As First Phase of Kenyan Vaccine Trial Ends, ‘Key’ Scientist Resigns
Following the completion of the first sub-phase of a Kenyan test of a naked DNA HIV vaccine, Dr. Ephantus Njagi, a "key" trial physician trained to "particularly administer" the vaccine and monitor patient reaction, resigned, Kenya's Daily Nation reports. In two weeks, after completion of the first stage, involving 18 volunteers who experienced "no serious side effects," the vaccine trial is supposed to move into the second stage, which will test the safety and production of killer T-cells produced in response to the vaccine. Three additional volunteers have been recruited for the second phase. Njagi's departure has raised "new worries" over the trials, although Program Manager Dr. Omu Anzala "insist[ed]" that the trials will proceed as planned. "I am now doing what is necessary, as I have always been there as a back-up to Dr. Njagi. As a program manager, I am supposed to be on top of everything. We are however going to train someone else to perform his job," Anzala added. Observers said that if the study was a double blind trial, in which neither the clinical staff nor the patients know which patients receive the vaccine and which receive a placebo, it may be "unethical" for another researcher to take Njagi's place.
What Sparked the Resignation?
Njagi declined to comment on his reasons for leaving the trial, but observers speculated that it may have something to do with "interference" by the International AIDS Vaccine Initiative, which some claim is acting as both "financier and implementer" of the trials, a potential conflict of interest. Sources say IAVI has "attached" someone to the study site at Kenyatta National Hospital and that person is "tak[ing] part" in the study. Sources also speculate that "professional differences and a lack of administrative support" from the Kenyan AIDS Vaccine Initiative could be to blame for Njagi's departure.
'Impressive' Number of Volunteers
Researchers at the trial site are "upbeat" about volunteer turnout, which Anzala described as "extremely impressive." Because of a "patent tussle" prior to the beginning of the trials, researchers were "apprehensive" that potential volunteers would "recoil," Anzala said, adding "emphatic[ally]" that no money was used to entice volunteers to take part in the study, as the only funds provided to volunteers were for transportation. Results of the first phase are not yet ready because volunteers must be checked eight times over 189 days. Results are expected by the end of the year (Okwemba, Kenyan Daily Nation, 5/24).