H1N1 Vaccine in Pregnant Women

NCT00963430 | Completed Phase 2 Results

• 2 other identifiers: 09-0056N01AI80004C
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate an investigational 2009 H1N1 influenza vaccine to determine vaccine safety in pregnant women and the body's immune response (body's defense against disease) to different strengths of the H1N1 influenza vaccine. In this study, 2 strengths of the H1N1 influenza vaccine will be tested (given 3 weeks apart). Participants will include approximately 120 healthy pregnant women, ages 18-39 years, in their second or third trimester of pregnancy (14-34 weeks gestation). Study procedures will include 2 doses of vaccine, blood samples, cord blood samples at delivery, and recording temperature and vaccine side effects in a memory aid for 8 days following each vaccination. Participants will be involved in study related procedures for about 7 months.

Conditions

Influenza

Keywords

H1N1, influenza A viruses, pregnant women

Outcome Measures

Primary Outcomes (13)

• Number of Participants Reporting Solicited Subjective Local Reactions After First Vaccination

  Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.

  Within 8 days (Day 0-7) post first vaccination

• Number of Participants Reporting Solicited Subjective Local Reactions After Second Vaccination

  Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.

  Within 8 days (Day 0-7) post second vaccination

• Number of Participants Reporting Solicited Quantitative Local Reactions After First Vaccination

  Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.

  Within 8 days (Day 0-7) post first vaccination

• Number of Participants Reporting Solicited Quantitative Local Reactions After Second Vaccination

  Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.

  Within 8 days (Day 0-7) post second vaccination

• Number of Participants Reporting Solicited Subjective Systemic Reactions After First Vaccination

  Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

  Within 8 days (Day 0-7) post first vaccination

• Number of Participants Reporting Solicited Subjective Systemic Reactions After Second Vaccination

  Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

  Within 8 days (Day 0-7) post second vaccination

• Number of Participants Reporting Fever After First Vaccination

  Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.

  Within 8 days (Day 0-7) post first vaccination

• Number of Participants Reporting Fever After Second Vaccination

  Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.

  Within 8 days (Day 0-7) post second vaccination

• Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine

  Blood was collected from all participants prior to the initial vaccination as well as 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination titer was an increase by 4-fold or more.

  Day 0 prior to and Day 21 after the first vaccination

• Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine

  Blood was collected from all participants at Day 21 post first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

  Day 21 after the first vaccination

• Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery

  Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.

  At time of delivery

• Number of Participants Reporting Neonatal Complications

  Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.

  At time of delivery

• Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)

  Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.

  Day 0 through Day 180 after last vaccination

Secondary Outcomes (4)

• Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in the Maternal Blood at the Time of Delivery

  At time of delivery

• Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in Cord Blood

  At time of delivery

• Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine

  Day 0 prior to first vaccination and Day 21 after the second vaccination

• Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine

  Day 21 after the second vaccination

Study Arms (2)

Group 2: 30 mcg H1N1 vaccine

EXPERIMENTAL

60 subjects to receive 30 mcg of inactivated H1N1 vaccine on Day 0 and Day 21.

Biological: Inactivated H1N1 Vaccine

Group 1: 15 mcg H1N1 vaccine

EXPERIMENTAL

60 subjects to receive 15 mcg of inactivated H1N1 vaccine on Day 0 and Day 21.

Biological: Inactivated H1N1 Vaccine

Interventions

Inactivated H1N1 Vaccine BIOLOGICAL

Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly (IM) as 15 or 30 mcg dose. The 15 mcg dose will be administered as a single 0.5 mL IM injection in the deltoid muscle of the preferred arm. The 30 mcg dose will be administered as a single 1.0 mL injection in the deltoid muscle.

Group 1: 15 mcg H1N1 vaccine; Group 2: 30 mcg H1N1 vaccine

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant female between the ages of 18 and 39 years, inclusive.
• Is from 14-34 weeks of gestation, inclusive.
• Had at least one prenatal visit during which pregnancy was confirmed.
• Is in good health, as determined by vital signs (heart rate 100 beats per minute; blood pressure: systolic 140 mm Hg; diastolic less than or equal to 90 mm Hg; oral temperature less than 100 degrees Fahrenheit), medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant, and targeted physical examination based on medical history. A stable medical condition is defined as health outcomes of the specific disease are considered to be within acceptable limits in the last 3 months.
• Able to understand and comply with planned study procedures.
• Provides written informed consent prior to initiation of any study procedures.
• Agrees to sign medical release for herself and her infant(s) to allow study staff to gather pregnancy outcome data, if needed per clinical site policy.

You may not qualify if:

• Has a known allergy to eggs or other components in the vaccines (these may include, but are not limited to: gelatin, formaldehyde, octoxinol and chicken protein).
• Has a history of severe reactions following previous immunization with influenza virus vaccines.
• Has participated in a novel influenza H1N1 2009 vaccine study in the past 2 years or has history of novel influenza H1N1 2009 infection prior to enrollment.
• Has received any other live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study prior to vaccination or plan receipt of such vaccines within 21 days following the last vaccination (except for seasonal inactivated influenza vaccine which may be received 2 weeks post either vaccination). Measles, mumps, and rubella vaccine and tetanus, diphtheria, and acellular pertussis vaccine are permitted post-partum.
• Has received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within one month prior to vaccination in this study, or expects to receive another experimental/investigational agent during the study period (prior to the Day 201 follow-up call - 180 days after the second vaccination).
• Has an acute illness and/or an oral temperature greater than or equal to 100.0 degrees Fahrenheit, within 72 hours of vaccination (This may result in a temporary delay of vaccination).
• Has immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months.
• Has an active neoplastic disease (excluding non-melanoma skin cancer), a history of any hematologic malignancy, current bleeding disorder, or taking anticoagulants.
• Long term use of glucocorticoids, including oral or parenteral, or high-dose inhaled steroids (\>800 micrograms/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed) or has received betamethasone or dexamethasone to accelerate fetal lung maturity.
• Has a history of receiving immunoglobulin or other blood product (with exception of Rhogam) within the 3 months prior to enrollment in this study.
• Has a diagnosis of a current and uncontrolled major psychiatric disorder.
• Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
• The subject is receiving any of the following psychiatric drugs: aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, trifluopromazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate. Subjects who are receiving an antidepressant drug (not listed above) and are stable for at least 3 months prior to enrollment without decompensating are allowed enrollment into the study.
• Known active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.
• History of alcohol or drug abuse in the last 5 years.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (5)

Saint Louis University - Center for Vaccine Development

St Louis, Missouri, 63104, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232-2573, United States

Location

Baylor College of Medicine - Department of Molecular Virology and Microbiology

Houston, Texas, 77030, United States

Location

Group Health Cooperative

Seattle, Washington, 98101, United States

Location

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: Lisa Jackson, MD, MPH
• Organization: Group Health Research Institute

206-442-5216

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 21, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 3, 2012
• Results First Posted: May 16, 2011

Record last verified: 2010-04

Locations

US (5)