Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03356561 | A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers | PHASE1 | COMPLETED | 100 | — | — | Nov 26, 2017 | Sep 23, 2019 | Oct 15, 2019 | 2 | United States |
Number of participants with solicited injection site (local) AEs will be evaluated. Solicited local AEs including pain, erythema, and induration at the study vaccine injection site, will be noted in the participant diary from Day 1 to Day 8. Local AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).
Number of participants with solicited systemic AEs will be evaluated. Following solicited systemic AEs: fever, chills, headache, fatigue, nausea, myalgia, and arthralgia, will be noted in the participant diary from Day 1 to Day 8. Systemic AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).
Number of participants with unsolicited AEs will be evaluated. Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).
Number of participants with SAEs will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Number of Participants with IREs will be evaluated. Any events of neuroimmunologic significance will be categorized as IREs.
| Arm | Type | Description |
|---|---|---|
| Group 1: Ad26.ZIKV.001 5*10^10 Viral Particles (vp) | EXPERIMENTAL | Participants will receive Ad26.ZIKV.001 at 5\*10\^10 viral particles (vp) via intramuscular (IM) route on Days 1 and 57. |
| Group 2: Ad26.ZIKV.001 5*10^10 vp and Placebo | EXPERIMENTAL | Participants will receive Ad26.ZIKV.001 5\*10\^10 vp on Day 1 and placebo on Day 57 via IM route. |
| Group 3: Ad26.ZIKV.001 1*10^11 vp | EXPERIMENTAL | Participants will receive Ad26.ZIKV.001 at 1\*10\^11 vp via IM route on Days 1 and 57. |
| Group 4: Ad26.ZIKV.001 1*10^11 vp and Placebo | EXPERIMENTAL | Participants will receive Ad26.ZIKV.001 1\*10\^11 vp on Day 1 and placebo on Day 57 via IM route. |
| Group 5: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo via IM route on Days 1 and 57. |
| Name | Type | Description |
|---|---|---|
| Ad26.ZIKV.001 5*10^10 vp | BIOLOGICAL | Participants will receive Ad26.ZIKV.001 at a dose of 5\*10\^10 vp via IM route. |
| Ad26.ZIKV.001 1*10^11 vp | BIOLOGICAL | Participants will receive Ad26.ZIKV.001 at a dose of 1\*10\^11 vp via IM route. |
| Placebo | BIOLOGICAL | Participants will receive placebo via IM route. |
Inclusion Criteria: * Participant must be healthy, without significant medical illness, on the basis of physical examination, medical history, and vital signs performed at screening * Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the...