A single dose of unadjuvanted novel 2009 H1N1 vaccine is immunogenic and well tolerated in young and elderly adults.

Background: When the novel H1N1 influenza A strain appeared in April of 2009, development of novel H1N1 vaccines became a public health priority.

Methods: We conducted a phase‐2, multicenter, randomized, placebo‐controlled, observer‐blind clinical trial of a 2009 H1N1 vaccine in 1313 young (age, 18-64 years) and older (age, >or=65 years) adults. Participants were randomized 1:4:4:4 to receive 2 doses of placebo or 7.

ISCOMATRIX() vaccines: Safety in human clinical studies.

ISCOMATRIX() adjuvant is a component of a variety of developmental vaccines. To evaluate the safety profile of ISCOMATRIX() adjuvant we have pooled and analyzed the safety data obtained from a number of vaccine development programs. Overall, the ISCOMATRIX() vaccines from studies included in the analysis were found to be safe and well tolerated, with no vaccine related deaths or Serious Adverse Events.

Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial.

Context: In the ongoing influenza pandemic, a safe and effective vaccine against 2009 influenza A(H1N1) is needed for infants and children.

Objective: To assess the immunogenicity and safety of a 2009 influenza A(H1N1) vaccine in children.

Design, Setting, And Participants: Randomized, observer-blind, age-stratified, parallel group study assessing 2 doses of an inactivated, split-virus 2009 influenza A(H1N1) vaccine in 370 healthy infants and children aged 6 months to less than 9 years living in Australia.

Response to a monovalent 2009 influenza A (H1N1) vaccine.

Background: A novel 2009 influenza A (H1N1) virus is responsible for the first influenza pandemic in 41 years. A safe and effective vaccine is needed. A randomized, observer-blind, parallel-group trial evaluating two doses of an inactivated, split-virus 2009 H1N1 vaccine in healthy adults between the ages of 18 and 64 years is ongoing at a single site in Australia.

A randomized, placebo-controlled, dose-escalation study to determine the safety, tolerability, and immunogenicity of an HPV-16 therapeutic vaccine in HIV-positive participants with oncogenic HPV infection of the anus.

Objective: Study aimed to assess safety, tolerability, and immunogenicity of novel therapeutic HPV-16 E6E7 ISCOMATRIX vaccine for treatment of human papilloma virus (HPV)-related anal intraepithelial neoplasia in HIV-infected men who have sex with men with moderate immunosuppression.

Design: Randomized, multicenter, blinded, placebo-controlled, dose-escalating study investigating 3 different doses of vaccine and different dose schedule. Primary objective to determine safety and tolerability, including clinical status, maintenance of virological control, and CD4 cell count for more than 252 days.

ISCOMATRIX adjuvant for prophylactic and therapeutic vaccines.

The ISCOMATRIX adjuvant has antigen-delivery and -presentation properties, as well as immunomodulatory capabilities that combine to provide enhanced and accelerated immune responses. The responses are broad, including a range of subclasses of antibodies as well as both CD4+ and CD8+ T cells. A range of ISCOMATRIX vaccines (ISCOMATRIX adjuvant combined with antigen) have been evaluated in clinical trials.