Key result
The V160 CMV vaccine was well-tolerated with no serious adverse events or viral shedding, and elicited robust neutralizing antibody and T-cell responses maintained through 12 months.
Why the study?
A conditionally replication-defective CMV vaccine expressing the pentameric complex was developed and required phase 1 safety and immunogenicity evaluation.
Does the V160 CMV vaccine elicit a safe and immunogenic response in CMV-seronegative and CMV-seropositive adults?
RCT
Does the V160 CMV vaccine elicit a safe and immunogenic response in CMV-seronegative and CMV-seropositive adults?
The V160 CMV vaccine demonstrated an acceptable safety profile and elicited neutralizing antibodies and T-cell responses comparable to natural infection in a Phase 1 trial.
Supports further development for CMV prevention; extends Phase 1 immunogenicity data to durable responses in seronegative and seropositive adults.
BACKGROUND: A conditionally replication-defective human cytomegalovirus (CMV) vaccine (V160) derived from AD169 and genetically engineered to express CMV pentameric complex (gH/gL/pUL128/pUL130/pUL131) was developed and evaluated for phase 1 vaccine safety and immunogenicity in CMV-seronegative and CMV-seropositive adults. METHODS: Subjects received 3 doses of V160 or placebo on day 1, month 1, and month 6. Four vaccine dose levels, formulated with or without aluminum phosphate adjuvant, were evaluated. Injection-site and systemic adverse events (AEs) and vaccine viral shedding were monitored. CMV-specific cellular and humoral responses were measured by interferon-gamma ELISPOT and virus neutralization assay up to 12 months after last dose. RESULTS: V160 was generally well-tolerated, with no serious AEs observed. Transient, mild-to-moderate injection-site and systemic AEs were reported more frequently in vaccinated subjects than placebo. Vaccine viral shedding was not detected in any subject, confirming the nonreplicating feature of V160. Robust neutralizing antibody titers were elicited and maintained through 12 months postvaccination. Cellular responses to structural and nonstructural viral proteins were observed, indicating de novo expression of viral genes postvaccination. CONCLUSIONS: V160 displayed an acceptable safety profile. Levels of neutralizing antibodies and T-cell responses in CMV-seronegative subjects were within ranges observed following natural CMV infection. CLINICAL TRIAL REGISTRATION: . NCT01986010.
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Adler et al. (2019) conducted an RCT in Cytomegalovirus (CMV) infection prevention. V160 (conditionally replication-defective human CMV vaccine) vs. Placebo was evaluated on Vaccine safety (adverse events and viral shedding) and immunogenicity (cellular and humoral responses). The V160 CMV vaccine was well-tolerated with no serious adverse events or viral shedding, and elicited robust neutralizing antibody and T-cell responses maintained through 12 months.
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