Mwanza Intervention Trials Unit (MITU) has launched a new trial of human papilloma virus (HPV) vaccine (“Add-Vacc Trial”).  HPV vaccination has been included within the Tanzania national vaccination programme since 2018 and is delivered to girls around 14 years of age to protect them from cervical cancer. Apart from being the main cause of cervical cancer, HPV virus also causes other health problems including anogenital warts and other less common forms of cancer, such as penile cancer, anal cancer and throat cancer.

Staged consent process

Over the course of three years, the Add-Vacc trial will investigate the benefits of adding male vaccination to the existing national programme of female HPV vaccination in Tanzania. A number of countries have begun vaccinating boys in addition to girls – known as gender neutral vaccination. Vaccinating males can protect them from health problems caused by HPV virus infection while at the same time preventing them from passing the virus on to their unvaccinated female partners. This could help reduce the amount of HPV infection and associated health problems in the community.

Country side where the trial will take place

Twenty-six communities will be randomly assigned to receive either the intervention (male HPV vaccination plus female vaccination as part of the ongoing national vaccination programme) or the control condition (only female vaccination as part of the ongoing national vaccination programme). A single dose of male HPV vaccination will be provided to males 14-18 years of age. Two household surveys will be conducted – one before male vaccination is implemented and another one three years later, to assess whether this added vaccination reduces the amount of HPV infection present in the communities. Social science research will be conducted as part of this trial to help the research team to better understand community knowledge and perceptions of HPV vaccination.

Dr. Victoria Ewing who is coordinating the implementation of this trial said, “This trial is important because giving a single dose of HPV vaccine to males might provide a simple and cost-effective way to reduce the amount of HPV infection in the community. We are excited to be the first to conduct a trial of HPV vaccination in boys in sub-Saharan Africa.”

This trial is led by Prof. Debby Watson-Jones and Dr. Kathy Baisley from the London School of Hygiene & Tropical Medicine, and John Changalucha from MITU.