InfluenzaPhase 1NCT03816878
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
A Phase 1 study testing H5N1 pISV in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- H5N1 pISV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2019to 17 Mar 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: An Exploration of a Prime-Boost Approach for Universal Influenza Vaccination: 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
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.
Read the detailed description
This study will 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 (pLAIVs).
Participants will be enrolled in two cohorts. Cohort 1 will include participants who received two doses of live attenuated H2N2, H6N1, or H9N2 influenza vaccine during a prior Center for Immunization Research (CIR) study; Cohort 2 will include participants who have never previously received a pLAIV. Participants in both cohorts will receive one dose of H5N1 pISV vaccine by injection at Day 0.
Participants will attend study visits on Days 0, 7, 14, 28, 56, 90, and 360. Study visits may include a physical examination, medical history, and blood and urine collection. All participants will be followed for approximately 360 days after receiving the H5N1 pISV vaccine.
- Conditions
- Influenza
- Being tested
- H5N1 pISV
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H5N1 pISVBiological
Administered as an intramuscular (IM) injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: pLAIV Recipients | Experimental | Participants who have received the pandemic live attenuated influenza vaccines (pLAIVs) H2N2, H6N1, or H9N2 during a previous CIR study will receive a single dose of 0.5 mL H5N1 pISV vaccine at Day 0. Receives: Biological: H5N1 pISV |
| Cohort 2: pLAIV Naive | Experimental | Participants who have never previously received a pLAIV will receive one dose of 0.5 mL H5N1 pISV vaccine at Day 0. Receives: Biological: H5N1 pISV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
As measured by enzyme-linked immunosorbent assay (ELISA) and microneutralization assay (MN) using the chimeric cH6/N1 probe
Measured: Measured through Day 28
Secondary outcomes (1)
Number of Participants With Vaccine-related Adverse Events in the pLAIV Compared to the Control Cohort
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Measured: Measured through Day 28 for non serious adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start8 Jan 2019
- Primary completion18 Apr 2019
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kawsar R. Talaat, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816878
- Sponsor's protocol ID
- CIR 327
- Status last verified
- Sep 2025
- First submitted
- 23 Jan 2019
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploration of a Prime-Boost Approach for Universal Influenza Vaccination: 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
- ClinicalTrials.gov ID
- NCT03816878
- Acronym / sponsor ID
- CIR 327
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will 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 (pLAIVs).
Participants will be enrolled in two cohorts. Cohort 1 will include participants who received two doses of live attenuated H2N2, H6N1, or H9N2 influenza vaccine during a prior Center for Immunization Research (CIR) study; Cohort 2 will include participants who have never previously received a pLAIV. Participants in both cohorts will receive one dose of H5N1 pISV vaccine by injection at Day 0.
Participants will attend study visits on Days 0, 7, 14, 28, 56, 90, and 360. Study visits may include a physical examination, medical history, and blood and urine collection. All participants will be followed for approximately 360 days after receiving the H5N1 pISV vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: pLAIV Recipients | Experimental | Biological: H5N1 pISVParticipants who have received the pandemic live attenuated influenza vaccines (pLAIVs) H2N2, H6N1, or H9N2 during a previous CIR study will receive a single dose of 0.5 mL H5N1 pISV vaccine at Day 0. |
| Cohort 2: pLAIV Naive | Experimental | Biological: H5N1 pISVParticipants who have never previously received a pLAIV will receive one dose of 0.5 mL H5N1 pISV vaccine at Day 0. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H5N1 pISVAdministered as an intramuscular (IM) injection | Biological | Cohort 1: pLAIV Recipients, Cohort 2: pLAIV Naive |
Primary outcome
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
Time frame: Measured through Day 28
As measured by enzyme-linked immunosorbent assay (ELISA) and microneutralization assay (MN) using the chimeric cH6/N1 probe
1 secondary outcome
Number of Participants With Vaccine-related Adverse Events in the pLAIV Compared to the Control Cohort
Time frame: Measured through Day 28 for non serious adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kawsar R. Talaat, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing H5N1 pISV in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Measured through Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.