What is the mechanism of action of this treatment?

The mRNA-1893 Zika vaccine works by using messenger RNA (mRNA) to instruct cells to produce a protein that elicits an immune response against the Zika virus. This mechanism is crucial for Zika Virus patients as it prepares their immune system to recognize and fight the virus more effectively upon exposure. Other common treatments for Zika Virus primarily focus on supportive care, including rest, hydration, and pain relief, as there are no specific antiviral medications currently approved for Zika. The emphasis on vaccines like mRNA-1893 is important because they offer a proactive approach to preventing infection and reducing the spread of the virus.

What side effects are associated with this type of intervention?

The mRNA-1893 Zika vaccine, which uses mRNA to instruct cells to produce a protein that elicits an immune response, is similar to other mRNA vaccines like those developed for COVID-19. Common side effects of mRNA vaccines include pain at the injection site, fatigue, headache, muscle pain, chills, fever, and nausea. These side effects are generally mild to moderate and resolve within a few days. Serious side effects are rare but can include allergic reactions.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments or vaccines specifically for the Zika virus. The mRNA-1893 Zika vaccine, which uses mRNA technology to instruct cells to produce a protein that elicits an immune response, is currently under clinical investigation. This approach is similar to the mRNA vaccines developed for COVID-19, which have shown success in eliciting strong immune responses.

What other types of research exist?

Promising alternatives to the mRNA-1893 Zika vaccine for 2024 include DNA vaccines, which instruct cells to produce Zika virus proteins to elicit an immune response, and live-attenuated vaccines, which use a weakened form of the virus to stimulate immunity. Additionally, vector-based vaccines, such as those using adenovirus vectors to deliver Zika virus genes, are also being explored. These alternatives are in various stages of research and clinical trials, showing potential in providing effective protection against the Zika virus.

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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

Must not have

Participant has a body mass index (BMI) from ≤18 or ≥35 kilograms/square meter

Participant is acutely ill or febrile on the day of the first or second vaccination

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to days 8, 29, 36, and 57

Summary

This trial is testing the safety and effects of a new Zika vaccine called mRNA-1893. The vaccine uses genetic material to help the body learn to fight the Zika virus. The study includes healthy people who have and have not been exposed to similar viruses before.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My BMI is either below 18 or above 35.

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I was sick or had a fever when I got my first or second vaccine shot.

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I have had inflammation of the heart or its surrounding tissues.

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I have not received any blood products or immunoglobulins in the last 3 months.

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I have received a dengue vaccine before, either approved or under study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to days 8, 29, 36, and 57

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to days 8, 29, 36, and 57

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to days 8, 29, 36, and 57 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Percentage of Initially Seronegative Participants With a Seroresponse, as Measured by MN

Percentage of Initially Seronegative Participants With a Seroresponse, as Measured by PRNT

Percentage of Participants With Seroconversion, as Measured by MN

+1 more

Side effects data

From 2021 Phase 1 trial • 120 Patients • NCT04064905

58%

Injection site pain

50%

Headache

50%

Myalgia

38%

Fatigue

25%

Arthralgia

21%

Nausea

Back pain

Chills

Blood glucose increased

Pyrexia

Dyspepsia

Bacterial vaginosis

Haematuria

Calculus urinary

Pain in extremity

Gastrooesophageal reflux disease

Limb injury

Vertigo positional

Rash

Gastritis

Nasopharyngitis

Procedural pain

Dysmenorrhoea

Ecchymosis

Influenza

Activated partial thromboplastin time prolonged

Epistaxis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

mRNA-1893 10 mcg

mRNA-1893 30 mcg

mRNA-1893 100 mcg

mRNA-1893 250 mcg

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 2

~930

Placebo

1995

Completed Phase 3

~2670

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The mRNA-1893 Zika vaccine works by using messenger RNA (mRNA) to instruct cells to produce a protein that elicits an immune response against the Zika virus. This mechanism is crucial for Zika Virus patients as it prepares their immune system to recognize and fight the virus more effectively upon exposure. Other common treatments for Zika Virus primarily focus on supportive care, including rest, hydration, and pain relief, as there are no specific antiviral medications currently approved for Zika. The emphasis on vaccines like mRNA-1893 is important because they offer a proactive approach to preventing infection and reducing the spread of the virus.