Clinical and immunologic responses to multiple doses of IMVAMUNE (Modified Vaccinia Ankara) followed by Dryvax challenge.
Smallpox vaccination with replication deficient vaccinia strains such as Modified Vaccinia Ankara (MVA) may induce protective immunity with improved safety and tolerability profiles compared with currently available smallpox vaccines. Ninety subjects were randomized equally to six groups in a partially blinded, randomized, controlled clinical trial. IMVAMUNE (MVA-BN, Bavarian Nordic A/S, Kvistgård, Denmark) vaccine or placebo was administered at Study Days 0 and 28 by subcutaneous or intramuscular injection and five groups were challenged with Dryvax at study Day 112. Vaccination with two doses of IMVAMUNE was safe and well tolerated compared to Dryvax. IMVAMUNE produced comparable cellular and humoral immune responses to one dose of Dryvax and the immunity induced appears robust 90 days post-vaccination by evidence of attenuated primary cutaneous reaction responses following Dryvax. IMVAMUNE vaccination prior to Dryvax reduced virus replication at the Dryvax site, decreased the size of the primary cutaneous lesion, and decreased the time to healing but did not completely ameliorate the immune response.
Department of Medicine, Saint Louis University School of Medicine and National Institute of Allergy and Infectious Diseases Vaccine Treatment and Evaluation Unit, 1100 S. Grand Blvd (DRC-8), St. Louis, MO 63104, USA. freyse@slu.edu
Sharon E
SE
Frey
Frances K
FK
Newman
Jeffrey S
JS
Kennedy
Vera
V
Sobek
Francis A
FA
Ennis
Heather
H
Hill
Lihan K
LK
Yan
Paul
P
Chaplin
Jens
J
Vollmar
Bernard R
BR
Chaitman
Robert B
RB
Belshe
D000293:Adolescent; D000328:Adult; D002626:Chemistry, Pharmaceutical; D004797:Enzyme-Linked Immunosorbent Assay; D004890:Erythema / Q000276:immunology; D005260:Female; D006331:Heart Diseases / Q000235:genetics; D006801:Humans; D007074:Immunoglobulin G / Q000096:biosynthesis / Q000276:immunology; D007371:Interferon-gamma / Q000096:biosynthesis / Q000235:genetics; D008297:Male; D012867:Skin / Q000473:pathology; D012900:Smallpox Vaccine / Q000009:adverse effects / Q000276:immunology*; D013601:T-Lymphocytes / Q000276:immunology; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology*; D014616:Vaccinia virus / Q000276:immunology*; D010948:Viral Plaque Assay
D007074:Immunoglobulin G; D012900:Smallpox Vaccine; D014613:Vaccines, Attenuated; D007371:Interferon-gamma; C527606:smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic