A Phase 1 interventional study of Placebo and PIZV in Virus, Zika, Zika Virus Disease and Flavivirus Infections, sponsored by Takeda. Completed at 9 sites in 2 countries. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-11.
Sponsored by Takeda · Phase 1, Interventional, and Prevention
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Among 23 studies in Zika Virus Infection with a site in United States — 3 open to participants now, 3 under way, none of them phase 3. Zika Virus Infection · United States.
Among the 23 studies in Zika Virus Infection with a site in United States, this one is the 4th largest by enrollment of the 16 interventional ones that give a count, is one of 4 that started in 2017, is one of 12 in phase 1, and was the 12th registered.
78 studies on the registry are indexed under Zika Virus Infection; 8 are open to participants now.
Browse Zika Virus Infection studies →3 of the 23 studies in Zika Virus Infection with a site in United States are open now. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–65 · Healthy volunteers
Cepheid · Sites in United States
Ages 14+
Children's National Research Institute · Sites in United States, Colombia
Ages 3–7 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 4 Zika Virus Infection studies recruiting now, 2 set no upper age limit and 2 stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 49 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 4 started in 2017.
This study's enrollment of 271 is above the median of 120 across 43 interventional studies indexed under Zika Virus Infection.
Median enrollment 91 across the 16 interventional studies, 600 across the 7 observational. Of the 20 that completed or were terminated, 10 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 23 have an industry lead sponsor. The 10 most frequent:
Takeda is the lead sponsor of 1,026 studies on the registry; 88 are open to participants now.
Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.
Takeda has 1 study filed under Zika Virus Infection — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 23 studies in Zika Virus Infection with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to describe the safety, tolerability and immunogenicity of two doses of purified inactivated Zika virus vaccine (PIZV) given 28 days apart. Three different vaccine doses containing different protein concentrations (2, 5 or 10 microgram [mcg]) each, will be given as 2 dose schedule to flavivirus naive and primed healthy adults. Participants will be followed for 7 days post each dose for tolerability and up to 6 months post dose 2 for safety. Immunogenicity assessment will be performed at 28 days post each dose and 6 months post dose 2. In addition, the selected dose group and control group will be followed till 24 months post dose 2 for safety and persistence of immunity.
The vaccine being tested in this study is called PIZV or TAK-426 adjuvanted with aluminum hydroxide. The Zika virus vaccine is being tested to provide safety and immunogenicity data to enable the vaccine to be further developed clinically.
The study will enroll approximately 240 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four groups-which will remain undisclosed to the study observer:
All participants will be administered either placebo or PIZV by intramuscular (IM) injection into the middle third of the deltoid muscle, preferably in the non-dominant arm on Days 1 (Visit 1) and 29 (Visit 4).
This multi-center trial will be conducted in the United States and Puerto Rico. The overall time to participate in this study is up to 25 months. Participants will make multiple visits to the clinic on Days 1, 8, 29, 36, 57, 211, 393 and will be contacted by telephone on Day 133 (Visit 7) and Day 575 (Visit 9) and also visit the clinic on Day 757 (Visit 11) depending on the study arm, for a final follow-up assessment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Traveling to flavivirus endemic countries or flavivirus endemic regions of the United States (US) or US territories*, within 4 weeks prior to screening or planned travel through to Visit 6 (applicable only to participants to be enrolled into the flavivirus naïve cohort).
a. Centers for Disease Control and Prevention (CDC) website define the information about the flavivirus endemic countries and US regions and territories.
Known or suspected impairment/alteration of immune function, including:
If female participant of , sexually active, and who has not used any of the "acceptable methods" for at least 2 months prior to trial entry:
Acceptable birth control methods are defined as one or more of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
Drug: Placebo
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
Biological: PIZV
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
Biological: PIZV
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
Biological: PIZV
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
Drug: Placebo
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
Biological: PIZV
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
Biological: PIZV
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
Biological: PIZV
Placebo (normal saline (0.9% NaCl) IM injection.
