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Virus Vaccine
Zika Vaccine for Zika Virus
Phase 2
Waitlist Available
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 8, 29, 36 and 57
Awards & highlights
Study Summary
This trial will study the safety of a potential Zika vaccine in people who have and have not been previously infected with a flavivirus.
Who is the study for?
This trial is for healthy adults in areas with or without common flavivirus infections. Women who can have children must not be pregnant, agree to use birth control, and not breastfeed. Participants should be generally healthy, willing to follow the study plan, and give written consent. People with a fever on vaccination day, prior Zika vaccine trials, extreme BMI values, unstable health conditions that could affect safety or results are excluded.Check my eligibility
What is being tested?
The study tests two doses of mRNA-1893 Zika vaccine against a placebo in people who have never had flavivirus infections (seronegative) and those who have (seropositive). It aims to assess how safe the vaccine is and how participants' bodies react to it.See study design
What are the potential side effects?
While specific side effects aren't listed here, typically vaccines like this may cause pain at the injection site, fatigue, headache, muscle pain, chills or fever shortly after being administered.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1, 8, 29, 36 and 57
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 8, 29, 36 and 57
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAb) in All Participants, Initially Flavivirus Seronegative, and Initially Flavivirus Seropositive Participants, as Measured by Plaque Reduction Neutralization Test (PRNT)
Number Unsolicited Adverse Events (AEs)
Number of Medically Attended Adverse Events (MAAEs)
+2 moreSecondary outcome measures
GMFR of ZIKV-Specific nAbs in All Participants, as Measured by MN
GMFR of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants and Initially Flavivirus Seropositive Participants, as Measured by MN
GMFR of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants and Initially Flavivirus Seropositive Participants, as Measured by PRNT
+13 moreSide effects data
From 2012 Phase 3 trial • 6104 Patients • NCT0134659227%
Injection site pain
25%
Pyrexia
14%
Decreased appetite
14%
Upper respiratory tract infection
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Myalgia
7%
Hypersomnia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: mRNA-1893 Low Dose (2-Dose Regimen)Experimental Treatment1 Intervention
Participants will receive mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day (-3/+7 days) interval between vaccinations (administered on Day 1 and Day 29).
Group II: mRNA-1893 High Dose (2-Dose Regimen)Experimental Treatment1 Intervention
Participants will receive mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day (-3/+7 days) interval between vaccinations (administered on Day 1 and Day 29).
Group III: mRNA-1893 High Dose (1-Dose Regimen)Experimental Treatment2 Interventions
Participants will receive placebo matching to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There will be 28-day (-3/+7 days) interval between vaccinations.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matching to mRNA-1893 administered as a 2-dose regimen with 28-day (-3/+7 days) interval between vaccinations (administered on Day 1 and Day 29).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1893
2019
Completed Phase 1
~120
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,377,316 Total Patients Enrolled
2 Trials studying Zika Virus
210 Patients Enrolled for Zika Virus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had or plan to have a vaccine within 4 weeks of the trial treatment.My BMI is either below 18 or above 35.I was sick or had a fever when I got my first or second vaccine shot.I do not have any health or job-related issues that could make this study unsafe for me.I have had inflammation of the heart or its surrounding tissues.I am a woman who can have children and meet the study's rules on pregnancy tests, birth control, and breastfeeding.I have not received any blood products or immunoglobulins in the last 3 months.I have received a dengue vaccine before, either approved or under study.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: mRNA-1893 High Dose (1-Dose Regimen)
- Group 3: mRNA-1893 Low Dose (2-Dose Regimen)
- Group 4: mRNA-1893 High Dose (2-Dose Regimen)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If I meet the requirements, can I sign up for this research project?
"This study is looking for 809 patients that currently have zika virus and meet the age criteria of being between 18-65 years old. Most importantly, potential candidates must also: Understand and agree to follow study procedures, be in good general health (as assessed by the investigator), not be pregnant or breastfeeding, use contraception if they are of childbearing potential, and provide written informed consent."
Answered by AI
Are there any open positions in this clinical trial for new patients?
"Unfortunately, this trial is no longer recruiting patients according to the clinicaltrials.gov website. The original posting was on June 8th, 2021 but the site was updated as recently as August 31st, 2022. There are 4 other similar trials that are still looking for participants."
Answered by AI
Does this research study have an age limit?
"The age range for participation in this clinical trial is 18 to 65 years old."
Answered by AI
Are there any concerns with mRNA-1893's long term effects?
"While there is some evidence that mRNA-1893 is safe for human use, there is no data currently supporting its efficacy. Therefore, it received a score of 2."
Answered by AI
Who else is applying?
What site did they apply to?
Benchmark Research - Fort Worth
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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