Safety and reactogenicity of canarypox ALVAC-HIV (vCP1521) and HIV-1 gp120 AIDSVAX B/E vaccination in an efficacy trial in Thailand.
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.


RESULTS
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
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.


BACKGROUND
ClinicalTrials.govNCT00223080.
Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. tmppt@mahidol.ac.th
Punnee
P
Pitisuttithum
Supachai
S
Rerks-Ngarm
Valai
V
Bussaratid
Jittima
J
Dhitavat
Wirach
W
Maekanantawat
Swangjai
S
Pungpak
Pravan
P
Suntharasamai
Sirivan
S
Vanijanonta
Sorachai
S
Nitayapan
Jaranit
J
Kaewkungwal
Michael
M
Benenson
Patricia
P
Morgan
Robert J
RJ
O'Connell
Jeffrey
J
Berenberg
Sanjay
S
Gurunathan
Donald P
DP
Francis
Robert
R
Paris
Joseph
J
Chiu
Donald
D
Stablein
Nelson L
NL
Michael
Jean-Louis
JL
Excler
Merlin L
ML
Robb
Jerome H
JH
Kim
D016915:AIDS Vaccines / Q000009:adverse effects* / Q000276:immunology*; D000293:Adolescent; D000328:Adult; D005260:Female; D015699:HIV Envelope Protein gp120 / Q000009:adverse effects / Q000276:immunology*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary / Q000009:adverse effects*; D008297:Male; D011247:Pregnancy; D011256:Pregnancy Outcome; D012449:Safety; D013785:Thailand; D014611:Vaccination / Q000009:adverse effects*; D055815:Young Adult
D016915:AIDS Vaccines; D015699:HIV Envelope Protein gp120; C514793:gp120 protein, Human immunodeficiency virus 1