Publication: Safety and reactogenicity of canarypox ALVAC-HIV (vCP1521) and HIV-1 gp120 AIDSVAX B/E vaccination in an efficacy trial in Thailand
Issued Date
2011-12-21
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ISSN
19326203
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2-s2.0-83755174375
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Mahidol University
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SCOPUS
Bibliographic Citation
PLoS ONE. Vol.6, No.12 (2011)
Suggested Citation
Punnee Pitisuttithum, Supachai Rerks-Ngarm, Valai Bussaratid, Jittima Dhitavat, Wirach Maekanantawat, Swangjai Pungpak, Pravan Suntharasamai, Sirivan Vanijanonta, Sorachai Nitayapan, Jaranit Kaewkungwal, Michael Benenson, Patricia Morgan, Robert J. O'Connell, Jeffrey Berenberg, Sanjay Gurunathan, Donald P. Francis, Robert Paris, Joseph Chiu, Donald Stablein, Nelson L. Michael, Jean Louis Excler, Merlin L. Robb, Jerome H. Kim Safety and reactogenicity of canarypox ALVAC-HIV (vCP1521) and HIV-1 gp120 AIDSVAX B/E vaccination in an efficacy trial in Thailand. PLoS ONE. Vol.6, No.12 (2011). doi:10.1371/journal.pone.0027837 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/11214
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Title
Safety and reactogenicity of canarypox ALVAC-HIV (vCP1521) and HIV-1 gp120 AIDSVAX B/E vaccination in an efficacy trial in Thailand
Author(s)
Punnee Pitisuttithum
Supachai Rerks-Ngarm
Valai Bussaratid
Jittima Dhitavat
Wirach Maekanantawat
Swangjai Pungpak
Pravan Suntharasamai
Sirivan Vanijanonta
Sorachai Nitayapan
Jaranit Kaewkungwal
Michael Benenson
Patricia Morgan
Robert J. O'Connell
Jeffrey Berenberg
Sanjay Gurunathan
Donald P. Francis
Robert Paris
Joseph Chiu
Donald Stablein
Nelson L. Michael
Jean Louis Excler
Merlin L. Robb
Jerome H. Kim
Supachai Rerks-Ngarm
Valai Bussaratid
Jittima Dhitavat
Wirach Maekanantawat
Swangjai Pungpak
Pravan Suntharasamai
Sirivan Vanijanonta
Sorachai Nitayapan
Jaranit Kaewkungwal
Michael Benenson
Patricia Morgan
Robert J. O'Connell
Jeffrey Berenberg
Sanjay Gurunathan
Donald P. Francis
Robert Paris
Joseph Chiu
Donald Stablein
Nelson L. Michael
Jean Louis Excler
Merlin L. Robb
Jerome H. Kim
Other Contributor(s)
Mahidol University
Thailand Ministry of Public Health
Armed Forces Research Institute of Medical Sciences, Thailand
Walter Reed Army Institute of Research
Tripler Regional Med Center
Global Solutions for Infectious Diseases
Walter Reed National Military Medical Center
National Institute of Allergy and Infectious Diseases
The EMMES Corporation
Thailand Ministry of Public Health
Armed Forces Research Institute of Medical Sciences, Thailand
Walter Reed Army Institute of Research
Tripler Regional Med Center
Global Solutions for Infectious Diseases
Walter Reed National Military Medical Center
National Institute of Allergy and Infectious Diseases
The EMMES Corporation
Abstract
Background: 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. Methodology/Principal Findings: Reactogenicity 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/Significance: The 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 © 2011 Pitisuttithum et al.