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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

NCT02251288 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-01-27

No results posted yet for this study

Summary

A phase I prospective, randomized study in healthy adult subjects at a single center. Adult subjects age 18 to 47 years and meeting all enrollment criteria will choose to participate as subjects who receive inactivated vaccine followed by a live vaccine boost at 4 weeks (Group 1), 12 weeks (Group 2), or 24 weeks (Group 3), or to be in an observational group (Group 4) which will not be scheduled for a booster dose but may serve as a roll-over group for subjects who withdraw prior to the second vaccination but agree to remain in follow-up. A fifth group will receive two intramuscular doses of adjuvanted H7N9 pIIV separated by four weeks. The primary objectives of this study are to (1) assess the safety of H7N9 pLAIV administered to individuals who have previously received MF59-adjuvanted or unadjuvanted H7N9 pIIV, (2) evaluate the ability of a single dose of unadjuvanted H7N9 pIIV to prime for enhanced immunogenicity (booster response) to subsequent administration of antigenically-matched H7N9 pLAIV vaccine, and to (3) evaluate the ability of a single dose of MF59-adjuvanted H7N9 pIIV to prime for enhanced immunogenicity (booster response) to subsequent administration of antigenically-matched H7N9 pLAIV vaccine.

Conditions

  • Avian Influenza
  • Immunisation

Interventions

BIOLOGICAL

Influenza Virus Vaccine, Live Attenuated H7N9 Anhui 2013/AA ca

MedImmune supplies pLAIV vaccines as a colorless to pale yellow and clear to slightly cloudy suspension in single, unit-dose, Becton-Dickinson Accuspray™ Nasal Spray Systems sprayer devices. Each filled sprayer device contains a 0.5 mL dose of 10\^7FFU of H7N9 Anhui 2013/AA ca vaccine. Group I receives the IN dose on Day 29, Group 2 on Day 85, and Group 3 on Day 169.

BIOLOGICAL

Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Sanofi supplies the monovalent influenza A/H7N9 virus vaccine as a sterile, clear, and slightly opalescent suspension in single-dose vials containing 15 mcg HA per 0.5 mL. Group 1 through Group5 will receive the IM vaccine on Day 1

DRUG

MF59 adjuvant

Novartis supplies the MF59 adjuvant as an oil-in-water milky emulsion in single-use vials containing a fill volume of 0.7 mL. Group 1 through Group 5 will receive MF59 IM on Day 1.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
47 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-18
Primary Completion
2018-08-17
Completion
2018-08-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02251288 on ClinicalTrials.gov