CompletedPhase 1

Immunogenicity and Safety Study of Inactivated Subunit H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H2N2, H6N1 and H9N2 Influenza Vaccines and in H5N1 and Live Attenuated Vaccine Naïve Individuals

United States32 participantsStarted 2019-01-08

Plain-language summary

The purpose of this study is to evaluate the immunogenicity and safety of inactivated subunit H5N1 influenza vaccine in individuals who have previously received live attenuated H2N2, H6N1, or H9N2 influenza vaccine, as well as in individuals who have never previously received H5N1 or other pandemic live attenuated influenza vaccines.

Who can participate

Age range

18 Years – 60 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: * Adult males and non-pregnant females between 18 years and 60 years of age inclusive. * General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator. * Available for the duration of the trial. * Able to demonstrate understanding of key study concepts, study rationale, and study participation requirements by scoring greater than or equal to 70% on a written comprehension assessment in 3 or fewer attempts. * Willingness to participate in the study as evidenced by signing the informed consent document. * Willingness to allow storage and testing of laboratory samples for future research. * Received 2 doses of live attenuated H2N2, H6N1, or H9N2 vaccine in a prior trial (Cohort 1) or H2N2, H6N1 and H9N2 naïve (Cohort 2) * Willingness to forego seasonal influenza virus vaccination from 1 month before vaccination until 3 months after vaccination. * Female subjects of childbearing potential must agree to have used effective birth control methods beginning at least one month prior to vaccination, and continuing with 'per label/fully effective use' for the chosen method for duration of the study, from amongst these: * pharmacologic/hormonal contraceptives, including oral, parenteral, subcutaneous, and transcutaneous delivery; * condoms with spermicide; * diaphragm with spermicide; * intrauterine device; * absolute abstinence from heterosexual intercours…

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

Fold Rise in Titer of Anti-group 1 Stalk-antibodies in Recipients of the Pandemic Live Attenuated Influenza Vaccines (pLAIVs) (H2N2, H6N1 and H9N2) Compared to the Control pLAIV-naïve Cohort

Timeframe: Measured through Day 28

Trial details

NCT IDNCT03816878

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2019-04-18

Results submitted2024-10-30

View on ClinicalTrials.gov More Influenza trials