Response to smallpox vaccine in persons immunized in the distant past.
BACKGROUND
There is renewed interest in use of smallpox vaccine due to the potential for a bioterrorist attack. This would involve vaccinating health care workers who were previously vaccinated.


OBJECTIVE
To evaluate the use of diluted vaccinia virus in vaccination of previously vaccinated (non-naive) participants.


METHODS
Eighty non-naive participants, aged 32 to 60 years, were randomized in a single-blinded study to receive either undiluted or diluted (1:3.2, 1:10, or 1:32) doses of smallpox vaccine. A comparison group, aged 18 to 31 years, of 10 vaccinia-naive participants received undiluted vaccine. Participants were enrolled between April 1 and May 15, 2002, at the National Institute of Allergy and Infectious Diseases Vaccine and Treatment Evaluation Unit at Saint Louis University, St Louis, Mo.


METHODS
Smallpox vaccine was administered by scarification using 15 skin punctures in the deltoid region of the arm.


METHODS
Presence of a major reaction, defined as a vesicular or pustular lesion or area of palpable induration surrounding a central lesion following vaccination, and measures of viral shedding and antibody titers.


RESULTS
Initial vaccination resulted in a major reaction in 64 of 80 non-naive participants. Ninety-five percent of non-naive participants had major reactions in the undiluted group, 90% in the 1:3.2 dilution group, 81% in the 1:10 dilution group, and 52.6% in the 1:32 dilution group. All (n = 10) of the vaccinia-naive participants had major reactions. Compared with vaccinia-naive participants, non-naive participants had significantly smaller skin lesions (P =.04) and significantly less incidence of fever (P =.02). Preexisting antibody was present in 76 of 80 non-naive participants. Antibody responses were significantly higher and occurred more rapidly in the non-naive participants compared with the vaccinia-naive participants (P =.002 for day 28 and P =.003 for 6 months). Vaccinia-naive participants shed virus from the vaccination site 2 to 6 days longer and had significantly higher peak mean viral titers when compared with the non-naive participants (P =.002).


CONCLUSIONS
Previously vaccinated persons can be successfully revaccinated with diluted (<or=1:10) smallpox vaccine. Fewer adverse reactions were observed in this study of non-naive participants when compared with events in vaccinia-naive participants, which may be due to immunologic memory.
Frey
Sharon E
SE
Department of Medicine, Saint Louis University School of Medicine and National Institute of Allergy and Infectious Diseases Vaccine and Treatment Evaluation Unit, MO, USA.
Newman
Frances K
FK
Yan
Lihan
L
Lottenbach
Kathleen R
KR
Belshe
Robert B
RB
D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D006801:Humans; D007117:Immunization, Secondary / Q000009:adverse effects; D007156:Immunologic Memory; D008875:Middle Aged; D016037:Single-Blind Method; D017444:Skin Diseases, Papulosquamous / Q000209:etiology* / Q000276:immunology / Q000821:virology; D012900:Smallpox Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D014611:Vaccination / Q000009:adverse effects; D014616:Vaccinia virus / Q000302:isolation & purification; D017201:Virus Shedding
D000914:Antibodies, Viral; D012900:Smallpox Vaccine