InfluenzaPhase 2NCT00992433

H1N1 Vaccine at Two Dose Levels in HIV Positive Adults

A Phase 2 study testing Inactivated Influenza H1N1 vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Influenza
What is being tested?: Inactivated Influenza H1N1 vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 192 participants
Where: 6 sitesUnited States
Study dates: Nov 2009to Nov 2010
Phase: Phase 2
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 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Human immunodeficiency virus (HIV) infection defined as documented by an enzyme-linked immunosorbent assay (ELISA) and confirmed with a Western blot at any time prior to study entry. Serum HIV-1 antigen, plasma HIV-1 ribonucleic acid (RNA), or any Food and Drug Administration (FDA) approved antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
Males or non-pregnant females age 18-64, inclusive.
Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal to 1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, Depo-Provera injections or Implanon implants for at least 30 days following the last vaccination.
Are medically stable, as determined by the Investigator (based on review of health status, vital signs, medical history, and targeted physical examination. Vital signs must be within normal ranges prior to the first vaccination (heart rate 55-100, blood pressure systolic <160, blood pressure diastolic <90).
Receipt of the 2009-2010 seasonal influenza vaccine at least two weeks prior to enrollment in this study.
Intend to be available for follow-up visits and phone call access through 7 months following receipt of H1N1 vaccine.

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Are able to understand and comply with planned study procedures.
Subject receiving regular medical follow-up care for HIV.
Has a documented platelet count of >50,000mm^3 and an absolute neutrophil count (ANC) of >500mm^3 within the 3 months prior to study entry.
Provide written informed consent prior to initiation of any study procedures.

Who cannot join

Treatment for an opportunistic infection (OI) initiated within 2 weeks prior to enrollment, or have symptoms that have not stabilized.
Have a known allergy to eggs or other components of the vaccine (including polymyxin, neomycin, and chicken protein).
Women who are pregnant or breastfeeding.
Have a positive urine or serum pregnancy test within 24 hours prior to vaccination.
Use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
Have a neoplastic disease that will be treated with chemotherapy or radiation, or a history of any hematologic malignancy.

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Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids. For oral or parenteral: prednisone or equivalent (greater than or equal to 2.0 mg/kg per day or greater than or equal to 20 mg total dose) for more than 2 consecutive weeks (or 2 weeks total) in the past 3 months. For inhaled steroids: >800 mcg/day of beclomethasone dipropionate or equivalent within the preceding 6 months. (Nasal and topical steroids are allowed.)
Have an uncontrolled major psychiatric diagnosis.
Have a history of receiving immunoglobulin or other blood products within the 3 months prior to vaccination in this study.
Received an experimental agent (vaccine, drug, biologic, device, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study (prior to the Day 201 follow-up call).
Have received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following the second vaccination.
Have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, or would interfere with the evaluation of responses.
Have a history of severe reactions following previous immunization with influenza virus vaccines.
Have a moderate-severe acute illness, including an oral temperature greater than 100.4 degrees Fahrenheit, within 72 hours prior to vaccination. (This may result in a temporary delay of vaccination).
Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Participated in a novel influenza 2009 H1N1 influenza vaccine study or have history of novel 2009 H1N1 influenza infection prior to enrollment.
Have a history of alcohol or drug abuse in the last 3 months.
Plan to travel outside of North America at any time between the first vaccination and 42 days following the first vaccination.
Have a history of Guillain-Barré Syndrome.
Have any condition that the investigator believes may interfere with successful completion of the study.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

University of Maryland Baltimore - Institute of Human Virology
Baltimore, Maryland, 21201
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Washington
Seattle, Washington, 98104
Saint Louis University
St Louis, Missouri, 63104

Other trials in United States

About this study

Official title: A Phase II Study in HIV-seropositive Adults to Assess the Safety and Immunogenicity of an Unadjuvanted Novartis H1N1 Influenza Vaccine Administered at Two Dose Levels

The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot in persons infected with human immunodeficiency virus (HIV). This study will also compare how the CD4 count (cells that help fight disease) affects the body's response to the H1N1 flu shot. In this study, 2 strengths of the H1N1 flu shot will be given twice, about 3 weeks apart. The results of this study will help researchers find out if the different strengths of the H1N1 flu shot make the body produce H1N1 antibodies that are better at fighting H1N1 flu. About 240 HIV positive subjects, ages 18-64 years, will be asked to take part in this study. Study procedures include: blood sampling, physical exams, and use of memory aids to record temperature, medications and symptoms. The length of patient participation is about 7 months.

