HIV vaccine trial, which was being conducted worldwide including Malawi, has been halted after Data Safety Monitoring Board (DSMB), the body that was responsible for the monitoring the progress of the project, discovered that the vaccine was not effective. John Hopkins Project, an institution responsible for the project in Malawi confirmed.
John Hopkins Project Director Dr Newton Kumwenda said DSMB met on September 18, 2007 to review results of the interim efficacy analysis they concluded that the study will not meet its efficacy objectives and recommended that trial being stopped.
On a report posted on September 21,2007 on Merck website—A United States of America pharmaceutical company that was producing the vaccine— announced that the vaccine did not meet its objective and failed to prevent infection.
However, Dr Kumwenda said the latest findings of the vaccine efficacy failure would not affect Malawi participants as the institution did not enroll new volunteers for more than 2 years.
About eight Malawians were injected with a vaccine, HVTN 050, Merck V20-018 vaccine—that contains three HIV genes—in a Phase I, whose objective was to establish the safety and immunogenecity of the vaccine.
“The HIV Vaccine trial being conducted in Malawi is a Phase I safety and immunogenecity trial. The HIV vaccine candidates although similar, the two trials are different.
“Although the data for this finding is specifically from the STEP V520-023 trial , all study sites involved in similar Merck/HVTN vaccine program are advised to cease administering trial vaccine but to continue all other study follow-up procedures,” he said.
JHP spokesperson Fatima Zulu said the organization will continue monitoring the health of the eight Malawian participants as per agreements until the time that was agreed upon expires.
“We will continue monitoring them because we know that some of the side effects would take a long time to come out,” she said.
On Merck website, however, the company indicated that volunteers who had received at least two vaccinations and who were HIV negative for at least the first 12 weeks of the trial, 19 cases of HIV infection were observed in the 672 volunteers who received vaccine and 11 cases were observed in the 691 volunteers who received placebo.
"In addition, the vaccine did not reduce the amount of virus in the bloodstream of those who became infected; HIV RNA levels approximately 8 to 12 weeks after diagnosis of infection were similar in the vaccine and the placebo arms. The geometric means of the HIV RNA levels in the blood of infected individuals, the standard measure of ongoing HIV replication, were approximately 40,000 copies/mL in the vaccine group and approximately 37,000 copies/mL in the placebo group,” the website said.
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