Safety and Immunogenicity of the Human Cytomegalovirus (CMV) Vaccine (V160) in Healthy Japanese M… (NCT03840174) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity of the Human Cytomegalovirus (CMV) Vaccine (V160) in Healthy Japanese Men (V160-003)
Japan18 participantsStarted 2019-03-08
Plain-language summary
The purpose of the study is to assess the safety and tolerability of a 3-dose regimen of V160 administered by intramuscular (IM) injection in healthy Japanese male participants by cytomegalovirus (CMV) serostatus. There is no formal hypothesis.
Who can participate
Age range20 Years – 64 Years
SexMALE
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Inclusion Criteria:
* Healthy based on medical history and physical examination
* Serologically confirmed to be CMV seropositive or CMV seronegative at Visit 1
* If of reproductive potential, agrees to the following from randomization through at least 4 weeks after the last dose of V160-/placebo (from Day 1 through Month 7): 1) practice abstinence from heterosexual activity and remain abstinent, or 2) use contraception unless confirmed to be azoospermic as detailed in the protocol
Exclusion Criteria:
* History of any allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention
* Plans donation of sperm any time from signing the informed consent through 1 month after receiving the last dose of study drug
* Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition that requires immunosuppressive medication.
* Has a condition in which repeated venipuncture or injections post more than minimal risk for the participant, such as hemophilia, thrombocytopenia, other severe coagulation disorders, or significantly impaired venous access
* Has major psychiatric illness including: any history or schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicidal ideation within …
What they're measuring
1
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Timeframe: Up to 5 days after each vaccination
2
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Timeframe: Up to 14 days after each vaccination
3
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)