Phase 1
N=40
Dose Escalation, Open-Label Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of a Nipah Virus (NiV) mRNA Vaccine, mRNA-1215, in Healthy Adults
Nipah Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT05398796 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration — 1; 1; 0; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- mRNA -1215 (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration |
1; 1; 0; 4; 9; 9 | — |
| PRIMARY Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration |
8; 4; 2; 8; 2; 6 | — |
| PRIMARY Number of Participants With Serious Adverse Events Following Product Administration |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration |
0; 1; 5; 3; 5; 5 | — |
| PRIMARY Number of Participants With New Chronic Medical Conditions Following Product Administration |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration |
1; 0; 0; 0; 0; 1 | — |
| PRIMARY Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration |
1; 2; 0; 0; 0; 1 | — |
| SECONDARY Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs). |
4.44; 1.28; 1.83; 3.03; 1941.62; 1885.99 | — |
| SECONDARY Geometric Mean NiV(M) G Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs). |
12.48; 2.84; 4.12; 6.91; 4626.43; 5013 | — |
Summary
Background:
Nipah virus (NiV) is transmitted from animals to humans, from humans to humans, and through contaminated food. Infected people may have a cough and trouble breathing. Some people may develop serious symptoms, such as brain infection and inflammation, that can lead to death. There are no drugs or vaccines to treat or prevent NiV infection.
Objective:
To test the safety of an experimental vaccine (mRNA-1215) for NiV. Researchers will also evaluate how participants bodies respond to the vaccine.
Eligibility:
Healthy, nonpregnant adults aged 18 to 60 years.
Design:
Participants visited the NIH clinic 13 to 15 times over 14 to 16 months.
Participants received 2 doses of the experimental vaccine at 1 month apart. The vaccine was given as a shot into the muscle of the upper arm. Participants stayed in the clinic at least 30 minutes after each vaccination.
Participants were given a diary card and a thermometer. They recorded their temperature and any other reactogenicity symptoms for 7 days after each vaccination.
During each follow-up visit, 3 to 14 tubes of blood were drawn for research.
Some participants underwent an optional procedure called apheresis. A needle is placed into a vein in each arm. Blood is removed through one needle. The blood passed through a machine that separates some of the blood cells. The rest of the blood is returned to the body through another needle.
The mRNA-1215 vaccine cannot cause NiV infection.
Eligibility Criteria
- INCLUSION CRITERIA:
A volunteer must meet all of the following criteria:
- Healthy adults between the ages of 18-60 years inclusive.
- Based on history and physical examination, in good general health and without history of any of the conditions listed in the exclusion criteria.
- Able and willing to complete the informed consent process.
- Available for clinic visits for 52 weeks after last product administration.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) of 18 to 35 within the 56 days prior to enrollment.
Laboratory Criteria within 56 days before enrollment:
- White blood cells (WBC) and differential within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval.
- Total lymphocyte count >= 800 cells/microL.
- Platelets = 125,000 - 500,000 cells/microL.
- Hemoglobin within institutional normal range or accompanied by the PI or designee approval.
- Alanine aminotransferase (ALT) 6 months), or planned travel for any length of time during the study to countries where NiV infection is endemic, eg. Bangladesh, India, Philippines.
Volunteer has a history of any of the following clinically significant conditions:
- Serious reactions to vaccines that preclude receipt of the study vaccination, including allergic reaction (anaphylaxis, urticaria or allergic reaction requiring medical intervention) to SARS-CoV-2 mRNA vaccines, as determined by the investigator
- History of myocarditis and/or pericarditis
- Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
- Asthma that is not well controlled
- Diabetes mellitus (type I or II), with the exception of gestational diabetes
- Thyroid disease that is not well controlled
- Idiopathic urticaria within the past year
- Autoimmune disease or immunodeficiency
- Hypertension that is not well controlled
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- Malignancy that is active or history of malignancy that is likely to recur during the period of the study
- Seizure disorder other than 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years.
- Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
- Guillain-Barre Syndrome
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject s ability to give informed consent, including but not limited to clinically significant forms of: infectious diseases, drug or alcohol abuse, autoimmune diseases, psychiatric disorders, or heart disease.
Data sourced from ClinicalTrials.gov (NCT05398796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.