RECRUITING

A Study to Evaluate the Safety and Immunogenicity of Two Doses of a Novel H5 Central Antigen mRNA-LNP in Healthy Adults

Conditions

Avian Influenza H5N1 Healthy Adults Influenza Novel H5 Central Antigen mRNA-LNP Phase 1 Safety and Immunogenicity Vaccine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase 1, multicenter, randomized, double-blind trial of two influenza A/H5 mRNA-based vaccines on healthy adult participants, 18-49 years of age. Stage 1 will serve as the open-label, dose finding stage. The first 10 participants will receive 12.5 mcg of H5 AC-Anhui RNA vaccine (Group 1), and the second 10 participants will receive 25 mcg of H5 AC-Anhui RNA vaccine (Group 2). After Protocol Safety Review Team (PSRT) review of reactogenicity and safety data through Day 8 for both Groups 1 and 2, another 10 participants may be enrolled to receive 50 mcg of H5 AC-Anhui RNA vaccine (Group 3). Safety data from 7 days after dose 2 for Groups 1 and 2 participants will be reviewed by the PSRT prior to clearing Group 3 participants for the second dose of vaccine. Individual participants will be followed for approximately 6 months following the second dose of vaccine. The primary objective is to assess the safety of two doses of H5 AC-Anhui RNA vaccine or H5-Astrakhan RNA vaccine administered intramuscularly in healthy adults (18-49 years). Once the Day 36 data from Group 3 are reviewed by the PSRT, a dose will be chosen (12.5 mcg, 25 mcg, or 50 mcg) for advancement to Stage 2 where 50 participants will be randomized 1:1 to receive either H5 AC-Anhui RNA (Group 4) or H5 Astrakhan RNA (Group 5) in a double-blinded manner.

Official Title

A Phase 1 Study to Evaluate the Safety and Immunogenicity of Two Doses of a Novel H5 Antigenically Central (AC)-Anhui mRNA-LNP Vaccine in Healthy Adults

Quick Facts

Study Start:2025-06-10

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07019883

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 49 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Provides written informed consent prior to the initiation of any trial procedures 2. Can understand and agrees to comply with all planned trial procedures and be available for all study visits 3. Adult volunteers, age 18-49 years, inclusive, at time of enrollment. 4. In good general health.\* \* Good health is defined by the absence of a medical condition described in the exclusion criteria. If the participant has another current, ongoing medical condition, the condition cannot meet any of the following criteria: 1. was first diagnosed within 3 months of enrollment with a clinically significant condition, in the opinion of investigator 2. had non-elective surgery, clinically significant medical procedure, or hospitalization within 3 months of enrollment; 3. received new prescription for systemic medication within 30 days of enrollment, unless the new prescription is in the same class of agent or a transition from generic to/from brand name equivalent; or 4. takes medication that may pose a risk to participant's safety or impede assessment of adverse events or study endpoints if they participate in the study. 5. Participants of childbearing potential\* must agree to use or have practiced true abstinence\\ or use at least one acceptable primary form of contraception.\\\* \*These criteria apply to females who are in a heterosexual relationship who are of childbearing potential. Participants not of childbearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or permanently implanted contraceptive device placement). 6. Must agree to refrain from donating blood or blood products during the first 6 months of the study 7. Body mass index (BMI) 18 kg/m\^2 to 35 kg/m\^2, inclusive, and a weight of 130 kg or less at the time of screening	1. Positive pregnancy test at screening or prior to vaccine dose 2. Participant who is lactating 3. Presence of a significant psychiatric condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation 4. History of drug abuse or alcohol abuse within 6 months of enrollment that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation 5. Has a significant acute illness (with or without fever), as determined by the site PI or appropriate sub-investigator, within 72 hours prior to dosing\* \If the participant meets all other eligibility criteria, they may be enrolled and dosed once they meet this eligibility criterion. If the illness resolves within the 14-day screening window, they do not need to be rescreened, otherwise they will need to be rescreened 6. Currently enrolled in or plans to participate in another clinical trial with an investigational agent 7. Has a history of anaphylaxis to any drug compound, vaccine, food, or other substance, unless approved by the Investigator (or designee)\\* 8. Received any live-attenuated or mRNA vaccine in the 28 days prior or any other vaccine in the 14 days prior to study vaccination 9. Has used any prohibited medication within 30 days prior to Day 1 or plans to use prohibited medications\\\* through Day 57 10. Abnormal blood pressure or temperature (Grade 1 or higher) at time of vaccination 11. Abnormal heart rate (Grade 2 or higher) at time of vaccination 12. Known and current human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, based on medical history 13. Extended exposure (e.g., occupational or home exposure) to cattle or poultry since March 1, 2024 14. Ingestion of non-pasteurized milk since March 1, 2024, or plans to drink non-pasteurized milk during participation in the trial 15. Prior receipt of an influenza A/H5 vaccine 16. History of myocarditis or pericarditis 17. Has any medical disease or condition\\\\\* that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation\\\\\\ \\\\\Medical conditions include, but are not limited to, kidney disease with creatinine clearance \< 89 mL/min/1.73 cm2 (CKD-EPI method); known active liver disease; ischemic heart disease, clinically significant cardiac conduction disorder, arrythmia requiring treatment, congenital long QT syndrome, uncompensated heart failure; diabetes requiring insulin; neuropathy or myopathy; history of Guillain-Barré Syndrome; and malignancy (not including squamous cell skin cancer, basal cell skin cancer, or cervical lowgrade squamous intraepithelial lesions) \\\\\\*Participation may be precluded due to safety concern or inability to adequately evaluate clinical trial endpoints.

