Dose, Safety, Tolerability and Immunogenicity of an Influenza H10 Stabilized Stem Ferritin Vaccine, VRC-FLUNPF0103-00-VP, in Healthy Adults

Summary

Participation Requirements

Description

Design: This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of VRC-FLUNPF0103-00-VP in 2 regimens. The hypotheses are that the vaccine is safe and tolerable and will elicit an immune response. The primary objective is to evaluate the sa...

Design: This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of VRC-FLUNPF0103-00-VP in 2 regimens. The hypotheses are that the vaccine is safe and tolerable and will elicit an immune response. The primary objective is to evaluate the safety and tolerability of the investigational vaccine in healthy adults. Secondary objectives are related to immunogenicity of the investigational vaccine and dosing regimen. Study Products: The investigational vaccine, VRC-FLUNPF0103-00-VP (H10ssF-6473), was developed by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID) and is composed of Helicobacter pylori non-heme ferritin assembled with influenza virus H10 haemagglutinin (HA) insert to form a nanoparticle displaying eight HA stabilized stems trimers from A/Jiangxi/IPB13/2013 (H10N8) influenza. The vaccine is supplied in single-use vials at a concentration of 180 mcg/mL. VRC-PBSPLA043-00-VP consisting of sterile phosphate buffered saline (PBS) will be the diluent for H10ssF-6473. Prepared study product will be administered intramuscularly (IM) in the deltoid muscle via needle and syringe. Subjects: Healthy adults between the ages of 18-70 will be enrolled; adults born between 1965 and 1970 will be excluded from the trial. Study Plan: This study will evaluate the safety, tolerability and immunogenicity of 1 or 2 doses of H10ssF-6473 in a dose-escalation design. In Group 1, the first 3 subjects will receive a single low dose (20 mcg) of H10ssF-6473 on Day 0. If assessed as safe and tolerable two weeks after vaccination of the third subject, enrollment will continue for the additional subjects in Group 1 and begin for Group 2A. For Group 1, the protocol requires 1 vaccination visit, 8 follow-up visits, and a telephone contact after vaccination. Groups 2A and 2B are stratified by age as shown in the vaccination schema. In Group 2A, the first 3 subjects will receive a higher dose (60 mcg) of H10ssF-6473 on Day 0. If assessed as safe and tolerable two weeks after vaccination of the third subject, enrollment will continue in Group 2A, begin for Group 2B, and subjects may receive the second vaccination at week 16. For Groups 2A and 2B, the protocol requires 2 vaccination visits, 10 follow-up visits, and a telephone contact after each vaccination. For all groups, solicited reactogenicity will be evaluated using a 7-day diary card. Assessment of vaccine safety will include clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study. VRC 323 Va.ccination Schema: Group 1, Age Cohort: 18-50, Subjects: 5, Day 0: 20 mcg IM, Week 16: no dose Group 2A, Age Cohort: 18-50, Subjects: 10-15, Day 0: 60 mcg IM, Week 16: 60 mcg IM Group 2B, Age Cohort: 55-70, Subjects: 10-15, Day 0: 60 mcg IM, Week 16: 60 mcg IM Total Subjects: 25-35* *Enrollment up to 45 is permitted if additional subjects are needed for safety or immunogenicity evaluations. Study Duration: Subjects will be evaluated for 40 weeks following the first vaccine administration.

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