Influenza A Subtype H5N1 InfectionPhase 1NCT02171819
Influenza A/H5N1 Vaccine Clinical Trial (IVACFLU-A/H5N1) - Phase 1
A Phase 1 study testing IVACFLU-A/H5N1, 7.5 mcg and IVACFLU-A/H5N1, 15 mcg in people with Influenza A Subtype H5N1 Infection, run by Institute of Vaccines and Medical Biologicals, Vietnam at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A Subtype H5N1 Infection
- What is being tested?
- IVACFLU-A/H5N1, 7.5 mcg and IVACFLU-A/H5N1, 15 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteVietnam
- Study dates
- Jun 2014to Aug 2014
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 21Show fewer
- 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.
- Known chronic HBV or HCV infection.
- Known active tuberculosis or symptoms of active tuberculosis, regardless of cause.
- History of chronic alcohol abuse and/or illegal drug use.
- Pregnancy or lactation. (A negative pregnancy test will be required before administration of study product for all women of childbearing potential.)
- History of Guillain-Barré Syndrome
- Any condition that, in the opinion of the investigator, would increase the health risk to the subject if he/she participates in the study or would interfere with the evaluation of the study objectives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Double Blinded, Randomized, Placebo-Controlled Study to Examine the Safety and Immunogenicity of an Inactivated A/H5N1 Influenza Vaccine (IVACFLU-A/H5N1) Produced by IVAC in Healthy Adult Volunteers in Vietnam
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.
Read the detailed description
This is a phase 1, double blinded, randomized, placebo-controlled study. Seventy-six healthy male and female adults, 18 to 30 years of age, will be enrolled into the trial. Subjects will be randomized to one of three treatment allocations: 32 subjects to 7.5 mcg/dose vaccine (low dose), 32 subjects to 15 mcg/dose vaccine (high dose) and 12 subjects to placebo. This sample size was selected to enable at least 30 evaluable subjects in each of the groups receiving active vaccine. The study will utilize a "block randomization" to assure a balance of 8:8:3 vaccine and placebo when all subjects are enrolled. The study will be double blinded, meaning the study subjects, investigators, and the sponsor will be unaware of the treatment allocated to each subject until the clinical trial database is declared final and locked.
Since this is a first-in-human study, all injections of study product will be sequential and staggered and there will be a safety evaluation between a sentinel cohort of 19 subjects and the remaining 57 study subjects for both the 1st and 2nd doses in the study.
A sentinel group of 19 participants' enrollment and vaccination will precede the remainder of the study group by approximately 2-3 weeks.
Product administration for both injections of vaccine or placebo will be sequential and staggered.
- Conditions
- Influenza A Subtype H5N1 Infection
- Being tested
- IVACFLU-A/H5N1, 7.5 mcg, IVACFLU-A/H5N1, 15 mcg, Placebo Comparator
- Keywords
- Influenza, Avian, H5N1, Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVACFLU-A/H5N1, 7.5 mcgBiological
Contains 7.5 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose.
IVACFLU-A/H5N1, 15 mcgBiological
Contains 15 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose
Placebo ComparatorOther
Also called Phosphate Buffered Saline
PBS, pH 7.2 in 0.5 mL single-dose vials.
