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Also known as JNJ-66684657
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 candidate developed by Johnson & Johnson for protection against Zika virus. The designation 5*10^10 vp refers to a dose of 5 times 10 to the 10th power viral particles. It is a Phase 1 stage product and has not been approved by the FDA.
Ad26.ZIKV.001 5*10^10 vp is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker symbol JNJ. The company sponsored the Phase 1 clinical trial evaluating this Zika vaccine candidate.
Ad26.ZIKV.001 5*10^10 vp is in Phase 1 clinical development. It is an investigational product and has not received FDA approval. The Phase 1 trial has been completed.
Ad26.ZIKV.001 5*10^10 vp was evaluated in one clinical trial, NCT03356561, titled A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers. The trial was a completed Phase 1 study that enrolled 100 healthy adult volunteers in the United States.
The Phase 1 trial NCT03356561 was a randomized, double-blind, placebo-controlled study. It enrolled 100 healthy adult volunteers aged 18 years and older in the United States. The trial assessed safety, reactogenicity, and immunogenicity and has been completed.