Viewing Study NCT00992433



Ignite Creation Date: 2024-05-05 @ 9:56 PM
Last Modification Date: 2024-10-26 @ 10:11 AM
Study NCT ID: NCT00992433
Status: COMPLETED
Last Update Posted: 2012-05-16
First Post: 2009-10-08

Brief Title: H1N1 Vaccine at Two Dose Levels in HIV Positive Adults
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

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
Status: COMPLETED
Status Verified Date: 2011-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 bodys 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
Detailed Description: Recently a novel swine-origin influenza AH1N1 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 HIVacquired 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 200mL or greater than or equal to 200mL 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 CD4CD8 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
N01AI80002C None None None