Nipah Virus InfectionPhase 1NCT05398796
Dose Escalation, Open-Label Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of a Nipah Virus (NiV) mRNA Vaccine, mRNA-1215, in Healthy Adults
A Phase 1 study testing mRNA -1215 in people with Nipah Virus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nipah Virus Infection
- What is being tested?
- mRNA -1215
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2022to 17 Sep 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 21Show fewer
- 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
- Criteria applicable to women of childbearing potential:
- Negative beta-human chorionic gonadotropin (Beta-HCG) pregnancy test (urine or serum) on the day of enrollment.
- Agrees to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study.
Who cannot join
- A volunteer will be excluded if one or more of the following conditions apply:
- Breast-feeding or planning to become pregnant during the study.
- More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment.
- Blood products within 16 weeks prior to enrollment.
- Any vaccine, including COVID-19 vaccines, received within 4 weeks prior to enrollment.
- Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
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- Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule.
- Current anti-TB prophylaxis or therapy.
- Known immediate hypersensitivity to any component of the study product, including polyethylene glycol (PEG).
- Confirmed past NiV infection, prior residence in (>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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: VRC 322/DMID 21-0016: A Phase I, Dose Escalation, Open-Label Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of a Nipah Virus (NiV) mRNA Vaccine, mRNA-1215, in Healthy Adults
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.
Read more
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.
Read the detailed description
Design:
This Phase I, dose escalation, open label clinical trial was the first study of mRNA-1215 in healthy adults to evaluate the safety, tolerability, and immunogenicity of a Nipah virus (NiV) mRNA vaccine. The hypotheses were that the vaccine would be safe, tolerable, and would elicit an immune response in healthy adults.
Study Product:
The investigational mRNA-1215 vaccine 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 with a trimerization domain resulting in secretion of a trimer of heterodimers.
mRNA-1215 was co-developed by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Disease (NIAID) and ModernaTX, Inc, and manufactured by ModernaTX.
Participants:
Healthy adults, 18 to 60 years of age.
Plan:
Participants were enrolled at the NIH Clinical Center and received mRNA-1215 via intramuscular (IM) injection by needle and syringe into the deltoid muscle. A dose escalation safety evaluation occurred to ensure the safety data support proceeding to the higher dose groups. The mRNA-1215 vaccine dose for Group 4 was selected based on interim analysis of safety and immunogenicity data from Groups 1-3. Participants were evaluated for safety and immune responses through clinical observation and blood collection for safety labs at specified timepoints throughout the study. The study schema was as follows:
Study Schema
Group Participants Dose/Route Day 0 Week 4
- 10 25 mcg IM X X
- 10 50 mcg IM X X
- 10 100 mcg IM X X
- 10 10 mcg IM X X
Total **40
**Enrollment of up to 50 subjects was permitted in case additional evaluations were required for safety or immunogenicity.
Duration:
Participants were evaluated for safety and immune responses throughout the study for 52 weeks following the second vaccine dose.
- Conditions
- Nipah Virus Infection
- Being tested
- mRNA -1215
- Keywords
- mRNA Vaccine, Pandemic Threat, First in Human, Zoonotic Transmission
- Medical subject headings
- Henipavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA -1215Biological
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 25 mcg IM, 2 injections 4 weeks apart Receives: Biological: mRNA -1215 |
| Group 2 | Experimental | 50 mcg IM, 2 injections 4 weeks apart Receives: Biological: mRNA -1215 |
| Group 3 | Experimental | 100 mcg IM, 2 injections 4 weeks apart Receives: Biological: mRNA -1215 |
| Group 4 | Experimental | 10 mcg IM, 2 injections 4 weeks apart Receives: Biological: mRNA -1215 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Vaccine-induced binding antibody titers against Pre-F antigen of Nipah virus Malaysia strain (NiV(M)) were measured by ELISA. The value of the antibody response was determined by obtaining half of the maximum effective concentration (EC50) titer from the optical density 450 nm curves for the function of the reciprocal dilution using a four-parameter logistic curve fit in Prism (version 10.2.2). NiV Pre-F EC50 titers were normalized using the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC) international standard (IS, NIBSC code 22/130) and are reported as group geometric mean titers (GMTs) and 95% confidence intervals (CIs) in international units per milliliter (IU/ml).
Measured: 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).
Vaccine-induced binding antibody titers against G antigen of Nipah virus Malaysia strain (NiV(M)) were measured by ELISA. The value of the antibody response was determined by obtaining half of the maximum effective concentration (EC50) titer from the optical density 450 nm curves for the function of the reciprocal dilution using a four-parameter logistic curve fit in Prism (version 10.2.2). NiV G EC50 titers were normalized using the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC) international standard (IS, NIBSC code 22/130) and are reported as group geometric mean titers (GMTs) and 95% confidence intervals (CIs) in international units per milliliter (IU/ml).
Measured: Serum samples collected at baseline (Week 0) and at two weeks after the second product administration (Week 6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start11 Jul 2022
- Primary completion17 Sep 2024
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nipah Virus InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- ModernaTX, Inc.
- Responsible party
- Sponsor
- Investigators
- Lesia K Dropulic, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398796
- Sponsor's protocol ID
- 10000687
- Other IDs
- 000687-I
- Status last verified
- Oct 2025
- First submitted
- 27 May 2022
- Last updated
- 23 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregate data will be shared.
Publications
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.
PubMed 32595632Loomis 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.
