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Virus Therapy

mRNA Vaccine for Nipah Virus

Phase 1
Waitlist Available
Led By Lesia K Dropulic, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks after last product administration
Awards & highlights

Study Summary

This trial is testing the safety of an experimental vaccine for Nipah virus. The virus is transmitted from animals to humans, and can cause serious symptoms like brain inflammation and death. There is no cure.

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.Check my eligibility
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.See study design
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
Select...
I am a healthy adult aged between 18 and 60.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the safety and tolerability of a 2-dose vaccine regimen of mRNA-1215
Secondary outcome measures
To evaluate antibody responses to the mRNA-1215 vaccine

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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,261 Previous Clinical Trials
5,483,052 Total Patients Enrolled
Moderna TX, IncUNKNOWN
Lesia K Dropulic, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
4 Previous Clinical Trials
3,559 Total Patients Enrolled

Media Library

mRNA-1215 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05398796 — Phase 1
Nipah Virus Research Study Groups: Group 1, Group 2, Group 3, Group 4
Nipah Virus Clinical Trial 2023: mRNA-1215 Highlights & Side Effects. Trial Name: NCT05398796 — Phase 1
mRNA-1215 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05398796 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been recruited for this research project?

"Affirmative. Clinicaltrials.gov conveys that recruitment for this medical experiment is ongoing, having been posted on July 11th 2022 and last amended on October 28th 2022. The study aims to enlist 50 patients from a single site."

Answered by AI

May I have the opportunity to partake in this clinical investigation?

"This medical experiment seeks to take in 50 individuals with nipah virus infection, aged 18-60. To be eligible for enrolment, applicants must have no prior conditions and maintain a healthy state of being as per the physical examination."

Answered by AI

Does this research encompass adults aged 18 and up?

"The age requirements for this medical trial are between 18 and 60, inclusive."

Answered by AI

Are there still vacancies available for individuals to participate in this clinical experiment?

"Clinicaltrials.gov confirms that this clinical investigation is still recruiting participants, as the study was initially posted on July 11th 2022 and recently updated on October 28th of the same year."

Answered by AI

To what degree is mRNA -1215 a safe option for patients?

"Our group at Power assesses the safety of mRNA -1215 to be a 1 due to being in Phase 1. This means that only restricted evidence is available demonstrating its security and efficacy."

Answered by AI
Recent research and studies
~12 spots leftby Oct 2024