Despite the successful completion of this efficacy trial, the vaccine did not prevent HIV-1 infection or delay HIV-1 disease progression.

Yupik Eskimos of southwestern Alaska have the highest known prevalence of hepatitis B virus infection of any general population in the United States. Prospective serological surveys of 1,280 seronegative Yupik Eskimos, performed between 1971 and 1976, identified 189 (14.8%) who developed serological evidence of hepatitis B virus infection. Twenty-six (13.8%) developed clinical hepatitis during the interval when seroconversion occurred. The proportion of patients with clinically apparent hepatitis increased with age (P less than .01), ranging from 9.5% of infections in patients who were four years of age or less to 33.3% of infections in patients who were 30 years of age or older. Twenty-five (13.3%) of the 188 individuals who were studied became chronic carriers of hepatitis B surface antigen. The risk of becoming a carrier was inversely related to the age of the patient at the time of infection (P = .02). Among patients who were four years of age or less when infected, 28.8% became chronic carriers of hepatitis B, as compared with 7.7% of those who were 30 years of age or older.

Despite inducing a complex, robust immune response, the vaccine was unable to reduce the incidence of HIV-1. Two interpretations of the correlative results are that the levels of antibodies (i) caused both an increased (low responders) and decreased (high responders) risk of HIV-1 acquisition or (ii) represented a correlate of susceptibility to HIV-1 but had no causal effect on susceptibility. Although the data cannot definitively discriminate between these 2 explanations, (ii) appears to be more likely.

Two doses of HBsAg-1018, administered over 4 weeks, induced significantly higher seroprotection rates than three doses of HBsAg-Eng, given over 24 weeks, in adults with factors known to reduce the immune response to hepatitis B vaccines as well as in those without those factors. With fewer doses in a shorter time, and greater immunogenicity, HBsAg-1018 has the potential to significantly improve protection against hepatitis B in adults at risk for hepatitis B infection. Trial Registration clinicaltrials.gov Identifier: NCT02117934.

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