PMID- 22634443
OWN - NLM
STAT- MEDLINE
DCOM- 20130109
LR  - 20141009
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Linking)
VI  - 8
IP  - 5
DP  - 2012 May
TI  - Background morbidity in HIV vaccine trial participants from various geographic 
      regions as assessed by unsolicited adverse events.
PG  - 630-8
LID - 10.4161/hv.19454 [doi]
AB  - 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.
FAU - Schmidt, Claudia
AU  - Schmidt C
AD  - International AIDS Vaccine Initiative, New York, NY, USA.
FAU - Smith, Carol
AU  - Smith C
FAU - Barin, Burc
AU  - Barin B
FAU - Bakhtyari, Arash
AU  - Bakhtyari A
FAU - Bart, Pierre-Alexandre
AU  - Bart PA
FAU - Bekker, Linda-Gail
AU  - Bekker LG
FAU - Chomba, Elwyn
AU  - Chomba E
FAU - Clumeck, Nathan
AU  - Clumeck N
FAU - Ho, David
AU  - Ho D
FAU - Hoosen, Anwar
AU  - Hoosen A
FAU - Jaoko, Walter
AU  - Jaoko W
FAU - Kaleebu, Pontiano
AU  - Kaleebu P
FAU - Karita, Etienne
AU  - Karita E
FAU - Keefer, Michael C
AU  - Keefer MC
FAU - van Lunzen, Jan
AU  - van Lunzen J
FAU - McMichael, Andrew
AU  - McMichael A
FAU - Mehendale, Sanjay
AU  - Mehendale S
FAU - Peters, Barry
AU  - Peters B
FAU - Ramanathan, Vadakkuppatu D
AU  - Ramanathan VD
FAU - Robinson, Andrew
AU  - Robinson A
FAU - Rockstroh, Juergen
AU  - Rockstroh J
FAU - Vardas, Eftyhia
AU  - Vardas E
FAU - Vets, Eva
AU  - Vets E
FAU - Weber, Jonathan
AU  - Weber J
FAU - Graham, Barney S
AU  - Graham BS
FAU - Than, Soe
AU  - Than S
FAU - Excler, Jean-Louis
AU  - Excler JL
FAU - Kochhar, Sonali
AU  - Kochhar S
FAU - Ho, Martin
AU  - Ho M
FAU - Heald, Alison
AU  - Heald A
FAU - Fast, Patricia E
AU  - Fast PE
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20120501
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (AIDS Vaccines)
RN  - 0 (Placebos)
SB  - IM
MH  - AIDS Vaccines/*administration & dosage/adverse effects
MH  - Adolescent
MH  - Adult
MH  - Africa South of the Sahara/epidemiology
MH  - *Cost of Illness
MH  - Double-Blind Method
MH  - Europe/epidemiology
MH  - HIV Infections/*prevention & control
MH  - Human Experimentation
MH  - Humans
MH  - India/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Placebos/administration & dosage
MH  - United States/epidemiology
MH  - Young Adult
EDAT- 2012/05/29 06:00
MHDA- 2013/01/10 06:00
CRDT- 2012/05/29 06:00
PHST- 2012/05/29 06:00 [entrez]
PHST- 2012/05/29 06:00 [pubmed]
PHST- 2013/01/10 06:00 [medline]
AID - 19454 [pii]
AID - 10.4161/hv.19454 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2012 May;8(5):630-8. doi: 10.4161/hv.19454. Epub 2012 May 
      1.