Advertisement

Topics

Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth

2014-08-27 03:18:46 | BioPortfolio

Summary

Children and people infected with HIV are particularly susceptible to influenza infections. This study will test the safety and effectiveness of a vaccine for the new H1N1 influenza virus in children and youth infected with HIV.

Description

The new H1N1 influenza virus seen in 2009 has been designated a pandemic by the World Health Organization, due to the sustained community outbreaks seen in the United States and Mexico. Based on preliminary data, it appears children and young adults are particularly at risk of the H1N1 virus. People infected with HIV are also more susceptible to severe influenza infections than those who are uninfected. Children with HIV infection, then, have a compounded risk of H1N1 infection. Higher doses of influenza vaccines are associated with the development of higher levels of serum antibodies, which are needed to resist infection. Higher vaccine doses can be used to improve vaccine effectiveness in at-risk populations. This study will test the safety and immune response of HIV infected children and youth to a high dose of a vaccine for the new H1N1 influenza virus.

Participation in this study will last 7 months and have two steps. The first step involves receiving the first dose of H1N1 virus vaccine, and the second step, occurring 21 days later, involves receiving the second dose of vaccine. Each dose of vaccine will be delivered via two intramuscular shots (four total injections). After receiving each dose of the vaccine, participants will be given a diary to record any symptoms or reactions. Participants will be stratified into three groups by age, including 4 to 9 years, 9 to 18 years, and 18 to 25 years.

Participants will complete five scheduled visits, taking place at screening, study entry, Days 21 and 31, and after 7 months. Measurements taken on these visits will include a medical history, physical and neurological exams, a blood draw, and, when applicable, a pregnancy test. In addition to these visits, participants may receive up to three additional phone calls or visits occurring 2 and 10 days after the first dose of vaccine and 2 days after the second dose of vaccine to check for reactions to the vaccine.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

HIV Infections

Intervention

Influenza A (H1N1) 2009 monovalent vaccine

Location

University of Alabama Birmingham NICHD
Birmingham
Alabama
United States
35233-0011

Status

Not yet recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:46-0400

Clinical Trials [2852 Associated Clinical Trials listed on BioPortfolio]

Effect of Age and Prior Immunity on Response to H1N1 Vaccines in Children

A total of 51 children between the ages of 4 and 9 will be randomized to receive a two dose schedule of either licensed live attenuated A/California/07/09 influenza vaccine (LAIV) or licen...

A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine. Primary Objectives: - To describe the immunogenicity of the candidate vaccines ...

A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults

The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults.

A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children

The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy children.

A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA

The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults

PubMed Articles [5884 Associated PubMed Articles listed on BioPortfolio]

Influence of Birth Cohort on Effectiveness of 2015-2016 Influenza Vaccine Against Medically Attended Illness Due to 2009 Pandemic Influenza A(H1N1) Virus in the United States.

The effectiveness of influenza vaccine during 2015-2016 was reduced in some age groups as compared to that in previous 2009 pandemic influenza A(H1N1) virus (A[H1N1]pdm09 virus)-predominant seasons. W...

Influenza surveillance in Western Turkey in the era of quadrivalent vaccines: A 2003-2016 retrospective analysis.

Human influenza is predominantly caused by influenza A virus (IAV) - A/H1N1 and/or A/H3N2 - and influenza B virus (IBV) - B/Victoria and/or B/Yamagata, which co-circulate each season. Influenza survei...

Generation of a broadly reactive influenza H1 antigen using a consensus HA sequence.

H1N1, one of the most prevalent influenza A virus subtypes affecting the human population, can cause infections varying from mild respiratory syndrome to severe pneumonia. The current H1N1 vaccine nee...

Generation of a High-Growth Influenza Vaccine Strain in MDCK Cells for Vaccine Preparedness.

As shown during the 2009 pandemic H1N1 [A(H1N1)pdm09] outbreak, egg-based influenza vaccine production technology is insufficient to meet global demand during an influenza pandemic. Therefore, there i...

Decrease in the Uptake of Seasonal Influenza Vaccine in Persons Aged 65 Years and Older In Ireland since the 2009 Influenza A (H1N1) Pdm09 Pandemic.

In Ireland, there is year-on-year variation in the seasonal influenza vaccine uptake for people aged 65 years and older. We obtained aggregate vaccine uptake data (2004/05-2014/15) by area and age gro...

Medical and Biotech [MESH] Definitions

A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 1 and neuraminidase 1. The H1N1 subtype was responsible for the Spanish flu pandemic of 1918.

Vaccines used to prevent infection by viruses in the family ORTHOMYXOVIRIDAE. It includes both killed or attenuated vaccines. The composition of the vaccines is changed each year in response to antigenic shifts and changes in prevalence of influenza virus strains. The vaccine is usually bivalent or trivalent, containing one or two INFLUENZAVIRUS A strains and one INFLUENZAVIRUS B strain.

A vaccine containing L1 capsid proteins from four types of HPV (ALPHAPAPILLOMAVIRUS), types 6, 11, 16 and 18 that is used to prevent infections from HUMAN PAPILLOMAVIRUSES of these subtypes.

A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.

Species of the genus INFLUENZAVIRUS B that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.

More From BioPortfolio on "Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Human Immuno Deficiency Virus (HIV)
Human Immunodeficiency Virus (HIV), the causative agent of AIDS. The Human Immunodeficiency Virus, more commonly known as HIV, is a member of the lentivirus sub-set of the retrovirus family of pathogens. It causes AIDS, or Acquired Immuno Deficiency Sy...

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...


Searches Linking to this Trial