Purified inactivated Zika virus vaccine with aluminum hydroxide adjuvant IM injection.
Also known as: TAK-426
Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 1 of PIZV or Placebo
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.
Time frame: Within 7 days after Dose 1 (Day 8)
Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 2 of PIZV or Placebo
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.
Time frame: Within 7 days after Dose 2 (Day 36)
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo
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.
Time frame: Within 7 days after Dose 1 (Day 8)
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
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.
Time frame: Within 7 days after Dose 2 (Day 36)
Percentage of Participants Who Experienced at Least One Non-serious Unsolicited AE Within 28 Days After Dose 1 of PIZV or Placebo
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.
Time frame: Within 28 days after Dose 1 (Day 29)
Percentage of Participants Who Experienced at Least One Non-serious Unsolicited AE Within 28 Days After Dose 2 of PIZV or Placebo
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.
Time frame: Within 28 days after Dose 2 (Day 57)
Percentage of Participants Who Experienced at Least One Serious Adverse Event (SAE) Within 28 Days After Dose 1 of PIZV or Placebo
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.
Time frame: Within 28 days after Dose 1 (Day 29)
Percentage of Participants Who Experienced at Least One SAE Within 28 Days After Dose 2 of PIZV or Placebo
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.
Time frame: Within 28 days after Dose 2 (Day 57)
Geometric Mean Titers (GMTs) of Neutralizing Antibody for Zika Virus (ZIKV) 28 Days After Dose 2 of PIZV or Placebo
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).
Time frame: 28 days after Dose 2 (Day 57)
Percentage of Participants Who Experienced at Least One SAE During the Study
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.
Time frame: From day of first vaccination (Day 1) up to end of the study (Day 757)
GMTs of Neutralizing Antibody for ZIKV 28 Days After Dose 1 and 6 Months After Dose 2
GMTs of neutralizing antibodies for ZIKV were measured by Zika 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).
Time frame: 28 days after Dose 1 (Day 29); 6 months after Dose 2 (Day 211)
GMTs of Neutralizing Antibody for ZIKV 12 Months and 24 Months After Dose 2 in Applicable Groups
GMTs of neutralizing antibodies for ZIKV were measured by Zika 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). As prespecified in the protocol, only data for applicable groups (Placebo and PIZV 10 mcg who were followed beyond Day 211) were analyzed and reported at Days 393 and 757 for Flavivirus-naïve Cohort and Flavivirus-primed Cohort.
Time frame: 12 months after Dose 2 (Day 393); 24 months after Dose 2 (Day 757)
Percentage of Participants Seropositive for Neutralizing Antibodies Against PIZV 28 Days After Dose 1, 28 Days After Dose 2, and 6 Months After Dose 2
Seropositive participants were defined as participants with detectable serum antibodies (tested positive at or above limit of detection, LOD) as measured by the neutralization assay.
Time frame: 28 days after Dose 1 (Day 29); 28 days after Dose 2 (Day 57); 6 months after Dose 2 (Day 211)
Percentage of Participants Seropositive for PIZV 12 Months and 24 Months After Dose 2 in Applicable Groups
Seropositive participants were defined as participants with detectable serum antibodies (tested positive at or above limit of detection, LOD) as measured by the neutralization assay. As prespecified in the protocol, only data for applicable groups (Placebo and PIZV 10 mcg who were followed beyond Day 211) were analyzed and reported at Days 393 and 757 for Flavivirus-naïve Cohort and Flavivirus-primed Cohort.
Time frame: 12 months after Dose 2 (Day 393); 24 months after Dose 2 (Day 757)
Percentage of Participants Seroconverted for PIZV 28 Days Post Dose 1 and 28 Days Post Dose 2
Seroconverted participants were defined as participants at Baseline with detectable post-vaccination serum antibodies (test results are at or above LOD) and seropositive participants at Baseline with a four-fold increase in post-vaccination antibodies from Baseline, as measured by the neutralization assay.
