HIV Vaccine Trials and Preparedness with IAVI

RZHRG - Data Collection

RZHRG’s 25 years of research practice and experience, as well as the ongoing recruitment of study participants, enables our study sites to perform many of the procedures required for a preventive-vaccine efficacy trial, including: recruitment, retention, counseling, HIV testing, collection of demographic, risk and health data, drawing, processing, storage and shipping of blood samples, cryopreservation and shipping of viable lymphocytes (PBMCs), and recording and analysis of data. Sites will receive the relevant training required to execute a clinical trial according to good clinical and laboratory practices (GCP and GLP respectively).

The vaccine-development environment is dynamic and changing, with new discoveries constantly emerging. RZHRG research sites remain prepared and active in vaccine feasibility studies and clinical trials on new vaccine developments.

Rwanda and Zambia

Long Term Follow-up of Vaccine Trial Participants – Ongoing

The purpose of this study is to conduct long-term follow-up and assess the long-term health status of volunteers who have been enrolled previously in an IAVI-sponsored trial of an investigational HIV vaccine candidate; to evaluate the frequency of HIV infection in volunteers who participated in HIV vaccine clinical trials; to evaluate the persistence of vaccine-induced antibodies in volunteers who tested HIV positive at the end of the IAVI-sponsored vaccine trial; and to characterize immunological, virological, and immunogenetic responses in volunteers participating in IAVI-sponsored clinical trials.

Protocol C - Ongoing

The purpose of this study is to evaluate clinical, laboratory, immunologic and viral markers of disease progression in volunteers with recent HIV infection to prepare for activities relevant to the execution of preventive HIV vaccine efficacy trials. If identifiable and willing, HIV-infected partner(s) of enrolled volunteers will be assessed for virologic and immunogenetic parameters relevant to transmission.

Protocol D – Completed

The purpose of this study was to establish clinical laboratory reference ranges among adults to determine relevant inclusion and exclusion criteria and to interpret safety data for HIV vaccine trials in the context of medical conditions present in an asymptomatic adult population at multiple sites in Africa.

Protocol E – Completed

The purpose of this study was to characterise immune responses to HIV vaccine encoded proteins in HIV infected individuals and assess cryopreservation of Peripheral Blood Mononuclear cells in preparation for preventive vaccine studies

Protocol G – Ongoing

The purpose of this study was to generate broadly neutralizing monoclonal antibodies (mAbs) from volunteers who are HIV infected and have broadly cross-reactive serum neutralizing activity.

Protocol H – Ongoing

The purpose of this study is follow-up of HIV-infected participants.

Protocol L

Note there is no link for this on IAVI site but we have the protocol in our IRB folder and can get title and short description there

Rwanda

IAVI S001 – Ongoing

This Phase I clinical trial, expected to last two years, is the first to test SeV-G and will evaluate the vaccine candidate’s safety and tolerability among approximately 64 healthy volunteers age 18 to 50. Researchers also will assess immune responses elicited by a prime-boost regimen of SeV-G and a vaccine candidate based on adenovirus serotype 35.

IAVI B004 – Completed

This study is a randomized, double-blind placebo-controlled trial assessing the safety and immunogenicity of a multi-antigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human IL-12 pDNA (GENEVAX® IL-12) given intramuscularly by in vivo electroporation (IM/EP) using the Ichor Medical Systems TriGrid Delivery System (TDS-IM), followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine.

IAVI B003 – Completed

This study is a randomized, double-blind placebo-controlled trial assessing the order of vector priming and boosting (Ad26 versus Ad35), the timing of boost (3 versus 6 months) and the homologous versus heterologous regimen at the 3-month time interval.

IAVI V001 – Completed

The purpose of this trial to test the safety and immunogenicity of a multi-clade HIV-1 DNA plasmid followed by recombinant multiclade HIV-1 adenoviral vector vaccine or the multi-clade HIV-1 adenoviral vector alone.

Zambia

IAVI B002 - Completed

The purpose of this study was to evaluate the safety, tolerability, and immunogenicity of an adjuvanted investigational HIV vaccine developed by GlaxoSmithKline and Ad35-GRIN in 4 different regimens at months 1, 2, 3, and 4.

IAVI A002 – Completed

A clinical trial to evaluate the safety and immunogenicity of tgAAC09, an HIV vaccine containing clade C gag-PR-∆RT DNA in an adeno-associated virus (AAV) capsid, administered twice, at three dosage levels and two dosing intervals.

DID YOU KNOW...


• Approximately 25 million Africans are HIV+ and 225 million adults are HIV- and married, at risk of acquiring HIV within their marriages.

•The U.S. government spends $2.2 billion annually – 10 percent of the entire U.S. bilateral foreign aid budget -- to provide antiretroviral therapy to 3 million Africans.

•Treating one ART patient over the course of 10 years costs about $7000.

•The World Health Organization (WHO) estimates that five new people are infected by HIV for every two who receive antiretroviral therapy (ART).