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 range18 Years – 47 Years

SexALL

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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.
✕. Diastolic blood pressure is 55 to 90 mmHg, inclusive.
✕. Women of childbearing potential\* in sexual relationships with men must use an acceptable method of contraception\*\* from 30 days prior to pIIV administration until 90 days after last study vaccination.
✕0. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.

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

Timeframe: Day 169 through Day 179

Trial details

NCT IDNCT02251288

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2018-08-17

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