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

NCT03816878 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: CIR 327
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• 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 through Day 28

Secondary Outcomes (1)

• Number of Participants With Vaccine-related Adverse Events in the pLAIV Compared to the Control Cohort

  Measured through Day 28 for non serious adverse events

Study Arms (2)

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.

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.

Biological: H5N1 pISV

Interventions

H5N1 pISV BIOLOGICAL

Administered as an intramuscular (IM) injection

Cohort 1: pLAIV Recipients; Cohort 2: pLAIV Naive

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Kawsar Talaat
• Organization: Johns Hopkins University Center for Immunization Research

ktalaat1@jhu.edu

410-336-9164

Study Officials

• Kawsar R. Talaat, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 25, 2019
• Study Start: January 8, 2019
• Primary Completion: April 18, 2019
• Study Completion: March 17, 2020
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Locations

US (1)