Time frame: 28 days after Dose 1 (Day 29); 28 days after Dose 2 (Day 57)
Study participants, aged \>=18 to \<=49 years, were enrolled in this Phase 1 study in 9 sites in the United States and Puerto Rico from 13 November 2017 to 24 November 2020.
| Milestone | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Started | 31 | 31 | 31 | 32 | 36 | 37 | 37 | 36 |
| Safety analysis set | 31 | 31 | 31 | 32 | 36 | 37 | 37 | 36 |
| Full analysis set | 30 | 28 | 31 | 30 | 34 | 34 | 34 | 34 |
| Per protocol set | 28 | 25 | 29 | 30 | 34 | 33 | 34 | 33 |
| Completed | 25 | 26 | 29 | 24 | 29 | 32 | 32 | 25 |
| Not completed | 6 | 5 | 2 | 8 | 7 | 5 | 5 | 11 |
| Withdrew: Lost to follow-up | 4 | 3 | 2 | 5 | 4 | 4 | 4 | 7 |
| Withdrew: Withdrawal of consent | 2 | 1 | 0 | 3 | 3 | 1 | 1 | 2 |
| Withdrew: Reason not specified | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Data entry error | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
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.
| percentage of participants | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Pain, Mild | 13.3 | 30.0 | 32.3 | 38.7 | 8.3 | 33.3 | 30.6 | 34.3 |
| Pain, Moderate | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 9.1 | 8.3 | 2.9 |
| Pain, Severe | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 3.0 | 0.0 | 0.0 |
| Erythema, <25 mm | 0.0 | 0.0 | 0.0 | 3.2 | 5.6 | 3.0 | 2.8 | 0.0 |
| Induration, <25 mm | 0.0 | 0.0 | 9.7 | 6.5 | 0.0 | 3.0 | 5.6 | 0.0 |
| Swelling, <25 mm | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 6.1 | 5.6 | 2.9 |
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.
| percentage of participants | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Pain, Mild | 14.3 | 29.6 | 30.0 | 36.7 | 18.2 | 21.9 | 21.9 | 20.6 |
| Pain, Moderate | 0.0 | 0.0 | 6.7 | 3.3 | 0.0 | 0.0 | 6.3 | 8.8 |
| Erythema, <25 mm | 3.6 | 0.0 | 3.3 | 3.3 | 0.0 | 3.1 | 3.1 | 2.9 |
| Erythema, Mild | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 3.2 | 0.0 | 0.0 |
| Induration, <25 mm | 0.0 | 0.0 | 3.3 | 0.0 | 0.0 | 0.0 | 3.1 | 2.9 |
| Swelling, <25 mm | 0.0 | 0.0 | 6.7 | 0.0 | 0.0 | 0.0 | 0.0 | 5.9 |
| Swelling, Mild | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 3.1 | 0.0 | 0.0 |
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.
