CompletedPhase 1

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

United States62 participantsStarted 2015-05-18

Plain-language 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.

Who can participate

Age range

18 Years – 47 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provide written informed consent prior to initiation of any study procedures, including future use of specimens.
. Are able to understand and comply with planned study procedures and be available for all study visits.
. Are males or non-pregnant, non-breastfeeding females, 18 to 47 years old, inclusive.

Exclusion criteria

. Oral temperature is less than 100.4 degrees Fahrenheit.
. Pulse is 55 to 100 bpm, inclusive.
. Systolic blood pressure is 90 to 140 mmHg, inclusive.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Geometric mean titers determined by neuraminidase inhibiting antibody by enzyme-linked lectin assay (ELLA)

Timeframe: Day 29

Geometric mean titers determined by neuraminidase inhibiting antibody by enzyme-linked lectin assay (ELLA) for Group 2

Timeframe: Day 113

Geometric mean titers determined by neuraminidase inhibiting antibody by enzyme-linked lectin assay (ELLA) for Group 3

Timeframe: Day 197

Geometric mean titers determined by neuraminidase inhibiting antibody by enzyme-linked lectin assay (ELLA) for Groups 1, 5

Timeframe: Day 57

Occurrence of respiratory reactogenicity following pLAIV vaccination for Group 1

Timeframe: Day 29 through Day 39

Occurrence of respiratory reactogenicity following pLAIV vaccination for Group 2

Timeframe: Day 85 through Day 95

Occurrence of respiratory reactogenicity following pLAIV vaccination for Group 3

Trial details

NCT IDNCT02251288

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2018-08-17

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