Dose Escalation, Open-Label Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of a Nipah Virus (NiV) mRNA Vaccine, mRNA-1215, in Healthy Adults
-
- STATUS
- Recruiting
-
- End date
- Jun 24, 2024
-
- participants needed
- 50
-
- sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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 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 will visit the NIH clinic 13 to 15 times over 14 to 16 months.
Participants will get 2 doses of the experimental vaccine during this study at either 1 month or 3 months apart. The vaccine will be given as a shot into the muscle of the upper arm. Participants will stay in the clinic at least 30 minutes after each vaccination.
Participants will be given a diary card and a thermometer. They will record their temperature and any other symptoms for 7 days after each vaccination.
During each follow-up visit, 3 to 14 tubes of blood will be drawn for research.
Participants may undergo an optional procedure called apheresis. A needle will be placed into a vein in each arm. Blood will be removed through one needle. The blood will pass through a machine that separates some of the blood cells. The rest of the blood will return to the body through the other needle.
The study vaccine cannot cause NiV infection.
Description
- Design
This Phase I, dose escalation, open label clinical trial is 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 are that the vaccine will be safe, tolerable, and will elicit an immune response in healthy adults.
Study Product:
mRNA-1215 is a novel mRNA vaccine that encodes for the secreted prefusion stabilized F component covalently linked to G monomer (pre-F/G) of Malaysian strain NiV, resulting in a post-expression trimerization. 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.
- Subjects
Healthy adults, 18 to 60 years of age.
- Plan
Subjects will be enrolled at the NIH Clinical Center and will receive mRNA-1215 via intramuscular (IM) injection by needle and syringe into the deltoid muscle. A dose escalation safety evaluation will occur to ensure the safety data support proceeding to the higher dose group. The mRNA-1215 vaccine dose for Group 4 will be selected based on interim analysis of safety and immunogenicity data from Groups 1-3. Subjects will be evaluated for safety and immune responses through clinical observation and blood collection at specified timepoints throughout the study. The study schema is as follows:
Study Schema
Group Subjects Dose/Route Day 0 Week 4 Week 12
- 10 25 mcg IM X X
- 10 50 mcg IM X X
- 10 100 mcg IM X X
- 10 *XX mcg IM X X
Total **40
*mRNA-1215 dose for Group 4 will be chosen based on interim analysis of safety and immunogenicity data from Groups 1-3.
**Enrollment up to 50 subjects is permitted in case additional evaluations are required for safety or immunogenicity.
- Duration
Subjects will be evaluated for safety and immune responses throughout the study for 52 weeks following last product administration
Details
| Condition | Nipah Virus Infection |
|---|---|
| Treatment | mRNA -1215 |
| Clinical Study Identifier | NCT05398796 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Last Modified on | 4 October 2022 |
Eligibility
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer