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

NCT00686582 | Completed Phase 2 Results DMC

• 3 other identifiers: POX-MVA-023EudraCT-No.2007-006297-28DMID 08-0018
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief 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 of MVA-BN.

Conditions

Smallpox

Outcome Measures

Primary Outcomes (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.

  within 4 weeks

Secondary Outcomes (10)

• Booster Rate by ELISA (Percentage of Participants)

  within 26 weeks

• ELISA GMT

  within 26 weeks

• Booster Rate by PRNT (Percentage of Participants)

  within 26 weeks

• PRNT GMT

  within 26 weeks

• Correlation PRNT vs ELISA Titers

  within 26 weeks

Study Arms (3)

Initially Vaccinia Naive, 2 dose primed, 1 booster dose

EXPERIMENTAL

Group 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

Biological: IMVAMUNE

Initially Vaccinia Naive, 1 dose primed, 1 booster dose

EXPERIMENTAL

Group 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

Biological: IMVAMUNE

Vaccinia Experienced, boosted, blood draw only

OTHER

Group 4 Vaccinia Experienced 1 booster dose of MVA-BN in prior study (POX-MVA-005) Blood draw, Screening Visit only (POX-MVA-023)

Procedure: Blood Draw Only

Interventions

IMVAMUNE BIOLOGICAL

1x 10E8\_TCID50

Initially Vaccinia Naive, 2 dose primed, 1 booster dose

Blood Draw Only PROCEDURE

Vaccinia Experienced, boosted, blood draw only

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Bavarian Nordic: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Harrison Clinical Research Deutschland GmbH

München, 80636, Germany

Location

Related Publications (1)

• 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.

  PMID: 36408618 DERIVED

MeSH Terms

Conditions

Smallpox

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Program Lead, Clinical Operations
• Organization: Bavarian Nordic A/S

info@bavarian-nordic.com

+45 3326

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2009
• Last Updated: March 13, 2019
• Results First Posted: February 18, 2019

Record last verified: 2019-02

Locations

DE (1)