Read the detailed description

Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many countries around the world, prompting the World Health Organization (WHO) to declare a pandemic on June 11, 2009. The immunosuppression associated with human immunodeficiency virus (HIV)-infection has been related to diminished immune responses to vaccination against multiple pathogens, including influenza. The widespread use of antiretroviral therapy has resulted in a significant decrease in the mortality from HIV/acquired immune deficiency syndrome (AIDS) and, as a result, HIV-infected subjects constitute a demographically growing subpopulation in the United States. Currently, novel H1N1 vaccines are being evaluated in the general population. Researchers propose to evaluate the safety and immunogenicity of the novel H1N1 vaccines in HIV-infected subjects, because the data from clinical trials enrolling healthy subjects may not apply to immunosuppressed individuals; and an evaluation of the immune responses to vaccination against new, pandemic influenza viruses has never been performed in HIV-infected subjects. This is a randomized, open label, Phase II study in HIV seropositive males and non-pregnant females, aged 18-64 years. This study is designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 virus vaccine at 2 dose levels. Subjects will be randomized into 2 dose groups, stratified by cluster of differentiation (CD4) cell count at enrollment (120 subjects per dose group with 60 subjects per CD4 cell count stratum, <200/mL or greater than or equal to 200/mL) to receive intramuscular (IM) inactivated influenza H1N1 vaccine at 15 mcg (Group 1) or 30 mcg (Group 2). The H1N1 vaccine will be administered at Day 0 and Day 21. Following immunization, safety will be measured by assessment of adverse events through 21 days following the last vaccination (Day 42 for those receiving both doses and Day 21 for those who do not receive the second dose), serious adverse events and new-onset chronic medical conditions through 7 months post first vaccination (Day 201), and reactogenicity to the vaccine for 8 days following each vaccination (Day 0-7). A CD4/CD8 panel and viral load will be measured prior to first vaccination on Day 0 and at Day 10 post the second vaccination. Immunogenicity testing will include hemagglutination inhibition assay (HAI) and neutralizing antibody testing on serum obtained on the day of each vaccination (prior to vaccination), on Day 10 after each vaccination, 21 days following the second vaccination (Day 42) and 6 months after the second vaccination (Day 201). The primary objectives of this study are: (safety), to assess the safety of the unadjuvanted, inactivated H1N1 vaccine in HIV-1 seropositive adults when administered at the 15 mcg or 30 mcg dose and (immunogenicity) to assess the antibody response following 1 and 2 doses of inactivated H1N1 vaccine administered intramuscularly at the 15 mcg or 30 mcg dose levels in HIV-1 seropositive adults stratified by CD4 count at enrollment.

Conditions: Influenza
Being tested: Inactivated Influenza H1N1 vaccine
Keywords: influenza, H1N1, vaccine, human immunodeficiency virus
Medical subject headings: Influenza, Human, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inactivated Influenza H1N1 vaccineBiological
Two doses inactivated, licensed, Influenza A (H1N1) 2009 monovalent vaccine; 15 or 30 micrograms (mcg) per dose; slightly opalescent suspension in phosphate buffered saline. 15 mcg dose administered as a single 0.5 mL intramuscular (IM) injection. 30 mcg dose administered as two 0.5 mL IM injections.

