeks
Solicited Local Adverse Events
Time frame: within 8 days after any vaccination
Solicited General Adverse Events
Time frame: within 8 days after any vaccination
Unsolicited Non-serious Adverse Events
Time frame: within 31 days after any vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Results publication: PubMed 19944151von Krempelhuber A, Vollmar J, Pokorny R, Rapp P, Wulff N, Petzold B, Handley A, Mateo L, Siersbol H, Kollaritsch H, Chaplin P. A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE. Vaccine. 2010 Feb 3;28(5):1209-16. doi: 10.1016/j.vaccine.2009.11.030. Epub 2009 Nov 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf Pokorny, M.D. principal investigator
Swiss Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMVAMUNE (MVA-BN) in people with Smallpox, run by Bavarian Nordic at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ELISA seroconversion rate (time frame: Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00189956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.