CompletedPhase 1

Evaluating the Safety and Immune Response to a Live H7N9 Influenza Virus Vaccine Followed by an Inactivated H7N9 Influenza Virus Vaccine, Given at Varying Intervals

United States100 participantsStarted 2014-05

Plain-language summary

H7N9 viruses have caused a recent outbreak of severe illness in humans in China. The purpose of this study is to evaluate the safety and immune response of an H7N9 A/Anhui/13 ca influenza virus vaccine followed by an inactivated subvirion H7N9 vaccine at varying intervals.

Who can participate

Age range

18 Years – 49 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 49 years of age, inclusive. Children will not be recruited or enrolled in this study because they are not in the apparent risk group, for safety considerations, and because of the need for isolation. * General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator * Agree to storage of blood specimens for future research * Available for the duration of the trial * Willingness to participate in the study as evidenced by signing the informed consent document * Female participants of childbearing potential must agree to use effective birth control methods for the duration of the study (for example, pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse; surgical sterilization). All female participants will be considered being of childbearing potential except those who have undergone hysterectomy and those in whom menopause occurred at least 1 year prior to the study. Exclusion Criteria: * Pregnancy, as determined by a positive human choriogonadotropin (beta-HCG) test * Currently breastfeeding * Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or labo…

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

Measurement of the ability of the pLAIV vaccine to induce priming by assessing the response to a subsequent dose of pIIV

Timeframe: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)

Measurement of the optimal interval between the priming with pLAIV and the subsequent boost with pIIV

Timeframe: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)

Determination of whether 1 dose or 2 doses of pLAIV followed by a pIIV boost is sufficient to induce an optimal immune response

Timeframe: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)

Frequency of vaccine-related reactogenicity events (REs) for 2 doses of pLAIV vaccine followed by a single dose of inactivated pIIV and compare to 2 doses of pIIV alone

Timeframe: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)

Frequency of other adverse events (AEs) for 2 doses of pLAIV vaccine followed by a single dose of inactivated pIIV and compare to 2 doses of pIIV alone

Timeframe: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)

Trial details

NCT IDNCT02151344

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2015-02

View on ClinicalTrials.gov More Influenza A Virus, H7N9 Subtype trials