Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ad26.ZIKV.001 5*10^10 vp · 1 trial · 1 indication
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...
Ad26.ZIKV.001 5*10^10 vp is an investigational vaccine being studied for use in healthy adults. It is designed to evaluate safety, reactogenicity, and immunogenicity in a Phase 1 clinical trial. The drug is not approved and remains in clinical development.
Ad26.ZIKV.001 5*10^10 vp is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting a Phase 1 clinical trial to assess the vaccine's safety and immune response in healthy adult volunteers.
Ad26.ZIKV.001 5*10^10 vp is in Phase 1 clinical development. The Phase 1 trial has been completed, and the drug remains investigational. It is not FDA approved and is still being studied for safety and immunogenicity.
Ad26.ZIKV.001 5*10^10 vp has one completed Phase 1 trial, NCT03356561, which evaluated safety, reactogenicity, and immunogenicity in 100 healthy adult volunteers in the United States. The trial was randomized, double-blind, and placebo-controlled.
Ad26.ZIKV.001 5*10^10 vp is a specific dose formulation of Ad26.ZIKV.001, referring to the 5 times 10 to the 10th power virus particles dose. The clinical trial NCT03356561 studied this dose in healthy adults.