The BEe-HIVe Randomized Clinical Trial results are out. The study investigated whether vaccination with a hepatitis B vaccine with a cytosine phosphoguanine adjuvant (HepB-CpG vaccine) improve hepatitis B virus (HBV) seroprotection in people with HIV and nonresponse to prior hepatitis B vaccine?  The results compare the efficacy and safety of different hepatitis B vaccine regimens, particularly the efficacy of the Heplisav-B vaccine for individuals living with HIV.

Hepatitis B Vaccine Efficacy

The Heplisav-B vaccine, known scientifically as HepB-CpG, has proven to be highly effective in inducing protective antibody responses in people living with HIV. In a recent international study, Heplisav-B achieved protective levels of antibodies in up to 99.4% of participants, significantly outperforming the traditional HepB-alum vaccine (Engerix-B), which achieved protection in only 80.6% of subjects.

Comparison with Traditional Vaccines

The study compared the efficacy of the Heplisav-B vaccine with the HepB-alum vaccine and found that both the three-dose and two-dose regimens of Heplisav-B were superior to the three-dose regimen of Engerix-B. The three-dose Heplisav-B regimen resulted in 99.4% seroprotection, while the two-dose regimen yielded 93.1% seroprotection.

Specifics of the BEe-HIVe Trial

The NIH-sponsored BEe-HIVe trial involved 561 participants living with HIV from 40 sites across North and South America, Africa, and Asia. These participants had previously been vaccinated against hepatitis B but lacked protective antibody levels. The trial demonstrated the clear superiority of Heplisav-B over Engerix-B in inducing protective antibody responses.

Safety and Durability

Importantly, the trials did not uncover any new safety issues associated with the Heplisav-B vaccine. Moreover, earlier studies and the current analysis indicate that Heplisav-B induces high and durable antibody responses, crucial for long-term protection against hepatitis B.

High-Dose vs Standard-Dose Regimens

Additional studies have explored the efficacy of high-dose versus standard-dose HBV vaccine regimens for revaccination in patients with HIV. These studies found that high-dose regimens resulted in higher and longer-lasting serological responses compared to standard-dose regimens. For instance, a high-dose regimen of 40 μg recombinant hepatitis B vaccine achieved a 72% serological response rate, compared to just 51% for the standard-dose regimen.

Implications for Clinical Practice

The findings suggest that clinicians will likely prefer using the Heplisav-B vaccine over traditional alum-adjuvant vaccines to boost immunity against hepatitis B in adults with HIV, especially those with little or no existing antibody protection. This is critical, considering the impaired immune response in individuals with HIV, which often limits the effectiveness of traditional vaccines.

In conclusion, the Heplisav-B vaccine, with its cytosine phosphoguanine adjuvant, is significantly more effective in inducing protective antibody responses in people living with HIV compared to traditional vaccines. This positions it as the preferred option for vaccination and revaccination strategies in this vulnerable population.