A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

A Multicenter, Open-label, Controlled Phase II Study to Evaluate Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in 18-40 Year Old Subjects With Diagnosed Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316602
• Other study ID #: POX-MVA-008
• Secondary ID: HHSN266200400072
• Status: Completed
• Phase: Phase 2
• Start date: July 2006
• Est. completion date: April 2010

Study information

• Verified date: December 2018
• Source: Bavarian Nordic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 632
• Est. completion date: April 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

Group 1 (Healthy Participants):

Subjects without present or history of any kind of atopy.

Group 2 (Atopic Dermatitis Participants):

Subjects with diagnosed atopic dermatitis.

All study subjects:

1. Male and female subjects between 18 and 40 years of age without history of smallpox vaccination.

2. Women must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination.

3. Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the first 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 last vaccination.

4. Lab values without clinically significant findings.

5. Electrocardiogram (ECG) without clinically significant findings.

Exclusion Criteria:

1. Pregnant or breast-feeding women.

2. Uncontrolled serious infection i.e. not responding to antimicrobial therapy.

3. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.

4. Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.

5. 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 at the vaccination site are excluded.

6. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.

7. History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before age 50 years.

8. Ten 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) NOTE: This criterion applies only to volunteers 20 years of age and older.

9. History of anaphylaxis or severe allergic reaction.

10. Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.

11. Administration of immunomodulatory substances.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Smallpox

Intervention

Biological:
• IMVAMUNE
Subjects receiving two subcutaneous vaccinations

Locations

Country	Name	City	State
Mexico	Instituto Dermatologico de Jalisco "Dr. Jose Barba Rubio"	Guadalajara	Jalisco
Mexico	Hospital Juárez de México	Magdalena De Las Salinas	CP
Mexico	CIFBIOTEC (Centro de Investigacion Farmacologica y Biotecnologica)	Mexico City
Mexico	Hospital General de México	Mexico City
Mexico	Hospital Regional Lic. Adolfo Lopez Mateos. ISSSTE Ciudad de Mexico	Mexico City
Mexico	Centro Regional de Alergia e Inmunología Clínica del Hospital Universitario "Dr. José Eleuterio González"	Monterrey
Mexico	Hospital Angel Leañol, Dermatology	Zapopan, Jalisco
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Northwestern University	Chicago	Illinois
United States	Dermatology Treatment & Research Center	Dallas	Texas
United States	Rx Clinical Research, Inc.	Garden Grove	California
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Adult & Pediatric Dermatology PC	Overland Park	Kansas
United States	Oregon Dermatology & Research Center	Portland	Oregon
United States	Dermatology Associates of Rochester	Rochester	New York
United States	Saint Louis University	Saint Louis	Missouri
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	Dermatology Clinical Research	San Antonio	Texas
United States	Alta Clinical Research LLC	Tucson	Arizona
United States	Solano Clinical Research	Vallejo	California

Sponsors (2)

Lead Sponsor	Collaborator
Bavarian Nordic	National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Mexico, 

References & Publications (1)

Greenberg RN, Hurley MY, Dinh DV, Mraz S, Vera JG, von Bredow D, von Krempelhuber A, Roesch S, Virgin G, Arndtz-Wiedemann N, Meyer TP, Schmidt D, Nichols R, Young P, Chaplin P. A Multicenter, Open-Label, Controlled Phase II Study to Evaluate Safety and Im — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Seroconversion by ELISA	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 Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.	week 6
Secondary	Percentage of Participants With Seroconversion by ELISA	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 Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.	within 32 weeks
Secondary	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'.	within 32 weeks
Secondary	Percentage of Participants With Seroconversion by PRNT	Seroconversion rate based on Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers = detection limit (15) 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.	within 32 weeks
Secondary	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'.	within 32 weeks
Secondary	ELISPOT IFN-? Values	Number of interferon gamma (IFN-?) secreting peripheral blood mononuclear cells (PBMC) per 10^6 PBMC in response to restimulation with MVA-BN detected by ELISPOT assay	within 6 weeks
Secondary	Number of Participants With SAEs	Occurrence, relationship and intensity of any serious AE (SAE)	within 32 weeks
Secondary	Number of Participants With Related Grade >=3 Adverse Events	Number of Participants with any Grade >=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited (general) and unsolicited AEs.	within 29 days after vaccination
Secondary	Number of Participants With Solicited Local Adverse Events	Number of Participants with and Intensity of solicited local AEs (erythema, swelling and pain). Percentages based on subjects with at least one completed diary card.	within 8 days after any vaccination
Secondary	Number of Participants With Solicited General AEs	Number of Participants with solicited systemic/general AEs (elevated body temperature, headache, myalgia, nausea, fatigue and chills): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.	within 8 days after any vaccination
Secondary	Number of Unsolicited Non-serious Adverse Events: Intensity	Occurrence of unsolicited non-serious AEs by Intensity	within 29 days after any vaccination
Secondary	Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination	Occurrence of unsolicited non-serious AEs by relationship to study vaccine	within 29 days after any vaccination