PubMed 34956199Ploquin A, Mason RD, Holman LA, Happe M, Widge AT, Novik L, Ortega-Villa AM, Yamshchikov GV, Gordon IJ, Ola A, Arthur A, Costner PJM, Mendoza F, Saunders J, Wang X, Whalen WR, Utoh J, Cunningham J, Loftus LN, Heimann A, Korzeniwsky K, Andrew SF, Lamb E, Shyam Sunder S, Thompson A, McDonald M, Foulds KE, Sullivan NJ, Bahorich J, Coates EE, Loomis RJ, Graham BS, Bok K, Himansu S, Leav B, Dempsey W, Beigel JH, Roederer M, Dropulic LK; VRC 322 study team. A structure-based mRNA vaccine for Nipah virus in healthy adults: a phase 1 trial. Nat Med. 2026 Apr;32(4):1401-1410. doi: 10.1038/s41591-026-04265-1. Epub 2026 Mar 12.
PubMed 41820674Watanabe 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.
PubMed 38100536
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VRC 322/DMID 21-0016: A Phase I, Dose Escalation, Open-Label Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of a Nipah Virus (NiV) mRNA Vaccine, mRNA-1215, in Healthy Adults
- ClinicalTrials.gov ID
- NCT05398796
- Acronym / sponsor ID
- 10000687
- Conditions
- Nipah Virus Infection
- Keywords
- mRNA Vaccine, Pandemic Threat, First in Human, Zoonotic Transmission
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- ModernaTX, Inc.
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Posted 23 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design:
This Phase I, dose escalation, open label clinical trial was the first study of mRNA-1215 in healthy adults to evaluate the safety, tolerability, and immunogenicity of a Nipah virus (NiV) mRNA vaccine. The hypotheses were that the vaccine would be safe, tolerable, and would elicit an immune response in healthy adults.
Study Product:
The investigational mRNA-1215 vaccine 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 with a trimerization domain resulting in secretion of a trimer of heterodimers.
mRNA-1215 was co-developed by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Disease (NIAID) and ModernaTX, Inc, and manufactured by ModernaTX.
Participants:
Healthy adults, 18 to 60 years of age.
Plan:
Participants were enrolled at the NIH Clinical Center and received mRNA-1215 via intramuscular (IM) injection by needle and syringe into the deltoid muscle. A dose escalation safety evaluation occurred to ensure the safety data support proceeding to the higher dose groups. The mRNA-1215 vaccine dose for Group 4 was selected based on interim analysis of safety and immunogenicity data from Groups 1-3. Participants were evaluated for safety and immune responses through clinical observation and blood collection for safety labs at specified timepoints throughout the study. The study schema was as follows:
Study Schema
Group Participants Dose/Route Day 0 Week 4
- 10 25 mcg IM X X
- 10 50 mcg IM X X
- 10 100 mcg IM X X
- 10 10 mcg IM X X
Total **40
**Enrollment of up to 50 subjects was permitted in case additional evaluations were required for safety or immunogenicity.
Duration:
Participants were evaluated for safety and immune responses throughout the study for 52 weeks following the second vaccine dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: mRNA -121525 mcg IM, 2 injections 4 weeks apart |
| Group 2 | Experimental | Biological: mRNA -121550 mcg IM, 2 injections 4 weeks apart |
| Group 3 | Experimental | Biological: mRNA -1215100 mcg IM, 2 injections 4 weeks apart |
| Group 4 | Experimental | Biological: mRNA -121510 mcg IM, 2 injections 4 weeks apart |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (26 listed)
- Breast-feeding or planning to become pregnant during the study.
- More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment.
- Blood products within 16 weeks prior to enrollment.
- Any vaccine, including COVID-19 vaccines, received within 4 weeks prior to enrollment.
- Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA -1215mRNA-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 | Biological | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Time frame: 7 days after 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.
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Time frame: 7 days after 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.
Number of Participants With Serious Adverse Events Following Product Administration
Time frame: Day 0 after product administration through Day 392, up to Week 56
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.
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration
Time frame: Day 0 through 28 days post product administration, up to Week 4
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.
Number of Participants With New Chronic Medical Conditions Following Product Administration
Time frame: Day 0 after product administration through Day 392, up to Week 56
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
Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration
Time frame: Day 0 after product administration through Day 392, up to Week 56
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.
Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration
Time frame: First vaccination to 6 months
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.
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
Time frame: Day 0 after product administration through Day 392, up to Week 56
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.
2 secondary outcomes
Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).
Time frame: 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).
Time frame: Serum samples collected at baseline (Week 0) and at two weeks after the second product administration (Week 6).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32595632Loomis 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.
- Background: PubMed 34956199Loomis 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.
- Derived from this study: PubMed 41820674Ploquin A, Mason RD, Holman LA, Happe M, Widge AT, Novik L, Ortega-Villa AM, Yamshchikov GV, Gordon IJ, Ola A, Arthur A, Costner PJM, Mendoza F, Saunders J, Wang X, Whalen WR, Utoh J, Cunningham J, Loftus LN, Heimann A, Korzeniwsky K, Andrew SF, Lamb E, Shyam Sunder S, Thompson A, McDonald M, Foulds KE, Sullivan NJ, Bahorich J, Coates EE, Loomis RJ, Graham BS, Bok K, Himansu S, Leav B, Dempsey W, Beigel JH, Roederer M, Dropulic LK; VRC 322 study team. A structure-based mRNA vaccine for Nipah virus in healthy adults: a phase 1 trial. Nat Med. 2026 Apr;32(4):1401-1410. doi: 10.1038/s41591-026-04265-1. Epub 2026 Mar 12.
- Derived from this study: PubMed 38100536Watanabe 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Only aggregate data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lesia K Dropulic, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mRNA -1215 in people with Nipah Virus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration (time frame: 7 days after product administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05398796, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.