Safety and Efficacy of an H1N1 Influenza Vaccine in People With Asthma

This study has been completed.

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00978120

First received: September 15, 2009

Last updated: August 8, 2012

Last verified: August 2012

History of Changes

Results First Received: June 27, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	H1N1 Influenza Virus
Interventions:	Biological: H1N1 vaccine high dose Biological: H1N1 vaccine low dose

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study participants were recruited from October 16 to November 13, 2009 at the seven National Heart, Lung, and Blood Institute (NHLBI)- funded Severe Asthma Research Program sites.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)	Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
Mild/Moderate Asthma, High Dose Vaccine (30mcg)	Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
Severe Asthma, Low Dose Vaccine (15mcg)	Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
Severe Asthma, High Dose Vaccine (30mcg)	Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21. [1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Participant Flow: Overall Study

	Mild/Moderate Asthma, Low Dose Vaccine (15mcg)	Mild/Moderate Asthma, High Dose Vaccine (30mcg)	Severe Asthma, Low Dose Vaccine (15mcg)	Severe Asthma, High Dose Vaccine (30mcg)
STARTED	110	107	87	86
COMPLETED	108	107	84	84
NOT COMPLETED	2	0	3	2
Death	0	0	0	1
Lost to Follow-up	0	0	3	0
Withdrawal by Subject	2	0	0	0
Moved out of state	0	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)	Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
Mild/Moderate Asthma, High Dose Vaccine (30mcg)	Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
Severe Asthma, Low Dose Vaccine (15mcg)	Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
Severe Asthma, High Dose Vaccine (30mcg)	Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21. [1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)
Total	Total of all reporting groups

Baseline Measures

	Mild/Moderate Asthma, Low Dose Vaccine (15mcg)	Mild/Moderate Asthma, High Dose Vaccine (30mcg)	Severe Asthma, Low Dose Vaccine (15mcg)	Severe Asthma, High Dose Vaccine (30mcg)	Total
Number of Participants [units: participants]	110	107	87	86	390
Age [units: participants]
<=18 years	22	23	12	10	67
Between 18 and 65 years	80	79	67	68	294
>=65 years	8	5	8	8	29
Age [units: years] Mean ± Standard Deviation	39.1 ± 18.1	36.3 ± 17.0	45.2 ± 17.0	46.5 ± 17.3	41.3 ± 17.8
Gender [units: participants]
Female	72	62	52	45	231
Male	38	45	35	41	159
Region of Enrollment [units: participants]
United States	110	107	87	86	390
Age at Asthma Onset ^[1] [units: years] Mean ± Standard Deviation	17.1 ± 17.0	16.4 ± 14.9	21.9 ± 19.7	21.9 ± 20.1	19.0 ± 17.9
Asthma Duration ^[2] [units: years] Mean ± Standard Deviation	21.9 ± 13.9	19.9 ± 13.4	23.3 ± 16.5	24.6 ± 17.8	22.3 ± 15.3
Body Mass Index (BMI) ^[3] [units: kg/m^2] Mean ± Standard Deviation	29.5 ± 8.5	28.5 ± 6.8	31.8 ± 9.7	30.1 ± 8.0	29.9 ± 8.3
Forced Expiratory Volume in 1 second (FEV1) % Predicted ^[4] [units: percentage] Mean ± Standard Deviation	83.8 ± 16.3	86.6 ± 17.6	72.6 ± 19.4	69.8 ± 20.8	79.0 ± 19.7
Forced Vital Capacity (FVC) % Predicted ^[5] [units: percentage] Mean ± Standard Deviation	92.6 ± 14.3	94.3 ± 16.1	85.0 ± 17.1	80.9 ± 18.7	88.8 ± 17.3
FEV1/FVC Ratio ^[6] [units: Ratio (x 100)] Mean ± Standard Deviation	74.5 ± 9.07	75.7 ± 8.99	68.4 ± 10.91	68.4 ± 11.76	72.1 ± 10.62

