Changing dosing, administration of anthrax vaccine reduces side effects

Sep 30, 2008

Reducing the number of doses of an anthrax vaccine and changing its administration to intramuscular injection resulted in comparable measures of effectiveness but with fewer adverse events, according to a study in the October 1 issue of JAMA.

"Simpler and better tolerated regimens for vaccination with anthrax vaccine adsorbed (AVA) are needed," the authors write. The licensed AVA vaccination regimen is administered by injection below the skin (subcutaneously) at 0, 2, and 4 weeks and 6, 12 and 18 months, with annual boosters thereafter. Data supporting this regimen are limited.

The Centers for Disease Control and Prevention, Atlanta, in collaboration with several U.S. clinical study sites and the Anthrax Vaccine Research Program Working Group, conducted a randomized clinical trial, which included 1,005 enrollees, to assess safety and serological outcomes of alternative schedules and routes of administration of AVA. Participants received AVA by the subcutaneous (SQ) or intramuscular (IM) route at 0, 2 and 4 weeks and 6 months (4-SQ or 4-IM; n = 165-170 per group) or at a reduced 3-dose schedule (3-IM; n = 501). A control group (n = 169) received saline injections at the same time intervals.

The researchers found that at month 7, after completion of the priming series (1st four injections), all groups had serum antibody responses that were "noninferior to" (i.e., no less than) the licensed regimen. Most injection site adverse events (AEs), such as warmth, tenderness, itching, abnormal redness of the skin and swelling, occurred at lower proportions in the 4-IM group compared with the 4-SQ group. The odds ratio for ordinal pain (response ranging from no pain to extreme pain) reported immediately after injection was reduced by 50 percent for the 4-IM vs. 4-SQ groups.

"Our data demonstrate that a 3-IM regimen (omission of the week 2 dose) elicits serum antibody responses at month 7 that are noninferior when compared with regimens containing 4 doses of AVA (SQ or IM). Intramuscular administration was associated with a significant reduction in injection site AEs. Changing the injection route from SQ to IM may increase vaccine acceptability. Reducing the number of doses in the AVA regimen would have the added benefit of increasing the number of doses available for prophylactic use," the authors conclude.

Source: JAMA and Archives Journals

Explore further: Wearable artificial kidney safety testing receives go-ahead

add to favorites email to friend print save as pdf

Related Stories

Astronomers pinpoint 'Venus Zone' around stars

3 hours ago

San Francisco State University astronomer Stephen Kane and a team of researchers presented today the definition of a "Venus Zone," the area around a star in which a planet is likely to exhibit the unlivable ...

History books becoming next fight in Texas schools

4 hours ago

The next ideological fight over new textbooks for Texas classrooms intensified Wednesday with critics lambasting history lessons that they say exaggerate the influence of Moses in American democracy and negatively portray ...

Amazon deforestation up 29 pc in 2013

4 hours ago

Deforestation in the Amazon rose 29 percent between August 2012 and July of last year to 5,891 square kilometers (2,275 square miles), Brazilian officials said Wednesday, posting an amended figure.

Recommended for you

A novel therapy for sepsis?

17 hours ago

A University of Tokyo research group has discovered that pentatraxin 3 (PTX3), a protein that helps the innate immune system target invaders such as bacteria and viruses, can reduce mortality of mice suffering ...

Cellular protein may be key to longevity

Sep 15, 2014

Researchers have found that levels of a regulatory protein called ATF4, and the corresponding levels of the molecules whose expression it controls, are elevated in the livers of mice exposed to multiple interventions ...

User comments : 0