The MVA85A Vaccine Trial


 

Phase 2 Randomised Controlled trial to evaluate Safety and Immunogenicity of MVA85A AND Selective, delayed Bacille Calmette-Guerin (BCG) Vaccination in Infants of HIV Infected Mothers

 “The MVA85A Vaccine Trial”

We have completed enrolment on this study of a new TB vaccine, MVA85A, using a reverse prime boosting strategy, in HIV-exposed infants. We enrolled 144 babies born to HIV positive mothers. All babies were randomised to receive either MVA85A or placebo within four days of birth, followed by BCG vaccine at eight weeks if they tested HIV positive. All babies tested HIV negative at six weeks, although one has subsequently tested positive at the one year follow-up. Overall the mother-to-child transmission rate of HIV is very low at less than 1%.

The trial started at the end of 2012 and is scheduled to complete follow up in May 2015. Follow up of babies enrolled on the study is still ongoing, with 17 infants remaining on study. Study retention has been good at 89%, despite the marked mobility of our patient population between Khayelitsha and the Eastern Cape.

To date, 24 infants have undergone diagnostic workup for TB; 7 infants have been started on isoniazid preventive therapy (IPT) as a result of having a close infectious TB contact reported, and 4 children have been started on full TB therapy. One infant has been diagnosed with BCG peripheral lymphadenitis.

The clinical team has maintained good collaboration with local site personnel at Site B MOU and the UCT research team on-site (eKhayavac), and also excellent collaboration with the SATVI clinical and lab teams, as well as staff at Khayelitsha District Hospital.

A scientific dissemination planning meeting was held in November 2014 to plan the primary and secondary clinical and lab analyses, and dissemination strategies for the trial. During the next six months, we plan on completing clinical follow-up at both the DTTC and SATVI trial sites, completing data cleaning and extraction, and starting the immunological and clinical analyses.

Principal Investigator: Prof. Anneke Hesseling: annekeh@sun.ac.za