Study groups in NCT00992433
Study group	Role	What they receive
Group 2, 30 mcg	Experimental	CD4<200, n=60; CD4 greater than or equal to 200, n=60. 30 mcg H1N1 vaccine on Day 0 and Day 21. Receives: Biological: Inactivated Influenza H1N1 vaccine
Group 1, 15 mcg	Experimental	CD4<200, n=60; CD4 greater than or equal to 200, n=60. 15 micrograms (mcg) H1N1 vaccine on Day 0 and Day 21. Receives: Biological: Inactivated Influenza H1N1 vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine
Blood was collected from participants 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 10 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.
Measured: Day 0 prior to vaccination and 10 days after the first vaccination
Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine
Blood was collected from participants 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 first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Measured: Day 0 prior to vaccination and 21 days after the first vaccination
Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine
Blood was collected from participants 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 10 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.
Measured: Day 0 prior to vaccination and 10 days after the second vaccination
Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine
Blood was collected from participants 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 second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Measured: Day 0 prior to vaccination and 21 days after the second vaccination
Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Blood was collected from participants 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 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.
Measured: Day 0 prior to vaccination and 180 days after the second vaccination
Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine
Blood was collected from participants 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 10 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.
Measured: Day 0 prior to vaccination and 10 days after the first vaccination
Number of Participants in the CD4 CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine
Blood was collected from participants 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 first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Measured: Day 0 prior to vaccination and 21 days after the first vaccination
Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine
Blood was collected from participants 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 10 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.
Measured: Day 0 prior to vaccination and 10 days after the second vaccination
Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine
Blood was collected from participants 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 second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Measured: Day 0 prior to vaccination and 21 days after the second vaccination
Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Blood was collected from participants 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 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.
Measured: Day 0 prior to vaccination and 180 days after the second vaccination
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline and 10 Days Following the First Dose of H1N1 Vaccine
Blood was collected from all participants at Day 0 prior to vaccination and 10 days after the 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.
Measured: Day 0 prior to vaccination and 10 days after the first vaccination
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine
Blood was collected from all participants 21 days after the 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.
Measured: Day 21 after the first vaccination
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine
Blood was collected from all participants 10 days after the second 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.
Measured: Day 10 after the second vaccination
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine
Blood was collected from all participants 21 days after the second 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.
Measured: Day 21 after the second vaccination
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Blood was collected from all participants 180 days after the second 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.
Measured: Day 180 after the second vaccination
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline Prior to the First Dose of H1N1 Vaccine
Blood was collected from all participants at Day 0 prior to the 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.
Measured: Day 0 prior to the first vaccination
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine
Blood was collected from all participants 10 days after the 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.
Measured: Day 10 after the first vaccination
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine
Blood was collected from all participants 21 days after the 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.
Measured: Day 21 after the first vaccination
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 and 21 Days Following the Second Dose of H1N1 Vaccine
Blood was collected from all participants 10 and 21 days after the second 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.
Measured: Day 10 and Day 21 after the second vaccination
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Blood was collected from all participants 180 days after the second 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.
Measured: Day 180 after the second vaccination
Number of Participants Reporting Solicited Subjective Systemic Reactions After the 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 (Day 0-7) after vaccination 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.
Measured: Within 8 days post first vaccination (Day 0-7).
Number of Participants Reporting Solicited Subjective Systemic Reactions After the 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 (Day 0-7) after vaccination 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.
Measured: Within 8 days post second vaccination (Day 0-7).
Number of Participants Reporting Fever After the First Vaccination
Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.
Measured: Within 8 days post first vaccination (Day 0-7).
Number of Participants Reporting Fever After the Second Vaccination
Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.
Measured: Within 8 days post second vaccination (Day 0-7).
Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination
Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination 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.
Measured: Within 8 days post first vaccination (Day 0-7).
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination
Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination 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.
Measured: Within 8 days post second vaccination (Day 0-7).
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination
Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Measured: Within 8 days post first vaccination (Day 0-7).
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination
Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Measured: Within 8 days post second vaccination (Day 0-7).
Number of Participants Reporting Vaccine-Associated Serious Adverse Events (SAEs)
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnosis.
Measured: Day 0 through Day 180 after the last vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Nov 2010

First posted9 Oct 2009 (estimated)
Study startNov 2009
Primary completionNov 2010
Study completionNov 2010

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 InfluenzaStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00992433
Sponsor's protocol ID: 09-0073
Other IDs: N01AI80002C
Status last verified: Feb 2011
First submitted: 8 Oct 2009
Last updated: 16 May 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

El Sahly HM, Davis C, Kotloff K, Meier J, Winokur PL, Wald A, Johnston C, George SL, Brady RC, Lehmann C, Stokes-Riner A, Keitel WA. Higher antigen content improves the immune response to 2009 H1N1 influenza vaccine in HIV-infected adults: a randomized clinical trial. J Infect Dis. 2012 Mar 1;205(5):703-12. doi: 10.1093/infdis/jir837. Epub 2012 Jan 24.
PubMed 22275399

