Dose Escalation, Open-Label Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of a Nipah Virus (NiV) mRNA Vaccine, mRNA-1215, in Healthy Adults

NCT05398796 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 10000687000687-I
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nipah Virus Infection

Keywords

mRNA Vaccine; Pandemic Threat; First in Human; Zoonotic Transmission

Outcome Measures

Primary Outcomes (8)

• Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration

  Participants recorded the occurrence of solicited local symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.

  7 days after product administration

• Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration

  Participants recorded the occurrence of solicited systemic symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.

  7 days after product administration

• Number of Participants With Serious Adverse Events Following Product Administration

  SAEs were recorded from receipt of product administration through the last study visit at Week 56. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

  Day 0 after product administration through Day 392, up to Week 56

• Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration

  Unsolicited AEs and attribution assessments were recorded in the study database from receipt of study product administration through the visit scheduled for 4 weeks after study product administration. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

  Day 0 through 28 days post product administration, up to Week 4

• Number of Participants With New Chronic Medical Conditions Following Product Administration

  New chronic medical conditions that required ongoing medical management were recorded from receipt of study product administration through the last expected study visit through Day 392, up to Week 56. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity

  Day 0 after product administration through Day 392, up to Week 56

• Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration

  An AESI is an AE (serious or nonserious) of scientific medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the investigator to the Sponsor is required.

  Day 0 after product administration through Day 392, up to Week 56

• Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration

  MAAEs are defined as adverse events leading to hospitalization, an emergency room visit or an otherwise unscheduled visit to or from medical personnel, for any reason.

  First vaccination to 6 months

• Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration

  Abnormal lab results recorded as unsolicited adverse events (AEs) are summarized\*. Safety lab parameters included pregnancy test, hematology and chemistry labs, and HIV Serology diagnostic test. Institutional lab normal ranges as well as Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.

  Day 0 after product administration through Day 392, up to Week 56

Secondary Outcomes (2)

• Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).

  Serum samples collected at baseline (Week 0) and at two weeks after the second product administration (Week 6).

• Geometric Mean NiV(M) G Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).

  Serum samples collected at baseline (Week 0) and at two weeks after the second product administration (Week 6).

Study Arms (4)

Group 1

EXPERIMENTAL

25 mcg IM, 2 injections 4 weeks apart

Biological: mRNA -1215

Group 2

EXPERIMENTAL

50 mcg IM, 2 injections 4 weeks apart

Biological: mRNA -1215

Group 3

EXPERIMENTAL

100 mcg IM, 2 injections 4 weeks apart

Biological: mRNA -1215

Group 4

EXPERIMENTAL

10 mcg IM, 2 injections 4 weeks apart

Biological: mRNA -1215

Interventions

mRNA -1215 BIOLOGICAL

mRNA-1215 is a lipid nanoparticle dispersion containing mRNA that encodes for a secreted prefusion stabilized F component covalently linked to a G monomer (PreF/G) of a NiV Malaysian 1999 strain

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A volunteer must meet all of the following criteria:
• Healthy adults between the ages of 18-60 years inclusive.

You may not qualify if:

• 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) \<= 1.25 X institutional upper limit of normal (ULN).
• Aspartate aminotransferase (AST) \<= 1.25 X institutional ULN.
• Alkaline phosphatase (ALP) \<1.1 X institutional ULN.
• Total bilirubin within institutional normal range or accompanied by the PI or designee approval.
• Serum creatinine \<= 1.1 X institutional ULN.
• Negative for HIV infection by an FDA-approved method of detection

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• ModernaTX, Inc.: collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Loomis RJ, Stewart-Jones GBE, Tsybovsky Y, Caringal RT, Morabito KM, McLellan JS, Chamberlain AL, Nugent ST, Hutchinson GB, Kueltzo LA, Mascola JR, Graham BS. Structure-Based Design of Nipah Virus Vaccines: A Generalizable Approach to Paramyxovirus Immunogen Development. Front Immunol. 2020 Jun 11;11:842. doi: 10.3389/fimmu.2020.00842. eCollection 2020.

  PMID: 32595632 BACKGROUND

• Loomis RJ, DiPiazza AT, Falcone S, Ruckwardt TJ, Morabito KM, Abiona OM, Chang LA, Caringal RT, Presnyak V, Narayanan E, Tsybovsky Y, Nair D, Hutchinson GB, Stewart-Jones GBE, Kueltzo LA, Himansu S, Mascola JR, Carfi A, Graham BS. Chimeric Fusion (F) and Attachment (G) Glycoprotein Antigen Delivery by mRNA as a Candidate Nipah Vaccine. Front Immunol. 2021 Dec 8;12:772864. doi: 10.3389/fimmu.2021.772864. eCollection 2021.

  PMID: 34956199 BACKGROUND

• Watanabe S, Yoshikawa T, Kaku Y, Kurosu T, Fukushi S, Sugimoto S, Nishisaka Y, Fuji H, Marsh G, Maeda K, Ebihara H, Morikawa S, Shimojima M, Saijo M. Construction of a recombinant vaccine expressing Nipah virus glycoprotein using the replicative and highly attenuated vaccinia virus strain LC16m8. PLoS Negl Trop Dis. 2023 Dec 15;17(12):e0011851. doi: 10.1371/journal.pntd.0011851. eCollection 2023 Dec.

  PMID: 38100536 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Henipavirus Infections

Condition Hierarchy (Ancestors)

Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Lesia K. Dropulic, M.D./Principal Investigator; Laura Novik, R.N., M.A./Study Coordinator
• Organization: Vaccine Research Center Clinical Trials Program, NIAID

lesia.dropulic@nih.gov; laura.novik@nih.gov

301-451-8717

Study Officials

• Lesia K Dropulic, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 1, 2022
• Study Start: July 11, 2022
• Primary Completion: September 17, 2024
• Study Completion: September 17, 2024
• Last Updated: October 23, 2025
• Results First Posted: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)