Statistics Collaborative, Inc. (SCI) has played an integral role in the development and design of numerous studies of tropical diseases, including malaria, dengue fever, leishmaniasis, and leprosy. Malaria, dengue fever, and leishmaniasis are unusual among illnesses in the world of clinical trials for being parasitic infections transmitted by insects rather than by viruses or bacteria.
SCI has assisted with the design and analysis for several randomized Phase 1 and 2 clinical and field trials evaluating the safety, immunogenicity, and efficacy of single and multivalent vaccines and prophylactic treatments. We have also designed and analyzed observational, epidemiological studies in malaria. We have spent considerable time at field sites in sub-Saharan Africa and the Far East, as well as at clinical sites in the United States, where we have helped design trials, implement randomization procedures, develop study-specific case report forms, and establish data management systems.
SCI offers expertise in the unique design issues posed by challenge trials and field trials. In a challenge trial, investigators deliberately infect volunteers (who have signed detailed informed-consent forms) with the disease of interest. A field trial is a study conducted in an area where disease is endemic.
Examples of SCI’s work in tropical disease:
- P. falciparum malaria: SCI assumed leadership in the design and analysis of Phase 1 and 2 field trials in sub-Saharan Africa that evaluated the safety and efficacy of a blood-stage vaccine. Efficacy analyses assessed not only whether the vaccine delayed the onset of clinical malaria, but also whether the vaccine reduced the number of episodes of malaria that each person experienced over the duration of the trial.
- P. vivax and P. falciparum malaria: SCI was involved in the analysis of several clinical trials evaluating the sensitivity and specificity of a device for rapid diagnosis of malaria.
- Dengue fever: SCI prepared the final analysis of a Phase 1 study for the United States Army comparing a tetravalent dengue vaccine to four different monovalent dengue vaccines produced by Aventis Pasteur Limited. We designed and programmed patient profile plots displaying reactogenicity events over time that allowed the sponsors to compare the safety data from the five vaccine arms.
Examples of publications for trials with which SCI was involved:
- Ogutu BR, Apollo OJ, McKinney D, Okoth W, Siangla J, Dubovsky F, Tucker K, Waitumbi JN, Diggs C, Wittes J, Malkin E, Leach A, Soisson LA, Milman JB, Otieno L, Holland CA, Polhemus M, Remich SA, Ockenhouse CF, Cohen J, Ballou WR, Martin SK, Angov E, Stewart VA, Lyon JA, Heppner DG, Withers MR. Blood stage malaria vaccine eliciting high antigen-specific antibody concentrations confers no protection to young children in Western Kenya. PLoS ONE 2009; 4:e4708.
- Heppner DG, Jr., Kester KE, Ockenhouse CF, Tornieporth N, Ofori O, Lyon JA, Stewart VA, Dubois P, Lanar DE, Krzych U, Moris P, Angov E, Cummings JF, Leach A, Hall BT, Dutta S, Schwenk R, Hillier C, Barbosa A, Ware LA, Nair L, Darko CA, Withers MR, Ogutu B, Polhemus ME, Fukuda M, Pichyangkul S, Gettyacamin M, Diggs C, Soisson L, Milman J, Dubois MC, Garcon N, Tucker K, Wittes J, Plowe CV, Thera MA, Duombo OK, Pau MG, Goudsmit J, Ballou WR, Cohen J. Towards an RTS,S-based, multi-stage, multi-antigen vaccine against falciparum malaria: progress at the Walter Reed Army Institute of Research. Vaccine 2005; 23:2243-2250.
- Kanesa-thasan N, Sun W, Kim-Ahn G, Van Albert S, Putnak J, King A, Raengsakulsrach B, Christ-Schmidt H, Gilson K, Zahradnik J, Vaughn D, Innis B, Saluzzo J, Hoke CJ. Safety and immunogenicity of attenuated dengue virus vaccines (Aventis Pasteur) in human volunteers. Vaccine 2001; 19:3170-3188.