Inclusion Criteria

Exclusion Criteria

1. Provides written informed consent prior to the initiation of any trial procedures
2. Can understand and agrees to comply with all planned trial procedures and be available for all study visits
3. Adult volunteers, age 18-49 years, inclusive, at time of enrollment.
4. In good general health.\* \* Good health is defined by the absence of a medical condition described in the exclusion criteria. If the participant has another current, ongoing medical condition, the condition cannot meet any of the following criteria:
1. was first diagnosed within 3 months of enrollment with a clinically significant condition, in the opinion of investigator
2. had non-elective surgery, clinically significant medical procedure, or hospitalization within 3 months of enrollment;
3. received new prescription for systemic medication within 30 days of enrollment, unless the new prescription is in the same class of agent or a transition from generic to/from brand name equivalent; or
4. takes medication that may pose a risk to participant's safety or impede assessment of adverse events or study endpoints if they participate in the study.
5. Participants of childbearing potential\* must agree to use or have practiced true abstinence\*\* or use at least one acceptable primary form of contraception.\*\*\* \*These criteria apply to females who are in a heterosexual relationship who are of childbearing potential. Participants not of childbearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or permanently implanted contraceptive device placement).
6. Must agree to refrain from donating blood or blood products during the first 6 months of the study
7. Body mass index (BMI) 18 kg/m\^2 to 35 kg/m\^2, inclusive, and a weight of 130 kg or less at the time of screening

1. Positive pregnancy test at screening or prior to vaccine dose
2. Participant who is lactating
3. Presence of a significant psychiatric condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation
4. History of drug abuse or alcohol abuse within 6 months of enrollment that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation
5. Has a significant acute illness (with or without fever), as determined by the site PI or appropriate sub-investigator, within 72 hours prior to dosing\* \*If the participant meets all other eligibility criteria, they may be enrolled and dosed once they meet this eligibility criterion. If the illness resolves within the 14-day screening window, they do not need to be rescreened, otherwise they will need to be rescreened
6. Currently enrolled in or plans to participate in another clinical trial with an investigational agent
7. Has a history of anaphylaxis to any drug compound, vaccine, food, or other substance, unless approved by the Investigator (or designee)\*\*
8. Received any live-attenuated or mRNA vaccine in the 28 days prior or any other vaccine in the 14 days prior to study vaccination
9. Has used any prohibited medication within 30 days prior to Day 1 or plans to use prohibited medications\*\*\* through Day 57
10. Abnormal blood pressure or temperature (Grade 1 or higher) at time of vaccination
11. Abnormal heart rate (Grade 2 or higher) at time of vaccination
12. Known and current human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, based on medical history
13. Extended exposure (e.g., occupational or home exposure) to cattle or poultry since March 1, 2024
14. Ingestion of non-pasteurized milk since March 1, 2024, or plans to drink non-pasteurized milk during participation in the trial
15. Prior receipt of an influenza A/H5 vaccine
16. History of myocarditis or pericarditis
17. Has any medical disease or condition\*\*\*\*\* that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation\*\*\*\*\*\* \*\*\*\*\*Medical conditions include, but are not limited to, kidney disease with creatinine clearance \< 89 mL/min/1.73 cm2 (CKD-EPI method); known active liver disease; ischemic heart disease, clinically significant cardiac conduction disorder, arrythmia requiring treatment, congenital long QT syndrome, uncompensated heart failure; diabetes requiring insulin; neuropathy or myopathy; history of Guillain-Barré Syndrome; and malignancy (not including squamous cell skin cancer, basal cell skin cancer, or cervical lowgrade squamous intraepithelial lesions) \*\*\*\*\*\*Participation may be precluded due to safety concern or inability to adequately evaluate clinical trial endpoints.

Contacts and Locations

Study Contact

C. Buddy Creech

CONTACT

16153430332

buddy.creech@vumc.org

Study Locations (Sites)

Duke Vaccine and Trials Unit

Durham, North Carolina, 27703

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-0011

United States

Baylor College of Medicine

Houston, Texas, 77030-3411

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-10

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2025-06-10

Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

H5N1
Healthy Adults
Influenza
Novel H5 Central Antigen mRNA-LNP
Phase 1
Safety and Immunogenicity
Vaccine

Additional Relevant MeSH Terms

Avian Influenza