| percentage of participants | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Fever, Mild | 3.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 2.8 | 0.0 |
| Fever, Moderate | 0.0 | 0.0 | 0.0 | 3.2 | 0.0 | 0.0 | 0.0 | 0.0 |
| Headache, Mild | 20.0 | 13.3 | 19.4 | 12.9 | 11.1 | 12.1 | 13.9 | 11.4 |
| Headache, Moderate | 13.3 | 3.3 | 6.5 | 0.0 | 2.8 | 3.0 | 5.6 | 2.9 |
| Headache, Severe | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 2.8 | 2.9 |
| Fatigue, Mild | 16.7 | 16.7 | 16.1 | 25.8 | 16.7 | 6.1 | 25.0 | 17.1 |
| Fatigue, Moderate | 6.7 | 6.7 | 3.2 | 6.5 | 8.3 | 3.0 | 0.0 | 0.0 |
| Arthralgia, Mild | 3.3 | 0.0 | 3.2 | 6.5 | 8.3 | 12.1 | 11.1 | 5.7 |
| Arthralgia, Moderate | 0.0 | 3.3 | 0.0 | 3.2 | 0.0 | 0.0 | 0.0 | 0.0 |
| Myalgia, Mild | 6.7 | 6.7 | 16.1 | 12.9 | 19.4 | 12.1 | 13.9 | 8.6 |
| Myalgia, Moderate | 3.3 | 3.3 | 0.0 | 0.0 | 0.0 | 2.7 | 0.0 | 0.0 |
| Myalgia, Severe | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 3.0 | 0.0 | 2.9 |
| Malaise, Mild | 6.7 | 3.3 | 3.2 | 12.9 | 19.4 | 12.1 | 16.7 | 22.9 |
| Malaise, Moderate | 6.7 | 3.3 | 3.2 | 0.0 | 2.8 | 0.0 | 0.0 | 0.0 |
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.
| percentage of participants | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Fever, Mild | 3.2 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Fever, Severe | 3.2 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 6.4 | 0.0 |
| Headache, Mild | 6.9 | 14.8 | 0.0 | 16.7 | 6.1 | 6.3 | 12.5 | 2.9 |
| Headache, Moderate | 3.4 | 0.0 | 3.3 | 3.3 | 3.3 | 0.0 | 0.0 | 8.8 |
| Headache, Severe | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 3.1 | 0.0 |
| Fatigue, Mild | 13.8 | 11.1 | 3.3 | 13.3 | 9.1 | 3.1 | 9.4 | 11.8 |
| Fatigue, Moderate | 6.9 | 0.0 | 3.3 | 3.3 | 0.0 | 0.0 | 3.1 | 2.9 |
| Arthralgia, Mild | 0.0 | 7.4 | 0.0 | 0.0 | 0.0 | 9.4 | 3.1 | 2.9 |
| Arthralgia, Moderate | 3.4 | 0.0 | 0.0 | 3.3 | 0.0 | 0.0 | 3.1 | 2.9 |
| Arthralgia, Severe | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 3.1 | 0.0 |
| Myalgia, Mild | 0.0 | 7.4 | 3.3 | 3.3 | 9.1 | 12.5 | 6.3 | 2.9 |
| Myalgia, Moderate | 6.9 | 0.0 | 0.0 | 3.3 | 0.0 | 0.0 | 0.0 | 5.9 |
| Myalgia, Severe | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 3.1 | 2.9 |
| Malaise, Mild | 3.4 | 0.0 | 0.0 | 6.7 | 12.1 | 3.1 | 6.3 | 2.9 |
| Malaise, Moderate | 3.4 | 0.0 | 0.0 | 3.3 | 3.0 | 0.0 | 3.1 | 5.9 |
| Malaise, Severe | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 3.1 | 0.0 |
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.
| percentage of participants | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Who Experienced at Least One Non-serious Unsolicited AE Within 28 Days After Dose 1 of PIZV or Placebo | 29.0 | 19.4 | 29.0 | 9.4 | 22.2 | 21.6 | 21.6 | 16.7 |
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.
| percentage of participants | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Who Experienced at Least One Non-serious Unsolicited AE Within 28 Days After Dose 2 of PIZV or Placebo | 16.1 | 16.1 | 9.7 | 12.5 | 8.3 | 13.5 | 13.5 | 13.9 |
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.
| percentage of participants | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Who Experienced at Least One Serious Adverse Event (SAE) Within 28 Days After Dose 1 of PIZV or Placebo | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 2.7 | 0.0 | 0.0 |
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.
| percentage of participants | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Who Experienced at Least One SAE Within 28 Days After Dose 2 of PIZV or Placebo | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
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).
