Influenza A/H5N1 Vaccine Clinical Trial (IVACFLU-A/H5N1) - Phase 1

NCT02171819 | Completed Phase 1 Results DMC

• 2 other identifiers: IVAC A/H5N1VAC021
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first-in-human study of safety and immunogenicity of an A/H5N1 inactivated whole cell vaccine when given in two injections in two doses (low and high) compared to a placebo in 76 healthy adult subjects in Vietnam. Vaccine and placebo are manufactured by the IVAC in Vietnam.

Conditions

Influenza A Subtype H5N1 Infection

Keywords

Influenza; Avian; H5N1; Vaccine

Outcome Measures

Primary Outcomes (4)

• Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose

  Data presented are after 1st and 2nd vaccination combined. All participants were observed for immediate reactions for 60 minutes after administration of study product, with appropriate medical treatment readily available in case of an anaphylactic reaction following the administration of study product.

  60 min post injection

• Number of Participants With at Least One Solicted Reactogenicity After Both Injections

  Data presented are after 1st and 2nd vaccination combined. Solicted reactogenicity are local and systemic events that are expected after injection and specifically asked of the participant. Only reported reactogenicity is presented. If not shown, then no participant reported that reaction in any study group. Local reactions are redness, swelling, pain, tenderness, and hardness. Systemic reactions are actual and subjective fever, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion. convulsions/seizures, fatigue/malaise, muscle aches (generalized), joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes. ear pain or discharge, rash, abdominal pain, diarrhea, vomiting, and jaundice.

  Within 7 days after injection

• Number of Participants With at Least One Unsolicited AE

  Summary of number of participants with at least one unsolicited AE after 1st and 2nd vaccination combined. Please see the adverse event section of this report for full details.

  Within 7 weeks of injection

• All Serious Adverse Events (SAEs) Occurring Within 3 Weeks of Receipt of Any Dose

  Summary data. Data presented are after 1st and 2nd injections combined. Please see AE reporting section of this report for full details.

  Within 3 weeks of any injection

Secondary Outcomes (4)

• The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49)

  Day 0 to Day 49

• The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2

  Days 21 and 42

• Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose

  Days 0, 21 and 42

• Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose

  Days 0, 21, and 42

Study Arms (3)

IVACFLU-A/H5N1, 7.5 mcg

EXPERIMENTAL

IVACFLU-A/H5N1, 7.5 mcg HA per dose

Biological: IVACFLU-A/H5N1, 7.5 mcg

IVACFLU-A/H5N1, 15 mcg

EXPERIMENTAL

IVACFLU-A/H5N1, 15 mcg HA per dose.

Biological: IVACFLU-A/H5N1, 15 mcg

Placebo

PLACEBO COMPARATOR

Phosphate buffered saline

Other: Placebo Comparator

Interventions

IVACFLU-A/H5N1, 7.5 mcg BIOLOGICAL

Contains 7.5 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose.

IVACFLU-A/H5N1, 7.5 mcg

IVACFLU-A/H5N1, 15 mcg BIOLOGICAL

Contains 15 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose

IVACFLU-A/H5N1, 15 mcg

Placebo Comparator OTHER

PBS, pH 7.2 in 0.5 mL single-dose vials.

Also known as: Phosphate Buffered Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female adult 18 through 30 years of age at the enrollment visit.
• Literate and willing to provide written informed consent.
• Healthy adults, as established by the medical history and screening evaluations, including physical examination.
• Capable and willing to complete diary cards and willing to return for all follow-up visits.
• For females, willing to utilize reliable birth control measures (intrauterine device, hormonal contraception, condoms) through the Day 42 visit

You may not qualify if:

• Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
• Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 42 visit.
• Current or recent (within two weeks of enrollment) acute illness with or without fever.
• Receipt of immune globulin or other blood products within three months prior to study enrollment or planned receipt of such products prior to the Day 42 visit.
• Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this means prednisone or equivalent, ≥ 0.5 mg per kg per day; topical steroids are allowed.)
• History of asthma.
• Hypersensitivity after previous administration of any vaccine.
• Other AE following immunization, at least possibly related to previous receipt of any vaccine.
• Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein.
• Known hypersensitivities (allergies) to food or the natural environment.
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatobiliary, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives.
• History of any blood or solid organ cancer.
• History of thrombocytopenic purpura or known bleeding disorder.
• History of seizures.
• Known or suspected immunosuppressed or immunodeficient condition of any kind.

Sponsors & Collaborators

• Institute of Vaccines and Medical Biologicals, Vietnam: lead
• Department of Health and Human Services: collaborator
• World Health Organization: collaborator
• Institut Pasteur: collaborator
• PATH: collaborator

Study Sites (1)

Ben Luc Health Center

Bến Lức, Long An Province, Vietnam

Location

Related Publications (1)

• Phan TL, Ho VT, Vu MH, Nguyen TN, Duong HT, Holt R, Wahid R, Donnelly J, Flores J. Clinical testing of an inactivated influenza A/H5N1 vaccine candidate in a double-blinded, placebo-controlled, randomized trial in healthy adults in Vietnam. Vaccine. 2016 Oct 26;34(45):5449-5456. doi: 10.1016/j.vaccine.2016.08.055. Epub 2016 Aug 31.

  PMID: 27591953 RESULT

Related Links

• Journal "Vaccine" on line by Elsevier
• Results of clinical trial published on line in the journal Vaccine

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: Dr. Le Van Be
• Organization: IVAC

ivaclevanbe@gmail.com

Study Officials

• Le Hoang San, MD

  Pasteur Institute, Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 14, 2019
• Results First Posted: March 14, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)