Background morbidity in HIV vaccine trial participants from various geographic regions as assessed by unsolicited adverse events.
BACKGROUND
Recently, more clinical trials are being conducted in Africa and Asia, therefore, background morbidity in the respective populations is of interest. Between 2000 and 2007, the International AIDS Vaccine Initiative sponsored 19 Phase 1 or 2A preventive HIV vaccine trials in the US, Europe, Sub-Saharan Africa and India, enrolling 900 healthy HIV-1 uninfected volunteers.


OBJECTIVE
To assess background morbidity as reflected by unsolicited adverse events (AEs), unrelated to study vaccine, reported in clinical trials from four continents.


METHODS
All but three clinical trials were double-blind, randomized, and placebo-controlled. Study procedures and data collection methods were standardized. The frequency and severity of AEs reported during the first year of the trials were analyzed. To avoid confounding by vaccine-related events, solicited reactogenicity and other AEs occurring within 28 d after any vaccination were excluded.


RESULTS
In total, 2134 AEs were reported by 76% of all participants; 73% of all events were mild. The rate of AEs did not differ between placebo and vaccine recipients. Overall, the percentage of participants with any AE was higher in Africa (83%) compared with Europe (71%), US (74%) and India (65%), while the percentage of participants with AEs of moderate or greater severity was similar in all regions except India. In all regions, the most frequently reported AEs were infectious diseases, followed by gastrointestinal disorders.


CONCLUSIONS
Despite some regional differences, in these healthy participants selected for low risk of HIV infection, background morbidity posed no obstacle to clinical trial conduct and interpretation. Data from controlled clinical trials of preventive interventions can offer valuable insights into the health of the eligible population.
International AIDS Vaccine Initiative, New York, NY, USA.
Claudia
C
Schmidt
Carol
C
Smith
Burc
B
Barin
Arash
A
Bakhtyari
Pierre-Alexandre
PA
Bart
Linda-Gail
LG
Bekker
Elwyn
E
Chomba
Nathan
N
Clumeck
David
D
Ho
Anwar
A
Hoosen
Walter
W
Jaoko
Pontiano
P
Kaleebu
Etienne
E
Karita
Michael C
MC
Keefer
Jan
J
van Lunzen
Andrew
A
McMichael
Sanjay
S
Mehendale
Barry
B
Peters
Vadakkuppatu D
VD
Ramanathan
Andrew
A
Robinson
Juergen
J
Rockstroh
Eftyhia
E
Vardas
Eva
E
Vets
Jonathan
J
Weber
Barney S
BS
Graham
Soe
S
Than
Jean-Louis
JL
Excler
Sonali
S
Kochhar
Martin
M
Ho
Alison
A
Heald
Patricia E
PE
Fast
D016915:AIDS Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D017954:Africa South of the Sahara / Q000453:epidemiology; D017281:Cost of Illness; D004311:Double-Blind Method; D005060:Europe / Q000453:epidemiology; D015658:HIV Infections / Q000517:prevention & control*; D006805:Human Experimentation; D006801:Humans; D007194:India / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D014481:United States / Q000453:epidemiology; D055815:Young Adult
D016915:AIDS Vaccines; D010919:Placebos