At a glance
ClinicalIndex Comparison Record- ✓Healthy adults aged 18-60 years
- ✓Good general health without exclusionary conditions
- ✓BMI 18-35
- ✓Available for 52-week follow-up
- ✕Prior Nipah virus infection or endemic residence >6 months
- ✕Any vaccine received within 4 weeks prior to enrollment
- ✕Systemic immunosuppressive or cytotoxic medications within 4 weeks (or any within 14 days)
- ✕History of myocarditis and/or pericarditis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating mRNA -1215 for Nipah Virus Infection. Completed, enrolled 40 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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