Advertisement

Topics

Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults

2014-08-27 03:12:48 | BioPortfolio

Summary

The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA formulations.

Description

All currently licensed influenza vaccines in the United States are produced in embryonated hen's eggs. There are several well-recognized disadvantages to the use of eggs as the substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process that can be time consuming, is not always successful, and can select receptor variants that may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken flocks, and that might be an important issue in a pandemic due to an avian influenza virus strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore, development of alternative substrates for influenza vaccine production has been identified as a high-priority objective.

One potential alternative method for production of influenza vaccine is expression of the influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids dependence on eggs and is very efficient because of the high levels of protein expression under the control of the baculovirus polyhedrin promoter.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Influenza

Intervention

0.5mL Intramuscular Injection

Location

Vince and Associates Clinical Research
Overland Park
Kansas
United States
66210

Status

Not yet recruiting

Source

Protein Sciences Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:48-0400

Clinical Trials [1435 Associated Clinical Trials listed on BioPortfolio]

Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Given by an Alternate Route in the Elderly

All marketed influenza vaccines are injected by the intramuscular route. This study will test whether an influenza vaccine is effective when injected by other route than into the muscle. I...

Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza

The purpose of this study is to determine the safety and effectivess of a single intramuscular injection of peramivir for the treatment of subjects with acute, uncomplicated influenza.

The Effect of Needle Temperature on Pain Ratings Following Intramuscular Injection

This study will determine whether decreasing pain associated with intramuscular injection by decreasing needle temperature could be an inexpensive, simple way to decrease injection fear an...

Pharma-Pen (Formerly Innoject) Auto-Injectory TIV

The purpose of this study is to evaluate the safety, effectiveness, and tolerability, of the Pharma-Pen(TM) intramuscular (IM) and subcutaneous (SC) auto-injector systems used by untrained...

Imiquimod and Influenza Vaccine for Immunocompromised Patients

In this open label, single centre, pilot randomized controlled clinical trial the investigators aim to compare the immunogenicity and safety of a new influenza vaccination strategy consist...

PubMed Articles [2879 Associated PubMed Articles listed on BioPortfolio]

Spread of Quadratus Lumborum Block to the Paravertebral Space Via Intramuscular Injection: A Volunteer Study.

Several types of quadratus lumborum block (QLB) are used for postoperative analgesia and are believed to be effective against both somatic and visceral pain via a local anesthetic (LA) effect in the p...

Intramuscular Diclofenac Vs Periprostatic Lidocaine Injection For Controlling Pain Undergoing Transrectal Ultrasound Guided Prostatic Biopsy.

Transrectal ultrasound (TRUS) technique for getting prostatic tissue for histopathology is now the standard procedure for malignant lesions of the prostate and imperative diagnostic investigation of p...

Safety, Pharmacokinetics, and Immunogenicity of Obiltoxaximab After Intramuscular Administration to Healthy Humans.

Inhalational anthrax is a highly lethal infection caused by Bacillus anthracis and a serious bioterrorism threat. Protective antigen (PA) is a critical component required for the virulence of Bacillus...

Intramuscular allopregnanolone and ganaxolone in a mouse model of treatment-resistant status epilepticus.

Allopregnanolone (5α-pregnan-3α-ol-20-one) and its synthetic 3β-methyl analog, ganaxolone, are positive allosteric modulators of synaptic and extrasynaptic γ-aminobutyric acid (GABA)receptors that...

Universal influenza virus vaccines and therapeutics: where do we stand with influenza B virus?

The development of a broadly protective or universal influenza virus vaccine is currently a public health priority worldwide. The vast majority of these efforts is exclusively focused on influenza A v...

Medical and Biotech [MESH] Definitions

An uncommon complication of INTRAMUSCULAR INJECTION leading to variable degrees of necrosis of skin and underlying tissue.

A synthetic progestin that is derived from 17-hydroxyprogesterone. It is a long-acting contraceptive that is effective both orally or by intramuscular injection and has also been used to treat breast and endometrial neoplasms.

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.

Membrane glycoproteins from influenza viruses which are involved in hemagglutination, virus attachment, and envelope fusion. Fourteen distinct subtypes of HA glycoproteins and nine of NA glycoproteins have been identified from INFLUENZA A VIRUS; no subtypes have been identified for Influenza B or Influenza C viruses.

Infection of domestic and wild fowl and other BIRDS with INFLUENZA A VIRUS. Avian influenza usually does not sicken birds, but can be highly pathogenic and fatal in domestic POULTRY.

More From BioPortfolio on "Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

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...

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...


Searches Linking to this Trial