In collaboration with the Tanzania National Institute for Medical Research (NIMR) and London School of Hygiene and Tropical Medicine (LSHTM)

A phase IIIB, double-blind, randomized, controlled, multicentre study to assess the immunogenicity and safety of glaxosmithkline biologicals HPV-16/18 L1 AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 months) in...

Principal Investigators: John Changalucha, Deborah Watson-Jones

Project Coordinators: Basil Baltazar, Joelle Brown

Funding: GlaxoSmithKline Biologicals

Study staff preparing to take blood sample.

Study team group picture.

Summary: Cervical cancer is the second most common cancer among women worldwide. Up to 70% of cervical cancer cases are attributable to human papillomavirus (HPV) genotypes 16 and 18. Two prophylactic HPV vaccines are now available that have high efficacy against incident and persistent HPV-16/18 infections and associated cytological abnormalities. However, HPV vaccines have not yet been tested in Africa. Two sites in Africa, Mwanza in Tanzania and Dakar in Senegal, are participating in a multicentre immunogenicity and safety trial of GSK Biologicals’ bivalent HPV vaccine in young girls.

Objectives: The primary objectives of the trial are to evaluate antibody response against HPV-16 and HPV-18 at Month 7 in participants aged 15-25 years and also among those aged 10-14 years. The secondary objectives are to evaluate antibody responses against HPV-16 and HPV-18 in all participants at Month 2 and Month 12, and to evaluate the safety and reactogenicity of the study vaccine in all participants throughout the entire study period. Additional epidemiological studies are nested within the Mwanza cohort to determine risk factors for prevalence and incidence of HPV, HIV and other sexually transmitted infections; and to determine whether the presence and/or burden of parasitic infections and prior HPV infection influence the vaccine response.

Progress: 334 subjects have been enrolled from schools, colleges and family planning clinics in selected wards in Mwanza City and randomised in a 2:1 ratio into a HPV-16/18 L1 AS04 vaccine group or a control group. Enrolled subjects received three doses of vaccine or placebo at day 0, month 1 and month 6. The duration of follow-up is 12 months per participant. During the follow-up period, samples were taken to measure the immune response for HPV 16 and 18 and data were collected on adverse events, HIV/STI prevalence, including HPV at cohort screening and HPV incidence at 12 months, as well as risk factors associated with acquiring these infections. Follow-up ended in July 2010 and results were presented in 2011.