What side effects are associated with this type of intervention?

Common side effects of mRNA vaccines, which are being studied for Nipah Virus, typically include local reactions at the injection site (pain, redness, and swelling) and systemic reactions (fever, fatigue, headache, muscle pain, chills, and joint pain). Rarely, more severe allergic reactions may occur. These side effects are generally mild to moderate and resolve within a few days.

What prior FDA approvals exist?

There are no prior FDA approvals for treatments or vaccines specifically for Nipah Virus. The mRNA-1215 vaccine, currently under study, is an mRNA-based vaccine that induces an immune response by instructing cells to produce a viral protein. This approach is similar to the mRNA vaccines developed for COVID-19, which have been successful in eliciting robust immune responses.

What other types of research exist?

Promising, novel alternatives to mRNA-1215 for Nipah Virus patients could include recombinant vaccines, such as those using vesicular stomatitis virus vectors, which have shown efficacy in other viral infections like Ebola and Marburg viruses. Additionally, broad-spectrum antiviral drugs like favipiravir and remdesivir, which have been effective in nonhuman primates for other viral infections, may also be considered.

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Virus Therapy

mRNA Vaccine for Nipah Virus

Phase 1

Waitlist Available

Led By Alicia T Widge, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy adults between the ages of 18-60 years inclusive

Be between 18 and 65 years old

Must not have

History of asplenia, functional asplenia, or any condition resulting in the absence or removal of the spleen

Any vaccine, including COVID-19 vaccines, received within 4 weeks prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks after last product administration

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an experimental vaccine for Nipah virus in healthy adults aged 18 to 60. The vaccine uses genetic material to help the body recognize and fight the virus. Participants will receive two doses and be monitored for safety and immune response over several months.

Who is the study for?

Healthy adults aged 18-60, not pregnant or planning pregnancy during the study, with normal blood counts and organ function tests. Must be HIV negative, without serious allergies to vaccine components like PEG, no history of NiV infection or travel to endemic areas. Cannot have uncontrolled asthma/diabetes/thyroid disease/hypertension, bleeding disorders, certain seizure disorders, autoimmune diseases or immunodeficiencies.

What is being tested?

The trial is testing mRNA-1215 vaccine's safety and how well it triggers an immune response against Nipah virus in healthy adults. Participants will receive two doses via arm injection either one month or four months apart and will track their symptoms for a week after each dose.

What are the potential side effects?

Potential side effects are not detailed but may include typical reactions to vaccines such as soreness at the injection site, fever, fatigue or muscle pain. Serious side effects could involve allergic reactions; however specific risks will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a healthy adult aged between 18 and 60.

Exclusion Criteria

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

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I do not have a spleen or my spleen does not work properly.

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I have not received any vaccines in the last 4 weeks.

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My high blood pressure is not well controlled.

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I have a history of seizures, with certain exceptions.

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I have not received any blood products in the last 16 weeks.

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My asthma is not well controlled.

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I have a history of swelling attacks due to angioedema.

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My thyroid disease is not well controlled.

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I have had Guillain-Barre Syndrome in the past.

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I am currently on medication to prevent or treat tuberculosis.

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I haven't taken strong immune or cancer drugs in the last 14 days.

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I have had cancer that might come back during the study.

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I am on a maintenance schedule for my allergy shots.

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I have had myocarditis or pericarditis in the past.

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I have a bleeding disorder or experience significant bleeding or bruising.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks after last product administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks after last product administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks after last product administration for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To evaluate the safety and tolerability of a 2-dose vaccine regimen of mRNA-1215

Secondary study objectives

To evaluate antibody responses to the mRNA-1215 vaccine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4Experimental Treatment1 Intervention

Group II: Group 3Experimental Treatment1 Intervention

100 mcg IM

Group III: Group 2Experimental Treatment1 Intervention

50 mcg IM

Group IV: Group 1Experimental Treatment1 Intervention

25 mcg IM

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA -1215

2022

Completed Phase 1

~40

0 / 16Eligibility 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 vaccine, such as the one being studied in the mRNA-1215 trial for Nipah Virus, works by instructing cells to produce a viral protein that triggers an immune response. This immune response helps the body recognize and fight the virus if exposed in the future. This mechanism is important for Nipah Virus patients as it preemptively trains the immune system to combat the virus, potentially reducing disease severity and preventing fatalities.