[1]	The age at asthma onset is the age defined in years when the participant was told by a physician that he/she has asthma. This was calculated by subtracting the participant’s age at the baseline visit (visit 1) from the number of years the participant reported to have known having asthma.
[2]	Asthma duration is the number of years since the participant was told by a physician that he/she has asthma as reported at the baseline visit, visit 1.
[3]	BMI is a number calculated from a person’s height and weight that provides a reliable indicator of body fatness for most people. Higher values reflect greater amount of body fat. [1] In adults, a BMI less than 18.5 is underweight; 18.5 to 24.9 is a normal or healthy weight; greater than or equal to 25.0 is overweight. The height and weight was collected at baseline only. [1]: Healthy Weight , Assessing Your Weight , Body Mass Index http://www.cdc.gov/healthyweight/assessing/bmi/index.html
[4]	FEV1 is air volume exhaled in 1 second during spirometry. Asthma severity classification for trial: mild--pre-bronchodilator FEV1 ≥ 80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; moderate--pre-bronchodilator FEV1 <80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; severe--requiring high-dose inhaled glucocorticoids with/without continuous/near continuous oral glucocorticoids, or uncontrolled despite treatment. FEV1 percent of predicted value is FEV1 converted to a percentage of normal, based on height, weight, and race.
[5]	FVC is a lung function test that measures the total amount of air exhaled. The percent of predicted value is FVC converted to a percentage of normal, based on height, weight, and race. Estimates of severity of abnormalities in flow volume measured by FVC: Mild-65-80% of predicted value; Moderate-50-65% of predicted value; Severe-<50% of predicted value.
[6]	The FEV1 (forced expiratory volume 1))/ FVC (forced vital capacity) ratio is used to evaluate airways obstructions since pure restrictive ventilatory defects cause an equal reduction in the FEV1 and the FVC. An FEV1/FVC ratio below 80% indicates airflow obstruction. Normal FEV1/FVC: 8 – 19 years of age=85%; 20-39 years of age=80%; 40- 59 years of age 75%; 60-80 years of age 70% [1] [1]: National Asthma Education and Prevention Program Expert Panel Report 3, Guidelines for the Diagnosis and Management of Asthma. Oct. 2007. http://www.nhlbi.nih.gov/guidelines/asthma/asthsumm.pdf

Outcome Measures

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1. Primary:

Percentage of Participants With Serious Adverse Events (SAEs) Attributed To Vaccination [ Time Frame: Measured at Baseline Visit and Days 1, 8, 21, 28, 41, 80, 120, and 201 ]

Show Outcome Measure 1

2. Primary:

Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 1 [ Time Frame: Days 1 through 8 ]

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3. Primary:

Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 2 [ Time Frame: Days 21 through 28 ]

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4. Primary:

Percentage of Participants With Asthma Exacerbations Status Post Vaccine 1 [ Time Frame: Days 1 to 8 ]

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5. Primary:

Percentage of Participants With Asthma Exacerbations Status Post Vaccination 2 [ Time Frame: Days 21 to 28 ]

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6. Primary:

Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics [ Time Frame: Days 1 to 28 ]

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7. Primary:

Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics [ Time Frame: Days 1 to 28 ]

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8. Primary:

Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics [ Time Frame: Days 1 to 41 ]

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9. Primary:

Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics [ Time Frame: Days 1 to 41 ]

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10. Primary:

Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics [ Time Frame: Days 1 to 28 ]

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11. Primary:

Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics [ Time Frame: Days 1 to 28 ]

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12. Primary:

Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics [ Time Frame: Days 1 to 41 ]

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13. Primary:

Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics [ Time Frame: Days 1 to 41 ]

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14. Secondary:

Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics [ Time Frame: Days 1 to 21 ]

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15. Secondary:

Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Severe Asthmatics [ Time Frame: Days 1 to 21 ]

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16. Secondary:

Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics [ Time Frame: Days 1 to 21 ]

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17. Secondary:

Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Severe Asthmatics [ Time Frame: Days 1 to 21 ]

Show Outcome Measure 17

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Associate Director, Clinical Research Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsGov@niaid.nih.gov

Publications of Results:

Busse WW, Peters SP, Fenton MJ, Mitchell H, Bleecker ER, Castro M, Wenzel S, Erzurum SC, Fitzpatrick AM, Teague WG, Jarjour N, Moore WC, Sumino K, Simeone S, Ratanamaneechat S, Penugonda M, Gaston B, Ross TM, Sigelman S, Schiepan JR, Zaccaro DJ, Crevar CJ, Carter DM, Togias A. Vaccination of patients with mild and severe asthma with a 2009 pandemic H1N1 influenza virus vaccine. J Allergy Clin Immunol. 2011 Jan;127(1):130-7, 137.e1-3. Epub 2010 Dec 9.

Other Publications:

Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team; Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, Gubareva LV, Xu X, Bridges CB, Uyeki TM. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009 Jun 18;360(25):2605-15. Epub 2009 May 7. Erratum in: N Engl J Med. 2009 Jul 2;361(1):102.

Patriarca PA, Cox NJ. Influenza pandemic preparedness plan for the United States. J Infect Dis. 1997 Aug;176 Suppl 1:S4-7.

Proceedings of the ATS workshop on refractory asthma: current understanding, recommendations, and unanswered questions. American Thoracic Society. Am J Respir Crit Care Med. 2000 Dec;162(6):2341-51. Review.

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00978120 History of Changes
Other Study ID Numbers:	DAIT-AAIB-flu-001
Study First Received:	September 15, 2009
Results First Received:	June 27, 2012
Last Updated:	August 8, 2012
Health Authority:	United States: Food and Drug Administration United States: Federal Government

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