2013/2017 H7N9 Prime-Boost Interval

Status Completed

Clinical Trial Summary

This is a trial designed to assess the safety, reactogenicity and immunogenicity of one or two doses of monovalent inactivated split influenza 2013 and 2017 A/H7N9 virus vaccines administered intramuscularly at different dosages, given with or without AS03 adjuvant, using different vaccination schedules. This trial will enroll up to 180 males and non-pregnant females, 19 to 50 years of age, who are in good health and who are influenza A/H7 naïve. Subjects will be randomly assigned to 1 of 6 treatment arms (30 subjects per arm) to evaluate the interval between the first and second doses and the presence of the adjuvant in the first and second doses. The neuraminidase-specific antibody response and the neuraminidase content of the Inactivated Influenza Virus Vaccine will be determined using tests that are currently under development. Study duration is approximately 22 months with subject participation duration of approximately 18 months. The primary objectives of the study are: 1) to assess the safety and reactogenicity of 2013 and 2017 A/H7N9 IIVs given with or without AS03 adjuvant following receipt of each study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the second study vaccine.

Clinical Trial Description

This is a Phase II trial designed to assess the safety, reactogenicity and immunogenicity of one or two doses of monovalent inactivated split influenza 2013 and 2017 A/H7N9 virus vaccines (2013 and 2017 A/H7N9 IIVs) administered intramuscularly at different dosages (3.75 or 15 mcg of hemagglutinin (HA) per dose), given with or without AS03 adjuvant, using different heterologous and homologous prime-boost vaccination schedules. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. This trial will enroll up to 180 males and non-pregnant females, 19 to 50 years of age, inclusive, who are in good health and meet all eligibility criteria and who are influenza A/H7 vaccine/infection naïve by medical history. Subjects will be randomly assigned to 1 of 6 treatment arms (30 subjects per arm) evaluating the interval between the priming (first) and boosting (second) doses and the presence of the adjuvant in the priming (first) and boosting (second) doses. The neuraminidase-specific antibody response and the neuraminidase content of the Inactivated Influenza Virus Vaccine will be determined using tests that are currently under development. Study duration is approximately 22 months with subject participation duration of approximately 18 months. The primary objectives of the study are: 1) to assess the safety and reactogenicity of 2013 and 2017 A/H7N9 IIVs given with or without AS03 adjuvant following receipt of each study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the second study vaccine. The secondary objectives are: 1) to assess unsolicited non-serious adverse events (AEs) following receipt of each study vaccine; 2) to assess medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs), following receipt of each study vaccine; 3) to assess the kinetics and durability of serum HAI and Neut antibody responses following receipt of each study vaccine. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03589807
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	Phase 2
Start date	August 21, 2018
Completion date	June 14, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01698060` - Immunogenicity of ND1.1 by Delivery Directly to the Ileum	Phase 1
Completed	`NCT02213354` - H7N9 Mix and Match With MF59 in Healthy Elderly Persons	Phase 2
Completed	`NCT02295813` - Safety and Pharmacokinetics Study of FBF001	Phase 1
Completed	`NCT00561184` - Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine	Phase 2
Completed	`NCT02921997` - H7N9 Vaccination With and Without AS03 and Unadjuvanted H3N2v Vaccination: Standard and Systems Biology Analyses	Phase 2
Completed	`NCT03682120` - Safety/Efficacy Study of Seqirus A/H7N9 IIV With or Without MF59(R) Adjuvant to Prevent Avian Influenza	Phase 2
Completed	`NCT00895544` - Immunogenicity and Safety Study of a Single Prime-Boost Vaccination Schedule With a H5N1 Influenza Vaccine in Adults	Phase 1/Phase 2
Completed	`NCT02251288` - A Phase I Study Priming With an Inactivated A/H7N9 Influenza Virus Vaccine With or Without MF59 Adjuvant Followed by Live Attenuated A/H7N9 Influenza Virus Vaccine	Phase 1
Completed	`NCT02612909` - A Safety and Immunogenicity Study of IVACFLU-A/H5N1	Phase 2/Phase 3
Completed	`NCT02229357` - Evaluation of Priming Effects by PLAI Vaccine on the Subsequent Response to Inactivated H5N1 Vaccine	Phase 2
Completed	`NCT01150552` - Studies of Avian Influenza Transmission to Humans in Egypt	N/A
Completed	`NCT03472976` - H5N1 With or Without Topical Aldara in Healthy Adults	Phase 1
Completed	`NCT01897701` - A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1	Phase 1
Completed	`NCT01107262` - Avian Influenza Studies In Lebanon	N/A
Completed	`NCT02839330` - A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age	Phase 3
Completed	`NCT03014310` - H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults: Immunology	Phase 1
Completed	`NCT00298233` - High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza	Phase 2
Completed	`NCT03318315` - Co-Administration of AS03 Adjuvanted A/H7N9 IIV With IIV4	Phase 2
Completed	`NCT03312231` - Sanofi 2017 H7N9 With/Without AS03 in Adults/Elderly	Phase 2
Completed	`NCT03738241` - 2017 A/H7N9 IIV Revaccination	Phase 2