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study in HIV-seropositive Adults to Assess the Safety and Immunogenicity of an Unadjuvanted Novartis H1N1 Influenza Vaccine Administered at Two Dose Levels
ClinicalTrials.gov ID: NCT00992433
Acronym / sponsor ID: 09-0073
Conditions: Influenza
Keywords: influenza, H1N1, vaccine, human immunodeficiency virus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 192 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: Nov 2009
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 9 Oct 2009 (estimated)
Results: Posted 17 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 2, 30 mcg	Experimental	Biological: Inactivated Influenza H1N1 vaccineCD4<200, n=60; CD4 greater than or equal to 200, n=60. 30 mcg H1N1 vaccine on Day 0 and Day 21.
Group 1, 15 mcg	Experimental	Biological: Inactivated Influenza H1N1 vaccineCD4<200, n=60; CD4 greater than or equal to 200, n=60. 15 micrograms (mcg) H1N1 vaccine on Day 0 and Day 21.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Human immunodeficiency virus (HIV) infection defined as documented by an enzyme-linked immunosorbent assay (ELISA) and confirmed with a Western blot at any time prior to study entry. Serum HIV-1 antigen, plasma HIV-1 ribonucleic acid (RNA), or any Food and Drug Administration (FDA) approved antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
Males or non-pregnant females age 18-64, inclusive.
Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal to 1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, Depo-Provera injections or Implanon implants for at least 30 days following the last vaccination.
Are medically stable, as determined by the Investigator (based on review of health status, vital signs, medical history, and targeted physical examination. Vital signs must be within normal ranges prior to the first vaccination (heart rate 55-100, blood pressure systolic <160, blood pressure diastolic <90).
Receipt of the 2009-2010 seasonal influenza vaccine at least two weeks prior to enrollment in this study.

Key exclusion criteria (20 listed)

Treatment for an opportunistic infection (OI) initiated within 2 weeks prior to enrollment, or have symptoms that have not stabilized.
Have a known allergy to eggs or other components of the vaccine (including polymyxin, neomycin, and chicken protein).
Women who are pregnant or breastfeeding.
Have a positive urine or serum pregnancy test within 24 hours prior to vaccination.
Use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.

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
Inactivated Influenza H1N1 vaccineTwo doses inactivated, licensed, Influenza A (H1N1) 2009 monovalent vaccine; 15 or 30 micrograms (mcg) per dose; slightly opalescent suspension in phosphate buffered saline. 15 mcg dose administered as a single 0.5 mL intramuscular (IM) injection. 30 mcg dose administered as two 0.5 mL IM injections.	Biological	Group 1, 15 mcg, Group 2, 30 mcg

