CPG 7909 Adjuvant Improves Hepatitis B Virus Vaccine Protection in HIV Positive Adults on HAART

Individuals with HIV often have an incomplete response to HBV vaccination due to immunological impairment. In the present study, researchers evaluated CPG 7909, a synthetic oligodeoxynucleotide containing immunostimulatory CpG motifs, as an adjuvant to the Energix-B vaccine.

This randomized, double-blind controlled trial was conducted to determine safety and hepatitis B virus (HBV) immunogenicity in adult HIV subjects on effective antiretroviral therapy.

HBV-susceptible subjects, half of whom had failed previous vaccination, were vaccinated at 0, 1 and 2 months with a double dose of Energix-B with/without (+/-) 1 mg CPG 7909.

HBV immune subjects (anti-HBsAg titres >= 10 mIU/l) received either CPG 7909 alone or saline. Safety, anti-HBs titres and lymphocyte proliferation response (LPR) to HBsAg were assessed over 12 months.

Results:

·         Vaccinations with Energix-B +/- CPG 7909 were well tolerated locally and systemically.

·         HIV suppression and CD4 cell counts were maintained.

·         Anti-HBs titers were significantly higher in vaccinees receiving CPG 7909, for all time points after the second dose.

·         Seroprotective titres (>= 10 mIU/ml) by 6 and 8 weeks, and 12 months were found in 89, 89, and 100% of subjects receiving CPG 7909 compared to 53, 42, and 63% of controls respectively (P = 0.029, 0.005, and 0.008).

·         HBsAg LPR was increased at all time-points up to 12 months after vaccination with addition of CPG 7909 (P < 0.05).

The authors conclude, “Addition of CPG 7909 achieves rapid, higher, and sustained HBV seroprotection and increases HBV-specific T helper cell response to HBV vaccine in HIV subjects. These results confirm a potential adjuvant role for CPG 7909 in vaccine hyporesponsive populations including those living with HIV.”

09/19/05

Reference
C L Cooper and others. CPG 7909 adjuvant improves hepatitis B virus vaccine seroprotection in antiretroviral-treated HIV-infected adults. AIDS 19(14): 1473-1479, September 23, 2005.






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