Clinical Development

We conduct clinical research with the highest ethical, regulatory, and scientific standards

Clinical development is the stage of research and development when vaccine and drug candidates are safely tested in people. Functions of this stage include clinical trial strategy development, clinical monitoring, trial site management, community engagement, quality management, data management and biostatistics, medical and safety monitoring, and medical writing.  

IAVI’s clinical development team has the capabilities and expertise to ensure that our clinical research is conducted with the highest ethical, regulatory, and scientific standards. 

Phases of clinical trials 

Phase 2 trials are larger trials that collect more safety and tolerability data, as well as data on initial efficacy of the vaccine candidate in preventing the disease in people at risk of developing it.  

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We protect the rights and welfare of volunteers

Volunteers are the foundation of IAVI’s clinical trials: we and our partners are committed to protecting their rights, dignity, confidentiality, health, and welfare. 

We and our partners coordinate with communities to educate volunteers about vaccine research. We rely on counsel from Community Advisory Boards (CABs) — groups of community representatives that advise on IAVI’s clinical research trials. CABs ensure that the interests and concerns of the community and participant population are considered throughout the research process. They also provide input on trial design, recruitment, and retention procedures and the language used in the informed consent process. 

To protect the health of volunteers enrolled in IAVI’s clinical trials, clinical trial staff provide participants with basic health services, which may include voluntary HIV counseling and testing, basic physical examinations, and family planning counseling. Should the need arise, clinical trial staff make referrals for HIV treatment or more complex medical problems.

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Working with vulnerable populations

IAVI and partners develop and implement procedures for working with vulnerable populations such as pregnant women, children and adolescents, men who have sex with men, sex workers, and transgender people in a manner that maximizes safety and minimizes the difficulties and social risks associated with participating in vaccine research. 

Standards we follow

IAVI’s clinical research is informed by standard local, national, and international sources, including: 

We provide resources to those conducting clinical research

The IAVI Vaccine Literacy Library is a resource designed for people and communities involved in clinical research. It may be used for recruitment of trial participants and to engage communities and other stakeholders to build understanding of and support for clinical trials and eventual use of new vaccines. It may also be used as reference information for training workshops and to help those developing educational materials related to clinical research.   

Our pipeline

To learn more about IAVI products currently being evaluated in clinical trials, see our pipeline.

Our clinical research center partners

IAVI works with clinical research centers (CRCs) and contract research organizations to help implement clinical trials.

Learn more about our African and Indian CRC partners:

Enrolling in IAVI-sponsored clinical trials

We thank you for being interested in participating in IAVI’s clinical research. Visit ClinicalTrials.gov to learn which IAVI-sponsored clinical trials are enrolling volunteers and how you can contact researchers.