Botswana stops HIV vaccine trial

With a staggering 40 percent of the adult population infected with the HIV virus, the country of just over 1,7 million inhabitants, is facing a bigger challenge in its fight to contain the killer disease. The Botswana-Harvard Partnership has announced that the organisation has discontinued vaccinations in the Phase 1 HIV Vaccine Trial, known as HVTN 059. Project director of the Botswana-Harvard Partnership Joseph Makhema said in a statement the audits are taken periodically and the company that manufactures the study product called AVX101 had “documentation irregularities” in a totally different product to the study vaccine. He said the discontinuation was not due to the purity or safety of the drug AVX101. Makhema said that a warning letter from the United States Federal Drug Administration (FDA) was issued to the manufacturers and the sponsors of the study vaccine were alerted. The US National Institute of Health’s Division of Acquired Immunodeficiency Syndrome (DAIDS), which funds the trial, ordered an audit to review issues raised in the FDA warning letter. Makhema emphasised that there were no safety concerns with the study product itself and that there were no adverse effects on participants. However, there was extreme caution by the sponsor to stop vaccinations. Makhema would not disclose the name of the manufacturing company. The study began enrolling HIV negative volunteers in the US in October 2004 and in Botswana and South Africa in May 2005. Makhema said the study was completed in the US. He said the study has not been stopped, as the 10 participants would be followed for a year for assessments of safety and immune responses. The purpose of the trial was to evaluate the safety and tolerability of the study vaccine. Participants have been notified of the discontinuation of vaccinations including institutional review boards as well as other stakeholders. Makhema said the country would be on the lookout for the most efficacious vaccine. He said they would be conducting another trial in the not so distant future. Meanwhile, Southern African veterinary officials met in Botswana this week to discuss strategies of combating trans-boundary animal diseases (TADs) in the region. The annual meeting of the Southern African Development Community (SADC) Livestock Technical Committee coincided with reports of an outbreak of the foot-and-mouth disease (FMD) in northern Botswana. Director of Animal Health in the Ministry of Agriculture Musa Fanikiso said the FMD outbreak formed part of the agenda. “We have given our counterparts a verbal report on the outbreak,” said Fanikiso. “This is a normal annual meeting, it just happened that Botswana is hosting the meeting at a time when we have an FMD outbreak,” he said. The meeting discussed TADs such as avian flu and FMD and the role of individual countries in combating TADs was also outlined. Boventure Mtei, the sub-regional representative with the World Organisation on Animal Health, told the Mmegi newspaper that Zimbabwe ‘ where the FMD outbreak is suspected to have originated ‘ was not on the agenda. “Zimbabwe is doing its best to control FMD,” Mtei said, stressing that regional partners had a responsibility to help nations without the capacity to address TADs. He said as Botswana grapples with FMD, there was no need to point fingers at Zimbabwe. While claiming that Zimbabwe has FMD, he denied suggestions that the country might be the source of the FMD, which was discovered late last month in the Bobirwa area. He said there was no scientific evidence to link Zimbabwe to the current outbreak and suspected that buffaloes could have been responsible. “Let us point fingers at the buffaloes,” he said. Zimbabwean authorities have, however, denied the existence of FMD in their country at the moment although they have in the past suffered from spontaneous outbreaks of the disease. FMD broke out last month in Bobirwa, which is a mere 30km from Zimbabwe and 70km from South Africa, posing a threat to regional food security and economic activity. FMD outbreaks have seriously affected the Southern African cattle industry in the past. Botswana lost over US$37 million (199,9 million pula) in export revenue in 2002 alone, while Zimbabwe has lost US$50 million (P270 million) annually since 2001. With Botswana’s recent imposition of a voluntary ban on European Union (EU) cattle exports since lab tests confirmed FMD-infected cattle on April 20, pressure is high on government officials to address the outbreak immediately. However, these efforts were complicated by the easy transmission of FMD across national borders. There is no legal consequence for failing to report an outbreak, and even the FMD fence between Botswana and Zimbabwe is not always effective in restricting infected livestock. Mtei praised Botswana’s response to FMD but acknowledged that some regional partners had less capacity to address the disease. As part of the efforts to increase regional FMD response capacity, SADC and the European Commission signed a 7,9 million euro (P53,72 million) financing agreement on January 28, 2004. The EU is also consulting to allocate up to eight million euro (P54,4 million) to support emergency responses in the SADC region.

May 2006
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