A Subunit Cytomegalovirus Vaccine Based on Recombinant Envelope Glycoprotein B and a New Adjuvant

Abstract

A phase I randomized, double-blind, placebo-controlled trial was done with a cytomegalovirus (CMV) vaccine based on the envelope glycoprotein, gB, combined with a novel adjuvant, MF59. Participants received CMV gB vaccine with MF59 or CMV gB with alum or placebo at 0, 1, and 6 months. A fourth vaccine was given at 12 months to a subgroup. Levels of neutralizing antibody and antibody to gB 2 weeks after the third dose of vaccine exceeded those in seropositive control subjects. the formulation with MF59 was more immunogenic than that with alum. The optimal dose of gB appeared to be between 5 and 30 microg. The fourth dose produced a prompt rise in antibody level. There were no serious adverse events associated with vaccine. Local and systemic reactions were generally mild and, except for pain at the injection site, occurred with similar frequency in recipients of placebo and CMV vaccine.

Immune evasion proteins of human cytomegalovirus do not prevent a diverse CD8+ cytotoxic T-cell response in natural infection

“…51 Subunit vaccines incorporating only pp65, IE-1, and gB have been developed and elicit both T-cell and antibody responses. 52,53 Studies to identify the viral genes that encode additional CMV antigens recognized by CD8 ϩ CTLs and to elucidate their role in protective immunity should provide insights into the necessity to incorporate additional determinants in a CMV vaccine. …”

Evaluation of recombinant modified vaccinia Ankara virus-based rhesus cytomegalovirus vaccines in rhesus macaques

“…Although a larger numbers of Mmu are needed to conWrm this observation, it further indicates the protective role of neutralizing antibodies against CMV [14,17,18,24] and a gB-based vaccine strategy [15,17,25]. Natural immunity studies have suggested that a vaccine that stimulates immunity equivalent to levels associated with natural infection could reduce the morbidity due to congenital CMV infection by »80% [8,9].…”

A DNA-Based Vaccine for the Prevention of Human Cytomegalovirus-Associated Diseases

“…Preliminary results from human Phase I trials of recombinant gB vaccine suggest that the vaccine is safe and immunogenic. [47][48][49] While promising, these vaccines have yet to proceed past initial safety trials.…”