| Study group | Role | What they receive |
|---|---|---|
| IVACFLU-A/H5N1, 7.5 mcg | Experimental | IVACFLU-A/H5N1, 7.5 mcg HA per dose Receives: Biological: IVACFLU-A/H5N1, 7.5 mcg |
| IVACFLU-A/H5N1, 15 mcg | Experimental | IVACFLU-A/H5N1, 15 mcg HA per dose. Receives: Biological: IVACFLU-A/H5N1, 15 mcg |
| Placebo | Placebo comparator | Phosphate buffered saline Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: Days 21 and 42
Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose
Measured: Days 0, 21 and 42
Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose
Measured: Days 0, 21, and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014
- Study completionAug 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza A Subtype H5N1 InfectionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Vaccines and Medical Biologicals, Vietnam
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services, World Health Organization, Institut Pasteur, PATH
- Responsible party
- Sponsor
- Investigators
- Le Hoang San, MD, Principal investigator, Pasteur Institute, Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171819
- Sponsor's protocol ID
- IVAC A/H5N1
- Other IDs
- VAC021
- Status last verified
- Nov 2018
- First submitted
- 20 Jun 2014
- Last updated
- 14 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27591953
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double Blinded, Randomized, Placebo-Controlled Study to Examine the Safety and Immunogenicity of an Inactivated A/H5N1 Influenza Vaccine (IVACFLU-A/H5N1) Produced by IVAC in Healthy Adult Volunteers in Vietnam
- ClinicalTrials.gov ID
- NCT02171819
- Acronym / sponsor ID
- IVAC A/H5N1
- Conditions
- Influenza A Subtype H5N1 Infection
- Keywords
- Influenza, Avian, H5N1, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Institute of Vaccines and Medical Biologicals, VietnamIndustry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services, World Health Organization, Institut Pasteur, PATH
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Posted 14 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 1, double blinded, randomized, placebo-controlled study. Seventy-six healthy male and female adults, 18 to 30 years of age, will be enrolled into the trial. Subjects will be randomized to one of three treatment allocations: 32 subjects to 7.5 mcg/dose vaccine (low dose), 32 subjects to 15 mcg/dose vaccine (high dose) and 12 subjects to placebo. This sample size was selected to enable at least 30 evaluable subjects in each of the groups receiving active vaccine. The study will utilize a "block randomization" to assure a balance of 8:8:3 vaccine and placebo when all subjects are enrolled. The study will be double blinded, meaning the study subjects, investigators, and the sponsor will be unaware of the treatment allocated to each subject until the clinical trial database is declared final and locked.
Since this is a first-in-human study, all injections of study product will be sequential and staggered and there will be a safety evaluation between a sentinel cohort of 19 subjects and the remaining 57 study subjects for both the 1st and 2nd doses in the study.
A sentinel group of 19 participants' enrollment and vaccination will precede the remainder of the study group by approximately 2-3 weeks.
Product administration for both injections of vaccine or placebo will be sequential and staggered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IVACFLU-A/H5N1, 7.5 mcg | Experimental | Biological: IVACFLU-A/H5N1, 7.5 mcgIVACFLU-A/H5N1, 7.5 mcg HA per dose |
| IVACFLU-A/H5N1, 15 mcg | Experimental | Biological: IVACFLU-A/H5N1, 15 mcgIVACFLU-A/H5N1, 15 mcg HA per dose. |
| Placebo | Placebo comparator | Other: Placebo ComparatorPhosphate buffered saline |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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.)
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 |
|---|---|---|
| IVACFLU-A/H5N1, 7.5 mcgContains 7.5 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose. | Biological | IVACFLU-A/H5N1, 7.5 mcg |
| IVACFLU-A/H5N1, 15 mcgContains 15 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose | Biological | IVACFLU-A/H5N1, 15 mcg |
| Placebo ComparatorAlso: Phosphate Buffered SalinePBS, pH 7.2 in 0.5 mL single-dose vials. | Other | Placebo |
Primary outcome
Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose
Time frame: 60 min post injection
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.
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Time frame: Within 7 days after injection
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.
Number of Participants With at Least One Unsolicited AE
Time frame: Within 7 weeks of injection
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.
All Serious Adverse Events (SAEs) Occurring Within 3 Weeks of Receipt of Any Dose
Time frame: Within 3 weeks of any injection
Summary data. Data presented are after 1st and 2nd injections combined. Please see AE reporting section of this report for full details.
4 secondary outcomes
The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49)
Time frame: 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
Time frame: Days 21 and 42
Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose
Time frame: Days 0, 21 and 42
Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose
Time frame: Days 0, 21, and 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27591953Phan 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.
- Journal "Vaccine" on line by ElsevierLink provided by the sponsor.
- Results of clinical trial published on line in the journal VaccineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Le Hoang San, MD principal investigator
Pasteur Institute, Ho Chi Minh City
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 IVACFLU-A/H5N1, 7.5 mcg and IVACFLU-A/H5N1, 15 mcg in people with Influenza A Subtype H5N1 Infection, run by Institute of Vaccines and Medical Biologicals, Vietnam at 1 site in Vietnam.
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 5 inclusion and 21 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 14 Mar 2019. 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 Vietnam. 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. Some participants in this study may receive a placebo. 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 14 Mar 2019). 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?
Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose (time frame: 60 min post injection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02171819, which also lists 1 linked publication.
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 14 Mar 2019.