| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03343626 | Safety, Immunogenicity, and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Participants | PHASE1 | COMPLETED | 271 | — | — | Nov 13, 2017 | Nov 24, 2020 | Feb 11, 2022 | 9 | United States, Puerto Rico |
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after first vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), erythema (\<25 mm, mild: \>=25 to- \<=50 mm, moderate: \>50 to \<=100 mm, severe: \>100 mm), and swelling and induration (\<25 mm, mild: \>=25 to \<=-50 mm, moderate: \>50 to \<=100 mm, severe: \>100 mm). Only categories for which there was at least 1 participant are reported.
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after first vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), erythema (\<25 mm, mild: \>=25 to \<=50 mm, moderate: \>50 to \<=100 mm, severe: \>100 mm), and swelling and induration (\<25 mm, mild: \>=25 to \<=50 mm, moderate: \>50 to \<=100 mm, severe: \>100 mm). Only categories for which there was at least 1 participant are reported.
Solicited systemic AEs included fever, headache, fatigue, malaise, arthralgia, and myalgia that occurred within 7 days of first vaccination. Solicited systemic AEs (headache, fatigue, malaise, arthralgia, and myalgia) was graded from 0 to 3 by severity; where 0=None, 1=Mild: No interference with daily activity, 2=Moderate: Interference with daily activity, 3=Severe: Prevents daily activity; A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was graded from 1 to 4 by severity; where 1=Mild: 38.0-38.4°C, 2=Moderate: 38.5-38.9°C, 3=Severe: 39.0-40°C, and 4=Potentially life threatening:\>40°C. Only categories for which there was at least 1 participant are reported.
Solicited systemic AEs included fever, headache, fatigue, malaise, arthralgia, and myalgia that occurred within 7 days of first vaccination. Solicited systemic AEs (headache, fatigue, malaise, arthralgia, and myalgia) was graded from 0 to 3 by severity; where 0=None, 1=Mild: No interference with daily activity, 2=Moderate: Interference with daily activity, 3=Severe: Prevents daily activity; A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was graded from 1 to 4 by severity; where 1=Mild: 38.0-38.4°C, 2=Moderate: 38.5-38.9°C, 3=Severe: 39.0-40°C, and 4=Potentially life threatening:\>40°C. Only categories for which there was at least 1 participant are reported.
An AE was defined as any untoward medical occurrence in participants administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration.
An AE was defined as any untoward medical occurrence in a clinical investigation participants administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration.
A SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization.
A SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization.
GMTs of neutralizing antibodies for ZIKV were measured by the Zika plaque reduction neutralization test (PRNT) test, by assessing the quantity of neutralizing antibodies that bind ZIKV in the assay. The assay results were reported as titers (reciprocal value of the dilution of the serum from the vaccinated individual that inhibits for 50% the plaque formation).
| Arm | Type | Description |
|---|---|---|
| Flavivirus-naïve Cohort: Placebo | PLACEBO_COMPARATOR | Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose). |
| Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | EXPERIMENTAL | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | EXPERIMENTAL | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | EXPERIMENTAL | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| Flavivirus-primed Cohort: Placebo | PLACEBO_COMPARATOR | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | EXPERIMENTAL | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | EXPERIMENTAL | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| Flavivirus-primed Cohort: PIZV 10 mcg (High dose) | EXPERIMENTAL | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo (normal saline (0.9% NaCl) IM injection. |
| PIZV | BIOLOGICAL | Purified inactivated Zika virus vaccine with aluminum hydroxide adjuvant IM injection. |
Inclusion Criteria: 1. Participants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and eligibility screening tests (hematology, biochemistry and urinalysis) and clinical judgment of the investigator. Vital si...