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Phase 2 N=226 Randomized Triple-blind Prevention

MVA Post-Event: Administration Timing and Boost Study

Smallpox

Enrolled (actual)
226
Serious AEs
2.7%
Results posted
Sep 2025
Primary outcome: Primary: Geometric Mean Titer (GMT) of Bavarian Nordic's (BN) Plaque Reduction Neutralizing Antibody Titer (PRNT) Assay in Groups A and B — 10.8; 30.2 titer

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Live vaccinia virus vaccine (Biological); MVA Smallpox Vaccine (Biological); Placebo (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion
Apr 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Geometric Mean Titer (GMT) of Bavarian Nordic's (BN) Plaque Reduction Neutralizing Antibody Titer (PRNT) Assay in Groups A and B
10.8; 30.2
PRIMARY
GMT of Saint Louis University's (SLU) PRNT Assay in Group A and Group B
27.4; 212.2
PRIMARY
Frequency of Serious Adverse Events (SAEs)
1; 2; 0; 0; 0; 3
PRIMARY
Frequency of Non-Serious AEs
32; 43; 4; 1; 0; 26
PRIMARY
Frequency of Local Solicited Reactogenicity AEs for Groups A, B, and D and Placebo A, B, and D
47; 50; 4; 1; 2; 0
PRIMARY
Frequency of Local Solicited Reactogenicity AEs for Groups C and F and Placebo F
8; 50; 1
PRIMARY
Frequency of Local Solicited Reactogenicity AEs for Group E and Placebo E
1; 0; 2; 2
PRIMARY
Frequency of Systemic Solicited Reactogenicity AEs for Groups A, B, and D and Placebo A, B, and D
31; 41; 2; 4; 3; 0
PRIMARY
Frequency of Systemic Solicited Reactogenicity AEs for Groups C, E, and F and Placebo E and F
5; 2; 33; 1; 3
SECONDARY
GMT of BN Enzyme Linked Immunosorbent Assay (ELISA) in Groups A and B
108.7; 501.7
SECONDARY
GMT of SLU ELISA in Groups A and B
60.5; 510.9

Summary

The purpose of this study is to evaluate an investigational smallpox vaccine, called IMVAMUNE®, with respect to safety and immune (body's defense system) response. Participants will include healthy adults, age 18 or older born after 1971, who have not had smallpox vaccine before. Participants were originally assigned to 1 of 5 groups. In July 2007, a hold was placed on the Dryvax® groups and the study was modified. Participants, will be assigned by chance to one of 3 groups to be vaccinated twice with IMVAMUNE® vaccine or placebo (inactive substance) in Groups A and B, or to receive a single vaccination with IMVAMUNE® or placebo in Group F. Participants will complete a memory aid (diary) for 15 days following vaccination. Blood samples will be collected. Participants may participate for up to 425 days.

Eligibility Criteria

Inclusion Criteria

-At least 18 years of age and born after 1971 -Never received smallpox vaccination -Read, signed, and dated informed consent document -Available for follow-up for the planned duration of the study (one year after last immunization) -Acceptable medical history by screening evaluation and limited physical assessment -If the subject is female and of childbearing potential, negative serum pregnancy test at screening and negative urine or serum pregnancy test within 24 hours prior to vaccination -If the subject is female and of childbearing potential, she agrees to use acceptable contraception, and not become pregnant for the duration of the study a. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized b. Acceptable contraception methods are restricted to effective devices (e.g., Intrauterine Devices (IUD)s, NuvaRing®) or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination, and abstinence from sexual intercourse with men (vaginal penetration by a penis, coitus) c. Women who are not sexually active must agree to use one of the acceptable contraception methods if they are of childbearing potential -Negative enzyme linked immunosorbent assay (ELISA) for human immunodeficiency virus (HIV) -Alanine aminotransferase (ALT) 140 mm Hg) or are on antihypertensive medication, and/or c. have a family history of coronary heart disease in male first-degree relative (father or brother) <55 years of age or a female first-degree relative (mother or sister) <65 years of age. -Current use of immunosuppressive medication a. Corticosteroid nasal sprays are permissible b. Persons who are using a topical steroid can be enrolled after their therapy is completed c. Inhaled steroids for asthma are not permissible -Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol -Any history of illegal injection drug use -Receipt of inactivated vaccine 14 days prior to vaccination -Receipt of live attenuated vaccine within 30 days prior to vaccination -Use of experimental agent within 30 days prior to vaccination -Receipt of blood products or immunoglobulin within six months prior to vaccination -Donation of a unit of blood within 56 days prior to vaccination or for the duration of the study -Acute febrile illness (greater than or equal to 100.5 degrees F) on the day of vaccination -Pregnant or lactating women -Eczema of any degree or history of eczema -People with atopic dermatitis, chronic exfoliative skin disorders/conditions, current Varicella zoster, or any acute skin disorders of large magnitude, e.g., laceration requiring sutures, burn greater than 2×2 cm -Any condition that, in the opinion of the investigator, might interfere with study objectives -Known allergy to IMVAMUNE® vaccine -Known allergy to egg or aminoglycoside -Study personnel

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00437021). 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.

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