An open-label, controlled Phase II trial was conducted at 36 centers in the United States and Puerto Rico for HIV-infected and healthy subjects.

Subjects received 2 doses of Jynneos administered 4 weeks apart.

Safety was evaluated by assessment of adverse events, focused physical exams, electrocardiogram recordings, and safety laboratories.

Immune responses were assessed using an enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT).

Results

The results of this trial were published on May 5, 2015, in Open Forum Infectious Diseases.

579 subjects were vaccinated at least once and had data available for analysis.

Rates of ELISA seropositivity were comparably high in vaccinia-naive healthy and HIV-infected subjects, whereas PRNT seropositivity rates were higher in healthy compared with HIV-infected subjects.

Jynneos was safe and well-tolerated with no adverse impact on viral load or CD4 counts. There were no cases of myo-/pericarditis reported.

Conclusions

Modified vaccinia Ankara was safe and immunogenic in subjects infected with HIV and represents a promising smallpox vaccine candidate for use in immunocompromised populations.