Phase 1
N=128
Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults
Cytomegalovirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT02826798 ↗Enrolled (actual)
128
Serious AEs
3.9%
Results posted
Apr 2020
Primary outcome: Primary: Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period — 11; 14; 13; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- VBI-1501A 0.5 μg (Drug); VBI-1501A 1.0 μg (Drug); VBI-1501A 2.0 μg (Drug); VBI-1501 1.0 μg (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- VBI Vaccines Inc.
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period |
11; 14; 13; 5; 3; 10 | — |
| PRIMARY Number of Participants With Any Adverse Event |
12; 11; 10; 10; 15; 8 | — |
| PRIMARY Number of Participants With Any Serious Adverse Event |
0; 2; 0; 2; 0 | — |
| PRIMARY Number of Participants With Any Hematological or Biochemical Laboratory Abnormality |
14; 10; 15; 8; 11; 13 | — |
| SECONDARY Geometric Mean Titer of Antibody Binding to CMV gB |
1126.00; NA; NA; 1077.29; 505.00; NA | — |
| SECONDARY Geometric Mean Titer of Antibody Avidity Index Value Against gB |
38.98; 41.83; 33.81; 35.53; 38.67; 64.56 | — |
| SECONDARY Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells |
77.48; 88.80; 140.38; 107.06; NA; 139.40 | — |
| SECONDARY Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells |
NA; NA; NA; NA; NA; NA | — |
Summary
The purpose of this study is to compare the safety and effectiveness of four different doses of cytomegalovirus vaccines in healthy adults.
Eligibility Criteria
Inclusion Criteria
- Generally healthy adult female and male 18 to 40 years of age, inclusive;
- Serologically confirmed to be CMV seronegative at screening;
- Female volunteers must agree to use an adequate contraception method as deemed appropriate by the investigator
- Sign an informed consent document indicating understanding of the purpose and procedures required for the study and willingness to participate in the study
Exclusion Criteria
- History of or current clinically significant medical illness or any other illness that in the opinion of the investigator interferes with the interpretation of the study results
- Clinically significant abnormal physical examination, vital signs, or clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as determined by the investigator
- Previous receipt of any cytomegalovirus vaccine
- History of allergic reactions or anaphylactic reaction to any vaccine component
- Pregnant or breastfeeding or plans to conceive from two weeks before the study start through six months after the last dose of study vaccine
- Known or suspected impairment of immunological function, including but not limited to autoimmune diseases, splenectomy, or HIV/AIDS
- Chronic administration (defined as more than 14 days in total) of immune-suppressive or other immune-modifying drug with six months prior to the product dose (for corticosteroids, this is defined as prednisone ≥20 mg/day or equivalent). Inhaled and topical steroids are allowed
- Participation in another clinical study within 30 days or plans to participate in another treatment based clinical study during the conduct of the present study
- Any skin abnormality or tattoo that would limit post-vaccination injection site assessment
- Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease
- Are family members of study center staff
Data sourced from ClinicalTrials.gov (NCT02826798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.