| titer | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Geometric Mean Titers (GMTs) of Neutralizing Antibody for Zika Virus (ZIKV) 28 Days After Dose 2 of PIZV or Placebo | 5.00 (NA to NA) | 1129.69 (749.38 to 1703.1) | 1992.33 (1401.28 to 2832.70) | 3689.89 (2676.75 to 5086.49) | 198.82 (91.73 to 430.97) | 597.63 (340.48 to 1049.00) | 1276.92 (806.00 to 2022.97) | 2590.54 (1649.18 to 4069.22) |
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.
| percentage of participants | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Who Experienced at Least One SAE During the Study | 3.2 | 3.2 | 0.0 | 6.3 | 2.8 | 5.4 | 0.0 | 11.1 |
GMTs of neutralizing antibodies for ZIKV were measured by Zika 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).
| titer | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Day 29 | 5.00 (NA to NA) | 41.28 (18.74 to 90.95) | 93.76 (44.34 to 198.30) | 291.41 (161.74 to 525.06) | 164.06 (77.37 to 347.88) | 513.62 (259.90 to 1015.03) | 1002.69 (566.72 to 1774.06) | 1572.58 (864.63 to 2860.20) |
| Day 211 | 5.00 (NA to NA) | 151.24 (87.27 to 262.10) | 364.10 (237.97 to 557.08) | 613.28 (382.29 to 983.83) | 125.80 (48.02 to 329.55) | 258.44 (93.32 to 715.73) | 506.97 (228.56 to 1124.50) | 866.26 (445.59 to 1684.08) |
GMTs of neutralizing antibodies for ZIKV were measured by Zika 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). As prespecified in the protocol, only data for applicable groups (Placebo and PIZV 10 mcg who were followed beyond Day 211) were analyzed and reported at Days 393 and 757 for Flavivirus-naïve Cohort and Flavivirus-primed Cohort.
| titer | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|
| Day 393 | 5.00 (NA to NA) | 413.71 (215.67 to 793.58) | 103.88 (39.85 to 270.78) | 505.10 (287.58 to 887.15) |
| Day 757 | 18.48 (6.00 to 56.91) | 427.41 (171.06 to 1067.93) | 324.26 (131.54 to 799.36) | 149.68 (56.68 to 395.24) |
Seropositive participants were defined as participants with detectable serum antibodies (tested positive at or above limit of detection, LOD) as measured by the neutralization assay.
| percentage of participants | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Day 29 | 0.0 (NA to NA) | 72.00 (50.61 to 87.93) | 82.14 (63.11 to 93.94) | 96.43 (81.65 to 99.91) | 85.29 (68.94 to 95.05) | 96.77 (83.30 to 99.92) | 100.00 (89.72 to 100.00) | 100.00 (89.42 to 100.0) |
| Day 57 | 0.0 (NA to NA) | 100.00 (85.18 to 100.00) | 100.00 (87.66 to 100.00) | 100.00 (87.66 to 100.00) | 87.10 (70.17 to 96.37) | 96.67 (82.78 to 99.92) | 100.00 (88.78 to 100.00) | 100.00 (88.43 to 100.00) |
| Day 211 | 0.0 (NA to NA) | 100.00 (83.16 to 100.00) | 100.00 (86.28 to 100.0) | 100.00 (85.18 to 100.00) | 76.67 (57.72 to 90.07) | 84.00 (63.92 to 95.46) | 100.00 (86.77 to 100.00) | 100.00 (86.77 to 100.00) |
Seropositive participants were defined as participants with detectable serum antibodies (tested positive at or above limit of detection, LOD) as measured by the neutralization assay. As prespecified in the protocol, only data for applicable groups (Placebo and PIZV 10 mcg who were followed beyond Day 211) were analyzed and reported at Days 393 and 757 for Flavivirus-naïve Cohort and Flavivirus-primed Cohort.
