In October 2012, the Institute of Immunobiologic Technology (Bio-Manguinhos/Fiocruz), through its Clinical Department, the responsible area for planning and carrying out studies on humans using products developed in-house or using technology transfer, has signed a new contract with Fiotec. The purpose is to manage and execute clinical research projects which focus on meningitis B and C and MMR vaccines, on reagents for the diagnosis of syphilis, on microtiter multitests and on the biodrug epoetin alfa. This new partnership will result in more efficient and effective supply of products and services by Bio-Manguinhos as a response to the demands of public health.

One of the goals is to develop a vaccine against meningitis B, the first result of a 100% Brazilian initiative to be produced by Bio-Manguinhos. The study is currently between phases II and III, consisting in selecting the best concentration of the vaccine in order to request product registration, after which the vaccine will be offered to the National Vaccination Program (PNI in Portuguese) of the Ministry of Health.

Developing a vaccine against meningitis C is another goal. The formulation of this vaccine is currently undergoing improvements and a clinical trial will soon begin in public health units in Rio de Janeiro and Belém (in the northern state of Pará), with about 2,000 volunteers between 2 and 19 years old. The vaccine will also be offered to the Ministry of Health, with a differential: it will be extended to a wider age group than the vaccine currently available on the market.

The MMR vaccine (measles, mumps and rubella) is a transfer of technology from the GlaxoSmithKline (GSK) private laboratory, which is currently being concluded. The clinical trial which aims to evaluate the immunogenicity and reactogenicity of the MMR vaccine produced entirely by Bio-Manguinhos, as well as the consistency of the production batches, is scheduled to begin on the third trimester of this year. The study will be carried out in Belém, in four health units (Unidade do Marco, Jurunas, Marambaia and Guampa), with about 1,560 volunteers (aged 2 to 15 months).

Project also intends to validate multitest kits

Another purpose of this project is the validation of quick test kits for the detection of syphilis. The study will start in the first quarter of this year and is expected to last for 12 months. Five thousand samples will be evaluated in five health centers in Rio de Janeiro. After validation the kit will be included in the STD/Aids program of the Ministry of Health.

Other studies to be carried out will evaluate the accuracy and reproducibility of the multitest kit based on the fluid microtiter platform, on the serological triage of infections by HIV-I and HVI-II, HTLV-I and HTLV-II, HBV, HCV, Treponema pallidum and Trypanosoma cruzi in blood donors. There will be 40 thousand samples of candidates to blood donation, collected in blood centers in Brazil. The project is scheduled to begin in the second quarter of 2013. The reagent will also be included in the STD/Aids program of the Ministry of Health.

Biodrug

Thanks to a technology transfer from the Center of Molecular Immunology of Cuba (CIM), since 2006 Bio-Manguinhos has manufactured and supplied epoetin alfa (EPO) to the Program of Exceptional Medications of the Ministry of Health. This medication is currently the most commonly used treatment of anemia in patients with chronic kidney failure.

As requested by regulatory entities, the unit will carry out an active surveillance study for the identification of adverse events, therefore evaluating the safety of the EPO manufactured by Bio-Manguinhos. This study will be carried out on adult patients with chronic kidney failure, in hemodialysis and taking this drug, which is distributed by the Ministry of Health.