Trial Outcomes & Findings for Higher Dose Intradermal H5 Vaccine (NCT NCT00439335)

Last Updated: 2013-04-09

Results Overview

Number of participants in each vaccine group achieving a 4-fold or greater increase in serum hemagglutination inhibition (HAI) antibody titers against influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

227 participants

Primary outcome timeframe

Approximately Day 56.

Results posted on

2013-04-09

Participant Flow

Healthy ambulatory adults were recruited from the surrounding community of the research clinic from March 14, 2007 to June 20, 2007.

Participant milestones

Participant milestones
Measure	H5 HA ID Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
Overall Study STARTED	113	114
Overall Study COMPLETED	111	114
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Higher Dose Intradermal H5 Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	H5 HA ID n=113 Participants Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM n=114 Participants Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.	Total n=227 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	113 Participants n=5 Participants	114 Participants n=7 Participants	227 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	29.7 years STANDARD_DEVIATION 7.4 • n=5 Participants	30.5 years STANDARD_DEVIATION 8.0 • n=7 Participants	30.1 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	60 Participants n=7 Participants	134 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	54 Participants n=7 Participants	93 Participants n=5 Participants
Region of Enrollment United States	113 participants n=5 Participants	114 participants n=7 Participants	227 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately Day 56.

Outcome measures

Outcome measures
Measure	H5 HA ID n=113 Participants Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM n=113 Participants Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 2	47 Participants	40 Participants

PRIMARY outcome

Timeframe: Through Day 208.

Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.

Outcome measures

Outcome measures
Measure	H5 HA ID n=113 Participants Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM n=114 Participants Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
Number of Participants Spontaneously Reporting Any Serious Adverse Event.	2 Participants	2 Participants

PRIMARY outcome

Timeframe: Through approximately Day 56

The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 28 days of vaccination. Participants are counted only once but may have experienced events on multiple occasions.

Outcome measures

Outcome measures
Measure	H5 HA ID n=113 Participants Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM n=113 Participants Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
Occurrence of Unsolicited Symptoms During a 28-day Surveillance Period Following Vaccinations at Days 0 and 28.	39 Participants	26 Participants

PRIMARY outcome

Timeframe: 7 days after each vaccination

The number of participants reporting fever, feverishness, malaise, myalgia, headache and nausea. Participants are counted only once for each symptom but may have experienced symptoms on multiple occasions.

Outcome measures

Outcome measures
Measure	H5 HA ID n=113 Participants Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM n=114 Participants Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28. Fever	2 Participants	2 Participants
Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28. Feverishness	11 Participants	14 Participants
Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28. Malaise	40 Participants	39 Participants
Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28. Myalgia	19 Participants	23 Participants
Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28. Headache	53 Participants	45 Participants
Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28. Nausea	14 Participants	13 Participants

PRIMARY outcome

Timeframe: 7 days after each vaccination

The number of participants reporting pain, tenderness, itching, induration, erythema, and pigmentation. Participants are counted only once for each symptom but may have experienced symptoms on multiple occasions.

Outcome measures

Outcome measures
Measure	H5 HA ID n=113 Participants Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM n=114 Participants Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28. Erythema	113 Participants	59 Participants
Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28. Pain	23 Participants	61 Participants
Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28. Tenderness	93 Participants	91 Participants
Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28. Itching	95 Participants	8 Participants
Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28. Induration	113 Participants	34 Participants
Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28. Pigmentation	70 Participants	2 Participants

SECONDARY outcome

Timeframe: Approximately Day 56.

HAI geometric mean titer (GMT) against influenza A/H5N1 virus in each vaccine group 28 days after receipt of the second dose of vaccine.