| percentage of participants | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|
| Day 393 | 0.00 (0.00 to 14.82) | 100.0 (83.89 to 100.0) | 65.63 (46.81 to 81.43) | 100.0 (86.28 to 100.0) |
| Day 757 | 26.32 (9.15 to 51.20) | 93.75 (69.77 to 99.84) | 85.19 (66.27 to 95.81) | 76.19 (52.83 to 91.78) |
Seroconverted participants were defined as participants at Baseline with detectable post-vaccination serum antibodies (test results are at or above LOD) and seropositive participants at Baseline with a four-fold increase in post-vaccination antibodies from Baseline, as measured by the neutralization assay.
| percentage of participants | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Day 29 | 0.0 (NA to NA) | 72.00 (50.61 to 87.93) | 82.14 (63.11 to 93.94) | 96.43 (81.65 to 99.91) | 2.94 (0.07 to 15.33) | 38.71 (21.85 to 57.81) | 50.00 (32.43 to 67.57) | 69.70 (51.29 to 84.41) |
| Day 57 | 0.0 (NA to NA) | 100.00 (85.18 to 100.0) | 100.00 (87.66 to 100.00) | 100.00 (87.66 to 100.0) | 6.45 (0.79 to 21.42) | 46.67 (28.34 to 65.67) | 54.84 (36.03 to 72.68) | 76.67 (57.72 to 90.07) |
Collected over All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Flavivirus-naïve Cohort: Placebo | 0/31 (0%) | 1/31 (3.2%) | 4/31 (12.9%) |
| Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | 0/31 (0%) | 1/31 (3.2%) | 3/31 (9.7%) |
| Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | 0/31 (0%) | 0/31 (0%) | 3/31 (9.7%) |
| Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | 0/32 (0%) | 2/32 (6.3%) | 4/32 (12.5%) |
| Flavivirus-primed Cohort: Placebo | 0/36 (0%) | 1/36 (2.8%) | 5/36 (13.9%) |
| Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | 0/37 (0%) | 2/37 (5.4%) | 5/37 (13.5%) |
| Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | 0/37 (0%) | 0/37 (0%) | 7/37 (18.9%) |
| Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | 0/36 (0%) | 4/36 (11.1%) | 8/36 (22.2%) |
| Event | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Postpartum haemorrhagePregnancy, puerperium and perinatal conditions | 0/31 | 1/31 | 0/31 | 0/32 | 0/36 | 0/37 | 0/37 | 0/36 |
| DiverticulitisInfections and infestations | 1/31 | 0/31 | 0/31 | 0/32 | 0/36 | 0/37 | 0/37 | 0/36 |
| Pancreatitis acuteGastrointestinal disorders | 0/31 | 0/31 | 0/31 | 1/32 | 0/36 | 0/37 | 0/37 | 0/36 |
| AdenomyosisReproductive system and breast disorders | 0/31 | 0/31 | 0/31 | 1/32 | 0/36 | 0/37 | 0/37 | 0/36 |
| Major depressionPsychiatric disorders | 0/31 | 0/31 | 0/31 | 0/32 | 1/36 | 0/37 | 0/37 | 0/36 |
| DehydrationMetabolism and nutrition disorders | 0/31 | 0/31 | 0/31 | 0/32 | 0/36 | 0/37 | 0/37 | 1/36 |
| ColitisGastrointestinal disorders | 0/31 | 0/31 | 0/31 | 0/32 | 0/36 | 0/37 | 0/37 | 1/36 |
| Cholecystitis acuteHepatobiliary disorders | 0/31 | 0/31 | 0/31 | 0/32 | 0/36 | 0/37 | 0/37 | 1/36 |
| Gestational hypertensionPregnancy, puerperium and perinatal conditions | 0/31 | 0/31 | 0/31 | 0/32 | 0/36 | 0/37 | 0/37 | 1/36 |
| Premature deliveryPregnancy, puerperium and perinatal conditions | 0/31 | 0/31 | 0/31 | 0/32 | 0/36 | 0/37 | 0/37 | 1/36 |