Primary outcome

Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine
Time frame: Day 0 prior to vaccination and 10 days after the first vaccination
Blood was collected from participants 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 10 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.
Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine
Time frame: Day 0 prior to vaccination and 21 days after the first vaccination
Blood was collected from participants 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 first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine
Time frame: Day 0 prior to vaccination and 10 days after the second vaccination
Blood was collected from participants 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 10 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.
Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine
Time frame: Day 0 prior to vaccination and 21 days after the second vaccination
Blood was collected from participants 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 second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Time frame: Day 0 prior to vaccination and 180 days after the second vaccination
Blood was collected from participants 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 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.
Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine
Time frame: Day 0 prior to vaccination and 10 days after the first vaccination
Blood was collected from participants 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 10 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.
Number of Participants in the CD4 CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine
Time frame: Day 0 prior to vaccination and 21 days after the first vaccination
Blood was collected from participants 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 first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine
Time frame: Day 0 prior to vaccination and 10 days after the second vaccination
Blood was collected from participants 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 10 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.
Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine
Time frame: Day 0 prior to vaccination and 21 days after the second vaccination
Blood was collected from participants 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 second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Time frame: Day 0 prior to vaccination and 180 days after the second vaccination
Blood was collected from participants 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 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline and 10 Days Following the First Dose of H1N1 Vaccine
Time frame: Day 0 prior to vaccination and 10 days after the first vaccination
Blood was collected from all participants at Day 0 prior to vaccination and 10 days after the 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.
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine
Time frame: Day 21 after the first vaccination
Blood was collected from all participants 21 days after the 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.
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine
Time frame: Day 10 after the second vaccination
Blood was collected from all participants 10 days after the second 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.
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine
Time frame: Day 21 after the second vaccination
Blood was collected from all participants 21 days after the second 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.
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Time frame: Day 180 after the second vaccination
Blood was collected from all participants 180 days after the second 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.
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline Prior to the First Dose of H1N1 Vaccine
Time frame: Day 0 prior to the first vaccination
Blood was collected from all participants at Day 0 prior to the 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.
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine
Time frame: Day 10 after the first vaccination
Blood was collected from all participants 10 days after the 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.
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine
Time frame: Day 21 after the first vaccination
Blood was collected from all participants 21 days after the 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.
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 and 21 Days Following the Second Dose of H1N1 Vaccine
Time frame: Day 10 and Day 21 after the second vaccination
Blood was collected from all participants 10 and 21 days after the second 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.
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Time frame: Day 180 after the second vaccination
Blood was collected from all participants 180 days after the second 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.
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination
Time frame: Within 8 days post first vaccination (Day 0-7).
Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination 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.
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination
Time frame: Within 8 days post second vaccination (Day 0-7).
Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination 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.
Number of Participants Reporting Fever After the First Vaccination
Time frame: Within 8 days post first vaccination (Day 0-7).
Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.
Number of Participants Reporting Fever After the Second Vaccination
Time frame: Within 8 days post second vaccination (Day 0-7).
Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.
Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination
Time frame: Within 8 days post first vaccination (Day 0-7).
Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination 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.
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination
Time frame: Within 8 days post second vaccination (Day 0-7).
Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination 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.
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination
Time frame: Within 8 days post first vaccination (Day 0-7).
Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination
Time frame: Within 8 days post second vaccination (Day 0-7).
Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Number of Participants Reporting Vaccine-Associated Serious Adverse Events (SAEs)
Time frame: Day 0 through Day 180 after the last vaccination
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnosis.

Results and safety

Results posted to the registry on 17 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
15 Mcg H1N1 Vaccine	95	91
30 Mcg H1N1 Vaccine	97	90

Primary outcome: Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine

Time frame: Day 0 prior to vaccination and 10 days after the first vaccination. Number. Unit: Participants

Measure	15 Mcg H1N1 Vaccine n = 34	30 Mcg H1N1 Vaccine n = 34
Value	14	23

Population analysed: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Primary outcome: Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine

Time frame: Day 0 prior to vaccination and 21 days after the first vaccination. Number. Unit: Participants

Measure	15 Mcg H1N1 Vaccine n = 34	30 Mcg H1N1 Vaccine n = 32
Value	14	21

Primary outcome: Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine

Time frame: Day 0 prior to vaccination and 10 days after the second vaccination. Number. Unit: Participants

Measure	15 Mcg H1N1 Vaccine n = 34	30 Mcg H1N1 Vaccine n = 33
Value	15	23

Population analysed: Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Primary outcome: Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine

Time frame: Day 0 prior to vaccination and 21 days after the second vaccination. Number. Unit: Participants

Measure	15 Mcg H1N1 Vaccine n = 34	30 Mcg H1N1 Vaccine n = 32
Value	18	19

Adverse events

Time frame: Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
15 Mcg H1N1 Vaccine	8 of 95 (8.4%)	61 of 95 (64.2%)	Not reported
30 Mcg H1N1 Vaccine	5 of 97 (5.2%)	73 of 97 (75.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22275399El Sahly HM, Davis C, Kotloff K, Meier J, Winokur PL, Wald A, Johnston C, George SL, Brady RC, Lehmann C, Stokes-Riner A, Keitel WA. Higher antigen content improves the immune response to 2009 H1N1 influenza vaccine in HIV-infected adults: a randomized clinical trial. J Infect Dis. 2012 Mar 1;205(5):703-12. doi: 10.1093/infdis/jir837. Epub 2012 Jan 24.

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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.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inactivated Influenza H1N1 vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.

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 10 inclusion and 20 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 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 17 Nov 2011). 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?

Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine (time frame: Day 0 prior to vaccination and 10 days after the first vaccination). The study lists 29 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 NCT00992433, 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 16 May 2012.