This is a Phase 1, randomized, controlled, dose-ranging clinical trial to assess the safety and immunogenicity of novel influenza A Group 1 and influenza A Group 2 mRNA chimeric hemagglutinin (HA) vaccine candidates given as intramuscular injections alone and in combination. A total of 60 healthy men and non-pregnant, non-breastfeeding women aged 18 through 59 years will be enrolled in one of 6 study arms. The 6 arms will consist of: 1) Sequential influenza A Group 1 mRNA chimeric hemagglutinin: cH8/1 (25 µg) followed by cH5/1 (25 µg), 2) Sequential influenza A Group 2 mRNA chimeric hemagglutinin: cH15/3 (25 µg) followed by cH4/3 (25 µg), 3) Sequential combined influenza A Group 1 and Group 2 mRNA chimeric hemagglutinin: cH8/1 + cH15/3 (25 µg) followed by cH5/1 + cH4/3 (25 µg), 4) A single dose of combined influenza A Group 1 and Group 2 mRNA chimeric hemagglutinin: cH8/1 + cH15/3 (50 µg) followed by placebo, 5) A single dose of combined influenza A Group 1 and Group 2 mRNA chimeric hemagglutinin: cH5/1 + cH4/3 (50 µg) followed by placebo, 6) Sequential combined influenza A Group 1 and Group 2 mRNA chimeric hemagglutinin: cH8/1 + cH15/3 (50 µg) followed by cH5/1 + cH4/3 (50 µg). The primary objectives are to evaluate safety and immunogenicity: 1) To assess the safety and reactogenicity of one or two doses of monovalent or bivalent Group 1 and 2 study products and 2) To describe the Group 1 and 2 anti-HA stalk IgG antibody responses of one or two doses of monovalent or bivalent Group 1 and 2 study products by ELISA.
Provision of signed and dated informed consent form before the initiation of any study procedures.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Non-pregnant healthy adults, aged 18 to 59 years of age, inclusive, at the time of enrollment.
In good general health as evidenced by medical history or diagnosed with stable chronic medical or psychiatric diagnoses or conditions.*
Oral temperature is less than 100.4 degrees Fahrenheit*.
Heart rate (HR) is 55 to 100 beats per minute, inclusive*. *Screening heart rate values in the normal range or with grade 1 abnormalities deemed not clinically significant by the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572 are considered acceptable.
Systolic blood pressure is 90 to 140 mmHg, inclusive*.
Diastolic blood pressure is 55 to 90 mmHg, inclusive*. *Screening diastolic blood pressure values in the normal range or with grade 1 abnormalities deemed not clinically significant by the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572 are considered acceptable.
Sequential
cH15/3
Biological/VaccineThe cH15/3 RNA study product encodes for a novel chimeric hemagglutinin comprised of an H15 HA head domain derived from influenza A/wedge-tailed shearwater/Western Australia/2576/1979 (H15N9) and the conserved stem domain derived from influenza A/Hong Kong/2014 (H3N2) (GenBank: OQ349633). The cH15/3 RNA is encapsulated in LNPs for delivery. The LNP is comprised of 4 lipid components: ionizable lipid (ALC-0315), distearoylphosphatidylcholine (DSPC), cholesterol (non-animal derived), and PEG lipid (ALC-0159).
cH4/3
Biological/VaccineThe cH4/3 RNA encodes a novel chimeric hemagglutinin comprised of an H4 head domain from A/duck/Czechoslovakia/1956 (H4N6) and a conserved stem domain from A/Hong Kong/2014 (H3N2) (GenBank: OQ349617), delivered via lipid nanoparticles (LNPs) containing ionizable lipid (ALC-0315), distearoylphosphatidylcholine (DSPC), cholesterol (non-animal derived), and PEG lipid (ALC-0159).
cH5/1N1
Biological/VaccinecH5/1N1 is a H1N1 influenza vaccine: egg grown split inactivated influenza virus vaccines containing chimeric hemagglutinins (HAs). The chimeric viruses contain the globular heads of exotic viruses- and the HA stem domain and neuraminidase protein from currently circulating seasonal H1N1.
cH8/1N1
Biological/VaccinecH8/1N1 is a H1N1 influenza vaccine: egg grown split inactivated influenza virus vaccines containing chimeric hemagglutinins (HAs). The chimeric viruses contain the globular heads of exotic viruses- and the HA stem domain and neuraminidase protein from currently circulating seasonal H1N1.
Saline
DrugSodium chloride solution.
6
Treatment groupsSee each treatment group below.
Geometric mean fold rise (GMFR) from baseline in HA-stalk specific titers by ELISA
Geometric mean titer (GMT) by ELISA
Number and percentage of participants with greater than or equal to a 2-, 4-, and 10-fold rise from baseline in Hemagglutinin (HA)-stalk specific titers by ELISA
Occurrence of Adverse Events of Special Interest (AESIs)
Geometric mean fold-rise (GMFR) from baseline in Hemagglutinin (HA) stalk specific titers by ELISA
Hemagglutinin (HA)-stalk specific geometric mean titer (GMT) by ELISA
Number and percentage of participants with greater than or equal to a 2-, 4-, and 10-fold rise from baseline in Hemagglutinin (HA) -stalk specific titers by ELISA
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