Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| VAC26911ZIK1001 | Other Identifier | Janssen Vaccines & Prevention B.V. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of Ad26.ZIKV.001 at 2 dose levels, 5*10^10 viral particles (vp) and 1*10^11 vp, administered intramuscularly as single dose and as 2-dose schedules in healthy adults.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Solicited Injection Site (Local) Adverse Events (AEs) | 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). | 7 days post vaccination on Day 1 (Day 1 up to Day 8) |
| Number of Participants with Solicited Injection Site (Local) Adverse Events (AEs) | 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 57 to Day 64. Local AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). | 7 days post vaccination on Day 57 (Day 57 up to Day 64) |
| Number of Participants with Solicited Systemic AEs | 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). | 7 days post vaccination on Day 1 (Day 1 up to Day 8) |
| Number of Participants with Solicited Systemic AEs | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing Antibodies to the Vaccine Strain (or Other Strain) | Zika virus (ZIKV) neutralizing titers of the vaccine-induced immune response will be assessed using a virus neutralization assay (VNA). | Days 1, 8, 15, 29, 57, 64, 71, 85, 239, and 365 |
Not provided
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 laboratory screening tests are outside the laboratory normal reference ranges, and additionally within the limits representing Food and Drug Administration (FDA) toxicity Grade 1, the participant may be considered eligible only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
Participant must agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after the last study vaccine administration
Participant must be willing to provide verifiable identification
All female participants of childbearing potential must have:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Vaccines & Prevention B.V. Clinical Trial | Janssen Vaccines & Prevention B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johnson County Clinical Trials | Lenexa | Kansas | 66219 | United States | ||
| Beth Israel Deaconess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33587687 | Derived | Salisch NC, Stephenson KE, Williams K, Cox F, van der Fits L, Heerwegh D, Truyers C, Habets MN, Kanjilal DG, Larocca RA, Abbink P, Liu J, Peter L, Fierro C, De La Barrera RA, Modjarrad K, Zahn RC, Hendriks J, Cahill CP, Leyssen M, Douoguih M, van Hoof J, Schuitemaker H, Barouch DH. A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study of Ad26.ZIKV.001, an Ad26-Vectored Anti-Zika Virus Vaccine. Ann Intern Med. 2021 May;174(5):585-594. doi: 10.7326/M20-5306. Epub 2021 Feb 16. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 7 days post vaccination on Day 57 (Day 57 up to Day 64) |
| Number of Participants with Unsolicited AEs | 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). | 28 days post vaccination on Day 1 (Day 1 up to Day 29) |
| Number of Participants with Unsolicited AEs | 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). | 28 days post vaccination on Day 57 (Day 57 up to Day 85) |
| Number of Participants with Serious Adverse Events (SAEs) | 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. | First vaccination to the end of the study (approximately up to 12 months) |
| Number of Participants with Immediate Reportable Events (IREs) | Number of Participants with IREs will be evaluated. Any events of neuroimmunologic significance will be categorized as IREs. | First vaccination to the end of the study (approximately up to 12 months) |
| Boston |
| Massachusetts |
| 02215 |
| United States |