AzTrials
AzTrials

SmallpoxPhase 2NCT00686582

An Open-Label Phase II Study to Evaluate Immunogenicity and Safety of a Single IMVAMUNE Booster Vaccination Two Years After the Last IMVAMUNE Vaccination in Former POX-MVA-005 Vaccinees

A Phase 2 study testing IMVAMUNE and Blood Draw Only in people with Smallpox, run by Bavarian Nordic at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study was preformed to evaluate the persistence of antibodies following vaccination with MVA-BN and to assess the immunological memory response induced by a booster vaccination with MVA-BN in subjects two years after their participation in trial POX-MVA-005 (NCT00316524) in which they had received one or two doses… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Smallpox
What is being tested?
IMVAMUNE and Blood Draw Only
Type of treatment
Vaccines, Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
304 participants
Where
1 siteGermany
Study dates
Aug 2008to Jun 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Groups 1 and 2 (first consenting 75 subjects in each group to be vaccinated)
  • Male and female subjects having participated in Group 1 or 2 of the study POX-MVA-005 who completed the trial according to protocol.
  • Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination.
  • Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the vaccination, must agree to use an acceptable method of contraception during the study, and must not become pregnant for at least 28 days after the vaccination. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products.)
  • Read, signed and dated informed consent document after being advised of the risks and benefits of the study in a language understood by the subject signed, and prior to performance of any study specific procedure.
  • Troponin I within normal institutional limits.
Show all 21Show fewer
  • White blood cells ≥ 2,500/mm3 and <= 11,000/mm3.
  • Absolute neutrophil count within normal limits.
  • Negative urine glucose by dipstick or urinalysis.
  • Hemoglobin within the laboratory reference ranges (unless the investigator considers the deviation to be not clinically significant).
  • Platelets 100 - 440/nL.
  • Adequate renal function defined as:
  • Serum creatinine without clinically significant findings.
  • Urine protein <= 30 mg/dL or none or trace proteinuria (by urinalysis or dip stick).
  • Adequate hepatic function defined as:
  • Total bilirubin <= 1.5 x upper limit of normal (ULN) in the absence of other evidence of significant liver disease (healthy subjects without clinical disease; Morbus Meulengracht can be included).
  • AST (SGOT), ALT (SGPT), alkaline phosphatase without clinically significant findings.
  • Electrocardiogram (ECG) without clinically relevant abnormal findings (e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two premature ventricular contractions (PVC) in a row, ST elevation consistent with ischemia).
  • Group 4 (all subjects) and Groups 1 and 2 (subjects N > 75): blood draw only
  • Male and female subjects having participated in the study POX-MVA-005 who completed the trial according to protocol.
  • Read, signed and dated informed consent document after being advised of the risks and benefits of the blood draw in a language understood by the subject signed, and prior to performance of the blood draw.

Who cannot join

  • Groups 1 and 2 (first consenting 75 subjects in each group to be vaccinated)
  • Participation in another study with a smallpox vaccine after the POX-MVA-005 study.
  • Pregnant or breast-feeding women.
  • Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
  • History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject.
  • History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
Show all 26Show fewer
  • Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
  • History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous site of cancer.
  • History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
  • Clinically significant mental disorder not adequately controlled by medical treatment.
  • Any condition which might interfere with study objectives or would limit the subject's ability to complete the study or to be compliant in the opinion of the investigator.
  • History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.
  • History of an immediate family member (father, mother, brother, or sister) who died due to ischemic heart disease before age 50 years.
  • Twenty percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool. (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof).
  • History of intravenous drug abuse.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. tris (hydroxymethyl)-amino methane, chicken embryo fibroblast proteins, aminoglycosides (gentamycin).
  • History of any anaphylactic shock or severe allergic reaction requiring immediate treatment.
  • Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior or after study vaccination.
  • Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior or after study vaccination.
  • Chronic administration (defined as more than 14 days) of > 5 mg prednisone (or equivalent) per day or any other immune-modifying drugs during a period starting from three months prior to administration of the vaccine and ending at study conclusion (Visit 4).
  • 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 3 months prior to administration of the vaccine and ending at study conclusion.
  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding administration of the study vaccine, or planned administration of such a drug during the study period.
  • Group 4 (all subjects) and Groups 1 and 2 (subjects N > 75): blood draw only
  • Participation in another study with a smallpox vaccine after the POX-MVA-005 study.
  • Any condition which might interfere with a blood draw.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Harrison Clinical Research Deutschland GmbH

    München, 80636

Other trials in Germany

About this study

The study was preformed to evaluate the persistence of antibodies following vaccination with MVA-BN and to assess the immunological memory response induced by a booster vaccination with MVA-BN in subjects two years after their participation in trial POX-MVA-005 (NCT00316524) in which they had received one or two doses of MVA-BN.

