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Responses similar to double- vs. single-dose HBV revaccination in HIV patients
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Researchers found no difference in seroprotection rates between a double-dose hepatitis B virus vaccine regimen and a standard single-dose regimen in adults with HIV who did not respond to previous hepatitis B vaccination.
The safety profiles between the two regimens were similar, and the mean titer of protective hepatitis B surface antibodies (anti-HBs) was higher and had longer sustainability in those who received the double-dose regimen.
In a multicenter, open-label, randomized controlled trial conducted at 53 centers in France, researchers assigned 178 adults with HIV who did not respond to previous HBV vaccination or a 20-μg booster dose to receive either standard (20 μg; n = 90) or double-dose (40 μg; n = 88) recombinant HBV vaccine at 0, 4 and 24 weeks.
The study’s primary endpoint was the proportion of responders — defined as patients with anti-HB titers of 10 mIU/mL or more. At 28 weeks, 67% (95% CI, 57-77) of patients in the standard-dose group and 74% (95% CI, 63-82) in the double-dose group responded to the vaccine. Despite this similarity, the researchers found that more patients in the double-dose group (51%) had a high-level response (titer of protective anti-HBs of 100 mIU/mL or more) compared with the standard-dose group (26%). In addition, at 72 weeks, 54% of patients in the double-dose group vs. 31% in the standard-dose group had a sustained response.
There was no difference in safety between the groups besides more frequent local reactions in the double-dose group (15%) vs. the standard-dose group (4%). Vaccinations were discontinued in 7% of patients in the standard-dose group and 5% of patients in the double-dose group. Seven percent of patients in the standard-dose group and 4% in the double-dose group experienced serious adverse events, but none was considered vaccine-related.
Although the double-dose regimen did not yield a higher response rate, it “resulted in a more robust and durable immunological response, with a safety profile similar to that of the standard-dose regimen,” the researchers wrote. “Our results should be confirmed by future studies before double-dose vaccine can be considered for standard-of-care use in vaccine nonresponders.” – by Tina DiMarcantonio
Disclosure: Rey reports receiving honoraria from Gilead Sciences and travel support from Bristol-Meyers Squibb, Gilead Sciences, Janssen and Merck. Please see the full study for a list of all other authors’ relevant financial disclosures.
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