Dr.Kelvin Jerry Wandera is an experienced Associate Clinical Research Pharmacist with a strong background in clinical trials, currently working at the Kenya Impact Research and Development Organization Clinical Research Site at Kisumu, Kenya. He possesses over 12 years of practical experience in the field of clinical trials that brings a wealth of knowledge and expertise to his role. Before joining the Kenya Impact Research & Development Organization, Dr. Kelvin held a significant position as a lead pharmacy staff member at the Kenya Medical Research Institute (KEMRI) on various clinical trial protocols.
Dr. Kelvin has a hands-on experience in clinical trials and in his career, has been involved in various clinical trials focused on HIV, Tuberculosis, Malaria and COVID-19. He has worked in clinical trials from Division of AIDS (DAIDS), Aids Clinical Trial Group (ACTG), HIV Prevention Trial Network (HPTN), Microbicide Trial Network (MTN), CONRAD, Tuberculosis Trials Consortium (TBTC) networks.
He also has done industry led clinical trials from Sanofi Avensis France, Zvera India, GSK, Viiv Health and Merk. He possesses specialized knowledge in the submission of investigational drug importation dossiers and the customs clearance process. He has trial expertise in both industry and investigator-led clinical trials, pharmacokinetic and oncology based studies. In addition to his practical experience, he has undergone training in numerous areas related to clinical research including Good Clinical Practice, Protecting Human Research Participants, Aseptic technique, Clinical Trial Data Management, Risk Management in Clinical Trials, US FDA inspections in clinical trials and logistics for health commodities. His commitment to continuous learning and professional development enables him to stay up to date with the latest advancements in the field of clinical trials. Dr. Kelvin is looking forward to clinical trial research networking, academic and professional development.
Education
- Drug Development CaSE Matrix
- Bachelor of Pharmacy
- Bachelor of Development Studies
- Diploma in Pharmacy
Clinical Trials Participated/ study Protocols Executed
- Solidarity Trial Vaccines, An International Randomized Trial of Candidate Vaccines Against COVID-19.
- ACTG, ACTIV-2/A5401 Adoptive Platform Treatment Trial for outpatients with COVID-19 (Adapt Out COVID).
- Safety and Immunogenicity Study of Full Schedule (3-Dose SHAN6™) or SHAN6™- SHAN 5®- SHAN6™ Versus the Licensed Vaccine SHAN 5® With bOPV and IPV When Administered Per National Immunization Schedule in Healthy Kenyan Infants.
- Phase IIa, 90-Day Safety, Adherence, and Acceptability Study of Intravaginal Rings Releasing Tenofovir with and without Levonorgestrel among Women in Western Kenya. (CONRAD Ring study).
- MTN-034/IPM 045, A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population.
- HPTN 084, A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women.
- ACTG/A5263/AMC066, A Randomized Comparison of Three Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings.
- HVTN703/HPTN 081, A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection
- ACTG/A5349, A Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial.
- Malaria Chemoprevention with monthly treatment with dihydroartemisinin-piperaquine for the post-discharge management of severe anemia in children aged less than 5 years in Uganda and Kenya.
- ACTG/A5338, An Open-Label, Non-Randomized Study of Pharmacokinetic Interactions Among Depot Medroxyprogesterone Acetate (DMPA), Rifampicin (RIF) and Efavirenz (EFV) in Women Co-Infected with Human Immunodeficiency Virus (HIV) and Tuberculosis (TB).
- ACTG/A5288, Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy after Viral Failure.
- ACTG A5279, Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Individuals with Latent Tuberculosis Infection.
- ACTG A5297, An Open-Label, Proof of Concept, Randomized Trial Comparing a LPV/r-Based to an nNRTI-Based Antiretroviral Therapy Regimen for Clearance of Plasmodium Falciparum Subclinical Parasitemia in HIV-infected Adults with CD4+ Counts >200 and <350 cells/mm.
- ACTG A5316, Evaluating pharmacokinetic effects of ART treatment with vaginal contraceptive ring Nuvaring ®
- TBTC Study 31X, An Evaluation of a Rifapentine-containing regimen for intensive phase treatment of pulmonary tuberculosis.