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No adverse effects in volunteers following Phase I clinical trial of Sumagen AIDS vaccine
http://communications.uwo.ca/media/releases/2013/September/no_adverse_effects_in_volunteers_following_phase_i_clinical_trial_of_sumagen_aids_vaccine.htmlSumagen Canada Inc and Western University announced today that the Phase I Clinical Trial (SAV CT 01) of the first and only preventative HIV vaccine based on a genetically modified killed whole virus (SAV001-H) has been successfully completed with no adverse effects in all patients. Antibody production was also boosted after vaccination.
Developed by Dr. Chil-Yong Kang and his team at Western's Schulich School of Medicine & Dentistry, with the support of Sumagen Canada, the vaccine (SAV001-H) holds tremendous promise for success in the final phases of clinical testing now that the first hurdle has been accomplished. It is the only HIV vaccine developed in Canada currently in clinical trial, and one of only a few in the world. This vaccine is the first genetically modified killed whole virus vaccine (SAV001-H) in human clinical trial to evaluate its safety, tolerability and immune responses. The human clinical trial was initiated in March 2012 and completed in August 2013. This trial was a randomized, observer-blinded, placebo-controlled study of killed whole HIV-1 vaccine (SAV001-H) following intramuscular (IM) administration. HIV-infected, asymptomatic men and women, 18 to 50 years of age, have been enrolled in this study and randomized into two treatment groups to administer killed whole HIV-1 vaccine (SAV001-H) or placebo.
The adverse effects after vaccination were recorded on a volunteer diary card by the volunteers seven days after vaccination. Thereafter, the volunteers visited the test sites on Weeks 4, 6, 12, 18, 26 and 52 after vaccination and were analyzed for hematology, clinical chemistry, urinalysis and physical examination by principal investigators. No serious adverse event was observed in any volunteer vaccinees throughout the observation periods.
In addition to safety evaluation, HIV-1 specific antibody detections have been performed throughout the follow up period. The antibody against p24 capsid antigen increased as much as 64-fold in some vaccinees and antibody against gp120 surface antigen increased up to eight-fold after vaccination. The increased antibody titers were maintained during the 52 week study period. The boost antibody production in HIV-positive volunteer vaccinees is highly encouraging, since it forecasts a success of the Phase 2 human clinical trial, which will measure the immune responses.
Developed by Dr. Chil-Yong Kang and his team at Western's Schulich School of Medicine & Dentistry, with the support of Sumagen Canada, the vaccine (SAV001-H) holds tremendous promise for success in the final phases of clinical testing now that the first hurdle has been accomplished. It is the only HIV vaccine developed in Canada currently in clinical trial, and one of only a few in the world. This vaccine is the first genetically modified killed whole virus vaccine (SAV001-H) in human clinical trial to evaluate its safety, tolerability and immune responses. The human clinical trial was initiated in March 2012 and completed in August 2013. This trial was a randomized, observer-blinded, placebo-controlled study of killed whole HIV-1 vaccine (SAV001-H) following intramuscular (IM) administration. HIV-infected, asymptomatic men and women, 18 to 50 years of age, have been enrolled in this study and randomized into two treatment groups to administer killed whole HIV-1 vaccine (SAV001-H) or placebo.
The adverse effects after vaccination were recorded on a volunteer diary card by the volunteers seven days after vaccination. Thereafter, the volunteers visited the test sites on Weeks 4, 6, 12, 18, 26 and 52 after vaccination and were analyzed for hematology, clinical chemistry, urinalysis and physical examination by principal investigators. No serious adverse event was observed in any volunteer vaccinees throughout the observation periods.
In addition to safety evaluation, HIV-1 specific antibody detections have been performed throughout the follow up period. The antibody against p24 capsid antigen increased as much as 64-fold in some vaccinees and antibody against gp120 surface antigen increased up to eight-fold after vaccination. The increased antibody titers were maintained during the 52 week study period. The boost antibody production in HIV-positive volunteer vaccinees is highly encouraging, since it forecasts a success of the Phase 2 human clinical trial, which will measure the immune responses.
Potentially good news...