Could this be the end of yearly flu shots? early trial tests universal vaccine
NCT ID NCT03816878
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This early-stage study tested a 'prime-boost' approach for a universal flu vaccine. Researchers gave an inactivated H5N1 flu shot to 32 healthy adults, some of whom had previously received other experimental flu vaccines. The goal was to see if this method could trigger broad immunity against multiple flu strains. The study focused on safety and immune response, not on preventing flu itself.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- inactivated subunit H5N1 influenza vaccine
- What this could lead to
- If successful, this approach could help develop a universal flu vaccine that protects against many flu strains, reducing the need for annual shots.
- What could go wrong
- This is a very early Phase 1 trial with only 32 participants, so results may not apply broadly. The vaccine may not produce strong enough immunity or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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32 people
The number who actually took part.
- Started
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Jan 2019
- Finished
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Mar 2020
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 intercourse as a matter of normal preferred lifestyle; * or must be surgically sterile or must be age 50 AND have had no menses at all for at least one full year. * All females must provide urine for pregnancy testing prior to enrollment (immediately prior vaccination), as well as a statement of menstrual history and a summary of all potentially reproductive sexual activity for the month prior to vaccination, and at each study contact throughout the study, and report known or suspected pregnancy immediately. * Willingness to refrain from blood donation during the course of the study. Exclusion Criteria: * Pregnancy as determined by a positive test for human choriogonadotropin (beta-HCG), an indicator of pregnancy or history of recent unprotected intercourse in a woman of reproductive capacity. * Currently breast-feeding. * Evidence of clinically significant neurologic, cardiac, pulmonary, hematologic, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies. * Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol. * Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months. * Other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol. * History of anaphylaxis in response to any vaccine or vaccine component. * History of life-threatening reaction to prior influenza vaccine. * Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory test for human immunodeficiency virus type 1 (HIV-1). * Positive ELISA and confirmatory test (e.g., HCV RNA PCR) for hepatitis C virus (HCV). * Positive hepatitis B virus surface antigen (HBsAg) by ELISA. * Known immunodeficiency syndrome or history suggestive of impaired immune function. * History of Guillain-Barré syndrome. * Use of chronic oral or intravenous administration (greater than or equal to 14 days) of immunosuppressive doses of steroids, i.e., prednisone greater than 10 mg per day, immunosuppressants or other immune-modifying drugs within 30 days of starting this study. * Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination. * Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination. * Receipt of another investigational vaccine or drug within 30 days prior to study vaccination. * In addition to the above, participants in Cohort 1 (pandemic live attenuated influenza vaccine \[pLAIV\] recipients) and Cohort 2 (naïve cohort) must also not experience any of the following: * Previous enrollment in an H5N1 influenza vaccine trial. * Participants in Cohort 2 (naïve cohort) will be excluded if they are: * Seropositive to the H5N1 influenza A virus (serum hemagglutination inhibition assay (HAI) titer greater than 1:8). * Have previously received an investigational live attenuated influenza vaccine (LAIV) in another study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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