Outcome measures

Outcome measures
Measure	H5 HA ID n=113 Participants Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM n=113 Participants Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
HAI Geometric Mean Titer (GMT) After Dose 2	25.2 Antibody Titer Interval 18.3 to 34.5	18.1 Antibody Titer Interval 13.6 to 24.1

SECONDARY outcome

Timeframe: Approximately Day 56

Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group 28 days after receipt of the second dose of vaccine

Outcome measures

Outcome measures
Measure	H5 HA ID n=113 Participants Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM n=113 Participants Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
Number of Participants Achieving a HAI Titer of Greater Than or Equal to 40 After Dose 2	48 Participants	40 Participants

SECONDARY outcome

Timeframe: Approximately Day 28

Number of participants achieving a 4-fold or greater increase in HAI antibody titers against influenza A/H5N1 virus in each vaccine group one month after receipt of the first dose.

Outcome measures

Outcome measures
Measure	H5 HA ID n=113 Participants Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM n=114 Participants Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 1.	25 Participants	29 Participants

SECONDARY outcome

Timeframe: Approximately Day 28

HAI GMT against influenza A/H5N1 virus one month after receipt of the first dose of vaccine.

Outcome measures

Outcome measures
Measure	H5 HA ID n=113 Participants Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM n=114 Participants Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
HAI GMT After Dose 1	13.1 Antibody titer Interval 9.9 to 17.3	11.9 Antibody titer Interval 9.1 to 15.4

SECONDARY outcome

Timeframe: Approximately Day 28

Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group one month after receipt of the first dose of vaccine.

Outcome measures

Outcome measures
Measure	H5 HA ID n=113 Participants Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM n=114 Participants Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
Number of Participants Achieving a Serum HAI Titer of Greater Than or Equal to 40 After Dose 1.	26 Participants	29 Participants

SECONDARY outcome

Timeframe: Approximately Day 208

Number of participants achieving a 4-fold or greater increase in HAI antibody titers against influenza A/H5N1 virus in each vaccine group seven months after receipt of the first dose of vaccine.

Outcome measures

Outcome measures
Measure	H5 HA ID n=111 Participants Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM n=112 Participants Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers 7 Months After Dose 1.	17 Participants	16 Participants

SECONDARY outcome

Timeframe: Approximately Day 208

HAI GMT against influenza A/H5N1 virus in each vaccine group seven months after receipt of the first dose of vaccine.

Outcome measures

Outcome measures
Measure	H5 HA ID n=111 Participants Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM n=112 Participants Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
HAI GMT at 7 Months After Dose 1	10.0 Antibody Titer Interval 8.1 to 12.4	8.9 Antibody Titer Interval 7.3 to 10.9

SECONDARY outcome

Timeframe: Approximately Day 208

Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group 7 months after receipt of the first dose of vaccine.

Outcome measures

Outcome measures
Measure	H5 HA ID n=111 Participants Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM n=112 Participants Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
Number of Participants Achieving a Serum HAI Titer of Greater Than or Equal to 40 at 7 Months After Dose 1.	20 Participants	16 Participants

Adverse Events

H5 HA ID

Serious events: 2 serious events

Other events: 113 other events

Deaths: 0 deaths

H5 HA IM

Serious events: 2 serious events

Other events: 114 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	H5 HA ID n=113 participants at risk Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.	H5 HA IM n=114 participants at risk Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
Infections and infestations Appendicitis	0.88% 1/113 • Number of events 1 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 208. The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.	0.00% 0/114 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 208. The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
Psychiatric disorders Bipolar disorder	0.00% 0/113 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 208. The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.	0.88% 1/114 • Number of events 1 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 208. The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
Renal and urinary disorders Hydronephrosis	0.00% 0/113 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 208. The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.	0.88% 1/114 • Number of events 1 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 208. The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
Metabolism and nutrition disorders Insulin-requiring type II diabetes mellitus	0.88% 1/113 • Number of events 1 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 208. The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.	0.00% 0/114 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 208. The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.

Other adverse events

Additional Information

Shital Patel, MD

Baylor College of Medicine

Phone: 713-798-3793

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60