A Phase 1 Study of 4 Live, Recombinant Human Cytomegalovirus Towne/Toledo Chimera Vaccines in Cytomegalovirus–Seronegative Men

Stuart P. Adler, Anne-Marie Manganello, Ronzo Lee, Michael A. McVoy, Daniel E. Nixon(Virginia Commonwealth University), Stanley A. Plotkin(The Wistar Institute), Edward S. Mocarski(Emory University), Josephine H. Cox(International AIDS Vaccine Initiative), Patricia Fast(International AIDS Vaccine Initiative), Pavlo A. Nesterenko(Oregon Health & Science University), Susan Murray(Oregon Health & Science University), Ann B. Hill(Oregon Health & Science University), George Kemble(Pacific Biosciences (United States))
The Journal of Infectious Diseases
August 11, 2016
10.1093/infdis/jiw365
Cited by 55Open Access
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Abstract

BACKGROUND: Human cytomegalovirus (HCMV) infection causes disease in newborns and transplant recipients. A HCMV vaccine (Towne) protects transplant recipients. METHODS: The genomes of Towne and the nonattenuated Toledo strain were recombined, yielding 4 Towne/Toledo chimera vaccines. Each of 36 HCMV-seronegative men received 1 subcutaneous dose of 10, 100, or 1000 plaque-forming units (PFU) in cohorts of 3. Safety and immunogenicity were evaluated over 12 weeks after immunization and for 52 weeks for those who seroconverted. RESULTS: T-cell responses to IE1; 3 responded to 1-2 additional antigens. CONCLUSIONS: The Towne/Toledo chimera vaccine candidates were well tolerated and were not excreted. Additional human trials of chimeras 2 and 4 are appropriate. CLINICAL TRIALS REGISTRATION: NCT01195571.

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