Abstract
BackgroundA prime-boost vaccination regimen with ALVAC-HIV (vCP1521) administered intramuscularly at 0, 4, 12, and 24 weeks and gp120 AIDSVAX B/E at 12 and 24 weeks demonstrated modest efficacy of 31.2% for prevention of HIV acquisition in HIV-uninfected adults participating in a community-based efficacy trial in Thailand.Methodology/Principal FindingsReactogenicity was recorded for 3 days following vaccination. Adverse events were monitored every 6 months for 3.5 years, during which pregnancy outcomes were recorded. Of the 16,402 volunteers, 69% of the participants reported an adverse event any time after the first dose. Only 32.9% experienced an AE within 30 days following any vaccination. Overall adverse event rates and attribution of relatedness did not differ between groups. The frequency of serious adverse events was similar in vaccine (14.3%) and placebo (14.9%) recipients (p = 0.33). None of the 160 deaths (85 in vaccine and 75 in placebo recipients, p = 0.43) was assessed as related to vaccine. The most common cause of death was trauma or traffic accident. Approximately 30% of female participants reported a pregnancy during the study. Abnormal pregnancy outcomes were experienced in 17.1% of vaccine and 14.6% (p = 0.13) of placebo recipients. When the conception occurred within 3 months (estimated) of a vaccination, the majority of these abnormal outcomes were spontaneous or elective abortions among 22.2% and 15.3% of vaccine and placebo pregnant recipients, respectively (p = 0.08). Local reactions occurred in 88.0% of vaccine and 61.0% of placebo recipients (p<0.001) and were more frequent after ALVAC-HIV than AIDSVAX B/E vaccination. Systemic reactions were more frequent in vaccine than placebo recipients (77.2% vs. 59.8%, p<0.001). Local and systemic reactions were mostly mild to moderate, resolving within 3 days.Conclusions/SignificanceThe ALVAC-HIV and AIDSVAX B/E vaccine regimen was found to be safe, well tolerated and suitable for potential large-scale use in Thailand.Trial Registration ClinicalTrials.gov NCT00223080
Highlights
HIV/AIDS has emerged as a worldwide public health threat and is associated with high morbidity and mortality
This paper presents the safety and tolerability profile of ALVAC-HIV and AIDSVAX B/E in 16,402 volunteers participating in the RV144 Thai Phase III HIV vaccine study
Interventions RV144 was a community-based, multicenter, randomized, double blind, placebo-controlled efficacy trial of the recombinant canarypox vector vaccine ALVAC-HIV and recombinant gp120 AIDSVAX B/E administered in a prime-boost vaccination regimen [45]
Summary
HIV/AIDS has emerged as a worldwide public health threat and is associated with high morbidity and mortality. In Thailand, 14,000 new HIV infections occur each year despite the considerable efforts and success in controlling the HIV epidemic [2,3]. The development of a safe, effective, administered and inexpensive AIDS vaccine is desperately needed worldwide, and the Thai Ministry of Public Health has long recognized that need and has strongly supported HIV vaccine research in Thailand [6,7]. A prime-boost vaccination regimen with ALVAC-HIV (vCP1521) administered intramuscularly at 0, 4, 12, and 24 weeks and gp120 AIDSVAX B/E at 12 and 24 weeks demonstrated modest efficacy of 31.2% for prevention of HIV acquisition in HIV-uninfected adults participating in a community-based efficacy trial in Thailand
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