By: Dr. Kathy Mngadi (eThekwini CRS) and Dr. Susan Buchbinder (Bridge HIV CRS), with contributions from the HVTN 705 Protocol Team
HVTN 705/HPX2008 is a collaboration between the HVTN and Janssen Pharmaceuticals, designed to test an HIV preventive vaccine regimen that covers the different types of HIV found across the world.
The study is planned to start in November 2017 across approximately 26 sites in 5 countries in sub-Saharan Africa: South Africa, Zimbabwe, Mozambique, Malawi and Zambia.
The name “Imbokodo” has been chosen; this is an isiZulu word that means “rock” and comes from a popular African proverb which says, “Wathint’ Abafazi, Wathint’ Imbokodo!” (“You Strike the Women, You Strike the Rock!”).
This proverb was made famous by a resistance song symbolising the courage and strength expressed by women in African societies. Women in Africa are seen as the foundations of life as symbolized by huge strong rocks!
The protocol was distributed to all the sites in February 2017, and has already been submitted for approvals to some country regulatory bodies and sites’ ethics committees. The study logo has been finalized, and training of community education and recruitment staff took place in Johannesburg from 5th to 7th June 2017, followed by a stakeholder meeting on 08th and 09th June 2017.
The study is expected to enrol a total of 2600 women between the ages of 18 to 35 years, in recognition of the disproportionate burden of HIV that women in these countries face in comparison to men of the same age group. Enrolment is expected to take up to 14 months with sites starting in a staggered fashion through November 2018. Volunteers will be recruited by outreach teams in the communities in which sites are located and adjacent areas if needed, using a variety of educational, awareness and outreach activities. Research staff will assess potential participants at the sites to ensure they are healthy enough and they meet the study criteria for participating. All volunteers must be HIV uninfected, non-pregnant and be willing to adhere to the study visit schedule.
Each participant will be followed up for between 24 and 36 months (2-3 years), receiving 6 injections over a 12-month period. They will get one injection at enrolment and the third month, and two injections each at months 6 and 12. During follow-up participants will be closely monitored by the research team to ensure their safety and well-being. Vaccines prevent infection by teaching the immune system (the body’s defence system) to recognise and fight HIV, and antibodies to HIV are important in this fight. Although only one vaccine so far has shown some protection (Thai Trial or RV144 ), almost all vaccines tested have resulted in antibodies forming, but they have not been protective. Current rapid HIV fingerprick tests used in government and other clinics work by detecting antibodies to HIV, so people who have antibodies from a vaccine may be misunderstood to be infected. Special tests are done at the research clinic, that can tell the difference between actual HIV infection and VISP. Study participants will be provided with regular HIV testing during the study which will distinguish actual infection and a vaccine reaction. For participants who have VISP at the end of the study, these special tests will be made available for as long as they are needed, even when the study ends or a person moves away from a site. This will ensure that participants are not negatively impacted by VISP following the study closure.
This exciting, ground-breaking study has been in planning for many years, with Janssen testing several components of the vaccine regimen in previous studies to ensure that they are safe and get a response from the immune system. This study will add valuable information to the vaccine research field, and needs strong community support to be conducted successfully at all research sites.
TOGETHER WE CAN END HIV!!
For more information about this study, please go to: www.imbokodo.org.za
* Dr. Kathy Mngadi is the Principal Investigator for the ethekwini CRS in Durban, South Africa and is Co-Chair for the Imbokodo Study; Dr. Susan Buchbinder is the Principal Investigator and Director of the Bridge HIV CRS in San Francisco, CA, USA, and is Co-Chair for the Imbokodo Study.