NBA approves HIV prevention Vaccine Trial
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By Derrick Sinjela
NBA CEO (m) with SAC Chairperson Dr Patrick Chikoti (l) and SAC vice chairperson Dr Evans Kaimoyo (r)
THE National Biosafety Authority (NBA) has approved a second HIV vaccine clinical trial in Lusaka and Ndola at phase two for the prevention of HIV-1 infection in women involving 500 participants to be conducted by the Centre for Infectious Disease Research in Zambia (CIDRZ) and the Zambia Emory HIV Research Project (ZEHRP).
Last year, NBA approved one research trial involving HIV vaccine presented by CIDRZ on the safety and immunogenicity of HVTN 120/ALVAC which is being conducted in Lusaka) and a Malaria research involving use of modified bacteria to control malaria (by Macha Research Trust, which is still at confined stage, in Choma).
The NBA Board met on Friday11th May 2018 to approve the CIDRZ and ZEHRP controlled phase 2B clinical research trial lasting over a period of three years,” read a Media Statement circulated by NBA Communications Officer Sandra Lombe-Mulowa.
“The study will enroll 2600 healthy, HIV -1 uninfected female volunteers aged between 18- 35 years across sites in Zambia, South Africa, Mozambique, Zimbabwe and Malawi. Zambia will have three sites, two in Lusaka (Matero clinic and ZEHRP Lusaka) and one in Ndola (ZEHRP),” NBA Chief Executive Officer (CEO) Lackson Tonga.
NBA CEO MR LACKSON TONGA
NBA CEO MR LACKSON TONGA
The Scientific Advisory Committee (SAC) of the NBA made a recommendation to the NBA Board to consider the approval of the new HIV trials after a risk assessment was done on the genetic modifications involving the transformation of the organism and the applicants meeting the required set standards.
Mr. Tonga said the trial will involve the release of a heterologous prime/ boost vaccine regime for the HVTN 705/ALVAC, a phase 2b clinical trial to evaluate the efficacy of the genetically modified vaccine in healthy HIV- 1 uninfected female participants.
The Scientific Advisory Committee (SAC) considered the CIDRZ/ZEHRP application to conduct research on HIV vaccine. The committee was satisfied after further reviewing the application and found it to have met the expected safety threshold and other requirements from collaborating partners such as Zambia Medicines Regulatory Authority, National Health Research Authority (NHRA) and the relevant ethics committees.
NBA was established under the Biosafety Act No. 10 of 2007.
NBA establishes and maintains a database of GMOs and their products as well as making available such information to the public.
