CompletedNCT02171819Updated Mar 14, 2019Results posted

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

A Phase 1 interventional study of IVACFLU-A/H5N1, 7.5 mcg and IVACFLU-A/H5N1, 15 mcg in Influenza A Subtype H5N1 Infection, sponsored by Institute of Vaccines and Medical Biologicals, Vietnam. Completed at 1 site in Vietnam. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-14.

Sponsored by Institute of Vaccines and Medical Biologicals, Vietnam · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 75
Allocation: Randomized
Ages: 18 Years to 30 Years
Sex: All

Study 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 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 studied

Influenza A Subtype H5N1 Infection

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Keywords

Influenza
Avian
H5N1
Vaccine

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's enrollment of 75 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Institute of Vaccines and Medical Biologicals, Vietnam is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 30 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single group
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 75 participants (actual)

Study arms

Experimental
IVACFLU-A/H5N1, 7.5 mcg
IVACFLU-A/H5N1, 7.5 mcg HA per dose
Biological: IVACFLU-A/H5N1, 7.5 mcg
Experimental
IVACFLU-A/H5N1, 15 mcg
IVACFLU-A/H5N1, 15 mcg HA per dose.
Biological: IVACFLU-A/H5N1, 15 mcg
Placebo comparator
Placebo
Phosphate buffered saline
Other: Placebo Comparator

Interventions

BiologicalIVACFLU-A/H5N1, 7.5 mcg
Contains 7.5 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose.
BiologicalIVACFLU-A/H5N1, 15 mcg
Contains 15 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose
OtherPlacebo Comparator
PBS, pH 7.2 in 0.5 mL single-dose vials.
Also known as: Phosphate Buffered Saline

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 3 weeks of any injection

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

Posted Mar 14, 2019

Participant flow

Participant flow — Overall Study
Milestone	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Placebo
Started	31	32	12
Completed	31	32	12
Not completed	0	0	0

Outcome measures

PrimaryImmediate 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.

Time frame:: 60 min post injection
Reported as:: Count of participants · Participants

Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose
Participants	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Combined Vaccine	Placebo
Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose	0	0	0	0

PrimaryNumber 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.

Time frame:: Within 7 days after injection
Reported as:: Count of participants · Participants

Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Participants	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Combined Vaccine	Placebo
Subjects with at least one solicted AE	26	26	52	4
Subjects with at least one local solicted AE	25	24	49	3
Subjects with at least one systemic solicited AE	13	14	27	4
Local reactions--Pain	18	16	34	1
Local reactions--Tenderness	21	23	44	3
Systemic reactogenicity--Abdominal pain	1	0	1	0
Systemic reactogenicity--Chills	1	3	4	0
Systemic reactogenicity--Cough	3	2	5	2
Systemic reactogenicity--Diarrhea	0	1	1	0
Systemic reactogenicity--Ear pain/discharge	0	1	1	0
Systemic reactogenicity--Fatigue/Malaise	3	5	8	2
Systemic reactogenicity--Fever	0	3	3	0
Systemic reactogenicity--Sore eyes	1	0	1	0
Systemic reactogenicity--Sore throat	2	2	4	2

PrimaryNumber 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.

Time frame:: Within 7 weeks of injection
Reported as:: Count of participants · Participants

Number of Participants With at Least One Unsolicited AE
Participants	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Placebo
Number of Participants With at Least One Unsolicited AE	12	12	4

PrimaryAll 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.

Time frame:: Within 3 weeks of any injection
Reported as:: Count of participants · Participants

All Serious Adverse Events (SAEs) Occurring Within 3 Weeks of Receipt of Any Dose
Participants	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Placebo
All Serious Adverse Events (SAEs) Occurring Within 3 Weeks of Receipt of Any Dose	0	0	0

SecondaryThe 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
Reported as:: Count of participants · Participants

The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49)
Participants	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Combined Vaccine	Placebo
Post vaccination #1	7	9	16	0
Post vaccination #2	13	18	31	0

SecondaryThe 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
Reported as:: Count of participants · Participants

The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2
Participants	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Combined Vaccine
Baseline to post 1st vaccination	11	12	23
From post 1st- to post 2nd vaccination	9	11	20
Baseline to 2nd vaccination	21	23	44

SecondaryGeometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose

Time frame:: Days 0, 21 and 42
Reported as:: Mean · Titers

Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose
Titers	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Combined Vaccine	Placebo
Day 0	5.00 (5.00 to 5.00)	5.00 (5.00 to 5.00)	5.00 (5.00 to 5.00)	5.00 (5.00 to 5.00)
Post vaccination #1	12.8 (7.95 to 20.58)	11.9 (8.17 to 17.31)	12.3 (9.19 to 16.53)	5.00 (5.00 to 5.00)
Post vaccination #2	24.5 (15.51 to 38.58)	27.1 (19.98 to 36.71)	25.8 (19.77 to 33.57)	5.00 (5.00 to 5.00)

SecondaryGeometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose

Time frame:: Days 0, 21, and 42
Reported as:: Mean · Titers

Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose
Titers	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Combined Vaccine	Placebo
Day 0	5.00 (5.00 to 5.00)	5.00 (5.00 to 5.00)	5.00 (5.00 to 5.00)	5.00 (5.00 to 5.00)
Post vaccination #1	9.4 (5.99 to 14.60)	9.4 (6.52 to 13.46)	9.4 (7.09 to 12.36)	5.00 (5.00 to 5.00)
Post vaccination #2	21.9 (13.91 to 34.38)	23.3 (16.54 to 32.76)	22.6 (17.16 to 29.70)	5.00 (5.00 to 5.00)

Adverse events

Collected over 90 days. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
IVACFLU-A/H5N1, 7.5 mcg	0/31 (0%)	0/31 (0%)	12/31 (38.7%)
IVACFLU-A/H5N1, 15 mcg	0/32 (0%)	0/32 (0%)	12/32 (37.5%)
Placebo	0/12 (0%)	0/12 (0%)	4/12 (33.3%)

Most frequent other events

Showing 10 of 27

Most frequent other events
Event	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Placebo
HeadacheNervous system disorders	3/31	2/32	2/12
CoughRespiratory, thoracic and mediastinal disorders	5/31	2/32	2/12
Oropharanyngeal painRespiratory, thoracic and mediastinal disorders	3/31	2/32	2/12
RhinorrheaRespiratory, thoracic and mediastinal disorders	5/31	1/32	1/12
Blood bilirubin increasedInvestigations	3/31	0/32	0/12
Immune system disordersImmune system disorders	0/31	0/32	1/12
InfectionsInfections and infestations	0/31	0/32	1/12
PruritisSkin and subcutaneous tissue disorders	0/31	0/32	1/12
PyrexiaSkin and subcutaneous tissue disorders	1/31	0/32	1/12
PyrexiaGeneral disorders	1/31	0/32	1/12

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Placebo	Total
<=18 years	0	0	0	0
Between 18 and 65 years	31	32	12	75
>=65 years	0	0	0	0

Age, Continuous
Age, Continuous(years)	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Placebo	Total
Mean	23.7 (19 to 30)	23.5 (19 to 30)	23.7 (18 to 28)	23.6 (18 to 30)

Sex: Female, Male
Sex: Female, Male(Participants)	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Placebo	Total
Female	11	13	7	31
Male	20	19	5	44

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Placebo	Total
Kinh	31	32	12	75
Khmer	0	0	0	0
Hoa	0	0	0	0
Other	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Placebo	Total
Asian	31	32	12	75
Other	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	IVACFLU-A/H5N1, 7.5 mcg	IVACFLU-A/H5N1, 15 mcg	Placebo	Total
Vietnam	31	32	12	75

Study locations

1 site

Ben Luc Health Center
Bến Lức, Long An Province, Vietnam

References and documents

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 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02171819
Lead sponsor: Institute of Vaccines and Medical Biologicals, Vietnam
Collaborators: Department of Health and Human Services, World Health Organization, Institut Pasteur, PATH
Responsible party: Sponsor
First posted: Jun 24, 2014
Start date: Jun 2014
Primary completion: Aug 2014
Completion: Aug 2014
Results posted: Mar 14, 2019
Last update: Mar 14, 2019

Study contacts

Le Hoang San, MD

principal investigator · Pasteur Institute, Ho Chi Minh City

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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