Conditions
Smallpox
Being tested
IMVAMUNE, Blood Draw Only
Medical subject headings
Smallpox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMVAMUNEBiological

    1x 10E8_TCID50

  • IMVAMUNEBiological

    1x 10E8_TCID50

  • Blood Draw OnlyProcedure or surgery

Study groups in NCT00686582
Study groupRoleWhat they receive
Initially Vaccinia Naive, 2 dose primed, 1 booster doseExperimentalGroup 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005) 1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8_TCID50
Receives: Biological: IMVAMUNE
Initially Vaccinia Naive, 1 dose primed, 1 booster doseExperimentalGroup 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005) 1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8_TCID50
Receives: Biological: IMVAMUNE
Vaccinia Experienced, boosted, blood draw onlyOtherGroup 4 Vaccinia Experienced 1 booster dose of MVA-BN in prior study (POX-MVA-005) Blood draw, Screening Visit only (POX-MVA-023)
Receives: Procedure: Blood Draw Only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Individual Peak Booster Rate by ELISA (Percentage of Participants)

    Booster rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA) is defined as the percentage of subjects with an appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual Peak booster rate is based on the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4). Percentages based on number of subjects with data available.

    Measured: within 4 weeks

Secondary outcomes (10)

  1. Booster Rate by ELISA (Percentage of Participants)

    Booster rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA) is defined as the percentage of subjects with an appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.

    Measured: within 26 weeks

  2. ELISA GMT

    Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4). Titers below the detection limit are included with a value of '1'.

    Measured: within 26 weeks

  3. Booster Rate by PRNT (Percentage of Participants)

    Booster rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT) is defined as the percentage of subjects with an appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects.

    Individual Peak booster rate is based on the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4).

    Percentages based on number of subjects with data available.

    Measured: within 26 weeks

  4. PRNT GMT

    Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Individual peak is defined as the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4). Titers below the detection limit are included with a value of '1'.

    Measured: within 26 weeks

  5. Correlation PRNT vs ELISA Titers

    Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers

    Measured: within 26 weeks

  6. Number of Participants With Related Serious Adverse Events

    Number of participants with Serious Adverse Events (SAEs) probably, possibly or definitely related to the trial vaccine

    Measured: within 26 weeks

  7. Number of Participants With Unsolicited Non-serious Adverse Events

    Number of participants with any, grade >=3, and related non-serious unsolicited adverse events

    Measured: within 29 days after any vaccination

  8. Number of Participants With Related Grade >= 3 Unsolicited Adverse Events

    Number of participants with Grade >=3 Unsolicited Adverse Event probably, possibly, or definitely related to the study vaccine

    Measured: within 29 days after vaccination

  9. Number of Participants With Solicited Local Adverse Events

    Number of participants with and intensity of solicited local AEs (pain, erythema, swelling, induration, and pruritis). Percentages based on subjects with a completed diary card.

    Measured: within 8 days after vaccination

  10. Number of Participants With Solicited General Adverse Events

    Number of participants with solicited general AEs (body temperature increased, headache, myalgia, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with a completed diary card.

    Measured: within 8 days after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionDec 2008
  4. Study completionJun 2009

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00686582
Sponsor's protocol ID
POX-MVA-023
Other IDs
EudraCT-No.2007-006297-28, DMID 08-0018
Status last verified
Feb 2019
First submitted
27 May 2008
Last updated
13 Mar 2019
Data monitoring committee
Yes

Publications

  • Ilchmann H, Samy N, Reichhardt D, Schmidt D, Powell JD, Meyer TPH, Silbernagl G, Nichols R, Weidenthaler H, De Moerlooze L, Chen L, Chaplin P. One- and Two-Dose Vaccinations With Modified Vaccinia Ankara-Bavarian Nordic Induce Durable B-Cell Memory Responses Comparable to Replicating Smallpox Vaccines. J Infect Dis. 2023 May 12;227(10):1203-1213. doi: 10.1093/infdis/jiac455.

    PubMed 36408618

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMVAMUNE and Blood Draw Only in people with Smallpox, run by Bavarian Nordic at 1 site in Germany.

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 21 inclusion and 26 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 13 Mar 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 Germany. 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?

Yes. Results are posted in the registry (first posted 18 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Individual Peak Booster Rate by ELISA (Percentage of Participants) (time frame: within 4 weeks). 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 NCT00686582, 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 13 Mar 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in