| Event | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) |
|---|---|---|---|---|---|---|---|---|
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 0/31 | 0/31 | 0/31 | 0/32 | 1/36 | 0/37 | 1/37 | 3/36 |
| Upper respiratory tract infectionInfections and infestations | 1/31 | 2/31 | 1/31 | 1/32 | 1/36 | 3/37 | 2/37 | 2/36 |
| HeadacheNervous system disorders | 1/31 | 0/31 | 2/31 | 1/32 | 0/36 | 3/37 | 3/37 | 1/36 |
| BronchitisInfections and infestations | 2/31 | 0/31 | 0/31 | 0/32 | 0/36 | 0/37 | 0/37 | 0/36 |
| DysuriaRenal and urinary disorders | 0/31 | 2/31 | 0/31 | 0/32 | 0/36 | 0/37 | 0/37 | 0/36 |
| FatigueGeneral disorders | 0/31 | 0/31 | 1/31 | 2/32 | 0/36 | 0/37 | 0/37 | 0/36 |
| PruritusSkin and subcutaneous tissue disorders | 0/31 | 0/31 | 0/31 | 0/32 | 2/36 | 1/37 | 0/37 | 0/36 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/31 | 0/31 | 0/31 | 0/32 | 0/36 | 0/37 | 1/37 | 2/36 |
| DizzinessNervous system disorders | 0/31 | 0/31 | 0/31 | 0/32 | 1/36 | 0/37 | 2/37 | 0/36 |
Safety Analysis Set included all participants who received at least one (1) dose of PIZV or placebo.
| Age, Continuous(years) | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 36.7 ± 8.93 | 34.9 ± 9.52 | 35.8 ± 8.86 | 34.1 ± 8.50 | 34.7 ± 8.20 | 35.5 ± 8.71 | 37.0 ± 8.89 | 35.4 ± 8.45 | 35.5 ± 8.69 |
| Sex: Female, Male(Participants) | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 21 | 16 | 18 | 14 | 21 | 18 | 26 | 24 | 158 |
| Male | 10 | 15 | 13 | 18 | 15 | 19 | 11 | 12 | 113 |
| Ethnicity (NIH/OMB)(Participants) | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 | 4 | 36 | 36 | 36 | 35 | 151 |
| Not Hispanic or Latino | 30 | 30 | 29 | 28 | 0 | 1 | 0 | 1 | 119 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 3 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 2 |
| Black or African American | 6 | 5 | 3 | 4 | 6 | 4 | 7 | 10 | 45 |
| White | 23 | 26 | 26 | 27 | 27 | 31 | 30 | 25 | 215 |
| More than one race | 0 | 0 | 2 | 1 | 1 | 1 | 0 | 1 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | Total |
|---|---|---|---|---|---|---|---|---|---|
| United States of America | 31 | 31 | 31 | 32 | 21 | 21 | 21 | 21 | 209 |
| Puerto Rico | 0 | 0 | 0 | 0 | 15 | 16 | 16 | 15 | 62 |
| Body Mass Index (BMI)(kg/m^2) | Flavivirus-naïve Cohort: Placebo | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Flavivirus-primed Cohort: Placebo | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 27.921 ± 4.2049 | 27.527 ± 4.7632 | 27.541 ± 3.7165 | 26.750 ± 3.6511 | 27.398 ± 3.5244 | 27.054 ± 4.7105 | 26.982 ± 4.1240 | 28.072 ± 4.4735 | 27.398 ± 4.1433 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Nov 2017 to primary completion in Dec 2018, 13 months.
Results were first posted in Feb 2022, 3 years 1 month after primary completion.
Of 21 phase 1 interventional studies under Zika Virus Infection, half reached primary completion within 15 months of starting (the median); a quarter within 8 and three quarters within 25. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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