To Evaluate the Safety and Ability of the Medicine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults

2015-03-26 05:53:22 | BioPortfolio


The purpose of this study is to evaluate the safety and immunogenicity of two doses of the investigational RSV F subunit vaccine administered intramuscularly (IM). In this current Phase 1, first-in-human study, the three different antigen amounts that have been selected will be evaluated in a stepwise manner in three different cohorts (cohort 1: low dosage of RSV F subunit vaccine, cohort 2: middle dosage of RSV F subunit vaccine, and cohort 3: high dosage of RSV F subunit vaccine). In addition, the effect of an adjuvant, either aluminum hydroxide or MF59, and antibody kinetics post-vaccination at different time points will be evaluated as compared to unadjuvanted RSV F subunit vaccine at the same dosage levels

Study Design

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


Respiratory Syncytial Virus (RSV)


RSV F subunit vaccine-Low dosage; no adjuvant, RSV F subunit vaccine-Medium dosage; no adjuvant, RSV F subunit vaccine-High dosage; no adjuvant, RSV F subunit vaccine-Low dosage; with aluminum hydroxide, RSV F subunit vaccine-Medium dosage; with aluminum


Center for Vaccinology (CEVAC)
East Flanders





Results (where available)

View Results


Published on BioPortfolio: 2015-03-26T05:53:22-0400

Clinical Trials [4843 Associated Clinical Trials listed on BioPortfolio]

Safety and Immunogenicity of 3 Lots of Cell-Derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-Derived Subunit Influenza Vaccine in Healthy Adults (18-60 Years)

The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron’s cell-derived subunit influenza vaccine in healthy adult subjects as compared to a con...

Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects

This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults b...

A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines

Primary: To determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160 envelope gene recombinant vaccine (HIVAC-1e) followed by boosting with one of two subunit recombinan...

Immunogenicity and Safety of an Adjuvanted Inactivated Subunit Influenza Vaccine to Those of a Non-Adjuvanted Inactivated Subunit Influenza Vaccine, When Administered to Adults Affected by Chronic Diseases

This phase III is designed to confirm the previous trial results evaluating the safety, clinical tolerability and immunogenicity of the 2006-2007 formulation of Novartis Vaccines' adjuvant...

Immunogenicity and Safety of Subunit Plague Vaccine

Plague is a potentially fatal infection in humans caused by the bacterium Yersinia pestis. Pneumonic plague is typically diagnosed in humans with high mortality. It has a long history for ...

PubMed Articles [6104 Associated PubMed Articles listed on BioPortfolio]

The HSV-1 live attenuated VC2 vaccine provides protection against HSV-2 genital infection in the guinea pig model of genital herpes.

Although development of an HSV vaccine is a priority there is currently no vaccine available. The recent failure of subunit vaccines suggest that presentation of more antigens via a live attenuated va...

Immunogenicity and safety of an investigational tetravalent recombinant subunit vaccine for dengue: results of a Phase I randomized clinical trial in flavivirus-Naïve adults.

There is an unmet medical need for vaccines to prevent dengue. V180 is an investigational recombinant subunit vaccine that consists of truncated dengue envelope proteins (DEN-80E) for all 4 serotypes....

Optimal gender-specific age for cost-effective vaccination with adjuvanted herpes zoster subunit vaccine in Chinese adults.

Adjuvanted herpes zoster (HZ) subunit (HZ/su) vaccine is recommended for healthy adults aged ≥50 years, yet vaccine efficacy is expected to wane over time. Age-sex specific cost-effectiveness analys...

Food-Grade Saponin Extract as an Emulsifier and Immunostimulant in Emulsion-Based Subunit Vaccine for Pigs.

Subunit vaccines consisting of highly purified antigens require the presence of adjuvants to create effective and long-lasting protective immunity. Advances on adjuvant research include designing comb...

Efficacy of CpG-ODN and Freund's immune adjuvants on antibody responses induced by chicken infectious anemia virus VP1, VP2, and VP3 subunit proteins.

Chicken infectious anemia virus is an important pathogen that causes severe anemia and immunosuppression in chickens, leading to serious economic losses worldwide in the poultry industry. However, no ...

Medical and Biotech [MESH] Definitions

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.

A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)

A bacterial vaccine for the prevention of brucellosis in man and animal. Brucella abortus vaccine is used for the immunization of cattle, sheep, and goats.

The number of copies of a given gene present in the cell of an organism. An increase in gene dosage (by GENE DUPLICATION for example) can result in higher levels of gene product formation. GENE DOSAGE COMPENSATION mechanisms result in adjustments to the level GENE EXPRESSION when there are changes or differences in gene dosage.

A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had mumps or been immunized with live mumps vaccine. Children are usually immunized with measles-mumps-rubella combination vaccine.

More From BioPortfolio on "To Evaluate the Safety and Ability of the Medicine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults"

Quick Search


Relevant Topics

An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...

A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...

Searches Linking to this Trial